CurrentAvMedPolicy Pub. 100-2

Scenesse (afamelanotide) 16 mg implant prior authorization

Requirements and clinical criteria for prior authorization of Scenesse (afamelanotide) 16 mg implant (J7352) for treatment of erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP) for AvMed members.

Policy Summary

PayerAvMed

PolicyScenesse (afamelanotide) 16 mg implant prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign the prior authorization request and submit supporting documentation including labs, diagnostics, chart notes, genetic testing, and dermatologic exam notes as indicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 mgimplant strength

1/2 modosing interval

6 moinitial auth

12 moreauth length

≥18min age

Coverage Criteria for Scenesse (afamelanotide)

Reauthorization / Continued Therapy

Covered when ALL of the following are met:

Reauthorization Criteria: Member must continue to meet all initial authorization criteria; member is responding positively to therapy as evidenced by at least ONE of: improvement in acute non-blistering cutaneous reactions after sun exposure, improvement on a pain-intensity Likert scale or quality-of-life questionnaire, or member has received a full skin examination by a dermatologist within the last six months.

Documentation of clinical response (labs, diagnostics, chart notes, questionnaires, or dermatologic exam) is required for reauthorization.

Members with any of the following are excluded from approval: current Bowen's disease, basal cell carcinoma, or squamous cell carcinoma; a personal history of melanoma or dysplastic nevus syndrome; or significant EPP/XLP-associated liver disease. These conditions must be documented and will preclude coverage under this policy.

Requests must also comply with dosing limits: the requested dose must not exceed one 16 mg implant every 2 months. All required supporting documentation (labs, diagnostics, chart notes, genetic testing) must be provided or the request may be delayed or denied.

Coding and Dosing Information

Policy Summary

PayerAvMed

PolicyScenesse (afamelanotide) 16 mg implant prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign the prior authorization request and submit supporting documentation including labs, diagnostics, chart notes, genetic testing, and dermatologic exam notes as indicated.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Scenesse 16 mg implant (HCPCS J7352) requires prior authorization. The prescribing physician must sign and clearly print their name on the authorization request (preprinted stamps are not valid). Authorization periods: Initial authorization = 6 months; Reauthorization = 12 months. If information provided is not complete, correct, or legible, authorization can be delayed or denied.

Prior authorization required for Scenesse (afamelanotide) implant — HCPCS J7352
Prescriber must sign and PRINT name on request; preprinted stamps are not valid
Fax completed requests to 1-877-535-1391

Step Therapy

Step-Edit and Sample Policy

Step-edit/sample policy: Use of samples to initiate therapy does not meet step-edit or prior authorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; documentation of prior treatment attempts or failures should be provided when applicable.

Samples do not satisfy prior authorization/step-edit requirements
Provide documentation of previous therapies (claims or chart notes) when applicable

Documentation Required

Provider Submission Requirements and Incomplete Information Risk

Provider submission requirements and incomplete information risk: Authorization may be delayed or denied if documentation is incomplete, incorrect, or illegible. Prescribers must sign and clearly print their name on the request form (handwritten signature required). Submit complete member and prescriber information, drug form/strength, dosing schedule, length of therapy, diagnosis/ICD code, weight, supporting clinical documentation (labs, genetic testing, chart notes), and contact phone/fax numbers. Missing or illegible items that may trigger delays or denials include: member identifiers, prescriber signature/printed name, drug strength/form, dosing schedule, length of therapy, and required supporting documentation.

Required: Member name, AvMed ID#, DOB
Required: Prescriber name, handwritten signature, date, DEA or NPI
Required: Drug form/strength, dosing schedule, length of therapy, ICD code/diagnosis, weight
Required: Supporting documentation (lab results, erythrocyte porphyrin testing, genetic testing, chart notes)
Missing/illegible information may delay or result in denial of authorization

Background

Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) are inherited porphyrias that cause acute non‑blistering cutaneous phototoxic reactions — typically pain, stinging, redness, swelling, and blanching — after sun exposure. Afamelanotide (Scenesse) is an implant indicated to reduce phototoxic reactions in adults with EPP/XLP and is managed under prior authorization for AvMed members.

Per policy, initial authorization is for 6 months and is covered when all criteria are met: member is ≥18 years of age; medication is prescribed by or in consultation with a dermatologist; confirmed diagnosis of EPP/XLP (ICD‑10 E80.0) with supporting documentation; documentation of EPP/XLP‑associated acute non‑blistering cutaneous reactions; and laboratory or genetic confirmation of disease (elevated total erythrocyte protoporphyrin and erythrocyte fractionation showing ≥50% metal‑free protoporphyrin, or gene sequencing showing FECH, CLPX, or ALAS2 mutation). Reauthorization is for 12 months and requires continued meeting of initial criteria plus documentation of clinical response (for example, improvement in reactions, pain scales/QOL, or recent full skin exam).

OpenPayer

Scenesse (afamelanotide) 16 mg implant prior authorization

Coverage Criteria for Scenesse (afamelanotide)

Coding and Dosing Information

Provider Actions and Authorization Requirements

Background

Definitions and Diagnostic Confirmation