ModifiedmhnPolicy CP.PHAR.75

Bexarotene (Targretin) capsules and gel

This policy governs medical necessity and prior authorization criteria for bexarotene (Targretin) oral capsules and topical gel for treatment of cutaneous T-cell lymphoma (CTCL) and select cutaneous B-cell lymphoma (CBCL) indications in members of the payer's lines of business.

Policy Summary

Payermhn

PolicyBexarotene (Targretin) capsules and gel

Policy CodePolicy CP.PHAR.75

Change TypeModified coverage criteria, approval durations, and generic substitution requirements

Effective DateSep 1, 2011

Next Review Date

Key ActionPrior authorization requires meeting the listed criteria and providers must use generic bexarotene unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Policy/criteria revised to also include generic bexarotene and to add redirection to generic bexarotene gel for Targretin gel requests.

Commercial approval duration modified to '12 months or duration of request, whichever is less' for bexarotene capsules.

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

Off-label criteria related to mycosis fungoides/Sezary syndrome were removed because they are subtypes of CTCL, an already covered FDA approved indication.

12 monthsapproval duration (Medicaid/HIM/ICHRA)

12 monthscommercial approval duration

300-400 mg/m2/dayoral CTCL dosing range

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Coverage Criteria

Request for Capsules (Initial)

Covered for oral capsules when ALL of the following are met:

Oral capsule coverage criteria: Request is for bexarotene capsules.

Oral capsule coverage criteria: Diagnosis of cutaneous T-cell lymphoma (CTCL) (see Appendix D for CTCL subtypes).

Oral capsule coverage criteria: Prescribed by or in consultation with an oncologist.

Oral capsule coverage criteria: For Targretin capsule requests, member must use generic bexarotene capsules unless contraindicated or clinically significant adverse effects are experienced.

Oral capsule coverage criteria

ONE of: Dose does not exceed 400 mg/m2 per day.
ONE of: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Oral capsule coverage criteria: Prescribed regimen must be FDA-approved or recommended by NCCN.

Request for Gel (Initial)

Covered for topical gel when ALL of the following are met:

Topical gel coverage criteria: Request is for bexarotene gel.

Topical gel coverage criteria: Diagnosis of CTCL or cutaneous B-cell lymphoma (CBCL) (see Appendix D for CTCL and CBCL subtypes).

Topical gel coverage criteria: Prescribed by or in consultation with an oncologist.

Topical gel coverage criteria: Disease manifestation is localized to skin only.

Topical gel coverage criteria:

Continuation Therapy

Continuation therapy (all indications in Section I) — must meet ALL:

Continuation criteria: Member is currently receiving medication via the Centene benefit, or documentation supports current receipt of Targretin for a covered indication for at least 30 days.

Continuation criteria: Member is responding positively to therapy.

Continuation criteria: For Targretin requests, member must use generic bexarotene unless contraindicated or clinically significant adverse effects are experienced.

Continuation criteria

ONE of: Bexarotene capsules: new dose does not exceed 400 mg/m2 per day.

Requests for uses that are not FDA‑approved and are not explicitly addressed in this policy are generally not authorized. Such off‑label requests will only be considered when the prescriber submits sufficient documentation of efficacy and safety consistent with the payer's off‑label use policies (commercial: CP.CPA.09; HIM/ICHRA: HIM.PA.154; Medicaid: CP.PMN.53) or other applicable evidence of coverage documents.

Off‑label criteria that specifically referenced mycosis fungoides and Sezary syndrome were removed from this policy because these diagnoses are subtypes of cutaneous T‑cell lymphoma (CTCL), which is already an FDA‑recognized, covered indication within the policy.

Uses for non‑FDA approved indications that lack sufficient supporting documentation per the payer's off‑label use policies are considered not medically necessary (NMN) and are not authorized under this policy.

Initial Therapy Criteria

Initial therapy duration

Initial approval duration rules and updates:

Initial duration: Medicaid/HIM/ICHRA initial approval duration: 12 months (changed from 6 months per standard oncology approach).

Applied during 2Q 2026 and 2Q 2025 annual reviews.

Initial duration: Commercial initial approval duration: 12 months or duration of request, whichever is less (modified during 2Q 2022).

Continuation Therapy Criteria

Continuation requirements

General continuation requirements applicable to all indications:

General continuation: Member must have been receiving Targretin for at least 30 days (or documentation demonstrating current receipt for at least 30 days) and be responding to therapy.

General continuation: Member must use generic bexarotene unless contraindicated or clinically significant adverse effects are experienced.

General continuation: Prescribed regimen must be FDA-approved or recommended by NCCN.

General continuation: Approval duration for continuation: Medicaid/HIM/ICHRA 12 months; Commercial 12 months or duration of request, whichever is less.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for bexarotene (capsules or gel). Prescriber expectations: must be prescribed by or in consultation with an oncologist for CTCL, age ≥ 18, and prescriber must submit supporting clinical documentation (office chart notes, relevant lab results, and any rationale/evidence for off‑label dosing).

