CurrentColorado Rocky Mountain Health PlansPolicy IEXD0092.08

Scenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Medical benefit drug policy governing coverage criteria and administration requirements for Scenesse (afamelanotide) for adults with erythropoietic protoporphyria enrolled in UnitedHealthcare Individual Exchange plans (excludes MA, NV, NY).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyScenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Policy CodePolicy IEXD0092.08

Change TypeNo material clinical or coverage changes

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization with submitted medical records confirming EPP diagnostic labs, age ≥18, specialist involvement, and planned administration by a trained provider.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 mgimplant strength evaluated

J7352HCPCS code

E80.0Diagnosis code

≤12 moauthorization duration

≥18 yrsage requirement

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Coverage Criteria for Scenesse (afamelanotide)

Initial Therapy

Covered when ALL of the following are met

Age and diagnosis: Patient is 18 years of age or older; submission of medical records (e.g., chart notes, laboratory values) to support the diagnosis of erythropoietic protoporphyria (EPP) confirming either: both increased total erythrocyte protoporphyrin (usually 300 to 8000 mcg/dL; normal < 80 mcg/dL) AND increased percentage of erythrocyte metal-free protoporphyrin (generally >85% of total porphyrins), or molecular/genetic testing confirming a pathogenic FECH mutation or an ALAS2 gain-of-function mutation.see thresholds

Provide laboratory values or genetic test reports in submitted records.

Clinical history: Patient has a history of phototoxic reactions due to EPP.

Documented description of phototoxic episodes should be included.

Prescriber and administration: Prescribed by, or in consultation with, a hematologist or specialist experienced in the diagnosis and management of EPP; to be administered by a healthcare professional proficient in the subcutaneous implantation procedure who has completed requisite manufacturer training; dosing per FDA labeling.

Include specialist consult notes and documentation of provider training.

Authorization period: Initial authorization will be for no more than 12 months.12 months

Continuation of Therapy

Covered when ALL of the following are met

Prior use and response: Patient has previously received Scenesse (afamelanotide) for the treatment of EPP and has experienced a positive clinical response while on therapy.

Clinical response should be documented in submitted records (e.g., increased pain-free light exposure, reduced phototoxic episodes).

Include documentation of ongoing specialist oversight and provider training.

Reauthorization period: Reauthorization will be for no more than 12 months.12 months

This Medical Benefit Drug Policy applies to UnitedHealthcare Individual Exchange plans in all states except for Massachusetts, Nevada, and New York. The policy and its coverage criteria are not applicable to Individual Exchange members enrolled in those three states.

Coding and Diagnostic Data

HCPCS CodesHCPCS

J7352

Afamelanotide implant, 1 mg

Diagnosis CodesICD-10

E80.0

Hereditary erythropoietic porphyria

inv-06: Total erythrocyte protoporphyrin

Typical measured rangeUsually 300 to 8000 mcg/dL

Normal referenceNormal < 80 mcg/dL

Laboratory roleRequired diagnostic laboratory criterion to support EPP diagnosis for prior authorization

inv-07: Percentage metal-free protoporphyrin

Expected proportionGenerally greater than 85% of total porphyrins

Analyte describedPercentage of erythrocyte metal-free protoporphyrin rather than zinc protoporphyrin

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiation of Scenesse (afamelanotide). Requests must document the patient meets FDA‑labeled criteria and medical necessity for erythropoietic protoporphyria (EPP). Initial authorizations will be for no more than 12 months; reauthorization (continuation) requests will also be limited to no more than 12 months.

Initial and continuation authorizations limited to ≤ 12 months
HCPCS: J7352 (Afamelanotide implant, 1 mg)

Documentation Required

Required Documentation to Support Diagnosis

Submit supporting clinical documentation to demonstrate the diagnosis of EPP and medical necessity. Include objective laboratory evidence and clinical history documenting phototoxic reactions consistent with EPP.

Examples of acceptable documentation: chart notes, diagnostic consult notes, treatment history, laboratory reports (erythrocyte protoporphyrin concentration and metal‑free %), prior procedural notes for implant administration

Definitions and Diagnostic Criteria

inv-13: Erythropoietic protoporphyria (EPP)

Concise definitionInherited cutaneous porphyria causing painful, non‑blistering photosensitivity due to accumulation of protoporphyrin IX

Pathophysiology - enzyme defectImpaired ferrochelatase activity leading to protoporphyrin IX accumulation

Pathophysiology - distributionProtoporphyrin IX is released from erythroid cells into circulation, affecting vascular endothelium and liver and excreted via biliary system

inv-14: Diagnostic genetic abnormalities

FECH gene mutationFerrochelatase (FECH) gene mutation can provide molecular/genetic confirmation of EPP

ALAS2 mutationDelta‑aminolevulinate synthase‑2 (ALAS2) gain‑of‑function mutation can also confirm diagnosis

Background

Erythropoietic protoporphyria (EPP) is an inherited cutaneous porphyria caused by impaired ferrochelatase activity leading to accumulation of protoporphyrin IX. Clinically, EPP produces painful, typically non‑blistering, phototoxic reactions after light exposure and may be associated with hepatobiliary disease. Management traditionally focuses on photoprotection and supportive measures.

Scenesse (afamelanotide) is indicated to increase pain‑free light exposure in adults with a history of phototoxic reactions from EPP. The policy requires laboratory confirmation of EPP (elevated total erythrocyte protoporphyrin and an increased percentage of metal‑free protoporphyrin) or molecular/genetic confirmation (e.g., FECH mutation or ALAS2 gain‑of‑function) to support the diagnosis for coverage.

Relevant clinical considerations in authorization include that therapy is for adults ≥ 18 years, dosing and administration are per FDA labeling, and treatment must be prescribed by or in consultation with a hematologist or clinician experienced in EPP with implantation performed by a trained provider.