Scenesse (afamelanotide)

POLICY NUMBER

L.5.01.564

Scenesse (afamelanotide)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Erythropoietic protoporphyria (EPP) is an autosomal recessive disorder caused by mutations in the FECH gene, which leads to impaired activity of ferrochelatase (FECH), an enzyme in heme production. This leads to a build-up of protoporphyrin in the bone marrow, red blood cells, plasma, skin, and liver, which causes extreme sensitivity to sunlight (i.e., erythema, pruritus, etc.), liver damage, abdominal pain, gallstones, and enlargement of the spleen.

Supportive measures for EPP, such as sun and UV light avoidance, vitamin D supplementation, and protective clothing, have been mainstays of treatment. Scenesse (afamelanotide) is a synthetic α-melanocyte stimulating hormone analog that increases the amount of melanin, a skin-darkening pigment, produced by skin cells. Scenesse (afamelanotide) is a subcutaneous implant administered every 2 months and is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from EPP.

POLICY

Scenesse (afamelanotide) is considered not medically necessary as supportive measures are the mainstays of treatment.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

08/06/2020: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

10/28/2020: Code Reference section updated to add HCPCS codes C9399 and J3490.

12/22/2020: Code Reference section updated to add new HCPCS code J7352, effective 01/01/2021.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Removed investigative definition. Sources updated. Code Reference section updated to delete HCPCS codes C9399 and J3490.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that Scenesse (afamelanotide) is considered not medically necessary as supportive measures are the mainstays of treatment. Sources updated.

02/24/2026: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Scenesse (afamelanotide). Added statement that services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Sources updated.

SOURCE(S)

1. Autosomal erythropoietic protoporphyria. National Center for Advancing Translational Sciences, Genetic and Rare Diseases Information Center. https://rarediseases.info.nih.gov/diseases/4527/erythropoietic-protoporphyria . Last accessed January 2026.

2. Dickey, A., et al (2023). “Evidence-based consensus guidelines for the diagnosis and management of erythropoietic protoporphyria and X-linked protoporphyria.” Journal of the American Academy of Dermatology, 89(6), 1227-1237.

3. Scenesse prescribing information. Clinuvel Inc. November 2025. Last accessed January 2026.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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