French National Authority for Health (HAS) has published new set of decisions about add-on and medical aid reimbursement in July

07

Aug 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 10 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS).

Three decisions were released for wheelchair devices:

  • ALBER E-MOTION M15,  wheelchair add-on electric propulsion system (request of renewal of registration, approved)
  • ALBER TWION, manual wheelchair propulsion assist device (application for renewal of registration, approved)
  • ALBER SCALAMOBIL S35, adaptable and portable stair lift for manual wheelchair (application for registration, approved)

Two decisions were published for knee and feet prostheses:

  • PLIÉ  3.0, microprocessor controlled knee prosthesis (application for registration, rejected)
  • PRO-FLEX LP, prosthetic feet (III energy class) (application for registration, approved)

Five decisions were published for other devices:

  • EDWARS SAPIEN XT , pulmonary valve implanted by intravenous transcutaneous with its catheter insertion NOVAFLEX+ (request for extension of indication, approved)
  • VERCISE GEVIA, rechargeable deep brain stimulation device (application for registration, approved)
  • ACCU-CHEK MOBILE Kit & Cassette, kit and cassette for self-monitoring blood glucose (application for renewal of registration, approved)
  • PE TRIANON, highly crosslinked polyethylene (application for registration, approved)
  • SIMPLYGO, portable oxygen concentrator (application for renewal of registration, approved)

See full list of decisions in French here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

04

Dec 2019

In November 2019, the two new mini-method assessments for ankyloglossia and rapid testing for chlamydia and gonorrhea were initiated by Oslo University. After the completion of the assessment procedure, the final reports would be available via a mini-HTA database.

Read more

03

Dec 2019

In October 2019, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has released an assessment report regarding the scientific evidence on personalized population screening for breast cancer. The current evidence does not allow to recommend any concrete models for individualized risk prediction for breast cancer but allows to recommend the development and evaluation of new models for personalized risk prediction directed to offering different strategies to the screening of population.

Read more

03

Dec 2019

In October 2019, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for midcarpal hemiarthroplasty for wrist arthritis) and two new MedTech innovation briefings (for superDimension Navigation System to help diagnostic sampling of peripheral lung lesions and MR-proADM test for use with clinical deterioration scores in cases of suspected infection).

Read more

29

Nov 2019

On September 16, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes and modification of existing codes.

Read more

27

Nov 2019

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether wearing a lower jaw protrusion splint (Unterkieferprotrusionsschiene, UPS) is beneficial for obstructive sleep apnea.

Read more

26

Nov 2019

In October 2019, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has released an assessment report regarding the evaluation of Сerenkov luminescence image projection system for intraoperative evaluation of surgical margins in breast, prostate and gastrointestinal cancer. This new technology is expected to get an improvement in the effectiveness of oncological surgery and a reduction in costs.

Read more

25

Nov 2019

The New Therapies (NT) Council provides comments on medical technology products and methods that are evaluated within the framework of the Dental and Pharmaceutical Benefits Agency (TLV) medical technology assignment. In October 2019, the NT Council recommended the use of FoundationOne CDx comprehensive genomic profiling test as support for the drug treatment choice in the context of clinical studies as there is a great need for knowledge and validation.

Read more

22

Nov 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2019 concern various types of devices, including orthopedic, cardiovascular devices, and hearing aids. A total of twenty-four decisions were made.

Read more

21

Nov 2019

In order to promote the video consultations, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) have agreed on several new regulations. Thus, a video consultation will also be possible if the patient has not been previously treated by the doctor. For psychotherapies, the video consultations were reopened.

Read more

20

Nov 2019

The HTA center of Swedish Västra Götaland region is aimed to work for the continuous development of knowledge-based care in the region and ensure that healthcare is supported by science and evaluation. Currently, Västra Götaland HTA-Centre works on several HTA projects related to medical procedures or devices: alertness therapy, MRI linac, and investigation, and treatment of PANS / PANDAS. After completion of assessments, the final reports would be released on the website of Västra Götaland region.

Read more

18

Nov 2019

In September 2019, the Andalusian Health Technology Assessment Department (AETSA) has released an assessment report regarding the evaluation of epigenetic profiling to classify cancer of unknown primary (EPICUP). It was observed that people received empirical therapy without considering the results of EPICUP had a three times higher risk of dying compared to those with specific treatment of the location of the primary tumor, adjusting due to possible confounding factors.

Read more

15

Nov 2019

In September 2019, the French High Authority for Health released an assessment report for analysis on DNA chips (ACPA) in different types of oncological conditions to determine its place in comparison with more conventionally used techniques. The ACPA allows to detect a large number of copy number of variations at the whole genome level, ploidy abnormalities, and heterozygosity losses; it is of interest as a cytogenetic technique with some specific advantages among existing technologies.

Read more

13

Nov 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released a systematic review on surgical treatment of abdominal rectus diastasis one year after delivery. The literature search was performed, only one RCT was identified, but as the design of the study was associated with a high risk of bias, no conclusions could be drawn.

Read more

12

Nov 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern scar revision, robotic-assisted thymectomy, prophylactic oophorectomy/ hysterectomy, percutaneous electrical nerve stimulation, delivery of fraction of proton beam therapy for non-ocular adult tumors and diagnostic codes for myriad breast and ovarian cancer panel 101 test, clinical exome sequencing MPLA test, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes and inactivated codes.

Read more

08

Nov 2019

In September 2019, the French High Authority for Health (HAS) released an assessment report for gastric bypass, also known as omega loop in severe obesity. The evaluation aimed to compare omega-loop gastric bypass (OLGB) with Roux-en-Y Gastric Bypass (RYGB) in terms of efficacy and safety. OLGB cannot be determined as an alternative treatment to RYGB considering the safety aspects due to a lack of efficacy and safety data. The method should be studied in a framework of clinical research.

Read more

07

Nov 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including spine technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for spine devices in Europe.

Read more

06

Nov 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including robotic surgery technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for robotic surgery devices in Europe.

Read more

06

Nov 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released a systematic review on SMS alerts to laypersons for cardiopulmonary resuscitation in out-of-hospital cardiac arrest (OHCA) that aimed to clarify SMS efficacy on survival after OHCA. Currently, the best available evidence does not support the use of SMS alarm to laymen as a means of improving survival after OHCA.

Read more

05

Nov 2019

In October 2019, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for midcarpal hemiarthroplasty for wrist arthritis and two new MedTech innovation briefings (for superDimension Navigation System to help diagnostic sampling of peripheral lung lesions and MR-proADM test for use with clinical deterioration scores in cases of suspected infection).

Read more

04

Nov 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including radiotherapy technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for radiotherapy devices in Europe.

Read more

04

Nov 2019

In early October 2019, the Health Evaluation and Quality Agency of Catalonia (AQuAS) published the assessment of cosmetic laser iridoplasty. The work revealed that it is recommended to undergo this intervention exclusively within clinical investigation settings and after getting approval by the ethics committee.

Read more

01

Nov 2019

New material codes for an implantable sensor for continuous measurement of glucose in interstitial fluid and embolization equipment were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in October 2019.

Read more

31

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including radiology technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for radiology devices in Europe.

Read more

31

Oct 2019

Reimbursement of optical coherence tomography (OCT) for diagnosis and therapy control in retinal diseases will be available from October 2019 via the EBM (Einheitlicher Bewertungsmaβstab, German Uniform Evaluation Standard).

Read more

30

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including pulmonary and airways technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for pulmonary and airways devices in Europe.

Read more

29

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including peripheral vascular technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for peripheral vascular devices in Europe.

Read more

28

Oct 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in September 2019 concern various types of devices, including orthopedic, cardiovascular devices, and hearing aids. A total of eighteen decisions were made.

Read more

25

Oct 2019

In Norway, the mini-HTA for intraepidermal nerve fiber density in skin biopsy was released in September 2019. The method was determined as efficient and safe. It was recommended to be introduced as part of the clinical routine in the hospital with a two-year follow-up to get enough data regarding the diagnostic volume and financial aspects.

Read more

24

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including orthopedics technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for orthopedics devices in Europe.

Read more

24

Oct 2019

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether a systematic test of newborns for sickle cell disease (SCD) in Germany would make sense.

Read more

23

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including ophthalmology technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for ophthalmology devices in Europe.

Read more

23

Oct 2019

In September 2019, Skåne Region released a report for ultrasound in symptoms of the acute scrotum that aimed to understand whether increased ultrasound use could improve the diagnostic of the studied condition. Although no studies investigating the direct benefit of ultrasound in patients with symptoms of acute scrotum were identified, its high precision, sensitivity, and specificity were outlined.

Read more

22

Oct 2019

In September 2019, the National Institute for Health and Care Excellence (NICE) published three new interventional procedure guidance (for implant insertion for prominent ears, high-intensity focused ultrasound for glaucoma, and bioprosthetic plug insertion for anal fistula) and five new MedTech innovation briefings (for SuperNO2VA for the relief of upper airway obstruction in people with obstructive sleep apnoea, The V.A.C. Veraflo Therapy system for infected wounds, UroShield for preventing catheter-associated urinary tract infections, InterDry for intertrigo, and Alpha-Stim AID for anxiety).

Read more

22

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including neuromodulation technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for neuromodulation devices in Europe.

Read more

21

Oct 2019

In mid-September 2019, the report of the project OTCA19, titled “Screening for osteoporosis in the general population” was published on the website of the European Network for HTA (EUnetHTA).

Read more

21

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including nephrology and urology technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for nephrology and urology devices in Europe.

Read more

18

Oct 2019

In September 2019, the Andalusian Health Technology Assessment Department (AETSA) has released an assessment report regarding the evaluation of PET scan usefulness in non-oncological indications. The performed analysis showed that the quality of available systematic reviews related to the issue is generally low and, in some cases, moderate. The high-quality reviews, which conclude that routine use cannot be recommended, were found only for the indication of cognitive impairment with suspected Alzheimer's disease.

Read more

18

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including in-vitro and in-vivo diagnostics tests. This post provides some key facts about the HTA, funding and innovation payment landscape for in-vitro and in-vivo diagnostics tests in Europe.

Read more

17

Oct 2019

The insurance company AOK Saxony-Anhalt concluded that patients are much less frequently prescribed an antibiotic after the examination via a rapid test for a bacterial cause of the infection. In more than 40% of the tested patients, the doctors waived the antibiotics prescription.

Read more

17

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including gastrointestinal technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for gastrointestinal devices in Europe.

Read more

16

Oct 2019

In September 2019, Regional Methods Council of South East healthcare region released a report where compared the prostate artery embolization (PAE) for benign prostatic hyperplasia with the transurethral resection of the prostate (TURP). It was outlined that costs and the need for blood transfusions for PAE are lower than for TURP. The use of registries for follow-up of patients and registration of side effects is strongly recommended.

Read more

15

Oct 2019

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment, and rehabilitation methods. Currently, PALKO is working on the only one assessment related to medical technologies - rehabilitation and treatment of lumbar spine dislocation. In the final report, the Council would conclude whether the procedure is a part of publicly funded services or not.

Read more

11

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including ENT technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for ENT devices in Europe.

Read more

11

Oct 2019

New material codes for extraction catheters were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in September 2019.

Read more

10

Oct 2019

The fee negotiations for the coming year are over - the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agreed on an increase in the monetary conversion factor for all medical and psychotherapeutic services in the amount of 1.52 percent. GKV-Spitzenverband and KBV have also agreed to sponsor the video consultations.

Read more

09

Oct 2019

In August 2019, the Decision Forum conducted the meeting towards the funding decisions for new methods, where concluded that prehospital CT ("stroke ambulance") for early diagnosis and treatment of suspected stroke can be used within the framework of controlled studies with a sufficient number of patients. The protocol of the Decision Forum meeting was released on the website of the New Method.

Read more

09

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including endoscopy technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for endoscopy devices in Europe.

Read more

08

Oct 2019

After a long time since the introduction of Healthcare Implementation Communique (SUT) for the first time (2007), the Reimbursement Commission made important changes to the SUT. The main changes relate to higher reimbursement fees for medical devices (reimbursement fees increased depending on the category from 5% to 100%).

Read more

07

Oct 2019

In September 2019, the French High Authority for Health (HAS) has released an assessment report regarding the evaluation of total or partial robotic-assisted nephrectomy, compared to open surgery and conventional laparoscopic surgery. Due to the lack of any prospective comparative studies reporting robust results with relevant judgment criteria and collected with appropriate follow-up time, HAS could not comment on the expected service or the expected service improvement of robot-assisted nephrectomy compared to open surgery or conventional laparoscopic surgery.

Read more

04

Oct 2019

On the 2nd of September 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on guideline recommendations comprising screening for diabetes mellitus.

Read more

03

Oct 2019

In order to diagnose pre-eclampsia in pregnancy, two new markers were included in the EBM catalog in early October 2019. The statutory health insurances then will take over the costs for the determination of the PIGF concentration and the sFlt-1 / PIGF quotient. In addition, another tumor marker for ovarian cancer will be included in the EBM.

