TARGRETIN (bexarotene)

TARGRETIN (bexarotene)

Self-Administration - oral and topical

Indications for Prior Authorization:

• Targretin (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
• Targretin (bexarotene) Gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.

Coverage Criteria:

Capsules

For diagnosis of cutaneous T-cell lymphoma (CTCL):

• Dose does not exceed 400 mg/m2/day, AND
• Patient is 18 years of age or older, AND
• Chart note documentation provided confirms diagnosis of cutaneous T-cell lymphoma, AND
• Prescribed by or in consultation with an oncologist or dermatologist, AND
• Trial and failure, contraindication, or intolerance to at least one prior systemic therapy [e.g., brentuximab vedotin, methotrexate, interferons, etc]), AND
• For Brand Targretin® capsules only: Trial and failure, contraindication, or intolerance to generic Targretin® capsules

Gel

For diagnosis of cutaneous T-cell lymphoma (CTCL):

• Dose does not exceed applied up to four times per day, AND
• Patient is 18 years of age or older, AND
• Chart note documentation provided confirms diagnosis of cutaneous T-cell lymphoma, AND
• Prescribed by or in consultation with an oncologist or dermatologist, AND
• Disease manifestation is localized to skin only, AND
• Trial and failure, contraindication, or intolerance to at least one prior therapy (including skin-directed therapies [e.g., corticosteroids {i.e., clobetasol, diflorasone, halobetasol, augmented betamethasone dipropionate}, topical mechlorethamine, phototherapy, etc] or systemic therapies [e.g., brentuximab vedotin, methotrexate, interferons, etc]), AND
• For Brand Targretin® gel only: Trial and failure, contraindication, or intolerance to generic Targretin® gel

Reauthorization Criteria:

Capsules and gel:

For diagnosis of cutaneous T-cell lymphoma (CTCL):

• Dose does not exceed the following:
  • Capsules: 400 mg/m2/day
  • Gel: applied up to four times daily, AND
• Patient does not show evidence of disease progression while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Targretin® capsules: The recommended initial dose is 300 mg/m2/day.
• Targretin® gel should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day. Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside.
• Targretin® (bexarotene) is contraindicated in pregnancy.
• Warnings and Precautions: hyperlipidemia; pancreatitis; hepatotoxicity, cholestasis, and hepatic failure; hypothyroidism; neutropenia; cataracts; vitamin A supplementation hazard; hypoglycemia risk in patients with diabetes mellitus; photosensitivity; laboratory test monitoring; drug/laboratory test interactions-CA125 assay values in patients with ovarian cancer may be increased by Targretin® therapy.

Policy Updates:

• 11/15/2022 – Added criteria for Targretin gel only, must step through generic Targretin gel
• 11/16/2021 – New policy reviewed by P&T.

References:

• Targretin prescribing information. Bausch Health US, LLC. Bridgewater, NJ. April 2020.
• Targretin gel 1% prescribing information. Bausch Health US, LLC. Bridgewater, NJ. February 2020.
• National Comprehensive Cancer Network (NCCN). Primary cutaneous lymphomas v.2.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf. Accessed on July 1, 2021.