COMET Pressure Guidewire from Boston Scientific for fractional flow reserve (FFR) measurement got positive appraisal at French HAS with only data about technical equivalency provided

30

Aug 2017

In 2015, the French National Authority for Health (HAS) published a report of the assessment of risk/benefit ratio of fractional flow reserve measurement during coronary angiography in comparison with coronary angiography without FFR measurement in patients with suspected stable angina or acute coronary syndrome. The evaluation was initiated by the application from the French Society of Cardiology.

Review of evidence showed that FFR measurement has a favorable risk/benefit ratio in patients with stable coronary disease in cases of multi-vessel lesions or intermediate lesions where previous examinations could not be performed. In the same time, no conclusions were possible to be drawn in relation to risk/benefit ratio for use of FFR measurement during coronary angiography in patients with STEMI or NSTEMI.

Then in the beginning of 2017 two FFR devices (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), St Jude Medical) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care (ASA level III). Add-on reimbursement has not been formally established yet (negotiation about pricing level takes place after the recommendation of CNEDiMTS).

In June 2017, new FFR guidewire Comet (Boston Scientific) was positively evaluated by CNEDiMTS for inclusion into LPPR List (for 3 years) with ASA level as V (no improvement) in comparison to other FFR devices for following indication:

  • FFR measurement during coronary angiography in stable coronary artery disease, multivessel lesions or mono-lesions with intermediate stenosis, when preliminary myocardial ischemia tests cannot be performed or contraindicated

It should be noticed that there were no clinical data specific to Comet submitted by the applicant and this device was approved on the basis of technical equivalence with other FFR devices. This is unusual for brand-specific applications, for which either equivalence or superiority should be demonstrated using clinical evidence.

When reimbursement for FFR guidewires is formally established, important insights can be developed for all participants on the French market. MTRC will keep its auditory updated about potential considerations related to LPPR List brand-specific applications for me-too products.

See decision by CNEDiMTS for Comet in French here.

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

Related news

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

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

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

02

Jan 2018

A 150-page reimbursement report covers angiography, intravascular ultrasound (IVUS), fractional flow reserve (FFR), cardiac computer tomography (CCT), optical coherence tomography (OCT) for angina and myocardial infarction in hospital settings. Stand-alone application of imaging / diagnostic methods and use in conjunction with percutaneous coronary intervention procedure was 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

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

20

Nov 2017

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

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

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

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). They include microprocessor controlled knee prosthesis, transcatheter pulmonary valve, deep brain stimulation device, kit for self-monitoring of blood glucose and others.

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

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

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