The German Financial Stabilization of Statutory Health Insurance System Act
Expected Impact and Implications for Manufacturers
AMNOG* rebate negotiations will be modified to give the GKV-SV increased powers in the pricing negotiations.
HIGH P&MA IMPACT: The new negotiation framework increases the threshold of added benefit required for therapies to receive a premium vs. comparator therapies, specifically by limiting the pricing of ‘No Added Benefit’ rating products.
HTA OUTCOME | CURRENT RULES | FUTURE PRICING RULES |
---|---|---|
Major & Considerable Added Benefit Rating | No Changes | No Changes |
Minor & Unquantifiable Added Benefit Rating | Manufacturers could enter price negotiations, potentially leading to premium over branded comparator therapies | Manufacturers can only expect parity vs. a branded comparator |
No Added Benefit Rating | Parity against comparator therapies, regardless of whether generic or branded | Guaranteed at least a 10% discount vs. non-generic comparators and at most parity vs. generic comparators |
The free pricing period for new medicines is expected to be cut from 12 to 6 months.
HIGH P&MA IMPACT: Impact revenue on the first-year post-market authorization and might see the reprioritization of Germany as a first-launch market in Europe given Germany’s inclusion in many countries’ reference baskets.
Mandatory manufacturer rebate on patent-protected drugs outside the reference pricing system will increase from 7% to 12% for one year and will be retrospectively applied on the seventh month on the market.
MEDIUM P&MA IMPACT: Manufacturers can expect to see a decrease in the price margin for drug sales with a reduction in the net-to-gross profit.
A new 20% discount will be included in the AMNOG rebate negotiation for brand-brand combination products (excluding combination therapies that receive a major or considerable added benefit rating), impacting for the first time the combination backbone which is currently not taking a price cut unless their label is updated.
HIGH P&MA IMPACT: Manufacturers can expect a decrease in the price margin for drug sales linked to a brand-brand combination, with a reduction in the net-to-gross profit.
The sales threshold at which orphan drugs become subject to the standard AMNOG evaluation process will be reduced from €50 million to €30 million per year, and only the first indication will be automatically granted additional benefit.
HIGH P&MA IMPACT: This policy will increase the number of rare disease therapies that qualify for the standard AMNOG evaluation, likely resulting in downgrades to a ‘No Added Benefit’ rating (and downstream negative pricing implications) given orphan drug evidence package limitations.
Implementation of volume-based price negotiations, new penalties for uneconomical packages and delays in the introduction of biosimilar substitution law by a year are expected in August 2023.
*The German HTA procedure for medicinal products, named after the German Medicines Market Reorganization Act in 2011
AUTHORS: Maria Florez-Cespedes, Caspar Kengeter, Salome Monreal Louly, Manon Ricard, Andreia Ribeiro
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