Afamelanotide (Scenesse)

Scenesse (afamelanotide) is covered only for the FDA‑approved indication — increasing pain‑free light exposure in adults with erythropoietic protoporphyria (including XLP); non‑FDA uses are not covered. Approval requires documented elevated free erythrocyte protoporphyrin or molecular genetic confirmation, history of ≥1 porphyric phototoxic reaction, age ≥18, prescribing/consultation by a dermatologist, gastroenterologist, hepatologist or porphyria specialist, dosing as one subcutaneous implant every 2 months, and authorization is limited to 12 months.

"FDA-approved indication: increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)."

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