Presentation (CTI)

OBJECTIVES: This study investigates (1) which MEAs currently exist for CGTs in Germany, (2) the rationale underlying these agreements, and (3) observable trends in the context of MFN pricing.
METHODS: Relevant MEAs were identified through systematic searches of G-BA and GKV-SV databases and official price database (Lauertaxe), complemented by hand searches of PubMed, press releases, and arbitration board decisions
RESULTS: As of June 2026, 16 EMA-approved CGTs are available in Germany, of which five have identifiable MEAs: Hemgenix®, Imlygic®, Kymriah®, Yescarta® and Zolgensma® Three are additionally subject to coverage with evidence development schemes. Risk-sharing arrangements were identified for three CGTs (Kymriah®, Yescarta®, Zolgensma®), while two others (Hemgenix®, Imlygic®) operate under performance-based agreements tied to treatment duration or re-intervention rates.
CONCLUSIONS: 31% of approved ATMPs in Germany are subject to MEAs, all performance-linked and concentrated among high-cost therapies. In the context of MFN pricing, MEAs can only serve as an effective mitigation strategy if the statutory reimbursement price remains nominally unchanged and the agreement incorporates a claw-back mechanism, ensuring confidential rebates do not trigger reference pricing obligations in other markets. Faster availability of claims data from statutory health insurers could further enhance the feasibility of such arrangements. Germany's existing MEA infrastructure may offer a replicable template — provided these structural prerequisites are met.