On August 7, 2024, the National Agency for Regional Health Services (AGENAS) announced a call for applications for Health Technology Assessment (HTA) for robotic surgery systems with intended use in the following surgical specialties: general surgery, gynecology and obstetrics, and urology, as part of the 2023-2025 National Health Technology Assessment Program for Medical Devices.

On August 2, 2024, the HAS published positive opinions on the inclusion of targeted high-throughput sequencing of gene panels in the medical management of lung cancer, gastrointestinal stromal tumors, and chronic lymphocytic leukemia in the NABM Nomenclature. This is a consequence of the efforts to disburden the innovation funding budget and clean the List of IVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List funded outside Statutory Health Insurance via the research and innovation budget).

On July 1, 2024, the annual call for proposals to the UK National Screening Committee (UK NSC) was launched. During the call, stakeholders can propose potential new screening topics or modifications of existing screening programs. The deadline for applications is September 30, 2024.

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

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 to better understand the potential scope of our support. From the week of the 12th of August, we are planning to work on 19 projects. Review the full list of planned activities in this post.

In July 2024, the UK National Screening Committee (UK NSC) released an annual report from April 1, 2023 to March 31, 2024. The report provides a summary of the Committee’s ongoing work and accomplishments, including recommendations regarding the introduction of national population screening programs.

At the end of July 2024, the French Ministry of Health released a document on the RIHN reform process, including the description on the new RIHN application and evaluation process, but also how the HAS will evaluate tests currently covered in the RIHN Nomenclature, with the purpose of of deciding whether these tests will be granted permanent reimbursement, or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need.

On July 10, 2024, the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) informed that the federal government, states, and sickness funds had defined their priorities for digitizing the healthcare system within the healthcare reform. The corresponding document, “eHealth Strategy Austria”, was presented on July 10, 2024, outlining the priorities up to 2030.

On July 30, 2024, NHS England announced the next steps in delegating commissioning responsibilities to local commissioners - integrated care boards (ICBs). NHS England plans to complete the delegation of all ‘suitable and ready’ specialized services (the 59 services already delegated in three regions, plus 11 other services) in all seven regions by April 2025

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2024. Nine recommendations were published concerning the registration of medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, interventional radiology, nephrology and urology, orthopedic, endocrine devices, and in-vitro diagnostic tests, as well as medical aids.

In July 2024, SBRI (Small Business Research Initiative) Healthcare launched new funding competitions in four priority areas: antimicrobial resistance, women’s health, urgent & emergency care, and stroke. All types of innovations are eligible, including but not limited to medical devices, in-vitro diagnostics, digital health, and AI solutions.

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 16951 of July 22, 2024, Tuscany Regional Healthcare published five new assessments and two reassessments of medical devices in the cardiovascular, peripheral vascular, surgical procedures, and obstetrics and gynecology areas.