Hyftor - NC Standard

Restricted Product(s)

• HyftorTM (sirolimus) topical gel 0.2%

FDA Approved Use

• For the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient is 6 years of age or older; AND
2. The patient has been diagnosed with tuberous sclerosis complex (TSC) (medical documentation required); AND
3. ALL of the following:
   1. The patient has 3 or more papules of angiofibroma on the face (medical documentation required); AND
   2. The angiofibromas must be ≥ 2 mm in diameter with redness in each (medical documentation required); AND
   3. The patient is not a candidate for laser therapy or surgery; AND
4. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., dermatologist); AND
5. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 90 days (3 months)

Continuation Coverage

1. The patient has been previously approved for Hyftor with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced clinical benefit since initiation of therapy (e.g., reduction in size and redness of facial angiofibroma) (medical record documentation required); AND
3. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
4. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., dermatologist).
   
   Duration of Approval: 365 days (1 year) 

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

February 2025: Criteria update: Clarified requirement of medical record documentation and allow attestation if patient is not a candidate for laser therapy or surgery. Added P&T statement.

August 2022: Original utilization management criteria issued.