SCENESSE (afamelanotide)

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