Read more

03

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including E-Health technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for cardiovascular devices in Europe.

Read more

02

Oct 2019

In August 2019, the Norwegian Institute of Public Health has released an HTA report regarding the effectiveness of treatment for localized prostate cancer commissioned by the Centre for joint decision-making to summarize the findings regarding this method. The effectiveness of the several treatment methods is unknown due to the lack of evidence. There is little or no difference in survival after radical prostatectomy compared to low-dose-rate brachytherapy.

Read more

01

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including diagnostic imaging technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for cardiovascular devices in Europe.

Read more

01

Oct 2019

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including cardiovascular technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for cardiovascular devices in Europe.

Read more

01

Oct 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In August 2019, CAMTÖ started its work on the assessment of sclerotherapy in Achilles tendinopathy. After the completion of the evaluation process, the report would be published at the web-site of Örebro County Council.

Read more

27

Sep 2019

In August 2019, the Norwegian Institute of Public Health (NIPH) has released a single technology assessment report for molecular profiling panel – Prosigna aimed to investigate its prognostic accuracy, clinical and cost-effectiveness in patients with breast cancer. It was outlined that it is uncertain to what extent Prosigna contributes prognostic information that turns into better clinical results; conclusions about the cost-effectiveness of Prosigna cannot be made due to the lack of existing information.

Read more

25

Sep 2019

Within the framework of the Federal HTA program, the benefits currently paid under the compulsory health insurance are being reevaluated. On the 4th of September, 2019, the health technology assessment of arthroscopy of the knee, developed by the Swiss Medical Board on behalf of the Federal Ofice for Public Health, has been published.

Read more

24

Sep 2019

In August 2019, the National Institute for Health and Care Excellence published one new MedTech innovation briefings for vacuum therapy for colorectal anastomotic leakage and two new interventional procedure guidance for endovascular insertion of an intrasaccular wire-mesh blood-flow disruption device for intracranial aneurysms and the Papillon technique for locally advanced rectal cancer.

Read more

23

Sep 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in July and August 2019 concern various types of devices, including orthopedic, cardiovascular, and blood glucose meters. A total of 29 decisions were made.

Read more

21

Sep 2019

We have released the second part of the interview on the Market Access Insider channel on Youtube. The interview covered key stakeholders, procedure coding, principles of functioning of DRG system and add-on reimbursement for medical devices via LPPR List. Reimbursement pathways for devices, evidence requirements, pricing considerations, innovation funding (PHRC, PRME, forfeit innovation, Article 51, ETAPES program) were also discussed.

Read more

20

Sep 2019

In mid-August 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA22 “Clinical utility of Point-of-care Tests (POCT) D-Dimer and Troponin.”

Read more

19

Sep 2019

The Institute for Quality and Efficiency in Health Care (IQWiG) has presented its second final report on the benefit assessment of vacuum therapy in wounds healing. The previous final report for vacuum therapy in the wounds healing by secondary intention was published by IQWiG in late March 2019.

Read more

18

Sep 2019

In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published four decision support documents. The assessed technologies are osteochondral allograft transplantation, allograft for anterior and posterior cruciate ligament reconstruction, human dermal allograft, and 177 Lutetium.

Read more

12

Sep 2019

In Sweden, the Priority Council of Skåne Region prepares and presents suggestions for new methods, routines, and treatments, to be included in the healthcare system. In August 2019, the HTA report for endoscopic procedures in dysphagia was released. The analysis showed that fiberoptic endoscopic evaluation of swallowing and videofluoroscopy are clinically well-established procedures that have good and equal coherence between different assessors and in repeated assessments.

Read more

11

Sep 2019

In August 2019, the mini-HTA for Tendyne transcatheter mitral valve implantation system was initiated by Oslo University Hospital. The finalized mini-method assessment will be published in the National Database for Mini-HTA.

Read more

10

Sep 2019

At the beginning of August 2019, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the applications of healthcare products and activities for conditional entry into the Basic Insurance Package. Two applications for heated intraperitoneal chemotherapy in ovarian cancer and GAG therapy in bladder pain syndrome were considered.

Read more

09

Sep 2019

NICE issued a consultation document about safety and efficacy of balloon cryoablation for Barrett’s oesophagus and squamous dysplasia of the oesophagus and balloon dilation for eustachian tube dysfunction which were considered for Interventional Procedures Guidance in development for public consultation until 20 September 2019.

Read more

06

Sep 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern hip replacement, endoscopic ablation, multiple arthroscopic operations on the ankle, collagen paste for closing an anal fistula and diagnostic codes for tests for next generations sequencing molecular intelligence, and others. The codes are introduced with a recommended adoption date being the 1st of November 2019. The documents also contain a list of textual changes in codes, inactivated codes, and an updated list of unacceptable combinations of codes.

Read more

05

Sep 2019

In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are The Barricaid® device for annulus Fibrosus Repair after lumbar discectomy, single-step scaffold-based treatment (AMIC) and two-step scaffold-based treatment (MACI), radiofrequency denervation and electrical stimulation of the hypoglossal nerve.

Read more

03

Sep 2019

In July 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis, two new interventional procedure guidance (for transurethral laser ablation for recurrent non-muscle-invasive bladder cancer and ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids), and one new MedTech innovation briefing for HemaClear for bloodless surgical field during limb surgery.

Read more

30

Aug 2019

In late July 2019, the report of the project OTJA10, titled “Stool DNA testing for early detection of colorectal cancer” was published on the website of the European Network for HTA (EUnetHTA).

Read more

28

Aug 2019

In July 2019, the Health Technology Evaluation Service of the Basque County, OSTEBA, published a report titled “Indications, utility, and use of ultrasound in primary care.”

Read more

27

Aug 2019

The HTA center of Swedish Västra Götaland region has published a report for the effectiveness of laminar versus turbulent airflow in operating theaters, with regard to risk for postoperative surgical infections. It was concluded that vertical laminar airflow, compared with any other type of ventilation system in operating rooms, is probably associated with a further reduction of CFU concentration in air sampled near the operation table.

Read more

26

Aug 2019

New material codes for hearing aids were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August 2019.

Read more

23

Aug 2019

In July 2019, the Norwegian Institute of Public Health (NIPH) has released a report for the effectiveness of treatment for knee osteoarthritis to summarize key findings from systematic reviews about relevant treatment options to ease the symptoms in patients with arthritis in the knee. It was outlined that self-management education program and physical aids give little or no difference in pain, whereas noncompartmental knee arthroplasty is superior to total knee arthroplasty in pain.

Read more

20

Aug 2019

The HTA center of Swedish Västra Götaland region has published a report for effectiveness and safety of microsurgical testicular sperm extraction (TESE) in infertile men with non-obstructive azoospermia (NOA) and concluded that it is uncertain whether there is any difference in complication rates for micro-TESE compared with testicular sperm aspiration (TESA). There is a need for extensive high-quality studies comparing results of micro-TESE with TESA

Read more

16

Aug 2019

The HTA center of Swedish Västra Götaland region has published a report for gene expression profiles to guide adjuvant chemotherapy in luminal, HER2-negative breast cancer. It was concluded that withholding adjuvant chemotherapy in breast cancer patients with intermediate clinical risk of recurrence and low/intermediate risk according to a gene expression assay, compared with providing chemotherapy, probably results in little or no difference in overall survival within nine years and can probably not exclude a small increased risk of recurrence.

Read more

15

Aug 2019

Domestic use of motor-driven moving splints (continuous passive motion, CPM) after interventions at the knee or shoulder joint remains covered by statutory health insurance. This has been determined by the G-BA (the Federal Joint Committee).

Read more

12

Aug 2019

The test for severe combined immunodeficiencies (SCID) is part of neonatal screening since July 1, 2019, in Germany. At the beginning of July 2019, the Swedish National Board of Health and Welfare (Socialstyrelsen) has stated that health care should offer screening for the severe combined immunodeficiency (SCID) as approximately two or three children per each year can be diagnosed and treated for the fatal disease with the test available.

Read more

09

Aug 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern mastectomy and immediate reconstruction of the breast, coronary intravascular lithotripsy, angioplasty, insertion of a stent, portal vein embolization, and others and diagnostic codes for tests for primary hyperoxaluria panel, myeloid panel, and hereditary angioedema. The codes are introduced with a recommended adoption date being the 1st of August 2019. The documents also contain a list of textual changes in codes and an updated list of unacceptable combinations of codes.

Read more

08

Aug 2019

In early July 2019, the network of European HTA agencies, EUnetHTA, published the report titled “Irreversible electroporation for the treatment of liver and pancreatic cancer”.

Read more

07

Aug 2019

The HTA center of Swedish Västra Götaland region has published a report for the impact of postmastectomy radiotherapy (PMRT) on complications and results of immediate breast reconstruction (IBR). PMRT compared with no radiotherapy (RT) results in a clinically significant increase of implant or tissue expander loss in patients undergoing IBR with moderate certainty of evidence. Other findings (decrease in patient satisfaction, an increase of re-operations or capsular contracture rate increase) gained low certainty of evidence.

Read more

06

Aug 2019

In June 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, one new Medical technologies guidance for Endocuff Vision for assisting visualisation during colonoscopy, and two new MedTech innovation briefings (for Danis stent for acute oesophageal variceal bleeds, and The OPTIMIZER smart system for managing heart failure).

Read more

05

Aug 2019

The mini-HTA for internal emergency medicine ultrasound in patients with urgent medical conditions was released in July 2019 in Norway. The method was determined as efficient, safe, and was recommended to be introduced as part of the clinical routine in the hospital.

Read more

31

Jul 2019

The report presents a summary of the reimbursement situation for use of hypoglossal nerve stimulation system for the treatment of Obstructive Sleep Apnea Syndrome in Europe. The analysis will cover adult patients only. The following stages of procedure will be considered for hospital settings: implantation, replacement, removal of hypoglossal nerve stimulation system. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

Read more

29

Jul 2019

In late June 2019, the Committee on Evaluation and Public Health (CEESP) of the French High Authority for Health (HAS) validated a second, provisional version, updating the methodological guide for the evaluation of effectiveness at the HAS.

Read more

26

Jul 2019

On July 12, 2019, the Swiss Medical Tariff Commission (MTK/CTM), announced that the new tariff structure for the ambulatory sector, TARDOC, is ready to replace TARMED. The Medical Professional Association (FMH) and curafutura, the other involved partners, delivered TARDOC to the Federal Council for approval. The entry into force is scheduled for January 1, 2021.

Read more

24

Jul 2019

In June 2019, the Norwegian Institute of Public Health (NIPH) has released an HTA report for prehospital CT for early diagnosis and treatment of suspected acute stroke or severe head injury to evaluate the documentation for clinical efficacy, safety and possible initiation of treatment prior to arrival in hospitals, compared with current hospital practice. Although the mobile stroke unit care increases the number of patients who receive thrombolysis, its efficacy is unknown due to the lack of evidence.

Read more

23

Jul 2019

The French High Authority for Health (HAS) develops clinical guidelines and recommendations whose objective is to guarantee the quality and safety of care delivery within the French setting. In the second quarter of 2019, clinical guidelines/recommendations have been developed for 16 topics.

Read more

19

Jul 2019

In June 2019, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the cost-effectiveness of the comprehensive genomic profiling test for all solid tumors FoundationOne CDx. TLV believes that in most cases, the use of FoundationOne CDx is more expensive in comparison to current treatment methods. However, it has greater sensitivity and accuracy in the diagnostics.

Read more

17

Jul 2019

On June 6, 2019, the Swiss Federal Department of Home Affairs (FDHA) has changed the Services Ordinance (OPre/KLV), which determines coverage of health care services in Switzerland. The changes regard mostly the reimbursement rules for various services. Furthermore, there are updates regarding the Health Insurance Law (LAMal/KVG), List of Analyses, List of Medical Aids and Equipment, and clinical coding.

Read more

16

Jul 2019

In June 2019, the Norwegian Institute of Public Health (NIPH) has released an HTA report for TAVI in patients with severe aortic stenosis and intermediate surgical risk commissioned by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway. The cost-utility analysis indicated that TAVI was slightly more effective and more costly than open surgery. These findings can help decision makers appraise the intervention against the official priority setting criteria in health care sector applicable in Norway.

Read more

15

Jul 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in June 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices, and cochlear implants. A total of 32 decisions were made.

Read more

12

Jul 2019

On the 11th of June 2019, the Dutch National Healthcare Institute (Zorginstituut Nederland, ZIN) has published a position regarding the positively assessed indications and the appropriate protocols for Hyperbaric Oxygen Therapy (HBOT) that have been included in the basic package since 2009 in order to promote the appropriate use of this care. Health insurers can include this information and the quality criteria of the protocols when purchasing HBOT.

Read more

11

Jul 2019

On 17th June 2019, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalog version of SwissDRG 9.0/2020 (2017/2020). Eleven days later, the planning version of SwissDRG (2018/2020) has been published as well.

