CurrentMass General Brigham Health PlanPolicy N/A

Hyftor (sirolimus topical) — Prior Authorization (Pharmacy Benefit)

Defines prior authorization rules for Hyftor (topical sirolimus) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including eligibility, renewal, and specialty dispensing requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHyftor (sirolimus topical) — Prior Authorization (Pharmacy Benefit)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis and patient age; specialty pharmacy dispensing required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 yrsminimum patient age for coverage

3 moinitial approval duration

6 moreauthorization duration

Pharmacybenefit type

PAprogram type

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inv-01: Initial Therapy — Authorization may be granted if ALL of the following are met

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

Initial Authorization Criteria: 1. The member has a diagnosis of facial angiofibroma associated with tuberous sclerosis; 2. The member is > 6 years of age.

Documentation must be submitted showing diagnosis and age

inv-02: Continuation Therapy — Reauthorization may be granted when the following is met

Reauthorization may be granted when the following is met:

Reauthorization Criteria: Physician has submitted clinical documentation demonstrating clinical response to therapy.

Initial criteria must have been met previously

Authorization exclusions: members new to the plan will not be authorized when the product was obtained as samples or through the manufacturer’s patient assistance programs. Requests for new enrollees who are currently receiving Hyftor may be considered only when the medication was not sourced via samples or a manufacturer assistance program.

Initial Therapy

inv-10: Initial Therapy — Initial authorization terms

Initial authorization terms

Initial Authorization: Diagnosis of facial angiofibroma associated with tuberous sclerosis; patient >6 years; initial approval granted for 3 months

Specialty pharmacy dispensing required

Continuation of Therapy

inv-11: Continuation of Therapy — Reauthorization criteria and duration

Reauthorization

Reauthorization: Clinical documentation of clinical response submitted by the physician

Reauthorization duration: up to 6 months; initial criteria must have been met

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required (pharmacy benefit)

Prior authorization is required under the pharmacy benefit; authorization may be granted if the member has a diagnosis of facial angiofibroma associated with tuberous sclerosis and is older than 6 years.

Step Therapy

No step therapy required

No step therapy requirements are specified in this policy.

Documentation Required

Required clinical documentation

Clinical documentation must include the diagnosis of facial angiofibroma associated with tuberous sclerosis, the patient’s age (>6 years), and for reauthorization a physician-submitted statement documenting clinical response to therapy.

Denial Risk

New-to-plan enrollment restriction — potential denial

Requests may be denied for members new to the plan who are not currently receiving Hyftor; exceptions apply when the product was obtained as samples or through the manufacturer's patient assistance programs.

Key Definitions

inv-09: Facial angiofibroma associated with tuberous sclerosis — definition and relation to indication

DefinitionBenign skin lesions on the face that occur as a manifestation of tuberous sclerosis complex (facial angiofibroma); target indication for topical sirolimus (Hyftor).

Indication relationHyftor (topical sirolimus) is indicated for treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

Age thresholdApproved for patients aged 6 years and older.

Clinical contextFacial angiofibromas are benign but cosmetically and functionally significant lesions that are the specific treatment target for topical sirolimus in this policy.

Background

Hyftor (topical sirolimus) is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients aged 6 years and older. This policy applies to outpatient pharmacy dispensing under the pharmacy benefit and requires prior authorization; Hyftor is managed as a designated specialty medication and must be dispensed through a contracted specialty pharmacy.