CurrentCignaPolicy IP0159

Scenesse (afamelanotide) implant for erythropoietic protoporphyria

Defines prior authorization, coverage criteria, dosing, and coding for Scenesse (afamelanotide subcutaneous implant) for treatment of erythropoietic protoporphyria (including X-linked protoporphyria) for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyScenesse (afamelanotide) implant for erythropoietic protoporphyria

Policy CodePolicy IP0159

Change TypeAnnual review with material wording and criteria clarifications

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis confirmation (biochemical or genetic) and history of phototoxic reaction to approve for 1 year.

SourceLink

POLICY UPDATE CHANGES

Removed 'Other Photosensitivity Disorders or Photodermatoses (for example, polymorphous light eruption, solar urticaria, drug-induced photosensitivity)' from Conditions Not Covered.

Removed 'of erythropoietic protoporphyria (including X-linked protoporphyria)' from diagnosis criteria and removed 'medical geneticist' from list of prescribers.

Changed Conditions Not Covered wording to 'Scenesse for any other use is considered not medically necessary.' (replacing prior 'experimental, investigational, or unproven').

16 mgafamelanotide per implant

every 2 monthsmaximum dosing interval

≥18 yearsage requirement for coverage

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Coverage Criteria for Scenesse (afamelanotide)

Erythropoietic Protoporphyria (Including X-Linked Protoporphyria)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

EPP coverage criteria: A. Patient is ≥ 18 years of age;

EPP coverage criteria: B. Patient has a history of at least one porphyric phototoxic reaction (documentation required);

EPP coverage criteria

ONE of: i. Free erythrocyte protoporphyrin level above the normal reference range for the reporting laboratory;
ONE of: ii. Molecular genetic testing consistent with the diagnosis;

EPP coverage criteria: D. Agent is prescribed by or in consultation with a dermatologist, gastroenterologist, hepatologist, or physician specializing in the treatment of cutaneous porphyrias.

Dosing: single 16 mg implant subcutaneously no more frequently than once every 2 months

Scenesse (afamelanotide) for any use other than treatment of erythropoietic protoporphyria (EPP) is not medically necessary. This policy replaces prior wording that classified non‑EPP uses as "experimental, investigational, or unproven" and clarifies that such uses will be denied unless future published data support coverage.

For clarity, Scenesse is considered not medically necessary for any indication other than erythropoietic protoporphyria (including X‑linked protoporphyria). Coverage criteria and the policy position will be updated if new peer‑reviewed evidence becomes available.

Coding

Considered Medically Necessary when criteria metHCPCSCovered

J7352

Afamelanotide implant, 1 mg

Provider Actions and Requirements

Prior Authorization

Prior authorization required — approve for 1 year if criteria met

Prior Authorization is required for benefit coverage of Scenesse. Approvals are recommended for those who meet the policy Criteria and Dosing and are granted for a duration of 1 year when criteria are met; extended approvals may be allowed if the patient continues to meet criteria. Scenesse must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approve for 1 year if the patient meets ALL listed criteria (A–D).
Dosing: single 16 mg implant subcutaneously no more frequently than once every 2 months.
Prescriber requirement: prescribed by or in consultation with a dermatologist, gastroenterologist, hepatologist, or physician specializing in cutaneous porphyrias.

Step Therapy

No step therapy required

No step therapy requirements are specified in this policy for Scenesse.

Background

Erythropoietic protoporphyria (EPP) is a cutaneous porphyria caused by defects in heme biosynthesis that lead to accumulation of protoporphyrin and severe photosensitivity. Patients typically experience acute phototoxic reactions—burning, tingling, or itching—often without visible skin changes, and these symptoms are not relieved by standard analgesics. Diagnosis is established biochemically by an elevated free erythrocyte protoporphyrin level and/or by molecular genetic testing. Scenesse (afamelanotide) is an implantable melanocortin 1 receptor agonist indicated to increase pain‑free light exposure in adults with a history of phototoxic reactions due to EPP.

Definitions

Erythropoietic protoporphyria (EPP) — definition and disease description

DefinitionErythropoietic protoporphyria (EPP) is a cutaneous porphyria caused by defects in heme biosynthesis leading to excessive accumulation of protoporphyrin and marked photosensitivity.

SubtypesIncludes classic autosomal recessive EPP (ferrochelatase deficiency) and X‑linked protoporphyria (XLP) due to upstream gain‑of‑function mutations; both share similar biochemical and clinical features.

Clinical featuresCharacterized by extreme photosensitivity with burning, tingling, and itching on light exposure; phototoxic pain often occurs without visible skin damage and is not responsive to analgesics.

DiagnosisConfirmed biochemically by markedly elevated free erythrocyte protoporphyrin and/or by molecular genetic testing.

EpidemiologyEstimated prevalence approximately 2 to 5 per 1,000,000 individuals; XLP accounts for about 2% to 10% of EPP cases.