Read more

10

Jul 2019

After having identified the eligibility conditions for teleconsultation and teleexpertise in 2018, the French High Authority for Health (HAS) published a series of documents in late June 2019, for the operational deployment of eHealth services. Each of the new modalities of practice is discussed: teleconsultation, teleexpertise, and teleimaging. Also, the HAS proposed an information document to be given to patients before a teleconsultation.

Read more

09

Jul 2019

In June 2019, the Belgian Health Care Knowledge Center (KCE) published a report of the health technology assessment of bariatric surgery.

Read more

08

Jul 2019

At the beginning of June 2019, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare services, which were excluded or included with restrictions into Basic Insurance Package. Percutaneous liver perfusion with melphalan in patients with metastases from a uveal melanoma was included with restrictions, whereas CardioMEMS PA Monitoring was included in the context of research only.

Read more

05

Jul 2019

Mini-method assessment regarding the treatment of lymphedema with lymph node transplantation after breast cancer treatment was initiated by Oslo University Hospital in June 2019. The finalized mini-method evaluation will be published in the National Database for Mini-HTA.

Read more

03

Jul 2019

Notification to the Belgian Federal Agency for Medicines and Health Products (AFMPS) is a condition for obtaining reimbursement of compulsory medical insurance for implants and invasive medical devices for long-term use. Only devices that meet the notification requirements will be eligible for health care insurance.

Read more

02

Jul 2019

In May 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care, three new interventional procedure guidance (for therapeutic hypothermia for acute ischaemic stroke, collagen paste for closing an anal fistula, and percutaneous mitral valve leaflet repair for mitral regurgitation), two new Medical technologies guidance, and three new MedTech innovation briefings (for SEM Scanner for pressure ulcer prevention, Peezy Midstream for urine collection,and DuraGraft for preserving vascular grafts).

Read more

28

Jun 2019

The German Institute for Quality and Efficiency in Health Care (IQWiG) has investigated whether patients suffering from non-Hodgkin lymphoma have (better) chances of recovery in case of allogeneic stem cell transplantation. IQWiG concluded that the benefit of allogeneic SCT is unclear.

Read more

27

Jun 2019

In mid-May 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA18 “Regional hyperthermia for high-risk soft tissue sarcoma treatment.”

Read more

26

Jun 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices.

Read more

25

Jun 2019

In Norway, the mini-HTA for above cuff vocalization for patients, who are not able to speak due to tracheostomy, was released in June 2019. The method was determined as efficient, safe, and was recommended to be introduced as part of the clinical routine in the hospital with further monitoring.

Read more

24

Jun 2019

In Sweden, Skåne Region develops knowledge base and prepares questions for decisions on the introduction of evidence-based health and medical care throughout Region Skåne. In May of 2019, there are two ongoing projects for fast track for rapid diagnostic for giant cell arteritis and the impact of daily rhythm lighting on patients in psychiatric full-time care. The final reports are going to be published at the web-site of Skåne Region.

Read more

21

Jun 2019

On the 7th of May 2019, the new evaluation for bone-anchored prosthesis has been commenced in a framework of New Method, which provides a way for a managed introduction of innovations into Norwegian health care system. The proposal for the assessment was submitted by Oslo University Hospital in order to receive an opportunity to offer this method to achieve overall money saving and medical benefits as nowadays, only conventional prostheses are offered, and patients are sent to Gothenburg to receive the treatment, that is financed by the Norwegian health service.

Read more

19

Jun 2019

In May 2019, the Galician Agency for Health Technology Assessment, AVALIA-T, has released a report “Diagnostic and clinical utility of cerebral amyloid PET in mild cognitive impairment, Alzheimer's disease, and other dementias.”

Read more

18

Jun 2019

In May 2019, the National Institute for Health and Care Excellence published two new medical technology guidance for negative pressure wound dressings and preventing infections when using needleless connectors, and three new MedTech innovation briefings for pressure ulcer prevention, midstream urine collection and preserving vascular grafts.

Read more

17

Jun 2019

On April 18, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes for ultrasound examination during pregnancy.

Read more

14

Jun 2019

In early May 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment on robot-assisted surgery in thoracic and visceral indications as part of the EUnetHTA work.

Read more

12

Jun 2019

On the 24th of April 2019, the French Technical Agency for Hospital Information (ATIH) has released a technical note in connection with the 2019 DRG changes. Several key updates in relation to the financing of hospitalization benefits as a change of DRGs for fractional flow reserve, package to finance the rehabilitation and infusion costs of the pulmonary system and implementation of two innovative packages for PULSANTE and WISE CRT devices were outlined.

Read more

11

Jun 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern cytoreductive surgery for colorectal peritoneal carcinomatosis, cytoreductive surgery for ovarian malignancies, therapeutic sialendoscopy, intra corporeal salivary gland lithotripsy, and others and diagnostic codes for tests for common and rare mutations.

Read more

10

Jun 2019

In May 2019, the Galician Agency for Health Technology Assessment, AVALIA-T, has released a report “Laser or radiofrequency ablation in the treatment of recurrent thyroid cancer.”

Read more

07

Jun 2019

In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. On the 19th of April, the French National Authority for Health published two opinions regarding the inclusion of two devices into innovation package - eCLIPS: for treatment of cerebral aneurysm, Nuvaira™ Lung Denervation System for chronic obstructive pulmonary disease and asthma.

Read more

05

Jun 2019

HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies as they move from inception to adoption in the UK health and care system, was formally launched April 29th, 2019. The system, which is free to use, will help companies to understand what information is needed by decision makers in the UK health and care system, and clarify possible routes to market access.

Read more

04

Jun 2019

In April 2019, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report updating the map of genetic tests available in the Spanish National Health System.

Read more

31

May 2019

Between the 3rd of June and the 15th of July, SwissDRG will be receiving the requests/suggestions regarding the DRG system in the country.

Read more

29

May 2019

The report includes all published reimbursement decisions for IVD tests in 2018 in European countries with established frameworks for out-patient reimbursement laboratory tests (Belgium, France, Germany, Netherlands, Switzerland).

Read more

24

May 2019

At the end of April 2019, the network of European HTA agencies, EUnetHTA, published the “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery.”

Read more

23

May 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in April 2019 concern orthopedic devices, coronary stents, ventricular assist devices, remote monitoring systems in cardiovascular field, cochlear implants, bronchial thermoplasty device.

Read more

22

May 2019

The report presents a summary of the reimbursement situation report for percutaneous tibial neuromodulation in overactive bladder. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

Read more

22

May 2019

In Sweden, the Priority Council of Skåne Region prepares and presents suggestions for new methods, routines, and treatments, to be included in the healthcare system. In April 2019, the HTA report for thrombectomy 6 to 24 hours after stroke was released. The health economic analysis showed that the use of thrombectomy during extended time frames is expected to be cost-saving in a socio-economic perspective and increases patient benefit measured in terms of won quality-adjusted life years.

Read more

21

May 2019

In April 2019, the National Institute for Health and Care Excellence published two new interventional procedure guidance for endoscopic ablation for an anal fistula and a pilonidal sinus, and two new MedTech innovation briefings for urine test for detecting bladder cancer in people with symptoms associated with malignancy and imaging software designed to help clinicians to diagnose and stage liver disease.

Read more

20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

Read more

17

May 2019

The report summarizes HTA landscape, role of HTA in reimbursement processes in individual countries, provides list of HTAs per country, HTA body and program, per type of technology. In total, 12 countries, 51 organizations and more than 850 reports are included. Sample pages are available for download.

Read more

17

May 2019

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In April of 2019, the NIPH has released an HTA report for patent foramen ovale closure, antiplatelet or anticoagulation therapy alone for management of cryptogenic stroke commissioned by RHF Forum. Based on this HTA, the RHF Forum will make a decision regarding further implementation of current treatment method.

Read more

16

May 2019

German IQWiG assessed vacuum therapy and published the report in late March 2019. Evaluation found statistically significant impact of therapy on wound healing, rate of reinterventions and length of hospital stay.

Read more

15

May 2019

The HTA center of Swedish Västra Götaland region has published a report, which aimed to evaluate the effectiveness of EEG-based neurofeedback as a treatment for post-traumatic stress disorder (PTSD). It is uncertain whether the procedure compared with no or standard treatment reduces PTSD symptoms in adult patients. It is also uncertain whether the treatment results in any difference in suicidal thoughts, level of functioning, or medication use.

Read more

13

May 2019

On March 7, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes, deletion, and modification of existing codes. Changes mainly related to the in-vitro diagnostic testing.

Read more

10

May 2019

In January 2019, the Belgian Health Care Knowledge (KCE) published a report of health technology assessment that was dedicated to the evaluation of proton beam therapy in adults.

Read more

08

May 2019

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In April of 2019, the new mini-HTA regarding above cuff vocalization (ACV) was initiated by Oslo University Hospital. After completion of the assessment, hospital management will make a decision about funding of studied technology.

Read more

06

May 2019

Italian Ministry of Health, together with the national HTA agency, AGENAS, has published two Horizon Scanning reports in December 2018. Public consultations are open until May 25, 2019.

Read more

03

May 2019

The 2019/20 national tariff payment system has been published and took on the 1st of April 2019. There have been no substantial changes to the proposed tariff consulted on during January and February 2019. Under the published tariff, blended payment will be the default payment approach for emergency care services.

Read more

02

May 2019

At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implants Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).

Read more

01

May 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in healthcare region Uppsala-Örebro. Currently, CAMTÖ is working on several assessments related to the medical devices and technologies such as equipment for 3D Printing, robot Intuitive daVinci Xi etc. After the completion of assessment procedure, the reports will be published at the web-site of Örebro County Council.

Read more

30

Apr 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes concern circulating tumor DNA profile for the different type of cancers, myriad Prolaris test, PET Scan with florbetapir, etc. and a procedure code for robotic-assisted radical hysterectomy and lymphadenectomy. The codes are introduced with a recommended adoption date being the 1st of May 2019. The documents also contain a list of textual changes in codes and an updated list of unacceptable combinations of codes.

Read more

24

Apr 2019

In April 2019, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published a quick report with indication criteria for cochlear implants in children.

Read more

19

Apr 2019

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to in-vitro diagnostics - screening for a Serious Combined Immune Deficiency (SCID) from newborn heel. In final report, the Council will conclude whether the procedure is a part of publicly funded services or not.

Read more

18

Apr 2019

On behalf of the Institute for Quality and Efficiency in Health Care (IQWiG), a working group of the Hannover Medical School (MHH) has assessed the treatment outcomes in case of nasoalveolar molding (NAM) for cleft lip and palate. The report was published in February 2019.

Read more

17

Apr 2019

In January 2019, the Health Institute Carlos III published a report Diagnostic effectiveness and safety of elastography in oncology. An overview of systematic reviews and meta-analysis.

Read more

15

Apr 2019

The report presents a summary of reimbursement situation for sacral nerve stimulation. The following indications will be considered: urge urinary incontinence, retention of urine, faecal incontinence. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

15

Apr 2019

With a regional decree of March 7, 2019, Tuscany Regional Healthcare has published assessments of seventeen medical devices belonging to various therapeutic areas.

Read more

12

Apr 2019

On the 16th of February of 2019, the approval for financing of WISE CRT system in a framework of “forfait innovation” program was released in the Official French Gazette. This financing is provided for the 48-months period; it includes the amount of €25,600 and cannot be combined with other benefits. It is fully covered by the compulsory health insurance schemes.

Read more

10

Apr 2019

The Health Institute Carlos III published a report titled Analysis of the efficacy and safety of peripheral neurostimulators of the sphenopalatine ganglion for the treatment of refractory chronic clusters headache.

Read more

09

Apr 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in March 2019 concern various types of devices, including orthopedic, cardiovascular (coronary stents), ENT and other products.

Read more

04

Apr 2019

The Health Institute Carlos III published a report on efficiency and safety analysis of orthodontic-orthopedic devices for maxillary expansion as an alternative to adenotonsillectomy and/or pharmacological treatment for Pediatric Obstructive Sleep Apnea-Hypopnea Syndrome.

Read more

03

Apr 2019

In early 2019, the Memorandum of Understanding was signed to support HTA in Ireland, Scotland, and Wales. The Memorandum of understanding establishes a collaborative approach to the identification and assessment of new health technologies between Health Information and Quality Authority Ireland, Health Technology Assesment Group Ireland, Health Technology Wales, and the Scottish Health Technology Group. These bodies assess and give guidance on health technologies within their national healthcare systems.

Read more

02

Apr 2019

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

Read more

01

Apr 2019

In March 2019, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (for Barnett Continent Intestinal Reservoir (modified continent ileostomy) to restore continence after colon and rectum removal and high-intensity focused ultrasound for symptomatic benign thyroid nodules), and three new MedTech innovation briefings (for system for ruling out coronary artery disease in people with symptoms of stable coronary artery disease, medical imaging software tool for kidney stone evaluation, incision management system for closed surgical incisions).

