ModifiedmhnPolicy CP.PHAR.444

Clinical Policy: Afamelanotide (Scenesse)

Defines medical necessity criteria, authorization requirements, dosing and coding implications for Scenesse (afamelanotide) for adults with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP) for health plans affiliated with Centene.

Policy Summary

Payermhn

PolicyAfamelanotide (Scenesse) — Clinical Policy

Policy CodePolicy CP.PHAR.444

Change TypeMaterial clinical revisions and coding updates

Effective DateMar 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation confirming diagnostic test results, dermatologist involvement, age ≥18, treatment failures with sun avoidance/protective measures, and dosing limited to one 16‑mg implant every 2 months.

SourceLink

POLICY UPDATE CHANGES

Removed requirement for gene sequencing per consensus guidelines as not required for primary diagnosis and recommended as follow-up tests.

Added coding implications section and updated references to HIM.PA.154.

Appendix C updated with contraindications.

Age ≥ 18minimum age for coverage

16 mgimplant strength

every 2 monthsmaximum dosing interval

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gene sequencing removeddiagnostic requirement change

1Q 2025most recent annual review

Coverage Criteria

Requests for uses that are not FDA-approved and are not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the Health Plan's off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Coverage determinations under this clinical policy are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example: evidence of coverage, certificate of coverage, policy or contract). Providers must consult the applicable member coverage documents and Health Plan administrative policies when requesting authorization or submitting claims.

Therapeutic uses outside the documented indications in this policy that lack supporting evidence according to the Health Plan's off‑label use policies may be considered not medically necessary and may be denied.

This clinical policy is intended as a guide to medical necessity to assist with coverage decisions and administration of benefits; it is not a substitute for individualized medical judgment and does not constitute medical advice or a guarantee of payment.

Initial Therapy

inv-24: Initial Therapy — Initial therapy criteria for EPP/XLP

Initial therapy criteria for EPP/XLP

Initial therapy nodes: See Initial Approval Criteria: diagnostic confirmation via lab thresholds, dermatologist prescribing/consult, age ≥18, symptomatic acute non-blistering reactions, failure of sun avoidance/protective measures and pain meds, pain severity and QOL impact, absence of listed malignancy/liver disease, dosing limit of one 16 mg implant every 2 months.

Continuation Therapy

inv-26: Continuation Therapy — Requirements to continue therapy for EPP/XLP

Requirements to continue therapy for EPP/XLP

Continuation nodes: See Continued Therapy criteria: current therapy or prior initial criteria met; evidence of clinical response; full skin exam within 6 months; dose limit of one 16 mg implant every 2 months.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization before initiating treatment with Scenesse (afamelanotide) and follow the Health Plan's prior authorization processes and timelines.

Prior authorization required for initial and continuation therapy
Follow Health Plan administrative prior auth submission processes

Documentation Required

Required Documentation

Providers must submit office chart notes, relevant laboratory results, diagnostic testing (e.g., total erythrocyte protoporphyrin and erythrocyte fractionation), and any clinical questionnaires used (e.g., pain-intensity scale, DLQI or EPP-QoL) to document that the member meets all approval criteria.

Include documentation of diagnosis confirmation (elevated total erythrocyte protoporphyrin and ≥50% metal‑free fraction)
Include provider consultation notes (dermatologist) and evidence of moderate–severe pain and QOL impact

Coding and Billing

HCPCS CodesHCPCS

J7352

Afamelanotide implant, 1 mg

Coding Implications (references updated)mixed

No codes listed

Total erythrocyte protoporphyrin

TestTotal erythrocyte protoporphyrin: e.g., 300 to 5,000 mcg/dL (normal < 80 mcg/dL)

PurposeRequired as part of diagnostic confirmation for EPP/XLP initial approval

Laboratory guidanceUse certified laboratories (e.g., UTMB Porphyria Center, Mayo) for confirmatory testing

Erythrocyte fractionation

TestErythrocyte fractionation: ≥ 50% metal-free vs. zinc protoporphyrin

PurposeRequired alongside total erythrocyte protoporphyrin to confirm diagnosis of EPP/XLP

