Ad hoc announcement pursuant to Art. 53 LR
- AGAMREE® is the first product to receive an agreed federal price in Germany for the treatment of all DMD patients 4 years and older, and independent of genetic mutation
Santhera Pharmaceuticals (SIX: SANN), a specialty pharmaceutical company focused on rare diseases, today announces an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement for AGAMREE® (vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD). This milestone makes AGAMREE the first product to receive an agreed federal price in Germany for the treatment of DMD in patients 4 years of age and older, independent of the underlying genetic mutation.
The agreement secured with the GKV-SV reflects Santhera’s commitment to ensuring broad patient access while supporting sustainable healthcare outcomes. The agreed ex-factory price is EUR 3,612.50 per 100ml bottle, translating into approximately EUR 52,000 per year for an average patient when considering required rebates, patient weight and dosing.
“We are pleased to have reached an agreement on the reimbursement for AGAMREE with the GKV-SV, which provides health insurance coverage for approximately 90% of the German population,” said Dario Eklund, CEO of Santhera. “This agreement represents an important step in providing access to AGAMREE for boys and men living with DMD in Germany and underscores our dedication to addressing the needs of the rare disease community.”
Since its launch in Germany in January 2024, there are now more than 300 patients on continuing treatment with AGAMREE, representing almost 30% of those currently on steroid treatment. This is a significant achievement given the pivotal study of vamorolone did not include any German trial sites. Germany has 2,300 individuals living with DMD, of whom approximately 1,100 to 1,200 are treated with steroids at any one time. This highlights the potential for broader adoption and the positive impact of this reimbursement agreement.
Santhera remains committed to working closely with healthcare providers, patient organizations, and payers to support access to AGAMREE for all eligible boys and men with DMD. This agreement ensures that patients across Germany can benefit from this innovative therapy, enhancing the quality of care and outcomes for those affected by DMD.
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