Read more

29

Mar 2019

Norway established in 2013 a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. Currently, 13 ongoing mini-HTA projects are conducted in Norway: robotic-assisted procedures, microwave ablation, and tonsillectomy devices, among others.

Read more

28

Mar 2019

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).”
In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).”

Read more

27

Mar 2019

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

Read more

25

Mar 2019

Since 2018 the cost weight for a number of day surgery DRGs has become equal to the cost weight of the relevant hospital DRGs. In 2019 the number of DRGs has been extended, and in total 39 day surgery DRGs are included in the list in 2019.

Read more

18

Mar 2019

New material code for voice prosthesis was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in March 2019.

Read more

14

Mar 2019

Key changes in the Norwegian DRG system in 2019 include novel payment schemes for dialysis treatment, emergency conditions that occur as outpatient or day case, digital services. Pilot DRG payment models will be implemented for selected medical quality registers and selected procedures for contract specialists.

Read more

13

Mar 2019

The French National Authority for Health (HAS) regularly publishes new (32 in total) decisions about add-on reimbursement for medical devices. The decisions made in February 2019 concern various types of devices, including multiple orthopedic, cardiovascular and other devices.

Read more

12

Mar 2019

On February 19, 2019, the Nomenclature was updated. The update brought changes in chapter V and VI of Nomenclature, regarding the creation of new codes for laser destruction of congenital port-wine stains, hearing aids and cone beam computed tomography.

Read more

11

Mar 2019

On February 5, 2019, the Federal Department of Home Affairs (FDHA) decided that in case of suspected infection or fever of unknown origin, positron emission tomography (TEP) will be considered mandatory services. Also, percutaneous electrical stimulation of the posterior tibial nerve (PTNS) was approved for incontinence indication. Furthermore, the reimbursement amounts relating to incontinence and ostomy materials will be reduced. List of Analyses was also updated.

Read more

08

Mar 2019

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to medical technologies - surgical treatment of lumbar intervertebral disc herniation. In final report, the Council would conclude whether the procedure is a part of publicly funded services or not.

Read more

07

Mar 2019

In Norway, the mini-HTA for magnetic technology (Magseed) for breast lesions was released in February of 2018. The method was determined as efficient, safe and was recommended to be introduced as part of the clinical routine in the hospital.

Read more

06

Mar 2019

More than 50 new DRGs were introduced in the Swedish system in 2019, while two have been deleted. The changes affected nursing care, psychiatry, hospital and day case services of different major disease categories. Important changes relate to cardiac ablation, placement of neurostimulator.

Read more

05

Mar 2019

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

Read more

04

Mar 2019

In early 2019, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report regarding the hyperbaric oxygen therapy for osteonecrosis. The results have shown that the efficacy and safety evidence of the procedure is too uncertain for now, and its economic evidence is also very limited. Further controlled, prospective studies are recommended.

Read more

01

Mar 2019

Eleven new DRGs have been added in 2019, while three DRGs have been deleted. The significant changes have been made for disorders of the circulatory organs (MDC 5) and musculoskeletal, skeletal and connective tissue disorders associated with prosthetic surgery (MDC 8). They concern insertion of vagus stimulator, ablation of heart, percutaneous valve replacement, and others.

Read more

28

Feb 2019

In January 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, three medical technologies guidance, and three new MedTech innovation briefings for liver function capacity test, a functional electrical stimulation (FES) integrated cycling system used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury, laser shoe attachment used as a walking aid and is designed to help prevent freezing of gait in people with Parkinson's disease.

Read more

27

Feb 2019

In October of 2018, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the clinical efficacy and cost-effectiveness MiniMed 670G in comparison to MiniMed 640G device. TLV concluded that the use of the MiniMed 670G can increase the patients’ quality of life due to reduced concern for hypoglycemia, increased comfort, fewer complications and also lead to potential cost benefits.

Read more

26

Feb 2019

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.

Read more

22

Feb 2019

At the beginning of February of 2019, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare activities which were excluded or included with restrictions into Basic Insurance Package.

Read more

21

Feb 2019

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA12 “C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)”.

Read more

20

Feb 2019

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

Read more

14

Feb 2019

In late January 2019, the network of European HTA agencies, EUnetHTA, announced the ultimate project plan of the project OTCA20 “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR).”

Read more

12

Feb 2019

On January 31, 2019, NHS England and NHS Improvement launched the statutory consultation on the proposed 2019/20 national tariff. The consultation period ends at midnight, at the end of 21 February 2019.

Read more

08

Feb 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern robotic-assisted laparoscopic procedures, 2-dimensional radiotherapy, revision of anti-reflux operations, etc. The codes are introduced with a recommended adoption date being the 1st of May 2019. The document also contains a list of textual changes in codes and an updated list of unacceptable combinations of codes.

Read more

06

Feb 2019

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2019. The decisions were made for eighteen medical devices.

Read more

05

Feb 2019

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

Read more

04

Feb 2019

In January 2019, the Austrian HTA body Ludwig-Boltzmann Institute (LBI) has published the update of their decision support document (DSD) 103, which concerns the wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. The authors state that further research is necessary for the development of reliable conclusions.

Read more

01

Feb 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October/November 2018 new code for bilateral US Doppler vascular limb was added to the CCSD Schedule.

Read more

31

Jan 2019

New material code for the dynamic hip system was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in January 2019.

Read more

30

Jan 2019

In late 2018, the French Ministry of Health announced that the telemedicine pilot project “ETAPES” will be maintained for four more years.

Read more

29

Jan 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October/November 2018, five new procedure codes for laser correction of refractive error following non-refractive ophthalmic surgery, insertion of urethral catheterization device, injection of botulinum toxin for hyperhidrosis, laparoscopic and robotic-assisted pancreatoduodenectomy have been added to the CCSD Schedule.

Read more

28

Jan 2019

On December 27, 2018, the Belgian Official Gazette was updated. The update brought changes in chapter VIII of the Nomenclature, regarding the changing of the coding for flow reserve measurement.

Read more

25

Jan 2019

In December 2018, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report on the effectiveness and safety of electrical stimulation of peripheral nerves for treating chronic refractory pain.

Read more

24

Jan 2019

Dutch Healthcare Authority (NZa) has released key features of the DRG package for 2020, including complex chronic lung failure, stem cell transplant care and indexation of DRG tariffs.

Read more

23

Jan 2019

In November of 2018, the completed mini-method assessment for decompression due to entrapment neuralgia for patients with chronic pain in the neck, shoulders, and head was released. The method was determined as poorly documented and was not recommended to be introduced as a part of the routine clinical practice.

Read more

21

Jan 2019

Curafutura, an association of health insurance companies in Switzerland, started the initiative to change the current outpatient pricing structure (TARMED) in 2016. In late 2018, they let the public know that the new tariff structure for ambulatory medical benefits is almost ready to be submitted to the Federal Council.

Read more

18

Jan 2019

Two mini-method assessments regarding intraepidermal nerve fiber density in skin biopsy and neurovascular structure-adjacent frozen-section (NeuroSAFE) during robot-assisted laparoscopic prostatectomy (RALP) were initiated by Oslo University Hospital in December of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

Read more

17

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the final report of the project OTCA06 - “Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk.”

Read more

15

Jan 2019

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

Read more

11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

Read more

10

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the ultimate project plan of the project OTCA19 - “Screening for osteoporosis in the general population.”

Read more

09

Jan 2019

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

Read more

07

Jan 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2018 concern various types of devices (orthopedic, neurostimulators, drug-coated balloon and others). The decisions were brought for ten (10) medical devices.

Read more

03

Jan 2019

On November 30, 2018, the DRG-regulating body in Switzerland, SwissDRG, has notified the public that the tariff version of SwissDRG 8.0/2019 has been published.

Read more

21

Dec 2018

Changes will be made in sixteen chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include creation of new codes for ophthalmology, otorhinolaryngology, radiology, radiotherapy and nuclear medicine, clinical biology and genetic examinations.

Read more

19

Dec 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in November 2018 concern various types of devices. The decisions were brought for twenty-two (22) medical devices.

Read more

17

Dec 2018

In late November 2018, the Belgian Healthcare Knowledge Center (KCE) published a report with the title “Optimisation of RIZIV – INAMI lump sums for incontinence.” The primary aim of this report is to analyze the adequacy of the current payment model. The report was requested by the National Institute for Sickness and Disability Insurance (RIZIV-INAMI).

Read more

14

Dec 2018

In mid-November, 2018, the European HTA agency, EUnetHTA, published the ultimate project plan of the assessment on “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery”.

Read more

13

Dec 2018

In mid-November, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published their evaluation of bilateral cochlear implants in children and adults. The authors provided a list of criteria a patient has to fulfil in order to have a cochlear implant prescribed.

Read more

10

Dec 2018

At the end of September of 2018, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare activities, which were excluded or included with restrictions into Basic Insurance Package.

Read more

03

Dec 2018

On 13th of November, 2018, one of the Swiss insurers’ association, curafutura, announced on their website that the new benefit structure, which will be the basis for the new fee structure in ambulatory settings, is ready. The company ats-tms SA prepared this benefit structure.

Read more

30

Nov 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, one new diagnostic code.

Read more

29

Nov 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2018 concern various types of devices.

Read more

28

Nov 2018

The Health Data Agency published new DRG tariffs for hospital and outpatient care in the somatic and psychiatric area for 2019.

Read more

26

Nov 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, eight new procedure codes for operations on joints, morcellation of uterine leiomyomas, transurethral water vapour and water jet ablation for lower urinary tract symptoms and transoral surgery have been added to the CCSD Schedule.

Read more

23

Nov 2018

In October, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for selective internal radiation therapy for unresectable primary intrahepatic cholangiocarcinoma, one updated medical technologies guidance endoluminal stent graft system designed for treating aneurysms and dissections of the thoracic aorta and one new medical technologies guidance for a titanium implant intended for use in people with chronic sacroiliac joint pain and three new medtech innovation briefings for device used for babies and children up to 30 kg who need mechanical ventilation, gammaCore for cluster headache and system that delivers warmed and humidified respiratory gases, including at high-flow rates.

Read more

22

Nov 2018

In partnership with NHS England, NHS Improvement has set out some of the principal proposed changes to the payment system in 2019/20. The proposals include a change of the default way of paying for urgent and emergency care (moving away from episodic prices), recalculated market forces factor values and options for how the tariff might be used to fund the new NHS supply chain organisation.

Read more

20

Nov 2018

The Dutch Healthcare Authority advises to reward health care providers in specialist medical care on the basis of the health benefits for the patient.

Read more

16

Nov 2018

The Health Data Agency published new DRG tariffs for hospital and outpatient care in the somatic and psychiatric area for 2019.

Read more

14

Nov 2018

In October of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the external ultrasound stimulation - Exogen™ in the treatment of femoral or tibial non-union. The objective of the assessment was to evaluate the efficacy, safety and health economic documentation for EXOGEN™ compared to surgical treatment for the management of patients with non-union of a fracture. The results have shown that the present documentation does not give evidence to assess the clinical or cost-effectiveness of EXOGEN™ for the treatment of non-union fractures compared to surgery.

Read more

09

Nov 2018

Two mini-method assessments regarding the magnetic technology (Magseed) for labeling non-palpable breast lesions and robotic-assisted minimally invasive harvesting of muscle patches for reconstructive surgery were initiated in Norway this October of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

Read more

08

Nov 2018

On October 26, 2018, the French High Authority for Health (HAS) has announced that the composition of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been renewed.

Read more

07

Nov 2018

On October 26, 2018, the European Network for Health Technology Assessment has published the final report of femtosecond laser-assisted cataract surgery (FLACS) for the treatment of age-related cataract. The authors of this report are a group of experts from the Italian region of Emilia Romagna, together with Health Austria (Gesundheit Österreich, GÖG).

Read more

06

Nov 2018

In September, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia and intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer, one medical technologies guidance for neuropad for detecting preclinical diabetic peripheral neuropathy and two new medtech innovation.

Read more

05

Nov 2018

In the middle of October 2018, the Andalusian Agency for the Evaluation of Health Technologies, AETSA, has published a health technology report in which they have assessed the safety, efficacy and efficiency of FebriDx® test.

Read more

02

Nov 2018

In August, the National Institute for Health and Care Excellence (NICE) published four new interventional procedure guidance for leadless cardiac pacemaker implantation for bradyarrhythmias, superior rectal artery embolisation for haemorrhoids, sutureless aortic valve replacement for aortic stenosis and transurethral water vapour ablation for benign prostatic hyperplasia, and four new medtech innovation briefings.

Read more

01

Nov 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in the period July-September 2018 concern various types of devices. In total, 52 decisions were published.

Read more

31

Oct 2018

In mid-October 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published the evaluation of efficacy and safety home-based hospitalization. The authors have concluded that it is a valid patient care option.

Read more

30

Oct 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July/August new codes for genetic tests, including 18S rRNA gene and sequencing and ELA2 Cyclic Neutropenia Genetic Screen were added to the CCSD Schedule.

