Key 2024 Highlights of the European Med Tech Market Access

MTRC pleased to share our key insights on the most important developments in European market access for medical technologies and in-vitro diagnostic tests in 2024. 

Austria: Several developments, including the following:

• The 2025 DRG tariff system will provide additional incentives for day case procedures
• Ongoing healthcare reform with a special focus on digitalizing healthcare (digital health apps, telemedicine solutions, etc.)

Belgium: Multiple developments, including the following:

• Continued efforts to re-structure INAMI/RIZIV reimbursement Nomenclature
• The first health app was included in the permanent reimbursement scheme

Denmark: Multiple developments, including the following:

• Establishment of the Board for Health Apps, tasked with evaluating whether health apps can be recommended to citizens and healthcare professionals
• Approval of the 2024 Health Reform Agreement, which will restructure the healthcare system, redistribute tasks, and adjust the economy of the healthcare service in the coming years
• Preparatory work for the launch of the Danish Healthcare Quality Institute from January 1, 2025

England: Multiple developments, including the following:

• Further delegation of the prescribed specialized services from NHS England to Integrated Care Boards
• Selection of the first technologies to be supported in the Innovative Devices Access Pathway (IDAP) pilot

France: Multiple developments, including the following:

• Implementation of the framework of the reinforced care pathways (a bundled payment model, outcome of the Article 51 experiment)
• New framework agreement on the medical devices included in the LPPR concerning the conventional policy for setting and revising the prices
• Improvement of the methods guide to support submissions of the applications for procedure (CCAM, NABM, NGAP) codes 
• Creation of the new Economic Evaluation Department (S2E) for evaluation of efficiency and budgetary impact files for health products by the French National Authority for Health (HAS)
• Merging former lists of innovative tests covered within the RIHN framework – RIHN 1.0 and Supplementary list – into the List of acts outside the nomenclature (LAHN), with the purpose of their further evaluation by the HAS
• Reform of the Repository of Innovative Services outside the Nomenclature of biology and anatomopathology (RIHN) with creation of a new financing opportunity for innovative IVD tests – RIHN 2.0
• Registration of new telemonitoring solutions within the early digital support framework (PECAN) and regular reimbursement framework (LATM)

Germany: Multiple developments, including the following:

• Increase in the budget available for reimbursement of out-patient procedures via the EBM catalog
• Implementation and further development of the hybrid DRGs concept
• The Innovation Fund becomes permanent with an annual funding amount of 200 million euros from 2025
• The Federal Council approved the Hospital Care Improvement Law, which defines the cornerstones of the hospital reform with gradual implementation starting from 2025

Italy: Final approval of national LEA out-patient tariffs for use from 2025

Netherlands: Multiple developments, including the following:

• Release of additional payment options (supplementary payment, OZP) to increase flexibility and efficiency of the healthcare system within the DRG package
• Decision not to continue with the coverage with evidence development “Subsidy for promising care” program
• Launch of the “Appropriate Care Practices” program by ZIN with the objective to collect and accelerate examples of appropriate care practices in the Netherlands

Norway: Multiple developments, including the following:

• Decrease of the share of DRG part in reimbursement of somatic care to 30% from 2025
• Multiple administrative re-organization changes, including the growing role for the Directorate of Health
• Changes of processes within the “New Methods” framework, including moving responsibilities for national HTA for medical devices to Norwegian Medical Products Agency 

Spain: Introduction of the new national catalog for genetic and genomic tests, which lists genetic and genomic tests guaranteed to the population 

Switzerland: Multiple developments, including the following:

• Approval of the uniform financing of outpatient and inpatient care on the referendum 
• Further developments but not yet final approval of the novel outpatient reimbursement system
• Creation of a new health insurance association prio.swiss representing around 90% of the insured individuals in the Swiss mandatory health insurance system on the basis of former largest associations (curafutura and santésuisse)
• Negotiation of tariffs for laboratory analyses between collective bargaining partners (previously, tariffs for laboratory analyses were determined by the Federal Department of Home Affairs)
• Development of the new tariff model for IVD tests reimbursed via the List of Analyses, based on real cost and performance data, within the the "transAL" project

If you’d like to explore these market developments further and understand their potential impact on your products, we invite you to reach out. At MTRC, we provide top-tier reimbursement analysis, market access strategy, and Evidence Synthesis and Health Economics expertise for the medical technology industry.