CurrentAnthemPolicy CC-0159

Scenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Clinical medical necessity criteria for use of Scenesse (afamelanotide) implants in adults with light intolerance due to erythropoietic protoporphyria (EPP); governs prior authorization and coverage determination under the medical benefit.

Policy Summary

PayerAnthem

PolicyScenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Policy CodePolicy CC-0159

Change TypeClarified documentation for continuation criteria

Effective Date10/24/2025

Next Review Date

Key ActionProvide prior authorization documentation showing the patient is ≥18 years with a diagnosis of EPP, elevated free protoporphyrin in peripheral erythrocytes, history of phototoxic reactions, and for continuation requests evidence of initial diagnostic confirmation and a clinically significant response while on Scenesse.

SourceLink

POLICY UPDATE CHANGES

Updated continuation criteria to include documentation of diagnostic tests showing elevated free protoporphyrin in peripheral erythrocytes.

18+Minimum age for approval (years)

6 moInitial approval duration

1 yrContinuation approval duration

1/2 moQuantity limit (16 mg implant)

Medical Necessity Criteria for Scenesse (afamelanotide)

Policy Summary

PayerAnthem

PolicyScenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Policy CodePolicy CC-0159

Change TypeClarified documentation for continuation criteria

Effective Date10/24/2025

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial approval (medically necessary)

Initial requests for Scenesse (afamelanotide) may be approved if ALL of the following criteria are met:

ALL of the following

Individual is 18 years of age or older
Individual has a diagnosis of erythropoietic protoporphyria (EPP)
Documentation is provided that diagnostic tests show elevated free protoporphyrin in peripheral erythrocytes
Reference: NCT00979745
Individual has history of phototoxic reactions from EPP (such as skin burning, itching, and pain)

Continuation approval (medically necessary)

Continuation requests for Scenesse (afamelanotide) may be approved if ALL of the following criteria are met:

ALL of the following

Individual is using Scenesse for a diagnosis of erythropoietic protoporphyria (EPP)
Documentation is provided that at initial diagnosis, diagnostic tests showed elevated levels of free protoporphyrin in peripheral erythrocytes
While on Scenesse, individual experienced a clinically significant response to treatment, including a reduction in phototoxic reactions, or an increase in the pain-free period during direct sunlight exposure

Contraindications / Not approved

Scenesse (afamelanotide) may not be approved for individuals with any of the following (any one applies => not approved):

ANY of the following

History of melanoma or dysplastic nevus syndrome
Current diagnosis of Bowen's disease, basal or squamous cell carcinoma, or other malignant or premalignant skin lesions
Any other photodermatosis (e.g., polymorphous light eruption (PLE), discoid lupus erythematosus (DLE), or solar urticaria)
When the above criteria are not met and for all other indications

Quantity limits

Quantity limit for Scenesse 16 mg implant1 implant (16 mg) per 2 months

Prior Authorization, Documentation & Denial Guidance

Prior Authorization

Prior authorization documentation for initial requests

For initial prior authorization, provide documentation that the patient is 18 years or older, has a diagnosis of erythropoietic protoporphyria (EPP), diagnostic test results showing elevated free protoporphyrin in peripheral erythrocytes, and a history of phototoxic reactions (e.g., skin burning, itching, pain).

Affected code: J7352
Age ≥18 years
Diagnosis of EPP
Documented elevated free protoporphyrin in peripheral erythrocytes
History of phototoxic reactions (burning, itching, pain)

Prior Authorization

Prior authorization documentation for continuation requests

For continuation prior authorization, provide documentation that the initial diagnostic tests showed elevated free protoporphyrin in peripheral erythrocytes and that the patient had a clinically significant response while on Scenesse (reduction in phototoxic reactions or increased pain-free period during direct sunlight exposure).

Affected code: J7352
Documentation of elevated free protoporphyrin at initial diagnosis
Evidence of clinically significant response on Scenesse (reduced phototoxic reactions or increased pain-free sunlight exposure)

Documentation Required

Implant administration requirements

Scenesse must be administered by a healthcare professional who has completed the manufacturer's training program and is proficient in subcutaneous implantation using a device the manufacturer has deemed suitable; documentation of administration by a trained provider may be required.

Affected code: J7352

Denial Risk

Contraindication-related denials

Requests should be denied for members with a history of melanoma or dysplastic nevus syndrome, current malignant or premalignant skin lesions (e.g., Bowen's disease, basal or squamous cell carcinoma), other photodermatoses, or when the approval criteria are not met.

Affected code: J7352
History of melanoma or dysplastic nevus syndrome
Current Bowen's disease, basal or squamous cell carcinoma, or other malignant/premalignant skin lesions
Other photodermatoses (e.g., PLE, DLE, solar urticaria)
Indications not meeting clinical criteria

Clinical Background

Scenesse (afamelanotide) is a subcutaneous implant and a peptide analogue of human α‑melanocyte‑stimulating hormone (α‑MSH) that increases production of the pigment eumelanin, thereby increasing pain‑free light exposure in adults with erythropoietic protoporphyria (EPP). By raising eumelanin levels, Scenesse helps absorb ultraviolet light, neutralize free radicals, and act as a light filter, effectively ‘‘tanning’’ the skin to improve tolerance to sunlight. Scenesse does not affect porphyrin accumulation and therefore is not expected to reduce the risk of EPP‑related liver damage.

Quick Reference Metrics

This policy establishes the clinical medical necessity criteria that govern prior authorization and coverage determinations under the medical benefit for Scenesse (afamelanotide) implants in adults with light intolerance due to erythropoietic protoporphyria (EPP). It specifies eligibility requirements for initial and continuation approvals (including age, diagnosis, and documented elevated free protoporphyrin in peripheral erythrocytes), quantity limits (1 implant [16 mg] per 2 months), required administration by trained healthcare professionals, and contraindications that would preclude coverage.

E80.0-E80.20	Disorders of porphyrin and bilirubin metabolism
L56.0-L56.8	Other acute skin changes due to ultraviolet radiation

OpenPayer

Scenesse (afamelanotide) for erythropoietic protoporphyria (EPP)

Medical Necessity Criteria for Scenesse (afamelanotide)

Relevant Codes

Prior Authorization, Documentation & Denial Guidance

Clinical Background

Defined Terms

Policy Updates

Quick Reference Metrics