Read more

29

Oct 2018

In mid-October 2018, the French Ministry of Solidarity and Health has published an article which describes the change of the financing of the health care system and proposes medium-term strategies for this gradual change. The report has been developed by the Directorate of research, studies, evaluation and statistics (DREES) of this ministry.

Read more

26

Oct 2018

In October 2018, the Austrian HTA body, the Ludwig-Boltzmann Institue (LBI), published the update on the PET/PET-CT topic. The report was done together with the Berlin Technical University.

Read more

25

Oct 2018

In mid-September 2018, the Swiss Federal Council has placed in consultation the first group of actions that are intended to contain costs in the healthcare sector. The suggested measures will be discussed with all relevant healthcare stakeholders (tariff partners, Cantons, industry and patient associations). These measures should save hundreds of millions of Swiss francs in the long term.

Read more

22

Oct 2018

On 6th of September, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on external stimulation of the trigeminal nerve for the prevention and acute treatment of an episodic and chronic migraine. The method was not recommended for inclusion into catalogue of hospital benefits.

Read more

22

Oct 2018

The report presents a summary of reimbursement situation for gastric pacemaker stimulation. Two indications are considered: gastroparesis and obesity. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

18

Oct 2018

The report presents a summary of reimbursement situation for cochlear implants for hearing loss. The only reimbursement within public / statutory health insurance systems is considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

18

Oct 2018

In May 2018, the French National Authority of Health, HAS, has published an update of the assessment of coronary stents.

Read more

17

Oct 2018

On 3rd of October, 2018, the Italian Agency for Regional Healthcare Services, AGENAS, announced on their website that the reviewer volunteers are needed for reviewing the reports that should be published soon.

Read more

15

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of meniscal allograft transplantation for post-meniscectomy syndrome in Austria. It was concluded that there is not enough evidence demonstrating benefits in order to include MAT into the Austrian benefit catalogue.

Read more

12

Oct 2018

In mid-September 2018, the Andalusian HTA agency, AETSA, published a report in which they assessed the safety and effectiveness of the cardiopoietic stem cells therapy of secondary heart failure to myocardial ischemia.

Read more

10

Oct 2018

EUnetHTA is a network of HTA bodies within Europe that promote the development of health technology assessment in all European countries by working together. This article will present the plans for the projects that will be published in the near future.

Read more

09

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of allogeneic mesenchymal stem cells for Crohn’s disease-associated complex perianal fistulas. Currently, inclusion into Austrian catalogue of benefits was not recommended with reevaluation in 2022.

Read more

05

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an evaluation of baroreceptor activation therapy for treatment-resistant hypertension. The authors concluded that there is no sufficient evidence to conclude on effectiveness or safety of BAT and thus inclusion of the procedure into the Austrian benefit catalogue is not recommended. There are currently three RCTs going on, and their results may bring new evidence.

Read more

03

Oct 2018

On the 14th of August of 2018, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report in relation to autologous hematopoietic stem cell transplantation (AHSCT) comparing with standard treatment for patients with systemic sclerosis. The results have shown that the transplant‐related mortality after AHSCT is high, but risk of organ failure and death is lower after two years follow‐up and beyond compared to standard treatment, AHSCT provides a significant improvement of skin involvement and lung function measured by forced vital capacity compared to standard treatment with cyclophosphamide injections.

Read more

02

Oct 2018

On 24th of August, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that the planning version of SwissDRG (version 8.0 (2018/2019)) and the planning version of TARPSY (version 2.0 (2018/2019)) have been published.

Read more

01

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published an evaluation of efficacy and safety of carbon ion beam radiotherapy (CIRT) for twelve oncological indications.

Read more

28

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an assessment of left atrial appendage closure to prevent stroke to determine national coverage of the procedure. Considering this evidence, the authors do not recommend the inclusion in the hospital benefit catalogue, neither for percutaneous left atrial appendage occlusion nor for surgical closure using a special clip.

Read more

26

Sep 2018

In the second half of July, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing, fresh fractures at high risk of non-healing, superior capsular augmentation for massive rotator cuff tears, transaxial interbody lumbosacral fusion for severe chronic low back pain and two new Medtech Innovation Briefings for remote ECG interpretation consultancy services for cardiovascular disease and mechanical thrombectomy devices for acute ischaemic stroke.

Read more

24

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) released an assessment of the subcutaneous implantable cardioverter defibrillator to determine coverage of the service. Authors concluded that evidence is insufficient to make conclusions about the comparative effectiveness of subcutaneous and transvenous ICDs. However, a substantially lower risk for lead complications in patients treated with subcutaneous ICD.

Read more

20

Sep 2018

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

Read more

18

Sep 2018

On July 27th, 2018, the European network for HTA has published a rapid assessment of the continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin.

Read more

10

Sep 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July new codes for aminoglycoside induced deafness testing, Intra-Operative PTH profile, cytokine panels and lymphocyte immunophenotyping, streptococcus pneumoniae by PCR, OCT for cardiology, contract-enhanced ultrasound and faecal immunochemistry test were added to the CCSD Schedule.

Read more

06

Sep 2018

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

Read more

05

Sep 2018

In mid-July 2018, the Health Service of the Canary Islands, SESCS, has published a report in which they have assessed the safety, effectiveness and cost-effectiveness of the endoscopic ablation by radiofrequency in antral gastropathy and Actinic proctitis.

Read more

31

Aug 2018

In the first half of July, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance for biomarker tests to help diagnose preterm labour in women with intact membranesand one new medtech innovation briefing for airglove air warming system for venous access.

Read more

30

Aug 2018

Three mini-method assessments regarding the magnetic non-radioactive detection system SentiMag Sienna + of sentinel lymph nodes in breast cancer, cough reflex testing and emergency targeted ultrasound implementation were initiated by Oslo University Hospital in June of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

Read more

28

Aug 2018

In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation. The results have shown that the current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers, also the use of Micra appeared not to be cost-effective.

Read more

24

Aug 2018

In the second half of June, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for laparoscopic ventral mesh rectopexy for internal rectal prolapse and MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor, and two new medtech innovation briefings for negative pressure wound therapy for closed surgical incision wounds and ocular response analyzer to measure corneal hysteresis.

Read more

14

Aug 2018

On 6th of July, 2018, the European network for health technology assessment, EUnetHTA, has opened the public consultation on ‘Horizon Scanning, Topic Identification, Selection and Prioritisation for European Cooperation on HTA – Draft recommendations.’

Read more

13

Aug 2018

Six new DRGs have been added for 2019, including proton therapy, insertion of functional implants in the urinary tract or male genitals and replacement of processor in cochleart implant.

Read more

10

Aug 2018

In April 2018, a national HTA program has been launched in order to re-evaluate benefits presently covered by the mandatory health insurance.

Read more

09

Aug 2018

On June 29th, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that The planning version of SwissDRG (version 8.0 (2017/2019)) and the planning version of TARPSY (version 2.0 (2017/2019)) have been published.

Read more

07

Aug 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In June, new codes for genetic testing,including single gene tests and gene panel tests, next generation sequence and molecular profiling tests were added to the CCSD Schedule.

Read more

06

Aug 2018

In April 2018, the French National Authority for Health (HAS) proposed an updated nomenclature in LPPR for foot orthosis and heel cup.

Read more

03

Aug 2018

In late June 2018, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report on the efficacy and safety leadless pacemaker.

Read more

02

Aug 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in June. They concern orthopedic devices and endobronchial valve.

Read more

01

Aug 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In June, new codes for laparoscopic pelvic lymphadenectomy, robotic assisted total knee replacement, abdominal (mesenteric) and limb angiogram were added to the CCSD Schedule.

Read more

27

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in May. They concern pacemakers, orthopedic devices, radiofrequency ablation system, vagus nerve stimulator and some other devices.

Read more

26

Jul 2018

At the beginning of June 2018, the Federal Department of Home Affairs published an update of the Services Ordinance (Ordinanza sulle prestazioni, OPre). This update concerns many different fields, including the list of laboratory tests.

Read more

25

Jul 2018

At the beginning of June 2018, the Health Technology Evaluation Service of the Basque County, OSTEBA, has published an assessment of effectiveness, safety and indications of radiological bone suppression technology for the detection of lung cancer.

Read more

24

Jul 2018

On 8th of June 2018, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalogue version of Swiss DRG 8.0/2019.

Read more

23

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in April. They concern orthopedic prostheses, neurostimulators and some other devices.

Read more

20

Jul 2018

On 18th of June, 2018, the Federal Department of Home Affairs issued the latest update of the list of medical aids and equipment. This update will come into force on 1st of January, 2019. However, this list will be updated a few times in 2018.

Read more

18

Jul 2018

In the first half of June, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for Intranasal phototherapy for allergic rhinitis and one new medtech innovation briefing for lung volume analysis in emphysema.

Read more

16

Jul 2018

The report presents a summary of the reimbursement situation for use of spinal cord stimulation. Indications include neuropathic and ischemic pain. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

16

Jul 2018

The report presents a summary of the reimbursement situation for deep brain stimulation. Indications include Parkinson’s disease, dystonia, essential tremor, cluster headache, and epilepsy. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

13

Jul 2018

The report presents a summary of the reimbursement situation for vagus nerve stimulation. Indications include epilepsy and depression. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

11

Jul 2018

In the second half of May, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy and endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by cancer.

Read more

09

Jul 2018

Two mini-method assessments regarding brachytherapy for esophageal cancer and targeted gene deep-sequencing panels were initiated by Oslo University Hospital in May of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

Read more

06

Jul 2018

Norwegian Institute of Public Health (NIPH) conducted a full health technology assessment (HTA) of Peptide receptor radionuclide therapy (PRRT) using 177Luthetium (177Lu-PRRT) on the request from payers (“New methods” framework for introduction of innovations in Norway).

Read more

05

Jul 2018

Payment-for-performance schemes in health care remain controversial as there is no solid evidence that they improve quality of care. A new study, published in Health Policy by Herbst et al, did not show any positive long-term effects of the implementation of P4P on quality of care. The program was implemented within the integrated contract framework between one ophthalmological clinic and one statutory health insurance company in Germany.

Read more

04

Jul 2018

MedTech Europe has published a paper with reflections on how to facilitate the dialogue between industry and funding and reimbursement decision makers, in order to create an innovation-friendly environment for healthcare in Europe. MTRC report on innovative payment schemes is cited in the paper.

Read more

04

Jul 2018

A change in the Services Order (Ordinanza sulle Prestazioni, OPre), regarding surgery in general, will come into force on January 1st, 2019. This change makes it possible to reimburse a number of surgeries in hospital settings in exceptional circumstances because in general, these procedures should be performed in out-patient settings.

Read more

29

Jun 2018

The Ludwig Boltzmann Institute (LBI-HTA), the Austrian HTA body, develops health technology assessments of medical technologies to support decision-making about coverage of these methods in Austrian public reimbursement system. MTRC summarized the list of reports to be published by LBI-HTA until the end of 2018.

Read more

28

Jun 2018

At the beginning of June 2018, the Andalusian agency for health technology evaluation, AETSA, has published a meta-analysis on digital tomosynthesis in breast cancer.

Read more

25

Jun 2018

MTRC has developed reimbursement overviews for 14 EU countries. Overviews cover stakeholders, money flow, payment model, DRG system, innovation funding, coverage with evidence development, the role of health technology assessment, funding frameworks and reimbursement pathways. Reports are delivered in PowerPoint. Video explanations are available as well.

Read more

21

Jun 2018

In late May 2018, the Health Technology Evaluation Service of the Basque County, OSTEBA, has published an assessment where they compared the clinical utility (safety, morbidity and effectiveness) of radiofrequency tonsil reduction with that of traditional tonsillectomy and other surgical options for enlarged tonsils.

Read more

20

Jun 2018

On 28th of May, 2018, the Swiss Medical Tariff Commission (CTM-MTK) has agreed with the hospitals association (H+) on a transitional solution for the application of TARMED, which will last until July 31st, 2018.

Read more

19

Jun 2018

On the 29th of May of 2018, the Institute for the Hospital Remuneration System (InEK) has published a joint document with G-DRG proposals for 2019. According to the decision made on the basis of § 17b KHG, the names of the applicants and procedure proposals for 2019 were provided.

Read more

18

Jun 2018

On the 30th of May of 2018, Norwegian Institute of Public Health (NIPH) has published a report regarding effectiveness of shunt treatment for persons with idiopathic normal pressure hydrocephalus, which was earlier commissioned to NIPH by My treatment choices platform with the purpose to find and summarize key findings from systematic reviews about the effects of shunts in the treatment of idiopathic normal pressure hydrocephalus.

Read more

15

Jun 2018

In mid-May 2018, the Catalan Agency for Quality and Health Evaluation, AQuAS, has published an assessment of the efficacy of shoulder arthroscopy for different pathologies and the safety of the procedure for the treatment of shoulder disorders.

