Germany's Controversial Fixed-Reimbursement Plan for Blood Thinners Sparks Industry Backlash
Germany's Federal Joint Committee (G-BA) has announced plans to create a fixed-reimbursement group for direct oral anticoagulants (DOACs). The decision comes just before the patent expiry of rivaroxaban (Xarelto) and will include other patent-protected drugs like apixaban (Eliquis) and edoxaban (Lixiana). Industry groups have already raised strong objections to the move.
The new fixed-reimbursement category will cover four DOACs: rivaroxaban, dabigatran, apixaban, and edoxaban. Critics argue the G-BA is using rivaroxaban's upcoming patent expiry to push through a pricing system that also affects Eliquis—the top-selling drug in Germany's statutory health insurance scheme.
Pharma Deutschland has condemned the decision, calling it a breach of the Medicines Market Reorganization Act (AMNOG). The trade body warns that retroactively applying fixed reimbursement to AMNOG-regulated prices amounts to an illegal double regulation. Dorothee Brakmann, its managing director, stressed that such a move could erode trust in Germany's innovation framework.
The group also claims the fixed rates set for DOACs are too low. They point to past shortages of pancreatin and tamoxifen, where similar pricing policies led to market contraction and product withdrawals. From a legal and medical perspective, Pharma Deutschland insists that including patent-protected drugs like apixaban and edoxaban in the group is unjustified.
The G-BA's plan to bundle all DOACs under a single reimbursement rate has sparked concerns over drug supply stability. Pharma Deutschland warns of potential shortages and a weakened market for anticoagulants. The outcome will depend on how the fixed pricing affects manufacturers and patient access in the coming months.
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