In the LPPR process for Medical Devices, which also is applicable for therapeutic digital solutions, the focus would be on traditional outcomes, where these would be the most frequent:
- “mortality reduction in the short, medium or long term;
- reduction or improvement in morbidity (pain, healing, decrease in relapses, pain reduction, etc.);
- compensation of disability (degree of dependence and autonomy, resumption of lifestyle, mobility, socio-professional insertion, etc.);
- reduction in complications or adverse events attributable to the surgical technique or procedure: duration or number of hospital stays, infections, bleeding, reinterventions, etc.;
- improvement in the patient’s quality of life;
- impact on the organisation of care: reduction in the length of hospital stay, decreased consumption of healthcare products or decrease in the number of procedures, less reliance on medically-equipped transportation.” (1)
Based on the extensive experience with different pilot programs for telemedicine, starting already 2009, HAS (HTA body) has recognized the potential of organizational benefits from digital solutions.
This has led to the development of “GUIDE : Organisational impact map for health technology assessment for outcomes related to organisational improvements.” (2)
It is suggested that these organisational benefits, without clinical benefit, could be sufficient to establish reimbursement for digital solutions. At this point there is no such example.
Want to understand more:
- Don’t miss the upcoming webinar on January 25.
- Other blogposts about digital health solutions in France.
- If you need help in France, don’t hesitate to reach out to our partner, Meditech Access
- Assessment principles established by the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) to determine the reimbursement eligibility of medical devices for individual use [Internet]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2019-11/assessment_principles_established_by_cnedimts.pdf
- METHODOLOGICAL GUIDE: Organisational impact map for health technology assessment [Internet]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2021-04/organisational_impact_map_for_health_technology_assessment.pdf