CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cmp_Scenesse_20250521

Policy governs coverage of Scenesse (afamelanotide) implant (J7352) under Medical Benefit for Medicaid, Commercial, and Medicare members (Medicare only in absence of NCD/LCD), including prior authorization, clinical criteria for initiation and continuation, dosing, and billing code.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_Scenesse_20250521

Policy CodePolicy N/A

Change Typeclarified

Effective DateAug 1, 2020

Next Review Date

Key ActionCoverage of Scenesse will be reviewed prospectively via the prior authorization process; requests must meet all criteria in the procedure section.

SourceLink

POLICY UPDATE CHANGES

Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

1Covered Indication (EPP)

18+Minimum Age

6 moInitial Coverage Duration

12 moContinuation Coverage

Coverage Summary

Scope: This policy governs coverage of Scenesse (afamelanotide) implant (HCPCS/CPT code J7352) under the Medical Benefit for Medicaid, Commercial, and Medicare members (Medicare application is only in the absence of an NCD/LCD). Coverage stance: covered_with_criteria. Brief indication summary: covered for treatment of erythropoietic protoporphyria (EPP) to increase pain-free light exposure in patients with a history of phototoxic reactions. Age requirement: >= 18 years.

Quick policy thresholds

Minimum age>= 18 years

Initial coverage duration6 months

Continuation coverage duration12 months

Medicare prior exposure exceptionMedicare members who previously received this medication within the past 365 days are not subject to Step Therapy Requirements

Initial Therapy - Erythropoietic Protoporphyria (EPP)

Covered when ALL of the following are met:

ALL of the following

Age: Patient must be 18 years or older>= 18 years
Skin lesion exclusion: Patient does not have any malignant or premalignant skin lesions (e.g., melanoma, dysplastic nevus syndrome, Bowen's disease, basal cell or squamous cell carcinomas, etc.) as evidenced by a baseline full body skin examination for pre-existing skin lesions
Baseline full body skin exam required
Definitive diagnosis
- Diagnostic confirmation (ANY of): Confirmed by elevated free protoporphyrin in peripheral erythrocytes
- Diagnostic confirmation (ANY of): Confirmed by identification of pathogenic variants in ferrochelatase (FECH) on molecular genetic testing
Treatment intent: Used to increase the pain free light exposure in patients with a history of phototoxic reactions
Risk mitigation: Patient will continue to maintain sun and light protection measures during treatment to prevent phototoxic reactions

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title": "Initial Therapy - Erythropoietic Protoporphyria (EPP)"}

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Provider Actions & Requirements

Prior Authorization

Prior authorization required

Coverage of Scenesse will be reviewed prospectively via the prior authorization process; requests must meet all criteria in the procedure section.

J7352

Documentation Required

Baseline full body skin examination

Document baseline full body skin examination demonstrating no malignant or premalignant skin lesions prior to initiation.

J7352

Documentation Required

Diagnostic confirmation documentation

Provide laboratory evidence of elevated free protoporphyrin in peripheral erythrocytes and/or molecular genetic testing showing identification of pathogenic variants in ferrochelatase (FECH).

J7352

Documentation Required

Monitoring during therapy

Document continued full body skin examinations for pre-existing or new lesions and record clinical response (increased pain-free light exposure and/or decreased phototoxic reactions); document absence of unacceptable toxicity.

J7352

Billing Rule

Dose and billing unit

Dose for EPP is 1 implant every 2 months. Maximum dose = 16 units every two months (1 billable unit = 1 mg).

J7352
1 billable unit = 1 mg; maximum 16 units every two months

Clinical Evidence

Evidence: Scenesse [package insert], Clinuvel, Inc., August 2024. Clinical review summary: Trials showed significant reductions in the number and severity of phototoxic reactions and improvements in patient-reported outcomes (including pain and quality of life measures). Background adverse reactions reported include implant-site reaction, nasopharyngitis, and hyperpigmentation.

Background

Scenesse is a subcutaneously administered synthetic analog of endogenous alpha-melanocyte-stimulating hormone (α-MSH) that activates the melanocortin 1 receptor, resulting in increased production of eumelanin pigment in the skin. Clinical trials demonstrated reductions in the number of phototoxic reactions and the severity of pain experienced by patients with erythropoietic protoporphyria following sunlight exposure.

Revision History

2020-08-01policy_effective

Policy effective date 2020-08-01.

2024-01-04policy_review

Policy last reviewed on 2024-01-04.

clarified

Applies only to Medicare members; coverage criteria otherwise apply in absence of NCD/LCD. Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_Scenesse_20250521

Policy CodePolicy N/A

Change Typeclarified

Effective DateAug 1, 2020

Next Review Date

Key ActionCoverage of Scenesse will be reviewed prospectively via the prior authorization process; requests must meet all criteria in the procedure section.

SourceLink

On This Page

OpenPayer

Cmp_Scenesse_20250521

Coverage Summary

Initial Therapy - Erythropoietic Protoporphyria (EPP)

Continuation Therapy Criteria

Unproven Uses & Definitions

Provider Actions & Requirements

Applicable Codes

Clinical Evidence

Background

Revision History