Read more

13

Jun 2018

The list of the laboratory tests is based on the Services Order (Ordinanza sulle Prestazioni, OPre) of the September 29th, 1995; the latest update is in force since January 1st, 2018. The list contains the services whose costs are covered by the obligatory healthcare insurance (assicurazione obbligatoria delle cure medico-sanitarie, AOMS). With the latest update, there are 1931 tests on this list.
See the list of the January 2018 modifications in Italian here.
See the full list of current laboratory tests in Excel format (in French, German and Italian) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Read more

12

Jun 2018

At the end of April, 2018, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare activities, which were excluded or included with restrictions into Basic Insurance Package.

Read more

11

Jun 2018

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

Read more

06

Jun 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In April new codes for therapeutic arthroscopic operation of temporomandibular joint, pelvic angiogram and diagnostic small-bore needle arthroscopy were added to the CCSD Schedule.

Read more

01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

Read more

31

May 2018

In the first half of May, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for percutaneous balloon valvuloplasty for fetal critical aortic stenosis and three new medtech innovation briefings for patient position monitoring system for intracranial stereotactic radiosurgery, 3D/QFR imaging software to assess coronary fractional flow reserve non-invasively and point-of-care tests for diagnosing group A beta-haemolytic streptococcus (strep A) throat infection.

Read more

18

May 2018

In the second half of April, the National Institute for Health and Care Excellence (NICE) published one diagnostic guidance on adjunctive colposcopy technologies for assessing suspected cervical abnormalities, four Interventional Procedure Guidance for robot-assisted kidney transplant, nerve transfer to partially restore upper limb function in tetraplegia, prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia and microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma, and two new MedTech Innovation Briefings for sleep mask for diabetic retinopathy and diabetic macular oedema and disinfecting cap for needleless connectors.

Read more

16

May 2018

National Institute for Sickness and Disability Insurance (RIZIV/INAMI) reimburses some or all of the non-implantable medical devices provided by the pharmacist or in some cases by a supplier. In May 2018 the list of non-implantable medical devices has been updated.

Read more

15

May 2018

On 26th April, the Italian national agency for regional healthcare, AGENAS, announced that five new HTA documents will be produced for medical technologies during the next months.

Read more

14

May 2018

Dutch Healthcare Authority (NZa) has published the DBC product structure and maximum tariffs for specialist medical care for 2019. Healthcare providers and health insurers can start using it for the contract negotiations for 2019. The most important changes include reimbursement for telemonitoring consultation and reimbursement tariffs

Read more

10

May 2018

Between 28th of May and 9th of July 2018, SwissDRG will be accepting the requests/suggestions regarding the DRG system in the country.

Read more

08

May 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In March one new code for non-invasive nasal airway remodelling was added to the CCSD Schedule.

Read more

25

Apr 2018

In the first half of April, the National Institute for Health and Care Excellence (NICE) published one new medtech innovation briefing for device that usesroutinely available datasets to help identify people who are at high risk of developing colorectal cancer.

Read more

19

Apr 2018

Emilia Romagna Region published a preliminary information report on the Equistasi® device, a wearable proprioceptive stabilizer for rehabilitation of postural instability in Parkinson's disease, multiple sclerosis and athletes.

Read more

17

Apr 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has selected four out of 31 themes for the future health technology assessments, which were proposed by the citizens at the web-site of ThemenCheck Medizin service and will presumably be published at the beginning of 2019. The next process of topics’ selection will start in August of 2018.

Read more

16

Apr 2018

In February 2018, the DFI (the Federal Department of Home Affairs) has decided to make a change in the activity order (Ordinanza sulle prestazioni, OPre) concerning “out-patient before in-patient.” The modification is coming into force starting January 1st, 2019. Six procedures will be reimbursed only in out-patient settings.

Read more

13

Apr 2018

NHS England has announced the selected technology for the central funding to accelerate access within NHS. These technologies include HeartFlow, Plus Sutures, Endocuff Vision and SecurAcath. This is the second year selection of the technology for the fast track innovation payment scheme in England.

Read more

12

Apr 2018

In the second half of March, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance for a portable digital system for managing chest drains.

Read more

11

Apr 2018

Eight reimbursement reports with the total size of 882 pages cover the most common radiotherapy modalities including brachytherapy, 3D conformal radiation therapy, stereotactic radiosurgery, stereotactic body radiation therapy, intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), image-guided radiotherapy, proton therapy. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 12 EU countries including Austria, Belgium, Denmark, England, Finland, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

Read more

10

Apr 2018

New material codes for Ventricular Assist Device and Aortic Endoprotheses were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in April 2018.

Read more

02

Apr 2018

In January 2018, the Spanish Network of Technology and Services Evaluation Agencies of the National Health System (REDETS), together with the Basque regional government, has published a health technology assessment report on high intensity focused ultrasound in Tremor Essential, developed by the Basque Office for Health Technology Assessment.

Read more

30

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for genetic tests and immunological tests for infections were added to the CCSD Schedule.

Read more

28

Mar 2018

The Dutch Healthcare Authority (Nederlandse Zorgautoriteit) has published a draft version of the DBC package for specialist medical care for 2019 (RZ19a).

Read more

26

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for preparation and delivery of radiotherapy, knee resurfacing arthroplasty, balloon dilatation of the Eustachian tube and MRI-guided focused ultrasound (MRgFUS) thalamotomy for essential tremor were added to the CCSD Schedule.

Read more

22

Mar 2018

In the first half of March, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedures Guidance (laparoscopic mesh pectopexy for apical prolapse of the uterus or vagina and mosaicplasty for symptomatic articular cartilage defects of the knee) and one new Technology appraisal guidance for autologous chondrocyte implantation using chondrosphere for treating symptomatic articular cartilage defects of the knee.

Read more

21

Mar 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) released the final report on the assessment of benefit for telemonitoring of cardiac implantable electronic devices compared to a standard treatment without telemonitoring in patients with ventricular tachyarrhythmias and / or heart failure. It was concluded that the benefits of the telemonitoring for patients with cardiac failure or heart rhythm disorders with a fast heart rate remain unclear.

Read more

20

Mar 2018

In January 2018, the Galician HTA body, Avalia-T, released the technical review of The Vivistim® system, an implantable device for upper-limb rehabilitation after stroke. Evidence was found to be very limited to advice on the implementation of the technology.

Read more

16

Mar 2018

On March 12th, 2018, Institute of Health Carlos III has published an evaluation report on therapeutic efficacy and safety of hyperbaric oxygen therapy for complex regional pain syndrome sympathetic reflex dystrophy.

Read more

12

Mar 2018

In November 2017, the Andalusian Agency for Health Technology Assessment (AETSA) published an evaluation report (assessed within literature review) on the utility of exome sequencing for diagnosed dysmorphic syndromes.

Read more

08

Mar 2018

In some cases, compulsory health care insurance reimburses an implant or an invasive medical device only if it is placed in a hospital that meets specific criteria.

Read more

07

Mar 2018

In February, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern cardiac pacemakers, devices for aortic root replacement, orthopedic devices (double mobility cups, porous high-density polyethylene implants) and other devices.

Read more

05

Mar 2018

In the second half of February, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (unilateral MRI-guided focused ultrasound thalamotomy for moderate to severe tremor in Parkinson’s disease and supraciliary microstent insertion with phacoemulsification for primary open-angle glaucoma) and one Medical technologies guidance for transanal irrigation system for managing bowel dysfunction.

Read more

26

Feb 2018

In the first half of February, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for a compression bandage for venous leg ulcers and insertable cardiac monitor for detecting suspected asymptomatic atrial fibrillation after cryptogenic stroke, one new interventional procedures guidance (aortic valve reconstruction with a new valve made from chemically treated cow pericardium) and one Medical technologies guidance for Memokath-051 stent for ureteric obstruction.

Read more

20

Feb 2018

The method was under assessment by the Joint Federal Committee (G-BA) previously but the assessment was paused due to insufficient evidence in 2008. The final decision will concern the reimbursement of the method in the outpatient sector. The Institute for Quality and Efficiency in Health Care (IQWiG) is mandated to provide a health technology assessment (HTA) report to support G-BA’s decision.

Read more

16

Feb 2018

KCE performed health technology assessment of 3D high-risk printed medical devices. It provides description of evidence concerning efficacy, safety and cost-effectiveness of the 3D printed medical devices as well as legal issues (requirements to enter to the market, liability, data protection, patient’s rights, traceability, reimbursement, intellectual property rights).

Read more

15

Feb 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for Anti C1Q antibodies, soluble CD25, umbilical Cord Ph Level and several genetic tests were added to the CCSD Schedule.

Read more

14

Feb 2018

The Dutch Healthcare Authority (Nederlandse Zorgautoriteit) has published a draft version of the DBC package for specialist medical care for 2019 (RZ19a).

Read more

12

Feb 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for robotic assisted laparoscopic pelvic lymphadenectomy, ligation of the intersphincteric fistula tract and eminectomy of temporomandibular joint were added to the CCSD Schedule.

Read more

09

Feb 2018

In order to decide upon the inclusion of medical benefits into the German statutory health insurance, the Joint Federal Committee (G-BA) can commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the preparation of health technology assessments (HTA). At the turn of the year, IQWiG published its 220th evaluation dossier since its foundation in 2004. G-BA followed IQWiG’s recommendations in 70% of cases.

Read more

08

Feb 2018

In the second half of January, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for an amniotic membrane allograft for treating chronic wounds and minimally invasive percutaneous nephrolitholapaxy medium to remove kidney stones, and one new Clinical Guideline for assessment and management of oesophago-gastric cancer in adults.

Read more

07

Feb 2018

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) released seven decision support documents in 2017. In these, three technologies were recommended for inclusion into the national benefit catalogue. The rest was preliminarily not recommended for inclusion. HTA by LBI-HTA have indirect but strong connection to decision making about funding by the Ministry of Health.

Read more

01

Feb 2018

Plasmapheresis procedure has not been supported for application in patients with Alzheimer’s by Spanish Health Technology Assessment Agency (AETS) due to insufficient evidence.

Read more

31

Jan 2018

EUnetHTA analyzed HTA and reimbursement procedures in relation to pharmaceutical and non-pharmaceutical health technologies in EUnetHTA partner countries. About 59 HTA agencies and decision-makers provided country-specific information and outlined the process of HTA and reimbursement in 31 European countries.

Read more

26

Jan 2018

The Andalusian Agency for Health Technology Assessment (AETSA) performed evaluation of transcranial Doppler ultrasonography in patients with acute ischemic stroke. Available evidence was considered as insufficient for formulation of final conclusion. However, AETSA prepared recommendations for evidence generation strategy for this procedure.

Read more

24

Jan 2018

In December, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern respiratory prostheses for total laryngectomy, mandibular advancement devices, some cardiovascular devices (transcutaneous bioprosthetic aortic heart valve, ventricular assist device, etc.) and other devices.

Read more

23

Jan 2018

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .

Read more

19

Jan 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for allergy diagnostics, diagnostic profiles for certain diseases and detection of antibodies against Chlamydia were added to the CCSD Schedule.

Read more

11

Jan 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for reconstruction of breast, open adnexectomy, transoral laser microsurgery and surgical correction of hallux valgus were added to the CCSD Schedule.

Read more

09

Jan 2018

The new Diagnosis Related Group (DRG) system, called “LKF system” in Austria came into effect on January 1st 2018. It is used for the reimbursement, documentation and cost data collection of inpatient and day case services in Austrian hospitals. Compared to the last version, the LKF system for 2018 includes two newly established procedure groups (Oncological Immunotherapy and Transcranial Magnetic Stimulation) as well as several new procedures and changes in the association of procedures to specific groups. See details in the MTRC report.

Read more

29

Dec 2017

The Basque Office for Health Technology Assessment (OSTEBA) published results of assessments of home telemonitoring on patients with heart failure. This intervention was considered as effective and cost-effectiveness technology. However, further research is needed to specify criteria for better application.

Read more

27

Dec 2017

The further-developed tariff structure SwissDRG was approved by the Federal Council in Switzerland. The new tariff version for inpatient services will be effective from January 1st in 2018. The tariff structure SwissDRG defines how inpatient services in the acute care area of the hospitals and birthplaces are reimbursed within the framework of compulsory health care insurance in Switzerland.

Read more

19

Dec 2017

In the second half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for hypoglossal nerve stimulation for moderate to severe obstructive sleep apnoea and processed nerve allografts to repair peripheral nerve discontinuities).

Read more

18

Dec 2017

The meeting Improvement of Patient Quality of Life and Access to Innovation: Two Priorities in Medical Device Evaluations was organized by HAS on 24th of November to discuss evaluation principles of medical devices in France with manufacturers. In connection to the meeting new and updated policy documents were released.

Read more

15

Dec 2017

The Belgian Health Care Knowledge Centre and the Netherlands Organisation for Health Research and Care innovation have signed an agreement to invest 6 million euros in the pilot project Belgium-Netherlands Funding of International Trials (BeNeFIT) for conduction of comparative, practice-oriented clinical studies which is relevant to patients, caregivers and policymakers in Belgium and the Netherlands.

