CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bexarotene Targretin 1795 A Sgm P2023

Defines covered indications (FDA-approved and compendial) for oral bexarotene (Targretin) capsules and topical bexarotene 1% gel, authorization durations, and continuation criteria for members when approval criteria are met and no exclusions exist. Declares all other indications experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBexarotene Targretin 1795 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionRequest prior authorization for up to 12 months for covered indications and document that the member meets criteria and has no exclusions; for reauthorization, document no unacceptable toxicity and no disease progression.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

FDA & compendialCovered Indications

12 monthsTypical Authorization Duration

Other indicationsNot Medically Necessary

Coverage Summary

Defines covered indications for oral bexarotene (Targretin) capsules and topical bexarotene 1% gel (Targretin and generics). Coverage stance: covered_with_criteria — FDA-approved and compendial indications are covered provided all approval criteria are met and the member has no exclusions. Authorization durations and continuation/reauthorization criteria are specified (typically 12 months where applicable). All other indications are considered experimental/investigational and not medically necessary.

Covered Indications - FDA-Approved and Compendial

The indications below (FDA-approved and compendial) are covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy.

Either oral capsules or topical gel as applicable

Oral Targretin/bexarotene capsules - FDA indication
- Indicated for treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy
Topical Targretin/bexarotene gel - FDA indication
- Indicated for 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
Compendial uses for oral capsules
- Mycosis fungoides (MF)
- Sézary syndrome (SS)
- Examples of primary cutaneous CD30+ disorders
  - Primary cutaneous anaplastic large cell lymphoma (ALCL)
  - Lymphomatoid papulosis (LyP)
Compendial uses for topical gel
- Mycosis fungoides (MF)
- Sézary syndrome (SS)
- Chronic or smoldering adult T-cell leukemia/lymphoma (ATLL)
- Examples of primary cutaneous B-cell lymphoma
  - Primary cutaneous marginal zone lymphoma
  - Primary cutaneous follicle center lymphoma

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Authorization Durations

Authorization durations specified per indication

ANY of the following

Mycosis Fungoides (MF)/Sézary syndrome (SS): Authorization of 12 months may be granted for treatment of Mycosis Fungoides (MF) or Sézary syndrome (SS)
Primary cutaneous ALCL/LyP: Authorization of 12 months may be granted for treatment of primary cutaneous ALCL or LyP as a single agent
Adult T-cell Leukemia/Lymphoma (ATLL): Authorization of 12 months may be granted for treatment of chronic or smoldering Adult T-cell Leukemia/Lymphoma (ATLL)
Primary Cutaneous B-cell Lymphoma: Authorization of 12 months may be granted for treatment of primary cutaneous marginal zone lymphoma or primary cutaneous follicle center lymphoma

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Continuation Therapy Criteria

Continuation of Therapy (Reauthorization)

Criteria for continued therapy reauthorization

ALL of the following

Requested reauthorization indication: Requested reauthorization is for an indication listed in Section II
Toxicity: No evidence of unacceptable toxicity while on the current regimen
Disease progression: No evidence of disease progression while on the current regimen
Authorization duration: Authorization of 12 months may be granted for continued treatment when above are met

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Provider Actions

Prior Authorization

Authorization required for covered indications

Authorization (prior approval) of up to 12 months may be granted for the listed indications; provider must request authorization and ensure the member meets a covered indication and has no exclusions.

Documentation Required

Reauthorization documentation

For continuation, provider must document absence of unacceptable toxicity and absence of disease progression on the current regimen to support 12-month reauthorization.

Clinical Evidence & References

References: Package inserts for Targretin and generic bexarotene formulations and the NCCN Drugs & Biologics Compendium were consulted. Specifically cited: Targretin capsules and gel package inserts and generic bexarotene package inserts, and The NCCN Drugs & Biologics Compendium (accessed January 3, 2023). FDA package inserts and the NCCN compendium were referenced as the primary sources for indications and compendial uses.

Background

Background: This policy applies to bexarotene oral capsules and topical 1% gel (Targretin and generics). The policy references FDA package inserts and the NCCN Drugs & Biologics Compendium for FDA-approved indications and compendial uses to define covered indications, authorization durations, and continuation criteria.