In Germany, the G-BA determines the additional benefit (AB) of new therapies relative to the appropriate comparator therapy (ACT). For products without a (proven) AB, annual therapy costs cannot exceed those of the ACT. Drug prices are negotiated with the GKV-Spitzenverband; where manufacturers do not accept the (expected) price, they may stop distribution in Germany to protect the price in other markets.
Therefore, PRMA Consulting wanted to understand the number and timing of withdrawals and their impact on supply to patients.
Do market access withdrawals impact patient access to treatment in Germany?
We analyzed all G-BA assessments conducted before 13 May 2019 for products that were withdrawn. Publications and current sales status on Lauer Taxe were reviewed.
28 products were identified that are no longer marketed in Germany and 12 that were withdrawn but subsequently re-introduced.
Across the 40 product withdrawals, the G-BA assigned no AB to 29 products (72%). 16 of the 40 products were withdrawn within 4 weeks of the AB determination (opt-out); of these 15 (94%) were assigned no AB. The remaining 24 products were withdrawn after price negotiations.
However, supply is often continued through pre-approved or manufacturer-sponsored imports. Three products were withdrawn only from the ambulatory sector, and supply was continued for inpatients. In eight cases, a price was agreed after the withdrawal, and the product was re-introduced. For two products, the manufacturer initiated a re-assessment with new data.
This study shows that several pathways exist for continuing supply to German patients; however, treatment disruptions due to delayed price agreements or re-introductions are still likely.
Statutory health insurance funds argue that withdrawals from the market following no AB do not affect patients, since therapies with the same efficacy are available. However, 27% of products were withdrawn despite being assigned an AB.
Additionally, no AB is often assigned for purely methodological reasons, such as lack of comparative studies with the ACT. Therefore, further research is warranted on the impact of withdrawals and treatment switching on patients.