PA required for capsules and gel
Prescriber: oncologist or in consultation with oncologist
Submit office chart notes, labs, and supporting literature for off‑label dosing

Documentation Required

Required Clinical Documentation

Providers must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, clinical progress notes, relevant laboratory results, and any peer‑reviewed literature or guideline citations when requesting doses or indications that are off‑label.

Coding & Dosing Thresholds

Maximum dosing thresholds

Oral maximum dose400 mg/m2 per day (maximum) — typical dosing range 300–400 mg/m2/day

Topical maximum frequencyUp to 4 applications per day (titrate from every other day to 4x/day as tolerated)

Topical initiation scheduleInitially apply every other day for first week, then increase weekly to once daily, twice daily, three times daily, then four times daily as tolerated

Step Therapy

Indication	Step therapy / prior therapy requirement	Notes
Oral bexarotene capsules for cutaneous T-cell lymphoma (CTCL)	Member is refractory to at least one prior systemic therapy (per FDA label) and request meets all capsule coverage criteria: diagnosis of CTCL, prescriber is/oncology or in consultation with oncologist, age ≥ 18, dose ≤ 400 mg/m2/day or dose supported by practice guidelines/peer-reviewed literature.	Prescribed regimen must be FDA‑approved or NCCN‑recommended; member must use generic bexarotene capsules unless contraindicated or intolerable.
Topical bexarotene 1% gel for localized CTCL or cutaneous B‑cell lymphoma (CBCL)	Topical therapy required for localized skin disease; topical gel used when refractory to or intolerant of other therapies for Stage IA/IB disease per policy; prescriber must be or consult with an oncologist.	Application must not exceed four times daily unless supported by guidelines or literature; member must use generic bexarotene gel unless contraindicated or intolerable.

Coverage scenario	Requirement	Status / Rationale
Continuation of therapy when Targretin (brand) capsules are requested	Member must be switched to or use generic bexarotene capsules for continuation of therapy unless contraindicated or clinically significant adverse effects are experienced.	Requirement added/clarified during 2Q 2022 annual review; applies to continuation requests for Targretin capsules.
Initial or ongoing requests for bexarotene capsules	For all capsule requests, generic bexarotene is required unless contraindicated; prescriber must submit documentation if generic is not used.	Policy revisions redirect brand capsule continuation to generic to promote generic substitution and align with approval duration changes (see references).

Quantity Limits & Dosing

Bexarotene capsules — dosing

Dosing basisDosing for bexarotene capsules is per mg/m2 body surface area; typical regimen for CTCL is 300–400 mg/m2/day

Maximum daily doseDo not exceed 400 mg/m2 per day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence)

Capsule strengthAvailable as 75 mg capsules

Bexarotene 1% gel — topical dosing

Maximum application frequencyApply bexarotene 1% gel up to four times daily (titrate from every other day to 4x/day as tolerated)

Indication for topical useIntended for localized cutaneous disease (skin only) in CTCL and select CBCL per policy criteria

Site of Care

Note

Topical gel intended for localized cutaneous (skin‑only) disease

Topical bexarotene gel is intended for localized cutaneous disease (skin only) and is administered per an outpatient topical regimen for skin lesions.

Gel requests must document disease localized to the skin (cutaneous lesions) as required by the policy.

Note

Oral capsules are outpatient prescriptions

Oral bexarotene capsules (Targretin) are administered as an outpatient oral prescription; ensure outpatient prescription documentation is provided with the request.

Capsule requests must indicate outpatient oral administration and meet the policy's outpatient prescribing criteria (oncologist prescriber/consultation, age ≥ 18, dosing limits).

Background

Bexarotene is a retinoid‑class agent (a retinoid X receptor activator) available as oral capsules and a 1% topical gel. It is indicated for treatment of the cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL); capsules are used for systemic therapy in patients refractory to at least one prior systemic therapy, and the topical gel is indicated for treatment of CTCL skin lesions (and may be used for localized cutaneous disease per policy criteria). Product availability includes 75 mg capsules and 1% (600 mg/600 g) gel.

Definitions & Formulations

Appendix D: WHO‑EORTC classification

Appendix referenceAppendix D = WHO‑EORTC classification lists for CTCL and CBCL subtypes

CTCL examples listedMycosis fungoides (including variants), Sezary syndrome, primary cutaneous CD30+ lymphoproliferative disorders, primary cutaneous anaplastic large cell lymphoma, etc.

CBCL examples listedPrimary cutaneous marginal zone lymphoma, primary cutaneous follicle center lymphoma, primary cutaneous large B-cell lymphoma, leg type, and others

Bexarotene formulations

Available capsule strengthBexarotene capsules (Targretin) — 75 mg capsules

Gel concentration and contentBexarotene 1% gel (Targretin) — 600 mg active bexarotene per 600 g (1%)

Revision History

2026-03-30annual_review

Medicaid/HIM initial approval duration modified from 6 months to 12 months and ICHRA line of business added.

2025-02-05annual_review

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

2024-02-01annual_review

Policy/criteria revised to include generic bexarotene and added redirection to generic bexarotene gel for Targretin gel requests.