Read more

14

Dec 2017

In the second half of November, French HAS published new set of decisions for add-on reimbursement: four positive decisions for orthopedic medical devices, two negative decisions for coronary stents and two positive decisions for cochlear implant and kit for wheelchair.

Read more

13

Dec 2017

The changes of the DBC package for specialist medical care in 2019 (RZ19a) will include pediatric oncology, proton therapy, and telemedicine.

Read more

08

Dec 2017

Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.

Read more

06

Dec 2017

The Institute for Quality and Efficiency in Health Care (IQWiG), in agreement with the relevant manufacturers' associations, has drafted a model contract to regulate the conditions under which information provided by manufacturers for the evaluation of medical devices is used by IQWiG and made available to third parties.

Read more

05

Dec 2017

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

Read more

01

Dec 2017

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

Read more

27

Nov 2017

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

Read more

24

Nov 2017

In the first half of November, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (double-mobility cup, meniscal repair system), electrodes for radiofrequency ablation, portable oxygen concentrator, drug–coated balloons and other devices.

Read more

23

Nov 2017

In the first half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for total distal radioulnar joint replacement in symptomatic joint instability or arthritis and extracranial to intracranial bypass in intracranial atherosclerosis), one new diagnostics guidance for tests to identify people at high risk of ovarian cancer and four new Medtech innovation briefings.

Read more

16

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for trans-oral robotic surgery and joint replacement surgery.

Read more

13

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for nitrogen washout test for lung capacity and fractional flow reserve CT measurement.

Read more

09

Nov 2017

The Basque Office for Health Technology Assessment (OSTEBA) published results of assessments of different techniques for biopsy of prostate. In accordance to this report, biopsy with image fusion (MRI and ultrasound) can be considered as a first diagnostic option for prostate biopsy.

Read more

07

Nov 2017

In the second half of October, the National Institute for Health and Care Excellence (NICE) published two new clinical guidelines (for cataracts in adults and cystic fibrosis), and published two new Medtech innovation briefings for radiation dose monitoring software for medical imaging with ionising radiation and Promonitor for monitoring response to biologics in rheumatoid arthritis.

Read more

06

Nov 2017

The Belgian Health Care Knowledge Center (KCE) performed assessment of use of static automated external defibrillators (AED) by bystanders for out of hospital cardiac arrest. The aim was to inform government, whether current practice of placing AED for public use should be supported or not. No strict recommendations were given due to insufficient evidence for this device in use by bystanders.

Read more

03

Nov 2017

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

Read more

01

Nov 2017

Patients who have undergone mastectomy for the breast cancer or as a preventive measure can now benefit from better reimbursement of autologous tissue breast reconstruction if it is performed in a hospital that has an agreement with INAMI.

Read more

26

Oct 2017

In the first half of October, the National Institute for Health and Care Excellence published one new Technology appraisal guidance (for autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee) and four new Medtech innovation briefings for PleuraFlow Active Clearance Technology for maintaining chest tube patency, Mepilex Border dressings for preventing pressure ulcers, Thora-3Di for assessing asthma in children and Memokath-028, 044 and 045 stents for urethral obstruction.

Read more

24

Oct 2017

In June of 2017, the Ordering Forum RHF commissioned rapid method assessment for the Prosigna test. Only when the Norwegian Institute of Public Health receives documentation from the suppliers they carry out a quick method assessment. On 16th of the October, suppliers were requested to submit data to the Norwegian Institute of Public Health (NIPH) regarding clinical efficacy, safety and economics of Prosigna test.

Read more

23

Oct 2017

On 13th of October of 2017, the Ministry of Health of Poland commissioned Agency of Health Technology Assessment and Tariff Systems (AOTMiT) to assess the benefit of angioplasty of arteries of lower extremities (femoral and popliteal) with drug-eluting balloons.

Read more

19

Oct 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for ophthalmology, skin surgery, treatment of anal fistula.

Read more

18

Oct 2017

In the second two weeks of September, the National Institute for Health and Care Excellence published 2 new and 3 updated clinical, four new Interventional Procedures Guidance (for intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries and motor neurone disease, ab externo canaloplasty for primary open-angle glaucoma, high-intensity focused ultrasound for symptomatic breast fibroadenoma), and 3 Medtech innovation briefings (Farco-fill Protect, Caris Molecular Intelligence for guiding cancer treatment and Aptiva for painful diabetic neuropathy).

Read more

17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

Read more

12

Oct 2017

Irreversible electroporation (IRE) is a new minimally invasive method for the ablation of tumors. Currently, this method is not used in Norway. The conclusion of mini-HTA stated that IRE should be included as part of the routine clinical practice in the hospital.

Read more

10

Oct 2017

At the beginning of August 2017, the French National Authority for Health (HAS) published a health technology assessment of systems for remote monitoring for implantable cardioverter defibrillators (ICD). The aim of this assessment was an update and clarification of arrangements for the provision of implantable cardioverter defibrillator systems (ICDS) to improve the quality of care for patients with ICD and to promote the deployment of effective solutions in the country.

Read more

09

Oct 2017

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

Read more

28

Sep 2017

MTRC has analyzed timing of decision-making (negotiation about price, final ministerial decision and publication of the decision) after recommendation by CNEDiMTS about expected benefit (AS) and added clinical value (ASA) for invasive non-implantable medical devices reimbursed via LPPR list, title V. Since establishment of the title V program, 5 technologies were added to the List (stent retrievers for stroke; peripheral drug-coated balloons). Time from the recommendation by CNEDiMTS until the start of reimbursement varied from 7 to 13 months (9.4 months on average).

Read more

25

Sep 2017

Ministry of Health will close applications for proposals for inclusion of novel innovative tests into the List of Acts Outside Nomenclature in 2018 (Référentiel des actes Innovants Hors Nomenclatures, RIHN) 3rd of October 2017. RIHN provides early reimbursement for innovative tests, for which value is not yet validated to allow enlisting in the NABM Nomenclature.

Read more

21

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of a re-evaluation of percutaneous volume reduction of the intervertebral disk with a focus on chemolucleolysis. Based on current evidence, chemonucleolysis was recommended for inclusion into health benefit catalogue in Austria while percutaneous nucleotomy and percutaneous laser disc decompression were currently not recommended.

Read more

18

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of re-evaluation of leadless pacemakers for right ventricular pacing. Due to lack of comparative evidence vs conventional pacemakers, leadless pacemakers were not recommended for inclusion into health benefit catalogue in Austria.

Read more

08

Sep 2017

All significant innovations in Norway should undergo either national or hospital-based health technology assessment within “New Methods” framework. Guiding criteria for prioritization of topics for assessments were recently formulated by the administration of the program.

Read more

07

Sep 2017

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

Read more

06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

Read more

05

Sep 2017

Ludwig Boltzmann Institute HTA evaluated EST for GERD and found the current evidence insufficient to recommend its inclusion into health benefit catalogue. Reevaluation is recommended in 2022 when more evidence becomes available.

Read more

04

Sep 2017

There is an ongoing process to change the structure of add-on reimbursement for peripheral vascular stents in France. In July 2017 CNEDiMTS issued additional clarifications about proposed reimbursement requirements for stents and stent-grafts. Read about proposed changes in our post.

Read more

01

Sep 2017

In the second two weeks of August, the National Institute for Health and Care Excellence published three new Interventional Procedures Guidance for liposuction for chronic lymphoedema, radiofrequency treatment for haemorrhoids, biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer.

Read more

31

Aug 2017

New material codes for spinal distraction system and platinum surgical sealant for contact with lung tissue were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August. Codes for application of intramedullary nails were changed and conditions of reimbursement for valvulotomy and percutaneous closure of the left atrial appendage were amended.

Read more

30

Aug 2017

There is an ongoing process to establish add-on reimbursement for FFR guidewires. Earlier in 2017 two guidewires (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), Abbott) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care. In June 2017, COMET device also received a positive recommendation from CNEDiMTS (no improvement vs. already recommended devices) only on the basis of data about technical equivalency. This is unusual for brand-specific applications and may be an interesting precedent for further applications.

Read more

28

Aug 2017

In the first two weeks of August, the National Institute for Health and Care Excellence published three new Medtech Innovation Briefings for Biopatch for venous or arterial catheter sites, Urethrotech UCD for difficult or failed catheterization and VEST external stent for coronary artery bypass grafts.

Read more

22

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for video-assisted anal fistula treatment, infracoccygeal sacropexy using mesh to repair uterine and vaginal vault prolapse.

Read more

21

Aug 2017

New material codes for neurovascular self-expanding stent retrievers for clot removal (mechanical thrombectomy for stroke) and foam preparation for hysterosalpingosonography were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in July.

Read more

17

Aug 2017

In 2017, PAE was evaluated by the Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) to define whether evidence for this minimally invasive procedure can be sufficient for inclusion into benefit catalogue. Within this research work, evidence in relation to efficacy and safety of PAE was assessed in comparison to transurethral resection of the prostate (TURP) and open prostatectomy. Based on the results of literature review, LBI-HTA did not recommend PAE for inclusion into benefit catalogue in Austria. LBI-HTA recommended re-evaluating PAE procedure in the 2021 year when new potential evidence is available.

Read more

16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

Read more

15

Aug 2017

European Network for health technology assessment (EUnetHTA) is initiating a project on assessment of screening of fetal aneuploidies (trisomy 13, 18 and 21) using non-invasive prenatal test (NIPT) in collaboration with Galician Agency for Health Technology Assessment (AVALIA-T) and Italian HTA agency Regione Emilia-Romagna. Completion of the project is planned to be on 30th of January, 2018 and aimed to evaluate effectiveness and safety of prenatal screening with NIPT, and also to assess organizational, ethical, legal issues and patient outcomes associated with this procedure.

Read more

14

Aug 2017

In the first half of 2017, Galician Agency for Health Technology Assessment (AVALIA-T) published 4 HTAs for medical technologies and procedures including Impella ventricular assist device in cardiogenic shock, microwave ablation for tumors of the liver, microsurgery in limb lymphedema and intravitreal injections. Read high-level conclusions from these assessments.

Read more

11

Aug 2017

In the Netherlands, there is a possibility to test novel ways of delivering health care services (e.g. mobile diagnostic modules, online counselling, telemonitoring, screening/diagnostic for some complex conditions in primary care etc.) by establishing short (3 years) experiments between health provider and insurance company. After completion of experiment, analysis shall be performed about effect of the intervention. If it works, a new model can be population as novel type of care service in broader settings. See full list of ongoing small-scale experiment projects, extracted by MTRC.

Read more

10

Aug 2017

The National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) reviewed indications for number of devices on the LPPR list and made recommendations about structure of the section in the LPPR list.

Read more

09

Aug 2017

Changes will be made in eleven chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for Stomatology, Radiotherapy and Nuclear Medicine codes, introduction of new codes for IVD tests, including diagnostics of tuberculosis and screening for EGFR mutation.

Read more

08

Aug 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published report with results of systematic literature review of application extracorporeal cytokine adsorption therapy (ECAT) for treatment and prevention of sepsis or systemic inflammatory response syndrome (SIRS). Considered evidence was assessed as insufficient to prove that ECAT is effective and safe procedure in patients with sepsis, septic shock and SIRS. Therefore, ECAT is currently not recommended for inclusion into the benefit catalogue.

Read more

04

Aug 2017

The List determines devices (generic lines), which can be procured for provision of care within Program of State Guarantees in Health Care. Number of surgical implants, orthopedic implants, hemostatic materials, glue for surgical wounds, connector for spine drain, penile prosthesis, plates for facial surgery, surgical mesh, peritoneal catheter were added to the List.

Read more

03

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures for treatment of knee and hip osteoarthritis, robotic procedure, insertion of wireless pacemaker.

Read more

31

Jul 2017

The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.

Read more

28

Jul 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published results of systematic literature review of evidence in relation to efficacy and safety of radiofrequency ablation for patients with metastatic spinal lesions. In conclusion, LBI-HTA recommended radiofrequency ablation of spinal metastatic lesions for inclusion in benefit catalogue with restrictions.

Read more

27

Jul 2017

As of today, 11 Italian regions have specific regulations for health technology assessment. Medical devices are among the most commonly assessed types of technologies. Read English summary of the comprehensive report on HTA in Italy, developed by Agenas and SIHTA.

Read more

26

Jul 2017

In the first two weeks of July, National Institute for Health and Care Excellence published four Medtech Innovation Briefings (Nasal Alar SpO2 sensor for monitoring oxygen saturation by pulse oximetry, Arctic Sun 5000 for therapeutic hypothermia after cardiac arrest, L-Dex U400 for lymphoedema after breast cancer treatment, FreeStyle Libre for glucose monitoring), new clinical guideline for Parkinson’s disease in adults, and updated diagnostic guidance for a new generation cardiac CT scanners.

