CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Scenesse (afamelanotide) Implant

Medical benefit coverage and prior authorization requirements for Scenesse (afamelanotide) implant for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyScenesse (afamelanotide) Implant

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date08/01/2020

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming age ≥18, baseline full body skin exam showing no malignant or premalignant lesions, definitive EPP diagnosis, and intended use to increase pain-free light exposure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+min age

6 moinitial duration

12 mocontinuation

1 q2modosing

J7352billing code

Coverage Criteria for Scenesse (afamelanotide) implant

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Initial Therapy (EPP)

Covered when ALL of the following are met

EPP initial coverage criteria: Patient is 18 years or older; AND 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) as evidenced by a baseline full body skin examination for pre-existing skin lesions; AND patient has a definitive diagnosis of erythropoietic protoporphyria confirmed by elevated free protoporphyrin in peripheral erythrocytes and/or identification of pathogenic FECH variants on molecular genetic testing; AND used to increase the pain-free light exposure in patients with a history of phototoxic reactions; AND patient will continue to maintain sun and light protection measures during treatment to prevent phototoxic reactions

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

Continuation of Therapy

Continuation of therapy covered when ALL of the following are met

Continuation criteria: Patient meets initial criteria; AND absence of unacceptable toxicity from the drug (examples of unacceptable toxicity include severe skin darkening); AND disease response as evidenced by increased pain-free time during light exposure and/or a decrease in the number of phototoxic reactions; AND patient is monitored with full body skin examinations for pre-existing or new lesions

Coverage for Scenesse (afamelanotide) is limited to the FDA‑approved indication of erythropoietic protoporphyria (EPP) and is provided only when the clinical prior authorization criteria are met. Therapies used at a dose or for a condition other than recognized, medically accepted indications are considered investigational and not covered. Neighborhood does not provide coverage for drugs when used for investigational purposes, including uses not supported by standard reference compendia or peer‑reviewed literature.

Continuation Criteria

Continuation

Continuation of therapy requirements

Continuation: Patient meets initial criteria; AND absence of unacceptable toxicity; AND evidence of clinical benefit (increased pain-free light exposure or decreased number of phototoxic reactions); AND ongoing monitoring with full body skin examinations

Coverage duration for continuation: 12 months

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Coverage of Scenesse (afamelanotide) is reviewed prospectively via Neighborhood Health Plan of Rhode Island's prior authorization process. Requests must be submitted and approved before administration to avoid potential non-payment.

Submit prior authorization before administration
Approval required for coverage under the medical benefit

Step Therapy

Step Therapy Exception for Medicare Members

Step therapy exemption applies for Medicare continuity of care. Medicare members who have received afamelanotide within the prior 365 days are exempt from step therapy requirements.

Applies only to Medicare members with documented receipt within the past 365 days

Documentation Required

Required clinical documentation must accompany prior authorization requests. Include evidence supporting diagnosis and baseline assessment to confirm safety for treatment.

Baseline full body skin examination documenting absence of malignant or premalignant lesions
Laboratory documentation of elevated free protoporphyrin in erythrocytes and/or molecular genetic testing showing pathogenic FECH variants
Age documentation (patient ≥ 18 years)
Plan for continued sun/light protection and monitoring with periodic full body skin examinations during therapy

Denial Risk

Noncompliant Use May Be Denied

Noncompliant use may be denied. Use outside the stated indications, dose, or administration schedule (including investigational uses) may result in denial or non-payment unless an exception is approved.

Approved dose for EPP: 1 implant every 2 months; Maximum billed = 16 units (1 mg = 1 billable unit) every two months
Investigational or off-label indications and non-standard dosing are not covered without exception approval

Definitions

Erythropoietic Protoporphyria (EPP)

DefinitionErythropoietic protoporphyria (EPP) is a genetic porphyria causing painful phototoxic reactions to sunlight; diagnosis is confirmed by elevated free protoporphyrin in peripheral erythrocytes and/or identification of pathogenic FECH gene variants.

Key diagnostic criteriaDefinitive diagnosis confirmed by elevated free protoporphyrin in erythrocytes and/or pathogenic FECH variants on molecular testing.

Clinical featuresHistory of phototoxic reactions with painful responses to sunlight exposure; treatment aim is to increase pain-free light exposure.

Safety screeningBaseline full body skin examination required to document absence of malignant or premalignant skin lesions prior to treatment.

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