CurrentMass General Brigham Health PlanPolicy N/A

Scenesse (afamelanotide)

Medical-benefit prior authorization policy governing coverage of Scenesse (afamelanotide) implants for adult members with erythropoietic protoporphyria under the MassHealth plan; defines initial and continuation criteria, prescriber and site requirements, dosing expectation, and approval durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyScenesse (afamelanotide)

Policy CodePolicy N/A

Change TypeReviewed and updated for P&T; formatting and references updated

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization through the MassHealth medical-benefit prior authorization process and submit documentation meeting all initial criteria including diagnosis, prescriber specialty or dermatologist consultation notes, treatment site documentation, and dosing plan.

SourceLink

POLICY UPDATE CHANGES

Reviewed and updated for P&T; formatting and references updated.

Policy created for P&T and matched to MassHealth UPPL.

1Covered Indication

>=18Minimum age (years)

2 monthsInitial approval duration

6 monthsReauthorization duration

Coverage Summary

Coverage: Scenesse (afamelanotide) implants are covered with criteria under the MassHealth medical benefit. This policy requires prior authorization and applies to adults with erythropoietic protoporphyria (EPP).

Authorization requires meeting all initial criteria including diagnosis of EPP, age ≥18, dermatologist prescriber or consultation notes, documentation that the implant will be placed at a specialized treatment center, and appropriate dosing (e.g., one implant every two months). Initial approvals are granted for 2 months; reauthorizations up to three implants for 6 months.

Key thresholds and quick facts

Covered Indication1 (covered indication)

Minimum age>=18 years

Initial approval duration2 months

Reauthorization duration6 months (up to 3 implants)

Dosing intervalone implant every two months

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL the following criteria are met, and documentation is provided:

Diagnosis of erythropoietic protoporphyria
Age: Member is ≥18 years of age>=18 years
Prescriber is a dermatologist or consultation notes from a dermatologist are provided
Treatment site: Documentation that the implant procedure will be performed at a specialized treatment center (e.g., dermatology, surgeon)

Continuation Therapy / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Reauthorization criteria:

Reauthorization requested by prescriber
Clinical response: Prescriber reauthorization will infer a positive response to therapy
Approval durations: initial approvals 2 months; reauthorizations up to three implants for 6 months (operational expectation)

Case-by-Case Review for Members New to Plan

Coverage for members new to the plan currently receiving treatment

Case-by-case review:

New to plan receiving treatment: Authorization may be reviewed on a case by case basis for members new to the plan who are currently receiving treatment with Scenesse
Exclusions: Excludes instances when the product was obtained as samples or via manufacturer's patient assistance programs

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for medical benefit Scenesse

Prior authorization is required for Scenesse (afamelanotide) when billed as a medical-benefit implant under MassHealth. Obtain prior authorization through the MassHealth prior authorization process (Medical Benefit contact: Phone 833-895-2611; Fax 888-656-6671). Submit documentation that meets the initial authorization criteria: diagnosis of erythropoietic protoporphyria, member age ≥18 years, prescriber specialty or dermatologist consultation notes, documentation that the implant will be performed at a specialized treatment center, and an appropriate dosing plan (e.g., one implant every two months).

Diagnosis of erythropoietic protoporphyria
Member is ≥18 years of age
Prescriber is a dermatologist or provide dermatologist consultation notes
Documentation that implant will be performed at a specialized treatment center
Dosing plan (e.g., one implant every two months)

Applicable Codes

HCPCS / Medical benefit coding (not specified in policy)mixed

No codes listed

Clinical Evidence & References

Evidence and references available for Scenesse include the product package insert and published trial literature.

Key sources: Scenesse [package insert], Clinuvel Inc.; 2024 Aug.; Langendonk JG et al., N Engl J Med. 2015;373(1):48-59.

Background & Definitions

Background: Scenesse (afamelanotide) is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria.

Policy context: This document governs Scenesse as a medical-benefit implant under MassHealth, requiring prior authorization and specifying prescriber, site, age, diagnosis, and dosing requirements for approval.

Definitions

Specialized treatment centerExample settings such as dermatology clinic or surgeon where implant procedure will be performed.

Revision History

2023-04-01created

Initial creation effective 4/1/23. Policy created for P&T and matched to MassHealth UPPL.

2025-06-01revisedLatest

Effective date updated to 6/1/25; reviewed and updated for P&T; formatting and references updated; no clinical policy statement changes.

Policy Summary

PayerMass General Brigham Health Plan

PolicyScenesse (afamelanotide)

Policy CodePolicy N/A

Change TypeReviewed and updated for P&T; formatting and references updated

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Specialized treatment center examples: dermatology clinic or surgeon

Dosing: Appropriate dosing (e.g. one implant every two months)one implant every two months

Documentation Required

Documentation of treatment site and prescriber specialty

Provide documentation that the implant procedure will be performed at a specialized treatment center (for example, dermatology clinic or surgeon) and that the prescriber is a dermatologist. If the prescriber is not a dermatologist, include consultation notes from a dermatologist to meet the prescriber-specialty requirement.

Documentation of specialized treatment center (e.g., dermatology clinic, surgeon)
Prescriber is a dermatologist OR dermatologist consultation notes

Documentation Required

Documentation for members new to plan

For members new to the plan who are already receiving Scenesse, submit case-by-case documentation of ongoing treatment to support authorization. Do not rely on samples or medications obtained through the manufacturer's patient assistance programs; those instances are excluded from case-by-case consideration.

Case-by-case documentation of ongoing Scenesse treatment for members new to the plan
Excludes products obtained as samples or via manufacturer's patient assistance programs

Prior Authorization

Approval durations and reauthorization expectations

Initial approvals are granted for 2 months. Reauthorizations may be granted for up to three implants covering a 6-month period. Reauthorization requests must be submitted by the prescriber and will infer a positive clinical response to therapy.

Initial approval duration: 2 months
Reauthorization: up to three implants for 6 months
Prescriber reauthorization will infer positive response