Read more

25

Jul 2017

SwissDRG has released overview of planned update of DRG system (version 7.0) in 2018, including list of preliminary approved add-on reimbursement categories. Add-on will be established for endobronchial valves, proton therapy, autologous matrix-induced chondrocyte implantation at knee joint and intermitted hemodialysis for removal of proteins with molecular mass up to 60,000 Da.

Read more

24

Jul 2017

HAS is the key decision-making body in relation to evaluation of sufficiency of clinical evidence to establish add-on reimbursement for medical devices, development of new procedure (CCAM) and clinical biology (NABM) codes in France. Annual report provides valuable insights into evaluation landscape for medical device and IVD tests. MTRC has extracted key facts related to assessment of medical technologies from the report.

Read more

21

Jul 2017

Dutch Health Care Authority (NZa) has been working on developing tariffs for diagnosis-related groups (DBCs) to reimburse special medical rehabilitation care (medisch-specialistische revalidatiezorg, msrz). Originally, it was planned to roll out new payment model (DRGs with national tariffs) in 2019, however, NZa decided that more time is needed to collect cost data to determine appropriate tariffs.

Read more

20

Jul 2017

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.

Read more

19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

Read more

18

Jul 2017

The treatment with autologous fat transplantation (AFT) may be a part of the basic health insurance package under certain conditions, including defects of the head and / or neck region, HIV-associated lipoatrophy and, and fibrosis (scarring), as recommended by the Dutch Health Care Institute (Zorginstituut Nederland).

Read more

17

Jul 2017

The NIP test is a non-invasive prenatal test aimed at detecting Down's syndrome in fetus. This test is a screening performed using mother's blood sample from the 12th week of pregnancy. From 1 July 2017, non-invasive prenatal test will be reimbursed for all pregnant women.

Read more

13

Jul 2017

Current version of the DRG manual for hospital and day case care was approved in December 2016 by the Russian Federal Fund for Mandatory Medical Insurance (FFOMS). Since then, FFOMS has issued two updates of the DRG manual, mainly focused on use of organizational coefficients for DRGs in oncology, criteria for DRG for infections of upper respiratory tracts, change of definitions of frostbite.

Read more

11

Jul 2017

Recently, CNEDiMTS at HAS issued positive recommendation for inclusion of HeartMate 3 ventricular assist device into add-on reimbursement catalogue (LPPR title III). No added value was established vs earlier version of device (HeartMate II), despite better safety profile demonstrated in the randomized controlled trial.

Read more

06

Jul 2017

An assessment was initiated earlier this year. The Institute will evaluate compliance of dynamic fusion in lumbar spondylosis with the state of science and practice.

Read more

03

Jul 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 8 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include coronary stents, portable oxygen concentrators, Urolift device, spinal ganglion stimulator and insulin pumps.

Read more

29

Jun 2017

In last two weeks of June, National Institute for Health and Care Excellence published one Medtech Innovation Briefing (RIDASCREEN tests for monitoring infliximab in inflammatory bowel disease), four new interventional procedures guidance for vaginal vault prolapse and uterine prolapse and one new diagnostics guidance for multiple frequency bioimpedance devices to guide fluid management in people with chronic kidney disease having dialysis.

Read more

27

Jun 2017

KCE is working now on development of research program for 2018 and proposals for research topics can be submitted by filling in an online form until 6 September, 2017. Proposal can also be submitted by the industry.

Read more

27

Jun 2017

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

Read more

23

Jun 2017

An assessment was initiated earlier this year on the request from Dutch Hypertension Society and umbrella organization of 9 health insurance companies Zorgverzekeraars Nederland. The Institute will evaluate compliance of baroreflex activation therapy (BAT) for treatment of resistant hypertension with the state of science and practice.

Read more

22

Jun 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures on spine and endoscopy procedure.

Read more

21

Jun 2017

The deadline for acceptance of applications for conditional reimbursement in 2019 by the Care Institute Netherlands (Zorginstituut Nederland) is 29th of June 2017. Conditional reimbursement for the period of up to 4 years can be available for promising technologies, which did not meet criteria for “state of science and practice” in the assessments of Zorginstituut Nederland.

Read more

21

Jun 2017

In first two weeks of June National Institute for Health and Care Excellence published two Medtech Innovation Briefings (Neo Pedicle Screw System for spinal fusion surgery and device for securing cerebrospinal fluid drainage catheters) and updated two clinical guidelines for head injury and spondyloarthritis in adults.

Read more

20

Jun 2017

In May 2017, CNEDiMTS at the National Authority for Health (HAS) issued positive assessment of Urolift for add-on reimbursement via LPPR list. Added value was found to be minor in comparison with transurethral resection of prostate (TURP). This assessment provides better results compared to the earlier one in January 2017. Add-on reimbursement might be established within about one year period.

Read more

13

Jun 2017

The Care Institute Netherlands (Zorginstituut Nederland) has released information that real-time continuous glucose monitoring is now included into the basic health insurance package for two additional groups of patients suffered from diabetes: women with diabetes who wish to become pregnant and patients with type 1 diabetes with repeated severe hypoglycemia.

Read more

08

Jun 2017

Administrators of the “New Method” program, which is focused on managed introduction of innovations into Norwegian system, have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.

Read more

06

Jun 2017

HAS published updated program that defines priority areas of work for 2017, including evidence review as part of developing new procedure codes for robotic surgery, endoscopic procedures, and technology assessments of remote monitoring, dialysis, coronary stents and others.

Read more

05

Jun 2017

BCG published an overview of the study, including survey and interview of several thousand med tech professionals and executives. Among recommendations of the new study are focus on value-based health care, digitalization and low-cost products and services. The study strengthens the importance of market access for Med Tech companies.

Read more

05

Jun 2017

In second two weeks of May, National Institute for Health and Care Excellence has published two Medtech Innovation Briefings (collagen paste for anal fistulae and portable pulse‑echo ultrasound device to assist diagnosis of osteoporosis) one Interventional Procedure Guidance for endoscopic full thickness removal of non-lifting colonic polyps.

Read more

31

May 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 9 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May and April. Among others decision included MRI compatible and recharge free spinal cord stimulation devices, resorbable plates for osteosynthesis.

Read more

30

May 2017

The Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation of extracorporeal shock wave therapy in patients with heel. Results demonstrated benefit of the extracorporeal treatment in comparison with placebo, ultrasound and iontophoresis.

Read more

30

May 2017

AETSA aimed to establish recommendations for clinical practice on hip arthroplasty in patients with osteoarthritis through a systematic appraisal of evidence. High-level recommendations for hip arthroplasty and selection of type of implants were made.

Read more

29

May 2017

An updated form for notification of medical technology to Italian national health technology assessment program has been released in May. Any stakeholder, including industry, can make notification, which will be reviewed and prioritize every six months.

Read more

26

May 2017

Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is working on three health technology assessment projects, related to medical technologies and in-vitro diagnostics, including diagnostics of prostate cancer, diagnostics of endometriosis and surgery for arm fractures in elderly.

Read more

24

May 2017

In 2016, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform evaluation of controlled active motion (CAM) in patients with rupture of the anterior cruciate ligament. The final report of assessment was published on May of 2017. No definite conclusion can be made in relation to comparative efficacy and safety of studied technologies due to lack of evidence.

Read more

19

May 2017

In 2014, Federal Joint Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWiG) to conduct health technology assessment of different approaches for lung volume reduction in patients with severe pulmonary emphysema. And now IQWiG has published the final report. The main conclusion is that it was not possible to draw any conclusion about relative effectiveness of bronchoscopic and surgical methods due to lack of the data.

Read more

18

May 2017

The report issued within the framework of Joint Action 3 confirmed superiority of triclosan-coated sutures in reducing the risk of total incisional surgical site infections over non-antibacterial coated sutures. No conclusions were made in relation to the chlorhexidine-coated sutures due to lack of evidence.

Read more

17

May 2017

At the meeting of 18th of April National Commission for Evaluation of Medical Devices and Health Technologies made decisions about add-on reimbursement of 17 medical devices. Ten decisions have been released to date for orthopedic, osteointegrated processing, cardiac and intravascular devices.

Read more

16

May 2017

Cédric Carbonneil from the Ministry of Health published a letter in Value in Health in response to the article "New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues" published in January 2016. Dr Carbonneil offers an interesting insights into background, rationale and direction of development of this important coverage with evidence development program for medical devices, in-vitro diagnostics and medical procedures in France.

Read more

16

May 2017

Changes will be made in nine chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for two ophthalmology and endoscopy codes, new conditions for reimbursement of photodynamic therapy in dermatology, introduction of two new codes for IVDs, and creating of requirements for reimbursement of number of IVD tests in pregnancy.

Read more

16

May 2017

European Commission launched an evaluation of necessity to prolong support to cooperation between health technology assessment agencies beyond 2020, when the current EUnetHTA Joint Action 3 comes to an end) in September 2016. As part of the assessment, it launched an online public consultation in October 2016, which ended in January 2017. The objective of the consultation was to collect views of different stakeholders on the future of collaboration in the HTA field.

Read more

15

May 2017

In first two weeks of May NICE has published one Diagnostic Guidance, two Medtech Innovation Briefings, one Interventional Procedure Guidance, and has updated three Clinical Guidelines.

Read more

15

May 2017

From November 1, 2017, patients practicing urinary self-drilling at home will enjoy better reimbursement conditions.

Read more

10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

Read more

09

May 2017

National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) positively appraised Verrata and Verrate Plus guidewires for add-on reimbursement via LPPR title V. Level of added clinical value was considered moderate (ASA III) in comparison with management strategy, based solely on angiography data. This decision complements decision early this year in relation to St. Jude Medical’s (now Abbott) PressureWire FFR wires.

Read more

09

May 2017

Ludwig Boltzmann Institute - HTA conducted a budget impact analysis on request from the Federal Ministry of Health and Women (BMGF) for testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

Read more

08

May 2017

Ministerial decree to enlist Medtronic's IN.PACT Admiral for the LPPR title V for add-on reimbursement was published on 6th of May 2017 in the Official Journal of French Republic. This is not only the first peripheral DCB on the List, but one of the first invasive non-implantable devices to get add-on reimbursement in France.

Read more

08

May 2017

French National Authority for Health (HAS) has initiated an assessment of organizational impact of mechanical thrombectomy on the system of stroke management in France with objective to find the most adequate way of further introduction of the method into French health care system.

Read more

05

May 2017

A new decree changed reimbursement approach for critical care in France. Before, it was reimbursed via daily supplements on top of base DRG tariff. New model introduces a mixed payment system with daily supplements and additional annual flat-rate fee, which depends on the size of the intensive care unit and activity in the previous year.

Read more

04

May 2017

Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

Read more

04

May 2017

Currently there are 10 ongoing mini-health technology assessments of medical technologies in Norway. After completion of evaluation, decision will be made about funding of these technologies at hospital level.

Read more

03

May 2017

National Institute for Health and Care Excellence (NICE) in the UK issued one Interventional Procedure Guidance, one Med Tech Innovation Briefing and updated two of Clinical Guidelines in April 2017.

Read more

02

May 2017

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

Read more

01

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.

Read more

28

Apr 2017

Three mini-HTAs were published since beginning of 2017: procalcitonin for diagnostic of bacterial infections, Per Oral Endoscopic Myotomy (POEM) for achalasia, and use of the Prosigna test (PAM50 ROR) for decisions on adjuvant treatment in breast cancer. These assessments can support introduction of methods at local hospital level in Norway.

Read more

27

Apr 2017

Assessment using HTA Core Model framework revealed that technology is safe, but evidence of efficacy is limited.

Read more

26

Apr 2017

KCE issued a report, in which it reviewed provision of day surgery in Belgium, incentives for provision of day surgery in France and England and developed recommendations for incentive policy for day surgery in Belgium to policy-makers.

Read more

24

Apr 2017

National Institute for Health and Care Excellence (NICE) in the UK issued two Interventional Procedure Guidance, one Medical Technology Guidance, five Med Tech Innovation Briefings and updated number of Clinical Guidelines in March 2017.

Read more

24

Apr 2017

In Belgium, number of procedures and devices can only be reimbursed for the hospitals, that meet certain requirements. INAMI has released a new lists of hospitals eligible for reimbursement for a number of procedures and devices in cardiovascular, neuromodulation, urology and orthopedics areas.

Read more

19

Apr 2017

The French National Authority for Health (HAS) has released report about evaluation of cardiac defibrillation probes and proposed updated nomenclature.

Read more

17

Apr 2017

Belgian Health Care Knowledge Center issued information about ongoing and planned health technology assessments of medical technologies and IVD tests. They include external cardiac defibrillators, bariatric surgery, OncoType for breast cancer, peripheral drug eluting balloons and others.

Read more

06

Apr 2017

A paper comes in response to the European Commission's impact assessment on ways to strengthen the use of and cooperation on Health Technology Assessments (HTAs) at European level. Med Tech Europe proposes five key principles for such a cooperation.

Read more

04

Apr 2017

NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance). Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017.

Read more