CurrentHealth NetPolicy N/A

Afamelanotide (Scenesse) Clinical Policy

Defines medical necessity criteria, initial and continued therapy, dosing limits, contraindications, documentation and approval durations for afamelanotide (Scenesse) for treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyAfamelanotide (Scenesse) Clinical Policy

Policy CodePolicy N/A

Change TypeAnnual review (revisions)

Effective Date03.01.20

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2025 annual review removed requirement for sequencing per consensus guidelines and recommended sequencing as follow-up tests; references updated.

1Q 2024 annual review: references reviewed and updated.

1Q 2023 annual review: no significant changes; Appendix C reviewed.

1Q 2022 and 1Q 2021 annual reviews: no significant changes; coding implications and references updated.

1FDA-approved indication

16 mgImplant strength

J7352Primary HCPCS code

>=18Age requirement (years)

Coverage Summary

coverage_stance: covered_with_criteria; Indication: Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP/XLEPP) — afamelanotide (Scenesse) is FDA‑approved to increase pain‑free light exposure in adult patients with a history of phototoxic reactions from EPP. The implant is a 16 mg subcutaneous implant (manufacturer lists Implant 16 mg) administered by trained clinicians. Primary HCPCS (drug/J-code): J7352 (afamelanotide implant, 1 mg unit code; billing for 16 mg implant corresponds to J7352 per policy coding guidance). Age requirement: ≥ 18 years. Scope summary: Defines medical necessity criteria, initial and continued therapy, dosing limits, contraindications, documentation and approval durations for afamelanotide (Scenesse) for treatment of EPP and XLP across Commercial, HIM, and Medicaid.

Age>= 18 years

Maximum dosing frequency<= 1 x 16 mg implant every 2 months

Total erythrocyte protoporphyrin examplee.g., 300 to 5,000 mcg/dL (normal ~80 mcg/dL)

Erythrocyte fractionation>= 50% metal-free protoporphyrin vs zinc protoporphyrin

Initial Therapy Criteria

Initial Approval Criteria

Scenesse is medically necessary when ALL of the following are met:

ALL of the following

ALL of the following
- Elevated total erythrocyte protoporphyrin (e.g., markedly elevated vs normal reference range).
- Erythrocyte fractionation demonstrating a predominance of metal-free protoporphyrin (eg, ≥50% metal-free vs zinc protoporphyrin).
Prescribed by or in consultation with a dermatologist.
Patient is ≥ 18 years of age.>= 18 years

Continuation Therapy (Renewal) Criteria

Continued Therapy (Renewal) Criteria

Approve continuation when member meets ONE of the pathway options and additional requirements:

Top-level continued therapy requirements (all must be met)

Member status

Member is currently receiving medication via Centene benefit.
Member has previously met initial approval criteria.
Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

Other Diagnoses / Exclusions

Diagnoses/Indications NOT authorized

Coverage is not authorized for:

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety according to off-label use policies is provided.

Applicable Codes

HCPCS Codes (Drug/J-code)HCPCSCovered

J7352

Afamelanotide implant, 1 mg

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required / approval duration

Initial and continued approvals require prior authorization for HCPCS code J7352. Approval durations: Commercial — 6 months or to the member's renewal date (whichever is longer); Medicaid/HIM — 6 months. Medical justification is required for requests beyond 3 implants per year for seasonal coverage.

Affected code: J7352
Commercial approval duration: 6 months or to member renewal date
Medicaid/HIM approval duration: 6 months
Medical justification required for >3 implants/year

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, and other clinical information supporting that the member has met all approval criteria. Include documented lab results for diagnostic testing (e.g., total erythrocyte protoporphyrin and erythrocyte fractionation) when applicable.

Clinical Evidence

Key evidence sources cited in the policy: the pivotal randomized controlled trial Langendonk JG et al., N Engl J Med. 2015 demonstrating afamelanotide efficacy in EPP, and the Scenesse Prescribing Information (Clinuvel, Inc., August 2024) which provides dosing, administration, and implant details. These are listed as the primary evidence references supporting the policy.

