CurrentCignaPolicy N/A

Dermatology - Hyftor Prior Authorization Policy

Cigna prior authorization policy for prescription benefit coverage of Hyftor (sirolimus 0.2% topical gel) for treatment of facial angiofibroma associated with tuberous sclerosis complex in patients aged ≥6 years, including initial and continuation criteria, duration of approval, and non-covered uses.

Policy Summary

PayerCigna

PolicyDermatology - Hyftor Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document definitive diagnosis of tuberous sclerosis complex and prescriber specialty; approvals issued for initial (3 months) and continuation (1 year) durations.

POLICY UPDATE CHANGES

Annual Revision noted: No criteria changes as of review date 06/05/2024

1FDA-approved indication(s) covered

≥6Minimum age (years)

3Minimum facial lesions required

3mo / 1yrApproval durations (initial / continuation)

Coverage Summary

Cigna prior authorization policy covers Hyftor (sirolimus 0.2% topical gel) for the FDA‑approved indication of facial angiofibroma associated with tuberous sclerosis complex in patients aged ≥ 6 years. Coverage is covered_with_criteria and requires meeting the policy's initial or continuation criteria (including diagnosis verification, lesion count/size/redness, and prescriber specialty) for approval durations noted in the policy.

Medically Necessary - FDA-Approved Indication: Facial Angiofibroma Associated with Tuberous Sclerosis

Approve when ONE of the following (A or B) is met:

A) Initial Therapy

Patient is ≥ 6 years of age
Patient has a definitive diagnosis of tuberous sclerosis complex by meeting ONE of the following (a or b)
- a) Genetic testing: There is identification of a pathogenic variant in the tuberous sclerosis complex 1 (TSC1) gene or tuberous sclerosis complex 2 (TSC2) gene by genetic testing
- b) Clinical diagnostic criteria: According to the prescriber, clinical diagnostic criteria suggest a definitive diagnosis of tuberous sclerosis complex by meeting either two major features or one major feature with two minor features
  Major and minor feature examples listed in policy (e.g., angiofibroma: three or more; hypomelanotic macules; etc.)
Patient has three or more facial angiofibromas that are at least 2 mm in diameter with redness in each
Medication is prescribed by or in consultation with a dermatologist or a physician who specializes in the management of patients with tuberous sclerosis complex

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Hyftor. All approvals are provided for the duration noted below. Because of the specialized skills required for evaluation and diagnosis of patients treated with Hyftor as well as the monitoring required for adverse events and long-term efficacy, approval requires Hyftor to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Initial: 3 months
Continuation: 1 year

Documentation Required

Diagnosis verification and prescriber specialty

Document definitive diagnosis of tuberous sclerosis complex by genetic testing or prescriber-determined clinical diagnostic criteria; medication must be prescribed by or in consultation with a dermatologist or physician who specializes in tuberous sclerosis.

Acceptable evidence: identification of a pathogenic variant in TSC1 or TSC2 by genetic testing OR prescriber-determined clinical diagnostic criteria (two major features or one major feature with two minor features)

Documentation Required

Clinical response for continuation

For continuation approvals, document prescriber-determined response evidenced by reduction in the size and/or redness of the facial angiofibromas.

Clinical response is defined as reduction in size and/or redness of the lesions as determined by the prescriber

Clinical Evidence

n=62Pivotal trial size

12 weeksPrimary endpoint timeframe

A Phase III randomized, double‑blind, vehicle‑controlled multicenter trial (n=62) in patients ≥6 years demonstrated that Hyftor reduced facial angiofibroma lesion size and redness after 12 weeks versus vehicle; assessment after 4 weeks off treatment suggests that continued therapy is needed to maintain benefit.

Background & Definitions

Hyftor (sirolimus 0.2% topical gel) is a topical mTOR (mammalian target of rapamycin) inhibitor indicated for treatment of facial angiofibroma associated with tuberous sclerosis complex in patients ≥ 6 years of age. Efficacy was demonstrated in a Phase III randomized trial showing reductions in lesion size and redness at 12 weeks; assessments after discontinuation indicate that ongoing treatment is required to sustain benefit.

Definitive diagnosis of tuberous sclerosis complex may be established by genetic testing showing a pathogenic variant in TSC1 or TSC2, OR by prescriber‑determined clinical diagnostic criteria equating to either two major features or one major feature plus two minor features (major/minor feature examples are listed in the policy).

Thresholds

Minimum age≥ 6 years

Lesion requirementThree or more facial angiofibromas ≥ 2 mm in diameter with redness in each

Approval durationsInitial: 3 months; Continuation: 1 year