Update of wearable cardioverter-defibrillator (WCD) therapy assessment in Austria

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 project aimed at synthesizing the currently available evidence regarding the use of the WCD, in order to make sure that their previous assessment, done in collaboration with Italian AGENAS, was up to date. A systematic review regarding the effectiveness and safety of the WCD was performed. The systematic literature search was conducted on Cochrane (CENTRAL), Embase and Medline. The EUnetHTA Core Model © was used for the reporting. The methodological quality of the trials was assessed by the IHE-20 checklist for case series and the Cochrane Risk of Bias Tool for RCTs. In addition, the strength of the evidence was evaluated using the GRADE method.

Eventually, 11 eligible studies were identified: an RCT for the assessment of effectiveness and 10 observational studies for the evaluation of safety. The comparators of WCD was the pharmacological therapy alone.

Results

  • The scientific evidence from the RCT indicates the WCD in combination with guideline-directed medical therapy (GDMT) is not proven to be more effective than GDMT alone based on the arrhythmic mortality endpoint (1.6% in the intervention group (n=1,524) v 2.5% in the control group (n=778), p=0.18). In all-cause mortality, a statistically significant difference was found between the intervention group (WCD + GDMT) and the control group (GDT alone): 3.1% vs. 4.9% (p = 0.04). However, there is an increased risk that this result will be a random finding because no correction has been made for multiple testing
  • No statistically significant difference was identified at other (secondary) endpoints between the two groups:  Incidence of ventricular tachycardia / ventricular fibrillation (1.6% v 2.6%, p=0.1), hospitalization rate (31.2% v 32.5%, p = 0.51)
  • On average, the WCD was worn 14 hours per day (median = 18 hours per day)
  • The studies included in the evaluation of the safety of the device suggest that the WCD could be a relatively safe device. The safety was assessed based on adverse events (rash, false alarms, dizziness, fainting, palpitations, and comfort and lifestyle-related impairments)

The authors conclude that the comparative effectiveness of the WCD could not be established and that it is unclear if and especially for whom the plausible theoretical advantages of using the WCD can be translated into clinically relevant benefits. The authors state that further research is necessary for the development of solid conclusions.

See full details in German here.

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

Related news

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

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

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

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

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

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

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

Technical overviews include details of application processes for procedure codes and payments (e.g. DRG), inclusion into health benefit catalogs. Overviews are available as presentations in Acrobat PDF.

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

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

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

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

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

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

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

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

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

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

01

Jul 2019

Seminars on hospital reimbursement system for the Netherlands and Russia were added to the online school, as well as the webinar for the Austrian system. MTRC online school is the most cost-effective way to learn about reimbursement systems in a structured way.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

19

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment in which they have assessed the efficacy and safety of stereotactic radiotherapy (Cyberknife®), proton beam therapy and irreversible electroporation (Nanoknife®) for localized prostate cancer (PCa). It was concluded, there is inadequate and insufficient evidence to show that three evaluated technologies have either a positive impact on survival and quality of life or the ability to prevent or delay prostatectomy.

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

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

21

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an HTA report on efficacy and safety of endobronchial valve implantation for emphysema. The authors have concluded that the intervention is more effective but less safe than standard therapy in selected patients with severe emphysema. Inclusion in the national service catalogue is only recommended with restrictions.

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

17

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an update of the HTA of high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer. The report did not find the evidence of benefits of the treatment vs comparative treatments. The inclusion of the method hospital benefit catalogue was currently not recommended.

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

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

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

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

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

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

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

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

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

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

30

May 2018

In mid-May 2018, the Basque office for Health Technology Assessment, OSTEBA, has published a rapid assessment report on treating prostate cancer with high-intensity focused ultrasound. The article is published under EUnetHTA framework.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

22

Nov 2017

The Austrian HTA body LBI-HTA performed a systematic review of health economic evaluations of Transcatheter Aortic Valve Implantation (TAVI) compared to medical treatment and surgical aortic valve replacement for inoperable and operable patients with high or moderate surgical risk. The result of the review have only limited transferability to Austria, and LBI-HTA concluded, that the currently applied selection of patients based on clinical parameters can be considered as good practice.

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

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

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

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

26

Sep 2017

Austrian Ministry of Social Affairs engaged London School of Economics to undertake efficiency review of country’s social insurance system. Policy recommendations presented in the report include harmonisation of benefits (dentistry, non-medical services, medical aids and medical therapeutic devices), the introduction of an agency for quality assurance and modernisation of outpatient care.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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