The implementation of outcomes-based reimbursement for gene therapies, using the recent launch of CAR-T cell therapies as an example.

The method by which health-care systems manage the reimbursement of one-off, high-cost cell and gene therapies which come with decision uncertainty and affordability challenges is clearly seen in the real-world examples of Kymriah® and Yescarta®

This study provides an overview of the reimbursement schemes used for Kymriah® and Yescarta® in France, Germany, Italy, Spain, and the UK (EU5) as per the final quarter of 2019; to identify challenges and derive learnings for future product launches. Secondary research, combined with primary research from key market access stakeholders was used to review the reimbursement schemes for Kymriah® and Yescarta® in the EU5 countries of France, Germany, Italy, Spain, and the UK during the final quarter of 2019. This would facilitate identification of potential issues and help gain understanding that could be applied to future product launches.

Kymriah® and Yescarta® have similar list prices throughout the EU5, and their reimbursement is based on their marketing authorizations. In France and the UK, reimbursement is contingent on gathering additional data at the cohort level, and is subject to future reassessments. Meanwhile, in other countries, rebates (in Germany) or staged payments (in Italy and Spain) are linked to individual patient outcomes.

Real world examples like Kymriah® and Yescarta® have become an increasingly powerful resource for demonstrating the value of health benefits in the clinical settings, given that in this study they reveal an increased appetite for outcomes-based reimbursement in the EU5, with novel approaches applied in Italy and Spain.

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