CurrentMass General Brigham Health PlanPolicy N/A

Scenesse (afamelanotide) — Coverage Criteria (Erythropoietic Protoporphyria)

Policy governing prior authorization, quantity limits, and continuation criteria for Scenesse (afamelanotide) for adult members with erythropoietic protoporphyria under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyScenesse (afamelanotide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateFeb 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization with physician documentation confirming biochemically confirmed EPP, age >18, and elevated protoporphyrin in RBCs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

02/01/2021Policy effective

>18Min age

12 moApproval length

Case-by-caseTransfers in

Coverage Criteria

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Initial Authorization

Authorization may be granted when ALL of the following are met:

Initial Authorization: The member is using Scenesse for the treatment of biochemically confirmed erythropoietic protoporphyria.

Initial Authorization: The member is > 18 years of age.> 18 years

Initial Authorization: The physician provides documentation of increased level of protoporphyrin in peripheral red blood cells above the laboratory reference range.above lab reference range

Continuation of Therapy

Reauthorization requires ALL of the following:

Reauthorization: Physician documentation that the adult member is experiencing benefit from Scenesse.

Reauthorization: Approvals and reauthorizations will be granted for 12 months.12 months

Authorization review exclusions: prior authorization review does not apply when the product is obtained as samples or via the manufacturer's patient assistance programs.

Initial Therapy

Initial Therapy: Member has biochemically confirmed erythropoietic protoporphyria; member is >18 years old; documentation of increased protoporphyrin in peripheral red blood cells above the laboratory reference range.> 18 years; protoporphyrin above lab reference range

Continuation of Therapy

Reauthorization requires ALL of the following:

Reauthorization: Physician documentation that the adult member is experiencing benefit from Scenesse.

Duration: Reauthorizations granted for 12 months.12 months

Coding and Age

Covered CPT Codesmixed

No codes listed

Age

Minimum age> 18 years

Source contextAuthorization criteria list specifies member must be > 18 years of age.

Applies toInitial authorization and continuation criteria (adult members)

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Members new to the plan who are currently receiving Scenesse may be reviewed on a case-by-case basis; authorization may be granted only when documentation supports ongoing therapy (excludes product obtained as samples or via manufacturer patient assistance programs).

All plans: Phone: 877-519-1908; Fax: 855-540-3693
Non-specialty meds phone/fax: 800-711-4555 / 844-403-1029

Step Therapy

Step Therapy Note

Step therapy is listed as a program type for this product. No step-specific requirements are detailed in the policy; providers should confirm plan-specific step edits at time of authorization.

Documentation Required

Required Clinical Documentation

The physician must provide documentation that the member has biochemically confirmed erythropoietic protoporphyria and evidence of therapeutic benefit for continuation requests. Required confirmatory documentation includes lab results showing increased protoporphyrin in peripheral red blood cells above the laboratory reference range.

Diagnosis: biochemically confirmed erythropoietic protoporphyria
Lab: increased protoporphyrin in peripheral RBCs above lab reference range
Continuation: physician documentation of benefit for adult members

Denial Risk

Documentation Missing for Diagnostic and Age Criteria

Documentation missing for diagnostic and age criteria will result in denial risk. Specifically, absence of (1) documentation of biochemically confirmed erythropoietic protoporphyria, (2) evidence the member is >18 years of age, or (3) lab documentation of elevated protoporphyrin in peripheral RBCs may lead to authorization denial.

Member diagnosis not documented as biochemically confirmed EPP
Member age not documented as > 18 years
No lab documentation of elevated peripheral RBC protoporphyrin

Background

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

Coverage under this policy is for adults with biochemically confirmed EPP and requires documentation of elevated protoporphyrin levels in peripheral red blood cells; initial and reauthorization approvals are managed per the policy criteria and documentation requirements.

Definitions

Erythropoietic protoporphyria (EPP)

DefinitionErythropoietic protoporphyria (EPP) is a biochemical disorder causing phototoxic reactions.

Coverage requirementCoverage requires biochemical confirmation of EPP.

Diagnostic evidence requiredElevated protoporphyrin level in peripheral red blood cells above the laboratory reference range.

Indication contextScenesse is indicated to increase pain-free light exposure in adults with phototoxic reactions from EPP.

Step Therapy

Program Type	Step Details
Step Therapy	Step therapy is listed as a program type for Scenesse (afamelanotide), but no step-specific requirements or step details are provided in this document.

Quantity Limits

Scenesse (afamelanotide)

DrugScenesse (afamelanotide)

Drug classMelanocortin 1 receptor (MC1-R) agonist

Benefit/settingPharmacy benefit; specialty limitations N/A

Prior authorizationPrior authorization required; authorization granted when coverage criteria and documentation are met.

Site of Care

Note

Site of care: pharmacy benefit

Scenesse is provided under the pharmacy benefit; specialty limitations are listed as not applicable.