ModifiedCentenePolicy CP.PHAR.75

Bexarotene (Targretin) capsules and gel - Coverage Criteria

Defines medical necessity and authorization criteria for bexarotene (Targretin) oral capsules and topical gel for treatment of cutaneous T-cell lymphoma and select cutaneous B-cell lymphoma indications for Centene lines of business.

Policy Summary

PayerCentene

PolicyBexarotene (Targretin) capsules and gel - Coverage Criteria

Policy CodePolicy CP.PHAR.75

Change TypeMaterial updates to approval durations and generic-product requirements

Effective DateSep 1, 2011

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prescriber specialty, age, prior therapies, and evidence that member meets all specified approval criteria.

SourceLink

POLICY UPDATE CHANGES

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

Modified commercial approval duration to '12 months or duration of request, whichever is less' and clarified this applies to bexarotene capsule requests; required use of generic bexarotene capsules for continuation and redirection to generic gel for Targretin gel requests.

Removed off-label criteria related to mycosis fungoides/Sezary syndrome as they are subtypes of CTCL, an already covered FDA approved indication.

12 monthscommercial approval

12 monthsMedicaid/HIM/ICHRA approval

300-400 mg/m2/dayoral dosing range

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

4x/daytopical max frequency

Coverage Criteria

Initial therapy — Capsules

Initial therapy — Capsules (must meet ALL):

ALL of the following

Request is for bexarotene capsules.
Diagnosis of cutaneous T-cell lymphoma (CTCL) (see Appendix D for CTCL subtypes).
Prescribed by or in consultation with an oncologist.
Age >= 18 years.
For Targretin capsule requests, member must use generic bexarotene capsules, unless contraindicated or clinically significant adverse effects are experienced.
Request must meet one of the following:
- Dose does not exceed 400 mg/m^2 per day.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial therapy — Gel

Initial therapy — Gel (must meet ALL):

ALL of the following

Request is for bexarotene gel.
Diagnosis of CTCL or cutaneous B-cell lymphoma (CBCL) (see Appendix D for CTCL and CBCL subtypes).
Prescribed by or in consultation with an oncologist.
Age >= 18 years.
Disease manifestation is localized to skin only.
For Targretin gel requests, member must use generic bexarotene gel, unless contraindicated or clinically significant adverse effects are experienced.

Initial Therapy Requirements

Initial Therapy — Approval Duration Updates

Note on initial approval duration updates from annual review:

Initial approval duration update: Medicaid/HIM initial approval duration modified from 6 months to 12 months per standard oncology approach (implemented 2Q2025 and affirmed 2Q2026); commercial approval duration modified in 2Q2022 to '12 months or duration of request, whichever is less' as applicable to capsule requests

Added ICHRA as a line of business in 2Q2026

Continuation / Renewal Criteria

Continuation Therapy — Duration and Requirement Updates

Continuation therapy duration and requirement updates from annual reviews:

Generic product and redirection: For continuation of therapy, members must use generic bexarotene capsules for capsule requests; branded Targretin gel requests may be redirected to generic bexarotene gel as specified in 2Q2024 updates; failure to use generics when required could risk denial

Applies across commercial and other specified lines per 2Q2022 and 2Q2024 reviews

Continued approval duration change: Medicaid/HIM continued approval duration changed from 6 months to 12 months per standard oncology approach (implemented 2Q2025 and affirmed 2Q2026); commercial continuation duration set to 12 months or duration of request, whichever is less

ICHRA added as line of business in 2Q2026

Dosing and Coding Limits

Oral and topical maximum dosing - key thresholds

Oral maximum dose≤ 400 mg/m2 per day

Topical maximum frequency≤ 4 applications per day

Clinical dosing range (oral)Typical oral regimen 300–400 mg/m2/day

Topical titration guidanceStart every other day first week, then increase weekly to once, twice, three, then four times daily as tolerated

Bexarotene capsules — dose limit (quantity)

Dose limitBexarotene capsules dose limited to ≤ 400 mg/m2 per day

Typical capsule strength

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for bexarotene (capsules and gel) and Targretin requests. Providers must obtain PA before dispensing; include supporting clinical documentation with the request.

