Health Net bexarotene Coverage Update

Coverage and Medical Necessity Criteria

Initial Approval — Oral Capsules (CTCL)

Covered when ALL of the following are met

Initial oral capsule criteria: 1) Request is for bexarotene capsules; 2) Diagnosis of cutaneous T‑cell lymphoma (see Appendix D for CTCL subtypes); 3) Age > 18 years; 4) Prescribed by or in consultation with an oncologist; 5) For Targretin capsule requests, member must use generic bexarotene capsules unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 400 mg per day; 7) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN; OR b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Initial Approval — Topical Gel (Primary Cutaneous Lymphomas)

Covered when ALL of the following are met

Initial topical gel criteria: 1) Request is for bexarotene gel; 2) Diagnosis of CTCL or cutaneous B‑cell lymphoma (see Appendix D for CTCL and CBCL subtypes); 3) Age > 18 years; 4) Prescribed by or in consultation with an oncologist; 5) Disease manifestation is localized to skin only; 6) For Targretin gel requests, member must use generic bexarotene gel unless contraindicated or clinically significant adverse effects are experienced; 7) Dose does not exceed application of four times per day; 8) Request meets one of the following: a) Prescribed regimen is FDA‑approved or recommended by NCCN; OR b) Dose/regimen is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Initial Therapy — Initial therapy coverage requirements (group for initial therapy criteria)

Initial therapy coverage requirements

Initial therapy: See Initial Approval criteria for oral capsules and topical gel: diagnosis requirements, prescriber specialty (oncologist), age > 18 years, requirement to use generic product unless contraindicated or adverse effects occur, dosing limits (oral: do not exceed 400 mg/day; topical: do not exceed four times/day), and requirement that the prescribed regimen be FDA‑approved or recommended by NCCN or supported by practice guidelines/peer‑reviewed literature for off‑label uses (prescriber must submit supporting evidence).

Initial/topical dosing — Dosing initiation guidance for topical application

Dosing initiation guidance for topical application

Topical initiation: For topical therapy, apply once every other day for the first week; then increase application frequency at weekly intervals to once daily, then twice daily, then three times daily, and finally four times daily according to individual lesion tolerance.Topical maximum frequency: Four times daily

Initial/oral dosing — Oral dosing guidance

Oral dosing guidance

Oral dosing regimen: 300–400 mg/m2/day PO; maximum oral dose = 400 mg/m2/day (document also cites maximum oral dose as 400 mg/day for operational limits).max 400 mg/m2/day

Maximum oral dose also referenced operationally as 400 mg/day in approval criteria.

Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving medication via Centene benefit, or documentation supports that member is currently receiving bexarotene for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose must meet one of the following: a) New oral capsule dose does not exceed 400 mg/m2/day (operationally referenced as 400 mg/day); OR b) New topical dose does not exceed application four times per day; OR c) New dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 4) For continuation, member must use generic bexarotene unless contraindicated or clinically significant adverse effects are experienced.

inv-27: Continuation Therapy — Criteria for continued coverage

Criteria for continued coverage

Continuation: Member must have been on therapy for at least 30 days, be responding to therapy, and any dose increase must meet maximum dosing limits or be supported by practice guidelines or peer‑reviewed literature. Generic bexarotene must be used for continuation unless contraindicated or clinically significant adverse effects are experienced.

inv-28: Continuation Therapy — Continuation requirements noted in annual review language

Continuation requirements noted in annual review language

Continuation requirement: For continuation of Targretin (bexarotene capsule) therapy, the member must use generic bexarotene capsules as specified by the policy.

Added/clarified in 2Q 2022 and reiterated in later reviews.

Approval duration change for Medicaid/HIM: Medicaid/HIM continued approval duration changed from 6 months to 12 months per standard oncology approach.

2Q 2025 annual review.

Policy modifications affecting coverage and continuation — Key coverage-related policy modifications noted in this document portion

Key coverage-related policy modifications noted in this document portion

Generic requirement for continuation: For continuation of therapy with bexarotene capsules (Targretin), member must use generic bexarotene capsules.

Added/clarified in 2Q 2022 and reiterated in later reviews.

Inclusion of generic bexarotene in policy: Policy/criteria revised to include and emphasize generic bexarotene availability for capsule and gel formulations.

2Q 2024 annual review update.

Approval duration modification: Medicaid/HIM continued approval duration modified from 6 months to 12 months per standard oncology approach.

2Q 2025 annual review.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies. Refer to the off‑label policies for the member's line of business: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid). When a requested use is for a diagnosis, age, or dosing regimen not listed in this policy, follow the referenced off‑label or non‑formulary/no‑coverage guidance per the workflow described in the line‑of‑business policies.

This policy includes specific primary cutaneous lymphoma subtypes that are covered under the criteria. Included examples are: primary cutaneous acral CD8+ T‑cell lymphoma (provisional), primary cutaneous marginal zone lymphoma, primary cutaneous large‑cell lymphoma of the leg type, primary cutaneous follicle center lymphoma, Epstein‑Barr virus mucocutaneous ulcer (provisional), and intravascular large B‑cell lymphoma. Note that extranodal NK‑cell lymphoma is treated as a CTCL subtype for purposes of this policy.

