CurrentViva HealthPolicy IC-0512

Scenesse (afamelanotide) (Subcutaneous Implant)

Defines prior authorization, dosing, and coverage criteria for afamelanotide (Scenesse) subcutaneous implant for treatment of erythropoietic protoporphyria (EPP) for Viva Health members.

Policy Summary

PayerViva Health

PolicyScenesse (afamelanotide) (Subcutaneous Implant)

Policy CodePolicy IC-0512

Change TypeNo material clinical or coverage changes

Effective DateJan 3, 2020

Next Review DateMay 5, 2026

Key ActionObtain prior authorization: initial approvals valid for 6 months with renewals available every 12 months when renewal criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 mgimplant dose strength

16 units/2 mobilling units every 2 months

6 moinitial auth

12 morenewal auth

≥18minimum age

E80.0covered diagnosis

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial criteria: Member is at least 18 years of age; no malignant or premalignant skin lesions as evidenced by a baseline full body skin examination for pre-existing skin lesions; definitive diagnosis of erythropoietic protoporphyria (EPP) confirmed by either elevated free protoporphyrin in peripheral erythrocytes OR identification of biallelic pathogenic FECH variants on molecular genetic testing; used to increase pain-free light exposure in members with a history of phototoxic reactions; member will maintain sun and light protection measures during treatment.

FDA-approved indication

Continuation Therapy

Renewal granted when ALL of the following are met

Renewal criteria: Member continues to meet the indication-specific relevant criteria from Initial Therapy; absence of unacceptable toxicity (examples include serious hypersensitivity reactions such as anaphylaxis, severe skin darkening); disease response demonstrated by increased pain-free time during light exposure and/or decreased number of phototoxic reactions; member is monitored with full body skin examinations twice yearly for pre-existing or new pigmentary lesions.

Policy Summary

PayerViva Health

PolicyScenesse (afamelanotide) (Subcutaneous Implant)

Policy CodePolicy IC-0512

Change TypeNo material clinical or coverage changes

Effective DateJan 3, 2020

Next Review DateMay 5, 2026

Key ActionObtain prior authorization: initial approvals valid for 6 months with renewals available every 12 months when renewal criteria are met.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Validity

Prior authorization validity: Initial authorization is valid for 6 months (180 days). Renewals may be granted every 12 months (365 days) when renewal criteria are met.

Initial authorization: 6 months (180 days)
Renewal authorization: up to every 12 months (365 days) when renewal criteria are met

Step Therapy

Step Therapy / Utilization Management

Step therapy / utilization management: No step therapy requirements are specified. Prior authorization is applied primarily due to the drug cost and utilization management considerations.

No step therapy required
Prior authorization applied for utilization management primarily due to cost

Documentation Required

Required Documentation

Required documentation: Provide documentation to support the diagnosis and baseline assessment prior to initial approval, and ongoing monitoring documentation for renewals.

Baseline full body skin examination documenting absence of malignant or premalignant skin lesions
Diagnostic confirmation of erythropoietic protoporphyria by one of: elevated free protoporphyrin in peripheral erythrocytes OR identification of biallelic pathogenic FECH variants on molecular genetic testing
Documentation of history of phototoxic reactions and intent to use therapy to increase pain-free light exposure
Evidence that member will maintain sun and light protection measures during treatment
For renewals: documentation of disease response (increased pain-free time during light exposure and/or decreased phototoxic reactions) and monitoring notes including twice-yearly full body skin examinations
Documentation of absence of unacceptable toxicity (e.g., serious hypersensitivity, severe skin darkening)

Denial Risk

Triggers for Denial

Triggers for denial: Prior authorization may be denied when specified documentation or clinical criteria are not met.

Member is under 18 years of age
Baseline full body skin exam missing or documents malignant or premalignant skin lesions (e.g., melanoma, dysplastic nevus syndrome, Bowen's disease, basal cell or squamous cell carcinoma)
Missing definitive diagnostic confirmation for erythropoietic protoporphyria (no elevated free protoporphyrin and no confirmatory FECH testing)
No documentation of history of phototoxic reactions or lack of clinical rationale for therapy
Failure to document plan for ongoing sun and light protection measures
For renewals: lack of documentation of disease response or presence of unacceptable toxicity

Definitions

Erythropoietic protoporphyria (EPP)

DiseaseErythropoietic protoporphyria (EPP): a hereditary porphyria characterized by painful phototoxic reactions.

Covered diagnosis codeICD-10: E80.0 — Hereditary erythropoietic porphyria.

Diagnostic confirmation requiredDefinitive diagnosis confirmed by elevated free protoporphyrin in peripheral erythrocytes OR identification of biallelic pathogenic FECH variants.

Age requirementMember must be at least 18 years of age for coverage.

Scenesse implant — dosing and administration

Product and routeScenesse (afamelanotide) — single 16 mg subcutaneous implant.

Administration intervalInsert one 16 mg implant subcutaneously above the anterior supra-iliac crest every 2 months.

Provider requirementsMust be administered by a healthcare professional trained in the Scenesse implantation procedure; use the SFM Implantation Cannula.

Patient counselingMaintain sun and light protection measures during treatment to prevent phototoxic reactions.

OpenPayer

Scenesse (afamelanotide) (Subcutaneous Implant)

Coverage Criteria

Coding and Billing

Provider Actions and Requirements

Background

Definitions