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