Project plans of EUnetHTA reports to be published in 2018

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.

OTCA14 “Robotic surgery in thoracic and visceral indications” – plan published on 11th of July, 2018

  • Project done by: Austrian Ludwig Boltzmann Institue (LBI-HTA) and Italian Veneto Region (Azienda Zero)
  • Objectives: a rapid HTA in order to assess whether robot-assisted surgery in patients with an indication for surgery in the area of the thorax and viscera (abdomen) is more effective and safer (or at least as safe) than laparoscopic or open surgery (or thoracoscopic approach for thoracic surgery)
  • Method: a systematic review; literature searched on Embase, Medline, CRD database, Cochrane Library
  • Manufacturer commenting on the assessment: Intuitive Surgical
  • Expected date of the publication of the report: 30th of November 2018
  • Link to the detailed plan in English can be found here

OTJA10 “Stool DNA testing for early detection of colorectal cancer” – plan published on 25th of July, 2018

  • Project done by: Austrian Public Health Institute, Slovenian Public Health Institute, Slovenian Agency for Medical Products and Devices
  • Objectives: a rapid HTA in order to assess whether Stool DNA testing (alone or in addition to occult blood testing) in adult patients from a colorectal cancer screening population is more effective and/or safer than other available colorectal cancer screening tests
  • Method: a systematic review; literature searched on Embase, Medline, Cochrane Library, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP) and the EU Clinical Trials Register
  • Manufacturers commenting on the assessment: PharmGenomics GmbH, Exact Sciences Corp.
  • Expected date of the publication of the report: 25th of March 2019
  • Link to the detailed plan in English can be found here

OTCA16 Bioresorbable Stents in cardiovascular indications (coronary artery disease) – plan published on 21st of August, 2018

  • Project done by: Institute for General Practice and Evidence-based Health Service Research (IAMEV), Medical University of Graz, Austria and National School of Public Health, Management and Professional Development Bucharest (SNSPMPDSB), Romania
  • Objectives:  a rapid HTA  in order to assess the question whether percutaneous coronary intervention (PCI) with implantation of a fully bioabsorbable/biodegradable/bioresorbable vascular scaffold/stent (BVS) in adult patients with coronary artery disease (CAD) including stable angina, unstable angina, myocardial infarction (ICD-10 code I20-I25) who require and are eligible for myocardial revascularization is more effective and/or safer than PCI with implantation of other stent types or other revascularisation strategies
  • Method: a systematic review; literature searched on PubMed, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials, Cochrane Database for Systematic Reviews, ClinicalTrials.gov and WHO-ICTRP
  • Expected date of the publication of the report: 21st of December 2018
  • Link to the detailed plan in English can be found here

Furthermore, you can see the updated list of accomplished and coming EUnetHTA assessments here.

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See the list of the January 2018 modifications in Italian here.
See the full list of current laboratory tests in Excel format (in French, German and Italian) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

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Apr 2018

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Apr 2018

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Apr 2018

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Apr 2018

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Mar 2018

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Mar 2018

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Mar 2018

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Mar 2018

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Mar 2018

According to the recommendation of the National Board of Health and Welfare (Socialstyrelsen), hospitals and clinics should not offer screening for prostate cancer with PSA tests with or without other supplementary tests before tissue sampling. The recommendation is based on that the benefit of screening for prostate cancer with PSA tests does not outweigh the negative effects on a population level.

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Mar 2018

Within the Work Package 4 of EUnetHTA Joint Action 3, femtosecond laser-assisted cataract surgery (FLACS) is currently under assessment by a team led by Emilia Romagna Region.

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Mar 2018

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Feb 2018

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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.

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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).

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Feb 2018

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Feb 2018

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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.

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Feb 2018

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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.

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Feb 2018

Ninety-two new codes have been implemented, including protein fractions and reproductive medicine tests.

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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.

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Jan 2018

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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.

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Jan 2018

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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).

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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.

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Dec 2017

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Dec 2017

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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.

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Nov 2017

A 155-page reimbursement report covers coronary angioplasty (using a plain and drug-coated balloon, bare metal, drug-eluting and bioresorbable stents), mechanical thrombectomy and atherectomy in hospital settings. The analysis covers procedure coding, payment mechanism, reimbursement tariff and policy restrictions. The report provides an overview of reimbursement situation in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

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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.

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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.

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20

Nov 2017

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

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Nov 2017

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

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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.

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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.

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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.

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31

Oct 2017

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).

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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.

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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.

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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.

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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).

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17

Oct 2017

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

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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.

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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.

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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.

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03

Oct 2017

New procedure codes will be created for stem cell procedures, extracorporeal techniques (including hemodialysis and CO2 removal), surgical interventions, including growth-controlling spinal correction, transposition of peripheral nerve, interventions on veins, and percutaneous image-guided procedures (including code for pressure measurement in coronary arteries and additional code for drug-eluting balloon). Classification will be enabled from January 1, 2018.

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02

Oct 2017

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

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27

Sep 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes cover different indications and analytical methods.

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25

Sep 2017

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

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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.

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19

Sep 2017

NHS Improvement together with providers of pathology (laboratory) services in England determined ways to integrate laboratory services to increase efficiency and reduce cost. The final proposal includes integration of pathology services of 105 English hospitals into 29 pathology networks, which would save NHS up to £200m annually.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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09

Aug 2017

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

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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.

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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.

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03

Aug 2017

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

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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.

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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.

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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.

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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.

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24

Jul 2017

Hofmann and Gilbert published article exploring potential value of four novel diagnostic tests for clinicians: immunosignature for cancer and infections, breath test for lung cancer, patch vital sign monitoring and biomarkers for Alzheimer’s disease.

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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.

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17

Jul 2017

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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23

May 2017

MTRC has completed reimbursement report for robotic surgery in 11 EU countries. Procedure codes are available only in number of geographies, including Belgium, Denmark, England, Germany, Norway, Sweden and Switzerland. Robotic-specific procedure codes are not available in Austria, France, Italy and the Netherlands.

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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.

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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.

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16

May 2017

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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27

Apr 2017

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

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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.

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19

Apr 2017

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

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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.

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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.

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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.

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