CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 1393-4

Hyftor® (sirolimus topical gel) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyHyftor® (sirolimus topical gel) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1393-4

Change TypeRevised (annual review updates)

Effective DateNov 16, 2025

Next Review Date

Key ActionPrior authorization/notification required; initial approval issued for 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

Effective date set to 11/16/2025 and initial authorization updated to 12 months during 9/2024 annual review.

2Required Clinical Criteria

12mInitial Authorization Duration

12mReauthorization Duration

Coverage Summary

Prior authorization/notification policy for Hyftor (sirolimus topical gel) for UnitedHealthcare Commercial Plans administered by Colorado Rocky Mountain Health Plans governing initial authorization and reauthorization criteria, approval durations, and additional clinical/billing rules. Coverage stance: covered_with_criteria. Effective date: 2025-11-16. Status: CURRENT. Indication: Hyftor is indicated for treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years and older.

Initial Therapy Criteria

Initial Authorization

Hyftor will be approved based on both of the following criteria:

ALL of the following

Diagnosis of tuberous sclerosis
Patient has facial angiofibroma associated with tuberous sclerosis

Prior Authorization

Prior authorization required

Prior authorization/notification required; initial approval issued for 12 months when criteria met.

Initial authorization duration: 12 months

Continuation / Reauthorization Criteria

Reauthorization

Hyftor will be approved based upon the following criterion:

ALL of the following

Documentation of positive clinical response to therapy (e.g., improvement in skin lesions)

Documentation Required

Reauthorization requirement

Reauthorization requires documentation of positive clinical response to therapy; reauthorization issued for 12 months when criterion met.

Positive clinical response: Documentation of improvement in skin lesions (example provided in policy).

Provider Actions

Documentation Required

Allow automated approval based on claims

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval/ re-approval processes varies.

Billing Rule

Supply limits may apply

Supply limits may be in place per program or benefit plan.

Prior authorization processing details: initial and reauthorization durations are 12 months. The initial authorization duration was updated to 12 months during the 9/2024 annual review (change effective date noted). Effective date of the policy is 2025-11-16. Diagnosis codes (ICD-10) may be used for automated approval decisions; diagnosis codes are referenced for processing although specific code groups are not listed.

Clinical Evidence & Definitions

Primary reference: Hyftor [package insert], Nobelpharma America, LLC; May 2025.

Positive clinical response: Documentation of improvement in skin lesions (example provided in policy).

Background

Hyftor (sirolimus topical gel) is an mTOR inhibitor indicated for treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. This policy applies to UnitedHealthcare Commercial Plans administered by Colorado Rocky Mountain Health Plans and governs prior authorization and reauthorization criteria, approval durations, and additional clinical and billing rules.