Step Therapy / Requirements

Requirement	Documentation / Notes
Sun avoidance and protective measures tried
Provider must document attempts at sun avoidance, regular use of sunscreen and protective clothing prior to initiating therapy

Quantity Limits

Afamelanotide (Scenesse) — Quantity limits

Quantity limitMedical justification required for requests beyond 3 implants per year (seasonal coverage)

Typical approval duration6 months (Medicaid/HIM and Commercial durations documented)

UnitImplant (16 mg strength per implant)

Background

Afamelanotide (Scenesse) is a melanocortin 1 receptor (MC1‑R) agonist indicated to increase pain‑free light exposure in adults with erythropoietic protoporphyria (EPP) or X‑linked protoporphyria (XLP). EPP/XLP are disorders that cause acute, non‑blistering cutaneous phototoxic reactions characterized by severe pain and reduced quality of life; treatment with afamelanotide is intended to reduce phototoxic symptoms and improve functional light exposure.

Definitions & Abbreviations

Abbreviations

DLQIDermatology Life Quality Index

QoLQuality of life

EPPErythropoietic protoporphyria

XLP / XLEPPX-linked protoporphyria / X-linked erythropoietic protoporphyria

Clinical policy definition

DefinitionClinical policy: a guide to medical necessity used to assist coverage decisions and administer benefits; not a guarantee of payment.

PurposeProvides criteria to assist in making coverage decisions and administering benefits

Site of Care

Note

Office administration by trained healthcare professional using manufacturer implantation cannula

Scenesse should be administered in an office setting by a trained health care professional proficient in subcutaneous implantation; implantation uses the SFM Implantation Cannula and the implant is inserted above the anterior supra‑iliac crest.

Office setting administration by trained clinician.
Implant location: subcutaneous insertion above the anterior supra‑iliac crest.

Revision History

2025-02-25annual_reviewLatest

Removed requirement for gene sequencing per consensus guidelines; references reviewed and updated.

2024-10-21annual_review_note

1Q 2024 annual review: references reviewed and updated.

2023-02-23annual_review

Policy Summary

Payermhn

PolicyAfamelanotide (Scenesse) — Clinical Policy

Policy CodePolicy CP.PHAR.444

Change TypeMaterial clinical revisions and coding updates

Effective DateMar 1, 2020

Next Review Date

SourceLink

On This Page

Attach prior conservative therapy documentation (sun avoidance, sunscreen, protective clothing, pain medication)

Denial Risk

Off‑Label Use Denial Risk

Requests for indications that are not FDA-approved and not addressed in this policy may be denied unless the provider supplies sufficient supporting evidence of efficacy and safety consistent with the Health Plan's off‑label use policies.

Non‑FDA approved indications require strong supporting clinical evidence per applicable off‑label policies
Lack of adequate off‑label documentation may result in denial

Documentation Required

Conservative Therapy Requirement

Before approval, the provider must document that conservative measures (sun avoidance, use of sunscreen and protective clothing, and pain management) have been tried and were inadequate to control EPP‑associated painful skin reactions.

Document specific conservative measures attempted and clinical response
Describe duration and adherence to conservative strategies

Laboratory guidanceFractionation should be performed by certified laboratories (e.g., UTMB Porphyria Center, Mayo)

N/A

N/ANo numeric threshold; not applicable in this policy context

NoteListed as N/A in coding thresholds — no additional threshold specified

ReferenceSee Coding Implications and thresholds sections for other required tests

LimitationsDoes not constitute a contract or guarantee regarding payment or results

Medicaid precedence

Medicaid precedenceFor Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy.

ActionRefer to the state Medicaid manual for applicable coverage provisions

ApplicabilityApplies only when there is a conflict between state Medicaid provisions and this clinical policy

1Q 2023 annual review: Appendix C updated with contraindications; references reviewed and updated.

2021-02-21annual_review

1Q 2021 annual review: added coding implications and revised internal references (HIM.PHAR.21 -> HIM.PA.154).