Targretin - NC Standard

Restricted Product(s)

Restriction applies to brand and generic

• Targretin® (bexarotene)

FDA Approved Use

• For the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age of older; AND 
3. The dose requested is according to FDA approved labeling; AND 
4. The patient is being managed by or in consultation with an oncologist; AND 
5. If the request is for brand Targretin,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic bexarotene (medical record documentation required); AND 
6. The patient has been diagnosed with cutaneous T-cell lymphoma (medical record documentation required); AND 
7. The patient is having cutaneous manifestations (medical record documentation required); AND 
8. The patient is refractory to at least one prior systemic therapy (medical record documentation required); AND 
9. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND 
10. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval: 365 days (1 year)

References

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

Policy Implementation/Update Information

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. Added medical record documentation required for diagnosis and cutaneous manifestations.
March 2020: Criteria change: Reformatted criteria. Allow for approval if currently taking for a cancer diagnosis.
October 2018: Annual review; No change.
January 2017: Original utilization management criteria issued.