Understanding European Payer Readiness for Patient Centric Digital Health
As announced in a previous blog post, Synergus RWE initiated an internal project examining the readiness of reimbursement systems across Europe to support patient-centric digital health in Dementia / Alzheimer’s This project looked at the reimbursement systems of three key European countries (England, France and Germany) in order to understand what initiatives are in place, or are being developed, to support payment for patient-centric digital health more broadly. A thorough review of the available literature and conversations with key stakeholders revealed two key insights concerning the current state of digital health reimbursement in Europe were identified.
Shift to centralised reimbursement pathways
This project identified that the creation of centralised reimbursement pathways was important in clarifying the reimbursement process for new digital health technologies in Europe. Germany has been the most progressive nation in this respect with their recent introduction of a fast-track reimbursement pathway specifically for low risk (Class I and IIa) digital solutions. This pathway provides a clear and purpose-built pathway for the reimbursement of digital health technologies. France too has a centralised reimbursement pathway but has instead decided to include digital health solutions within existing medical device pathways. While this centralised pathway provides a clear route to reimbursement, it remains unclear whether it is suitable to assess digital technologies like medical devices. In England, reimbursement pathways are fragmented with decisions made in a bottom up fashion. This is set to change however with the introduction of a legal funding mandate for medical devices due to be introduced in 2020.
Development of suitable evidence frameworks
Another key insight generated in this project was the importance of establishing clear evidence guidelines to guide payer decision making. Given the fragmentation of reimbursement processes across Europe, evidence frameworks outlining the requirements for reimbursement play a hugely important role in guiding product development.
The key HTA bodies in England and France (NICE and HAS respectively) have both released evidence frameworks intended to guide evidence generation for new digital health solutions. NICE’s framework details the recommended evidence requirements for different categories of digital solutions, including self-management and behaviour modification as two categories of particular interest in this project.
Germany is yet to release guidelines for their new reimbursement pathway but have suggested that assessment criteria will be developed to reflect the unique outcomes generated by many patient-centric solutions.
While there are numerous initiatives being implemented across health systems in Europe to improve the readiness of reimbursement systems for patient-centric digital health solutions, two key activities from this project were identified:
- Shift to centralised reimbursement pathways
- Development of suitable evidence frameworks
The activities towards centralised reimbursement pathways and clear evidence frameworks will improve the clarity of reimbursement systems across Europe. While these are two important steps towards improving reimbursement systems for patient-centric digital health solutions, many other questions still need to be answered.