Why does market access fail despite a successful regulatory approval, and how do you plan reimbursement in from the start?

Approval proves efficacy and safety to the regulatory authority. Reimbursement proves added benefit to the payer, and that is a different question, with different comparators and its own time window. The four points where market access programs most often get stuck:

• Approval and reimbursement assess different things: approval requires evidence of efficacy and safety, the early benefit assessment under § 35a SGB V requires evidence of added benefit over an appropriate comparator therapy. A product tested only against placebo rather than against the relevant comparator can be approved and still fail to demonstrate added benefit.
• The appropriate comparator therapy and the patient-relevant endpoints are fixed in the G-BA and IQWiG procedure before the dossier is submitted. If they are addressed only after the studies are complete, the data basis is missing. An early scientific advice meeting with the G-BA serves precisely to clarify these benchmarks.
• The reimbursement price is negotiated in Germany after the benefit assessment under § 130b SGB V and mirrored into other markets via external reference pricing. A launch price negotiated or published too low therefore also lowers prices in the referencing markets.
• With the EU-HTA Regulation (EU) 2021/2282, the clinical assessment is consolidated as a Joint Clinical Assessment at EU level. Manufacturers must serve a joint EU evidence package and the national reimbursement procedures in parallel, rather than working through them one after another.