CurrentNeighborhood Health Plan of Rhode IslandPolicy 1795-A

Bexarotene (Targretin) — capsules and topical gel coverage criteria

Covers clinical indications, authorization durations, and continuation criteria for bexarotene (Targretin) oral capsules and topical gel for cutaneous T‑cell lymphomas and selected cutaneous lymphomas for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBexarotene (Targretin) — capsules and topical gel coverage criteria

Policy CodePolicy 1795-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionRequest authorization for up to 12 months when member meets listed approval criteria; capsules require prior systemic therapy trial for CTCL.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 motypical authorization period

capsules & gelformulations covered

CTCL & relatedprimary indications listed

NCCNcompendia referenced

Coverage Criteria for Bexarotene

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inv-01: Bexarotene capsules — covered indications

Covered when ALL of the following are met:

Capsules - CTCL: Member has cutaneous T-cell lymphoma (CTCL) and disease is refractory to at least one prior systemic therapy (e.g., mycosis fungoides or Sezary syndrome).

Based on FDA-approved indication for Targretin/bexarotene capsules.

inv-02: Bexarotene gel — covered indications

Covered when ALL of the following are met:

Gel - Topical CTCL: Member has cutaneous lesions of CTCL (Stage IA or IB) that are refractory or persistent after other therapies, or the member has not tolerated other therapies (topical use).

Based on FDA-approved indication for Targretin/bexarotene gel.

inv-03: Listed covered diagnoses

Covered for the following specific diagnoses when approval criteria are met:

Specific covered diagnoses: Mycosis fungoides; Sezary syndrome; subcutaneous panniculitis-like T-cell lymphoma; primary cutaneous CD30+ T-cell lymphoproliferative disorders (primary cutaneous anaplastic large cell lymphoma, lymphomatoid papulosis); smoldering adult T-cell leukemia/lymphoma; primary cutaneous marginal zone lymphoma; primary cutaneous follicle center lymphoma.

Authorization of 12 months may be granted for these diagnoses per policy.

Authorized Regimens and Durations

Regimen	Authorized Duration	Notes
Bexarotene oral capsules as single agent
12 months
For treatment of cutaneous T‑cell lymphoma (mycosis fungoides or Sézary syndrome); capsules indicated for patients refractory to prior systemic therapy per policy
Bexarotene oral capsules as single agent or in combination with prednisone
12 months
Specifically authorized for subcutaneous panniculitis‑like T‑cell lymphoma when used alone or with prednisone
Bexarotene topical gel (1%) as single agent
12 months
For cutaneous lesions of CTCL (e.g., Stage IA–IB) and related indications per FDA/compendial uses; used as single‑agent topical therapy
Bexarotene oral capsules as single agent for primary cutaneous ALCL or lymphomatoid papulosis
12 months
Authorized as single agent for primary cutaneous CD30+ T‑cell lymphoproliferative disorders
Bexarotene oral capsules for smoldering adult T‑cell leukemia/lymphoma
12 months
Authorization may be granted for smoldering ATLL
Bexarotene oral capsules for primary cutaneous B‑cell lymphomas (marginal zone or follicle center)
12 months
Authorization may be granted for primary cutaneous marginal zone lymphoma or primary cutaneous follicle center lymphoma

Line of Therapy / Prior Treatment Requirements

inv-13: second-line

Second-line (Capsules): Oral bexarotene (capsules) is indicated for CTCL in patients refractory to at least one prior systemic therapy.

Represents requirement that capsules are used after at least one prior systemic therapy (i.e., second-line use).

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization and reauthorization — Authorization of 12 months

Authorization of 12 months may be granted for listed indications; continuation also may be granted for 12 months when no unacceptable toxicity or disease progression is documented. Requests for indications not listed are considered experimental/investigational and not medically necessary.

Authorization length: 12 months for initial and reauthorization when criteria met
Not covered: indications not listed are experimental/investigational

Step Therapy

Prior systemic therapy requirement for capsules

Targretin (bexarotene) capsules require documentation of prior systemic therapy: capsules are indicated for treatment of CTCL (cutaneous T‑cell lymphoma) manifestations in patients who are refractory to at least one prior systemic therapy. Include documentation of the prior systemic therapy tried and inadequate response or intolerance.

Affected product: Targretin / bexarotene capsules
Requirement: refractory to ≥1 prior systemic therapy (document therapy and response/intolerance)

Documentation Required

Documentation and reauthorization

Ensure clinical documentation supports the requested indication and ongoing benefit. For continuation/reauthorization requests, document absence of unacceptable toxicity and lack of disease progression while on current regimen.

Include relevant clinical notes, treatment history, and response assessments
Reauthorization: document no unacceptable toxicity and no disease progression

Denial Risk

Not covered indications — experimental/investigational

Requests for indications not listed in the coverage criteria are considered experimental/investigational and are not medically necessary. Such requests are subject to denial.

Not covered: any indication not specified in the policy

Definitions and Related Indications

CTCL-related indications

Included CTCL-related diagnosesMycosis fungoides; Sézary syndrome; subcutaneous panniculitis‑like T‑cell lymphoma; primary cutaneous CD30+ T‑cell lymphoproliferative disorders (primary cutaneous ALCL, lymphomatoid papulosis); smoldering adult T‑cell leukemia/lymphoma; primary cutaneous marginal zone lymphoma; primary cutaneous follicle center lymphoma.

Oral capsule FDA indicationTargretin/bexarotene capsules: treatment of cutaneous manifestations of CTCL in patients refractory to at least one prior systemic therapy.

Topical gel FDA indicationTargretin/bexarotene gel: topical treatment of CTCL (Stage IA–IB) lesions that are refractory or persistent after other therapies or intolerant of other therapies.

Coverage stance for other indicationsAll other indications are considered experimental/investigational and not medically necessary.

Background

Bexarotene is indicated in both oral (capsules) and topical (1% gel) formulations for treatment of the cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL) and certain primary cutaneous lymphomas. Topical gel is used for CTCL skin lesions including mycosis fungoides (MF) and Sézary syndrome (SS), and the gel and/or oral formulations are also listed for other related diagnoses such as smoldering adult T‑cell leukemia/lymphoma (ATLL) and select primary cutaneous B‑cell lymphomas (primary cutaneous marginal zone lymphoma and primary cutaneous follicle center lymphoma).