SCENESSE (afamelanotide)
OFFICE ADMINISTRATION- Implant
Indications for Prior Authorization:
- Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Patients must meet the following criteria for the indication(s) above:
- Patient is 18 years of age or older, AND
- Prescribed by a dermatologist or a pertinent porphyria specialist, AND
- Patient has a diagnosis of EPP as confirmed by the following:
- Gene sequencing confirms a FECH mutation, AND
- Substantially elevated erythrocyte total protoporphyrin (between 300 and 5,000 mcg/dL), AND
- Chart note documentation confirms the patient has acute nonblistering photosensitivity (e.g. pain, erythema, swelling) following sunlight exposure, AND
- Patient has tried sun avoidance, sunscreen, and protective clothing, AND
- Patient has tried and failed high potency oral beta-carotene and pain medication (e.g. NSAIDs), AND
- Patient does not have any of the following conditions:
- Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions
- Personal history of melanoma or dysplastic nevus syndrome
- Significant EPP-associated liver disease
Reauthorization criteria:
- Patient had a positive response to Scenesse therapy as confirmed by chart note documentation (e.g. decreased severity and number of phototoxic reactions, increased duration of sun exposure, increased quality of life), AND
- Patient has received a full skin examination by a dermatologist within the last six months
Dosing:
- Insert a single implant, containing 16 mg of afamelanotide, subcutaneously every 2 months
Approval:
- Initial: 6 months
- Renewal: 6 months
Last review date: May 19, 2020