Scenesse®

Drug - Scenesse® (afamelanotide implant) [Clinuvel Inc.]

March 2025

Therapeutic Area - Erythropoietic Protoporphyria (EPP)

Initial approval criteria

Patient must be at least 18 years of age; AND
Patient has a definitive diagnosis of EPP as confirmed by elevated free protoporphyrin in peripheral erythrocyte and/or by the identification of pathogenic variants in ferrochelatase (FECH) on molecular genetic testing; AND
Provider attests that Scenesse is prescribed to increase the pain free light exposure in patients with a history of phototoxic reactions; AND
Provider attests that the patient is not involved in clinical trials for other EPP treatments; AND
Patient does not have any malignant or premalignant skin lesions (e.g., melanoma, dysplastic nevus syndrome, Bowen’s disease, basal cell or squamous cell carcinoma) as evidenced by a baseline full body skin examination for pre-existing skin lesions; AND
Patient will continue to maintain sun and light protection measures during treatment to prevent phototoxic reactions
Initial approval is for 6 months

Absence of unacceptable toxicity from the drug (e.g., severe skin darkening)
Disease response as evidenced by an increase in pain free time during light exposure and/or a decrease in the number of phototoxic reactions; AND
Documentation of full body skin examination every 6 months to monitor for preexisting or new skin abnormalities.
Renewal approval is for 12 months

Scenesse must be billed as a medical claim.

Provider Call Center (844) 575-7887