On March 8, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the coverage of the INTERVAPOR system for lung volume reduction under Forfait innovation program.

On March 1, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) updated three Articles of the Nomenclature related to in-vitro diagnostics. Twelve new codes concerning clinical biology, molecular biology for infections, and genetics were implemented.

Since 2017 MTRC has provided reimbursement and HEOR services for the medical device and IVD industry in Europe. We specialize in Pan-European projects and worked in 34 countries in Europe. In this post, we summarized statistics about our experience with reimbursement projects in different EU countries. Three leading countries are England (273 projects), Germany (247 projects), and France (203 projects).

MTRC is the leading provider of market access services in Europe. Since 2017 we have accomplished 700+ projects in Europe. We provide regular consulting services to 56% of top 30 med tech companies and multiple SMEs. The typical scope of model adaptation includes adjustment of epidemiological data, validation of comparator, an adaptation of resource use and cost data, and search for local utility data. MTRC has a unique ability to work on model adaptations due to its unparalleled knowledge of payment systems in 34 European countries. We worked on model adaptations in Belgium, Denmark, Finland, France, Germany, Italy, Norway, the Netherlands, Poland, Russia, Spain, Sweden, and the UK.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Conrads-Frank et al. performed a critical review of decision-analytic modeling studies to inform early HTA for high-risk medical devices. The study presented a summary of methodological approaches, and made a number of recommendations about technical aspects of health economic analysis for medical devices.

On March 2, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the determined funding priorities for new forms of care. A total of six prioritized topics are defined. The preparation of a complete application can be supported for a period of up to six months with a grant of up to a maximum of €75,000. The deadline for submitting ideas is May 16, 2023.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Horgan et al. completed a survey of the status of Next-Generation Sequencing (NGS) in Europe and globally. Based on the feedback from 62 experts, a framework for implementation of the NGS is proposed along with in-depth discussion about current aspects of demand-and supply-side issues, governance and strategy, clinical standardization, awareness and education, equipment used, reimbursement and funding.

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.

In March 2023, a new ‘AI and Digital Regulations Service’ for developers and adopters of artificial intelligence (AI) and digital technologies was launched in England. Four organizations provide this multi-agency advisory service: NICE, Care Quality Commission, Medicines and Healthcare products Regulatory Agency, and Health Research Authority. The website is currently in public beta and focused on information for developers.

The Ministry of Health has commissioned the Agency for Health Quality and Assessment of Catalonia (AQuAS) to develop, with the collaboration of the various agencies that make up the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS), a specific methodological framework for the evaluation of digital health technologies that would allow a comprehensive assessment of this type of technology. The methodological framework is in the final phase of development.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 3844 of March 02, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and neurovascular treatment areas.

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.