Afamelanotide (Scenesse ®) will continue to be available for the treatment of adult patients with EPP in Germany, where the drug has been initially evaluated in 2016, resulting in a positive recommendation for reimbursement. However, the competent national authority “Federal Joint Committee” at that time decided to re-evaluate afamelanotide in 2021, because more data on the safety and effectiveness of afamelanotide were expected to become available. Now, the second evaluation confirmed the initial assessment but this time, the positive recommendation is permanent. The outcome of the re-evaluation is also Good News for patients living in Switzerland and Austria, where reimbursement is still based on individual decisions by health insurers and other payers, which frequently take assessments of other countries like Germany into consideration.
Pharmaceutical Directive/Annex XII: Afamelanotide (Reassessment after the deadline: Phototoxicity in erythropoietic protoporphyria (EPP))
(last accessed 31 January 2022)