Background

Background: Afamelanotide is a melanocortin 1 receptor (MCI‑R) agonist indicated to increase pain‑free light exposure in adults with a history of phototoxic reactions from EPP. The Scenesse implant is inserted subcutaneously by trained healthcare professionals (proficiency and manufacturer training required); implantation is performed above the anterior supra‑iliac crest every two months using the SFM implantation cannula or other manufacturer‑recommended devices. Glossary/definitions: EPP = erythropoietic protoporphyria; XLP/XLEPP = X‑linked protoporphyria / X‑linked erythropoietic protoporphyria; DLQI = Dermatology Life Quality Index; MCI‑R = melanocortin 1 receptor.

Revision History

02.25P&T ApprovalLatest

1Q 2025 annual review removed requirement for sequencing per consensus guidelines and recommended sequencing as follow-up tests; references reviewed and updated.

02.24P&T Approval

1Q 2024 annual review: references reviewed and updated.

02.23P&T Approval

1Q 2023 annual review: no significant changes; Appendix C reviewed.

Policy Summary

PayerHealth Net

PolicyAfamelanotide (Scenesse) Clinical Policy

Policy CodePolicy N/A

Change TypeAnnual review (revisions)

Effective Date03.01.20

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

On This Page

Prior conservative therapy

Documented trial of and inadequate response to sun avoidance and use of sunscreen, protective clothing, and other protective measures.
Documentation that conservative measures have been inadequate to control EPP-associated painful skin reactions (eg, continued phototoxic reactions despite adherence to protective measures).

Evidence of EPP/XLP-associated acute non-blistering cutaneous reactions (for example: pain, stinging, burning, redness, swelling, blanching) following exposure to sunlight or visible light.

Reaction severity / impact

Cutaneous reactions are moderate to severe as measured by a pain-intensity Likert scale or equivalent clinical assessment.
Negative impact on quality of life as documented by a dermatology-specific or general QOL questionnaire (eg, DLQI) or clinical documentation of functional impairment attributable to phototoxic reactions.

Exclusionary conditions (member must NOT have any of the following)

Current diagnosis of Bowen’s disease, basal cell carcinoma, or squamous cell carcinoma.
Personal history of melanoma or dysplastic nevus syndrome.
Significant EPP/XLP-associated liver disease (clinical or laboratory evidence of advanced liver dysfunction).

Dose does not exceed one 16 mg implant every 2 months.<= 1 implant (16 mg) per 2 months

Medical justification required for requests exceeding 3 implants per year for seasonal coverage in applicable lines of business.

Other Diagnoses/Indications

Other Diagnoses/Indications (must meet 1 or 2):

ANY of the following

For uses covered by the applicable formulary/PDL, refer to the no-coverage criteria policy for the relevant line of business (eg, CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP.PMN.255 for Medicaid).
For uses not on the formulary/PDL, refer to the non-formulary policy for the relevant line of business (eg, CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP.PMN.16 for Medicaid).
If the requested use (diagnosis, age, dosing regimen) is not specifically listed under Diagnoses/Indications for which coverage is NOT authorized and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (eg, CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Documentation Required

Dermatology exam requirement for continuation

For continued therapy, the member must have received a full skin examination by a dermatologist within the last six months to support continuation of therapy.

Billing Rule

Dosing/administration device

The Scenesse implant must be administered by a trained healthcare professional via subcutaneous implantation above the anterior supra-iliac crest every 2 months. Use the SFM Implantation Cannula or other manufacturer-recommended implantation devices. Dose limit: one 16 mg implant every 2 months.

Denial Risk

Exclusionary conditions increase denial risk

Requests for members with the following exclusionary conditions may be denied: personal history of melanoma or dysplastic nevus syndrome; current Bowen's disease, basal cell carcinoma, or squamous cell carcinoma; significant EPP/XLP-associated liver disease. Presence of any of these conditions increases risk of denial.

Personal history of melanoma or dysplastic nevus syndrome
Current Bowen's disease, basal cell carcinoma, or squamous cell carcinoma
Significant EPP/XLP-associated liver disease

11.16.21Annual Review

1Q 2022 annual review: no significant changes; references reviewed and updated.

10.22.20Annual Review

1Q 2021 annual review: no significant changes; coding implications and references updated.