Litfulo - NC Standard

Restricted Product(s)

• Litfulo™ (ritlecitinib) 

FDA Approved Use

• Indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older
• Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants

Criteria for Approval of Restricted Product(s)

Initial Coverage for Approval

1. The patient is 12 years of age or older; AND 
2. The patient has a confirmed diagnosis of severe alopecia areata with no other cause of hair loss; AND 
3. The patient has tried and failed or has a clinical intolerance/contraindication to a high potency topical corticosteroid in the last 6 months (medical record documentation required); OR 
4. The patient has tried and failed or has a clinical intolerance/contraindication to conventional oral immunosuppressant therapy (e.g., corticosteroid, methotrexate, azathioprine) in the last 6 months (medical record documentation required); AND 
5. The patient has at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) without evidence of terminal hair regrowth for more than 6 months; AND 
6. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent, Zeposia or Otezla; AND 
7. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents used for the same indication as the requested agent will be terminated; AND 
8. The patient does NOT have any FDA labeled contraindications to the requested agent; AND
9. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
10. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., dermatologist); AND 
11. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

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 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; AND 
3. 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 Q2 annually.

April 2025: Criteria change: Updated list of medications that requested med will NOT be used with in combination. Removed continuation of therapy criteria to align with other agent for alopecia areata. Removed medical record documentation requirement of percentage of hair loss. Updated to allow approval if patient has tried and failed either high potency topical corticosteroid OR Oral immunosuppressant therapy. Added statement that patient does not have any FDA labeled contraindications and TB testing requirement.

July 2023: Original utilization management criteria issued.