Recommendations for reimbursement of personalised medicines
This guideline reviews how personalised medicines are currently funded and reimbursed, and suggests better ways to support their development and use. It recommends using performance-based payments and public-private funding partnerships, especially when the health benefits are proven.
At a glance
Use when
Deciding how to fund or reimburse high-cost, targeted therapies with uncertain long-term outcomes, especially gene and cell therapies
Avoid when
When dealing with well-established, low-cost treatments that fit traditional reimbursement models
Inputs
Evidence on clinical benefit, cost data, stakeholder collaboration structures, existing reimbursement frameworks
Outputs
Recommendations on suitable financing and reimbursement models for personalised medicine, including performance-based and value-based approaches
How it works
Based on a systematic review of 153 papers, this work identifies current financing and reimbursement models for personalised medicine (PM), including traditional models (e.g., fee-for-service, DRGs), financial-based agreements (e.g., rebates, price-volume agreements), and performance-based models (e.g., outcome-based rebates, coverage with evidence development). It evaluates facilitators and barriers to PM adoption, concluding that performance-based reimbursement and stronger stakeholder collaboration are key to advancing PM uptake where value is demonstrated.
- Project
- HEcoPerMed
- Funding
- Horizon 2020
- Project status
- Completed 2022
- HTA domains
- Aspects Beyond HTA
- Categories
- Pricing/Payer
- Technology
- Medicines
- Assumptions
- Personalised medicines require novel reimbursement models due to high upfront costs, uncertain long-term outcomes, and targeted patient populations
- Strengths
- Based on a comprehensive systematic review of peer-reviewed and grey literature; includes real-world examples of implemented models (e.g., for Luxturna®, Zolgensma®); developed by a multi-stakeholder consortium
- Limitations
- Limited by heterogeneity in definitions of personalised medicine and variability in healthcare systems; few models widely implemented or long-term evaluated
- Also known as
- Financing and Reimbursement Models for Personalised Medicine, HEcoPerMed reimbursement recommendations
Questions this answers
- › How are personalised medicines currently funded and reimbursed?
- › What reimbursement models work best for gene and targeted therapies?
- › When should outcome-based payments be used for personalised treatments?
- › What are the main barriers to reimbursing personalised medicine?
- › How can public and private sectors collaborate to fund personalised medicine?
- › When is coverage with evidence development appropriate for personalised therapies?
References & sources
- deliverableec.europa.eu ↗
- paperDOI: 10.1007/s40258-021-00714-9 ↗
- paperDOI: 10.1007/s40273-021-01010-z ↗
Related methods
Similar by meaning
- National framework for reviewing codependent technologies (personalised medicines)
- HEcoPerMed Guidance for Harmonisation and Improvement of Economic Evaluations in Personalised Medicine
- Pay for Innovation Observatory
- HEcoPerMed Modeling Case Studies for Validation of Methodological Guidance
- HTA appraisal framework for rare disease treatments
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.