On July 29, 2025, the French National Authority for Health (HAS) issued positive opinions on including targeted next-generation sequencing-based panels in certain clinical indications for patients with aminoacidopathy and acute leukaemia in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed by HAS as a part of the RIHN reform and ‘cleaning up’ the List of temporary covered tests.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Kakatum Rao et al. systematically reviewed economic evaluations of AI in healthcare to assess its financial impact.

At the end of July 2025, the Ministry of Health published the first report within the national HTA program for medical devices. The program was established in 2017; however, it became fully functional only in late 2023, and the first assessment was launched in 2024 concerning robotic surgery in general (gastrointestinal) surgery, gynecology, and urology areas.

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 study, De la Fuente et al. examined HTA guidance in 28 countries to understand methodological approaches to in vivo diagnostics for market access and reimbursement, focusing on molecular imaging tracers and contrast media.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients understand the potential scope of our support better. From the week of August 11th, we plan to work on 16 projects. Review the complete list of planned activities in this post.

MTRC is pleased to present 2025 In-Vitro Diagnostic Tests Market Access Playbook - your annual, refresh‑and‑reuse roadmap to every EU reimbursement deadline.

In July 2025, the National Institute for Health and Care Research (NIHR) in England released seven Med Tech-related assessments in its HTA Journal, which concerned nephrology and urology, pulmonology, gynecology, in-vitro diagnostics and e-Health fields.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Pickaert analysed patient involvement practices in HTA across seven countries (Canada, England, Scotland, France, Germany, Spain, and Italy) to identify lessons for the EU Joint Clinical Assessment (JCA) framework.

As of August 2025, the Scottish Health Technology Group is developing four Med Tech-related HTAs in cardiovascular, diagnostic imaging, neurology and neurosurgery, neuromodulation, and orthopedics areas.

MTRC has released a White Paper titled "Evidence Requirements for IVD Tests in NICE HealthTech Evaluations ". This white paper reviews five assessments of IVD diagnostic technologies conducted under NICE’s previous Diagnostics Assessment Programme (DAP) framework. While terminology and processes have evolved with the introduction of the HealthTech Evaluation Program, these case studies remain highly informative. They offer practical insights into NICE’s evidence expectations and common drivers of recommendation decisions, which continue to shape current evaluation approaches.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Lodhia et al. systematically reviewed staff attitudes, barriers, and enablers to implementing environmentally sustainable practices in operating theatres across eight countries.

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.