Reimbursement Is Assured, Value Is Negotiated
Author: Tobias Schüning, Consultant
Did you know, that when a new drug receives EMA approval, reimbursement in Germany is granted for all patients within the approved indication and label and a free price can be set for the first 6 month from launch?
However, after product launch the German HTA process begins, following a value-based principle and a two-step approach to adjust the medications final reimbursed price: First, a benefit assessment by the German Joint Federal Committee (G-BA) and second, a negotiation with the national payers’ association (GKV-SV). The G-BA evaluation critically depends on the clinical evidence submitted in an AMNOG-dossier. The added benefit is classified into six categories: less benefit, no added benefit, non-quantifiable, minor, considerable, or major added benefit. The higher the benefit category, the better the situation at the negotiation table.
For orphan drugs, a non-quantifiable added benefit is legally granted solely based on its approval – even without submitting clinical data. However, providing robust clinical evidence is highly recommended to support the value perception or a higher added benefit rating.
Key Points:
- Reimbursement is guaranteed for all in-label patients, regardless of the G-BA’s added benefit rating.
- A free price can be set for the first 6 months starting with launch, final price from month 7 depends on HTA assessment
- The extent of added benefit directly impacts price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV).
- For orphan drugs, a non-quantifiable added benefit is granted by law, but submitting clinical data can support a higher rating.
Strategic Implications:
Should a medicinal product receive an unfavorable added benefit assessment, it may be subject to significant price pressures during negotiations with the GKV-SV. In the most adverse scenario, this could lead to a reimbursement price that is not economically sustainable, potentially necessitating an opt-out or withdrawal from the German market despite of the privilege of in-principle guaranteed reimbursement in Germany.
Translating Innovation into Value
Market Access in Germany and across Europe begins early. At Kintiga, we provide end-to-end strategic and operational support, guiding pharmaceutical and biotech manufacturers through every step of their journey to maximize final reimbursement price outcomes.
Our AI-powered suite, deep local AMNOG expertise, and pan-European strategic insights enable us to navigate and guide our clients through complex HTA landscapes, anticipate payer expectations, strengthen their value propositions and unlock the full market potential of their innovations.