Requests for bexarotene that do not meet the specific coverage criteria in this policy and that are not supported by the applicable off‑label or non‑formulary policies may be considered not medically necessary and denied. For formulary or PDL drugs, apply the relevant no‑coverage/non‑formulary policies (for example, CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace). Providers should document clinical justification and supply supporting literature when requesting coverage for off‑label uses to avoid denial under these rules.

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for bexarotene (capsules or gel). Requests must document the diagnosis, prescriber specialty (or consultation), member age, dose, and that generic bexarotene capsules (for Targretin capsule requests) or generic bexarotene (for capsule or gel requests) is being used unless contraindicated or clinically significant adverse effects have occurred. Providers must submit supporting clinical documentation (office chart notes, lab results, prescribing information, or peer‑reviewed literature for off‑label uses) to demonstrate the member meets all applicable criteria.

Prior authorization required for bexarotene capsules and gel
Request must include diagnosis, prescriber specialty, age, and dose
For Targretin capsule requests, member must use generic bexarotene capsules unless contraindicated or adverse effects occur

Step Therapy

Generic‑First and Substitution Requirements

For initiation and continuation of therapy, members must use generic bexarotene unless the prescriber documents a contraindication or clinically significant adverse effects to the generic product. When continuation is requested for commercially insured members, approval may be contingent on use of the generic product; requests may be redirected to the generic bexarotene. Prescribers must document the medical rationale if brand therapy is requested instead of the generic.

Dosing Limits and Product Information

inv-08: Maximum oral dose — 400 mg/day (dose cap metric)

Maximum oral dose (absolute)400 mg per day (oral maximum)

Reference dosing rangeOral dosing regimen stated as 300–400 mg/m2/day

Continuation dose limitDose increase requests must not exceed 400 mg/day unless supported by guidelines or peer‑reviewed literature

inv-10: Maximum oral dose — 400 mg/m2/day (alternate dosing metric)

Maximum oral dose (body‑surface area)400 mg/m2 per day (maximum)

Typical oral dosing range300–400 mg/m2 per day as stated in dosing regimen

Step Therapy and Formulary Positioning

Step	Requirement
1	Member must use generic bexarotene (capsule) unless contraindicated or clinically significant adverse effects occur; prescriber must document reason to use brand if applicable. Dose must not exceed 400 mg per day.

Step	Requirement
1	For continuation of therapy and for requests for Targretin (bexarotene) capsules, member must use generic bexarotene capsules as specified by the policy; requests may be redirected to generic product.

Definitions and Safety Information

inv-21: CTCL definition — Cutaneous T‑cell lymphoma including mycosis Fungoides, Sezary syndrome and other WHO‑EORTC classified T‑cell lymphoma subtypes

CTCL definition (policy)Cutaneous T‑cell lymphoma, including mycosis fungoides and Sezary syndrome and other WHO‑EORTC classified T‑cell lymphoma subtypes

Included subtypes examplesMycosis fungoides; Sezary syndrome; folliculotropic MF; pagetoid reticulosis; primary cutaneous anaplastic large cell lymphoma; other listed subtypes

Reference for subtypesSee Appendix D for full list of CTCL subtypes as cited in policy

inv-22: Contraindications/boxed warnings — Pregnancy and known hypersensitivity to bexarotene; boxed warning for birth defects

Primary contraindicationsPregnancy; known hypersensitivity to bexarotene

Boxed warning

Background and Clinical Overview

Bexarotene (Targretin) is a retinoid X receptor activator used in the management of cutaneous lymphomas. The policy covers use of oral capsules for cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL) and topical 1% gel for localized CTCL. The document lists both CTCL subtypes and primary cutaneous B‑cell lymphoma subtypes as relevant to coverage decisions; clinicians should reference the specific subtype listings when documenting the diagnosis for authorization requests. Contraindications include pregnancy and known hypersensitivity, and prescribers must follow labeled indications and documented evidence when requesting treatment for non‑standard presentations.

Policy Revision History

05.22policy_revision

Commercial approval duration clarified to a 12-month duration of request for bexarotene capsules and requirement added that continuation of Targretin capsule requests must use generic bexarotene capsules (2Q 2022 annual review).

05.24policy_addition

Policy/criteria revised to include generic bexarotene (addition of generic to policy/criteria) during the 2Q 2024 annual review.

05.25policy_revisionLatest

Medicaid/Health Insurance Marketplace (HIM) continued approval duration modified from 6 months to 12 months per standard oncology approach (2Q 2025 annual review).

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Bexarotene (Targretin) Capsules and Gel

Coverage and Medical Necessity Criteria

Provider Responsibilities, Prior Authorization, and Documentation

Dosing Limits and Product Information

Step Therapy and Formulary Positioning

Definitions and Safety Information

Background and Clinical Overview

Policy Revision History