CurrentMass General Brigham Health PlanPolicy N/A

MassHealth UPPL

Policy Summary

PayerMass General Brigham Health Plan

PolicyMassHealth UPPL

Policy CodePolicy N/A

Change TypeClarified / Separated / Added

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization for Fyarro on the medical benefit; initial approvals are for 6 months and reauthorizations for 12 months, with documentation supporting diagnosis and appropriate dosing.

SourceLink

POLICY UPDATE CHANGES

Added Fyarro (sirolimus injection) to the policy criteria.

Separated out medical benefit policy for Fyarro while pharmacy policy is available on the MassHealth Drug List.

Updated reauthorization criteria language.

1Covered Indications

6 moInitial Approval Duration

12 moReauthorization Duration

Coverage Summary

This medical-benefit policy governs prior authorization, initial and continuation approvals, and quantity/coverage placement for Fyarro (sirolimus injection) for members covered under MassHealth UPPL (Mass General Brigham Health Plan) medical benefit. Coverage stance: covered_with_criteria. Indication: treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Effective date: 09/01/2025. Last review date: 08/13/2025.

Key Facts

Covered Indications1

Initial Approval Duration6 months

Reauthorization Duration12 months

Effective Date2025-09-01

Last Review2025-08-13

Initial Therapy Criteria

Initial Authorization

Authorization may be granted if the member meets ALL following criteria and documentation has been submitted:

ALL of the following

Diagnosis of locally advanced or metastatic malignant perivascular epithelioid cell tumor (PEComa)
Appropriate dosing

Continuation & Reauthorization Criteria

Continuation of Therapy / Reauthorization

Reauthorization by prescriber will infer a positive response to therapy:

ALL of the following

Prescriber attestation of positive clinical response on reauthorization

Case-by-Case / New-to-Plan Continuation

Authorization may be reviewed on a case by case basis

ANY of the following

Member is new to the plan and currently receiving treatment with the requested medication (excludes product obtained as samples or via manufacturer's patient assistance programs)

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required for Fyarro

Prior authorization is required for Fyarro on the medical benefit. Initial approvals will be granted for 6 months and reauthorizations will be granted for 12 months. Authorizations may be reviewed on a case-by-case basis for members who are new to the plan and currently receiving treatment with the requested medication (excluding product obtained as samples or via manufacturer's patient assistance programs).

Documentation Required

Required documentation

Documentation must support the diagnosis of locally advanced or metastatic malignant perivascular epithelioid cell tumor (PEComa) and that dosing is appropriate. Reauthorization by the prescriber will infer a positive clinical response to therapy and serves as evidence of benefit.

Background

Fyarro (sirolimus injection) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). The policy aligns medical-benefit prior authorization rules with the MassHealth UPPL and places Fyarro on the medical benefit while noting the product is also available on the pharmacy benefit per the MassHealth Drug List. Note: the medical-benefit policy for Fyarro was separated from the pharmacy policy (entry dated 09/11/24); this separation did not include clinical changes.

Definition

TermNew to the plan

DefinitionMember who recently enrolled and is currently receiving the requested medication prior to enrollment; excludes product obtained as samples or via manufacturer's patient assistance programs.

Clinical Evidence

No formal clinical evidence entries are included in the brief. Please populate the clinical evidence section with available studies, trials, efficacy and safety data, and relevant guidelines. If no clinical evidence is available, omit quantitative metric_cards.

Revision History

03/15/23material

Added Fyarro (sirolimus injection) to the policy; effective 4/1/23.

09/11/24separated

Separated out medical benefit policy for Fyarro; no clinical changes.

08/13/25clarifiedLatest

Updated reauthorization criteria language, effective 9/1/25.