CurrentCignaPolicy IP0511

Hyftor

Defines prior authorization and medical necessity criteria for coverage of Hyftor (sirolimus 0.2% topical gel) for treatment of facial angiofibroma associated with tuberous sclerosis in patients aged ≥6 years for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHyftor

Policy CodePolicy IP0511

Change TypeAdded continuation criteriadocumentation requirements

Effective DateAug 15, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (diagnosis, lesion details, and response) and ensure Hyftor is prescribed by or in consultation with a specialist.

SourceLink

POLICY UPDATE CHANGES

Added 'Patient is currently Receiving Hyftor' criteria allowing approval for 1 year for current users.

Updated title from Sirolimus to Hyftor.

Added '[documentation required]' throughout policy.

Annual review performed on 9/1/2024 and 8/15/2025 per revision history.

1Covered Indication

6Minimum Age (years)

3Required facial angiofibromas

Coverage Summary

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Surface thresholds and quick facts

Covered IndicationFacial angiofibroma associated with tuberous sclerosis complex

Minimum patient age≥ 6 years

Facial angiofibroma lesion requirementThree or more facial angiofibromas ≥ 2 mm in diameter with redness in each

Pivotal evidencePhase III randomized, double‑blind, vehicle‑controlled trial (62 patients ≥6 years) showed reduction in lesion size and redness at 12 weeks

Initial approval durationApprove for 3 months (initial therapy)

Current user continuationPatient currently receiving Hyftor: approve for 1 year with documented response

Medical Necessity Criteria

Medical Necessity — FDA-Approved Indication

Hyftor is considered medically necessary when ONE of the following is met:

Not Covered / Not Medically Necessary

Hyftor for any other use is considered not medically necessary.

Not medically necessary: Use of Hyftor for indications other than facial angiofibroma associated with tuberous sclerosis complex in patients ≥ 6 years of age.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Hyftor; approvals provided for specified durations (initial: 3 months; continuing: 1 year for current users).

Initial approval duration: 3 months
Continuing/current user approval duration: 1 year

Documentation Required

Documentation must be supplied for diagnosis (genetic testing results or clinical diagnostic criteria), lesion count/size/redness, and response to therapy for continuation; acceptable documentation includes chart notes, lab or medical test results, claims records, prescription receipts.

Chart notes
Laboratory or medical test results
Claims records
Prescription receipts

Prior Authorization

Specialist Prescriber Requirement

Hyftor must be prescribed by or in consultation with a dermatologist or a physician who specializes in management of tuberous sclerosis complex.

Dermatologist or TSC specialist / consult required

Documentation Required

Duration and Re-evaluation

If symptoms do not improve within 12 weeks of Hyftor treatment, the need for continuing Hyftor should be reevaluated; continuation requires documented response (reduction in size and/or redness of facial angiofibromas).

Reassess at 12 weeks; documented response required for continuation

Clinical Evidence

n=62Pivotal trial size

12 weeksEndpoint assessment

Pivotal trial: A Phase III randomized, double-blind, vehicle-controlled study in 62 patients ≥6 years demonstrated reduction in lesion size and redness at 12 weeks.

Response reassessment: Assessment at 4 weeks after discontinuation suggests that continuation of therapy is required for maintained benefit.

Background

Hyftor (sirolimus 0.2% topical gel) is indicated for facial angiofibroma associated with tuberous sclerosis in patients ≥6 years; it is a topical mTOR inhibitor used to reduce the size and redness of facial angiofibromas, and clinical data indicate benefits may require continued therapy.

Definitions: Definitive diagnosis of tuberous sclerosis complex — Either identification of a pathogenic TSC1/TSC2 variant by genetic testing, or clinical diagnostic criteria with either two major features or one major plus two minor features.

Revision History

9/1/2024annual_review

Annual review performed (summary of changes: added 'Patient is currently Receiving Hyftor' criteria allowing approval for 1 year for current users).

8/15/2025annual_reviewLatest

Annual review performed (summary of changes: added '[documentation required]' throughout policy; administrative update of policy title to 'Hyftor'; policy effective date 8/15/2025).

2025-08-15administrative_updateLatest

Policy effective date updated to 8/15/2025 and policy title updated to 'Hyftor' (administrative title update).

criteria_addedLatest

Added continuation criteria 'Patient Currently Receiving Hyftor' allowing approval for 1 year for current users (requires documentation of response to Hyftor).

documentation_requirementLatest

Added explicit documentation requirement tags '[Documentation Required]' throughout policy for diagnosis, lesion characteristics, and response to therapy.

noteLatest

Administrative and operational guidance: Prior authorization required; approvals provided for specified durations (initial: 3 months; continuing: 1 year for current users); specialist prescriber requirement and examples of acceptable documentation.