EU Reimbursement for Digital Apps

Jun 16, 2024

We are pleased to share this case study where we analyzed reimbursement opportunities in the UK and Europe for a digital application. Please contact us if you have any questions or would like to learn more.

Unlocking Reimbursement Opportunities for Digital Medical Applications in the UK and Europe

We are excited to share a recent success story that highlights our expertise in navigating the complex reimbursement landscape for a European developer of a digital application. We identified and prioritized potential reimbursement opportunities in the UK and Europe, enabling access for the digital app.

Why This Matters:

Traditional reimbursement pathways often are not well suited for innovative digital applications. Recognizing this, authorities in the UK and Europe are introducing new, more flexible pathways to facilitate the integration of these technologies into health systems. These pathways generally feature a provisional decision phase, allowing for evidence collection before a final reimbursement decision is made.

Our Strategic Approach:

We evaluated the market attractiveness of the UK and several European geographies for our client based on the:
• Company’s evidence to support the target price
• Ability to meet national requirements
• Rapid access to reimbursement

Our client successfully achieved DiGA listing in Germany and is now exploring additional pathways.

Key Pathways Highlighted:

Germany’s DiGA Pathway: Offers 12 months of reimbursement at a price set by the developer, followed by price negotiations based on technical specifications.

France’s PECAN Pathway: Introduced in 2023 and modeled after DiGA, the PECAN pathway allows for reimbursement while evidence is collected. Initial pricing is set by the Ministry of Social Security, not the manufacturer, for one year.

UK’s Early Value Assessment (EVA): Introduced by NICE two years ago, EVA supports NHS funding of digital apps with an evolving evidence base without initially requiring a fully developed evidence plan.

Health Belgium Preliminary Reimbursement System: Provides a three-year period for evidence collection before making a final decision.