PA required for capsules and gel
Requests for branded Targretin may be redirected to generic bexarotene per policy

Prior Authorization

Approval Duration and PA Implications

Approval duration varies by line of business. For Medicaid, HIM, and ICHRA the approval duration is 12 months. For Commercial, approval is 12 months or the duration of the request, whichever is less. Continuation requests must document current use and clinical benefit.

Medicaid/HIM/ICHRA: 12 months
Commercial: 12 months or duration of request, whichever is less
Continuation requires documentation of at least 30 days current therapy and positive response

Step Therapy / Product Substitution

Step	Requirement	Notes
1	Use of generic bexarotene (capsules) is required prior to approval of branded Targretin capsules unless contraindicated or clinically significant adverse effects are experienced.	Applies to initial and continuation requests for capsules; prescriber must document contraindication or adverse reaction to generic when claiming exemption.

Step	Requirement	Notes
1	Branded Targretin (capsules or gel) requests may be redirected to generic bexarotene products for continuation; members must use generic bexarotene for continuation unless contraindicated.	Policy updates in 2Q2024 added redirection to generic gel for Targretin gel requests; failure to use generic when required could risk denial.

Quantity Limits

Bexarotene capsules — quantity limits (duplicate)

Quantity restriction (oral)Capsule dosing capped at ≤ 400 mg/m2/day for authorization

Strength availableCapsules available as 75 mg strength

Continuation requirementDose increases on renewal must not exceed 400 mg/m2/day unless supported by guidelines/literature with prescriber evidence

Bexarotene gel 1% — quantity limits (duplicate)

Quantity restriction (topical)Gel application limited to ≤ 4 times per day for authorization

Titration scheduleIncrease application frequency weekly (every other day → once daily → twice → three → four times daily) as tolerated

Site of Care and Administration

Note

Home administration: topical gel to lesions; oral capsules outpatient

Topical bexarotene 1% gel is intended for application to lesions per the dosing schedule; oral bexarotene capsules are taken as an outpatient prescription per the dosing regimen.

Topical: applied to lesions with frequency titrated up to a maximum of four times daily based on tolerance.
Oral: dosing per CTCL regimen (300–400 mg/m2/day) administered as outpatient therapy.

Definitions and Brand Names

CTCL / CBCL subtypes (WHO‑EORTC)

Included CTCL subtypesMycosis fungoides (including variants), Sezary syndrome, primary cutaneous CD30+ disorders, primary cutaneous anaplastic large cell lymphoma, lymphomatoid papulosis, and others as per WHO‑EORTC appendix

Included CBCL subtypesPrimary cutaneous marginal zone lymphoma, primary cutaneous follicle center lymphoma, primary cutaneous large B‑cell lymphoma (leg type), and other specified subtypes per appendix

ReferenceSee Appendix D (WHO‑EORTC classification) for full subtype listings

Brand name — Targretin (capsules and gel)

Brand nameTargretin

Formulations marketedTargretin capsules and Targretin 1% gel

Background

Bexarotene is a retinoid X receptor activator used for cutaneous manifestations of cutaneous T‑cell lymphoma. Oral capsules are typically dosed at 300–400 mg/m2/day and the topical 1% gel is supplied as a 600 mg per 600 g (1%) formulation; topical application is initially once every other day during the first week and may be applied up to a maximum of 4 applications per day per policy dosing guidance. Product prescribing information and NCCN guidance are cited as primary references for clinical use.

Revision History

2022-01-25annual_review

Modified commercial approval duration to '12 months or duration of request, whichever is less'; clarified this applies to bexarotene capsule requests and required use of generic bexarotene capsules for continuation.

2024-02-01annual_review

Revised policy to include generic bexarotene and added redirection to generic bexarotene gel for Targretin gel requests.

2025-02-05annual_review

Policy Summary

PayerCentene

PolicyBexarotene (Targretin) capsules and gel - Coverage Criteria

Policy CodePolicy CP.PHAR.75

Change TypeMaterial updates to approval durations and generic-product requirements

Effective DateSep 1, 2011

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prescriber specialty, age, prior therapies, and evidence that member meets all specified approval criteria.

SourceLink

On This Page

Request must meet one of the following:

Dose does not exceed application of four times per day.
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

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

Available as 75 mg capsules

Authorization noteRequests must meet initial or continuation criteria and prior authorization requirements

Bexarotene gel 1% — application limit

Application limitBexarotene 1% gel application limited to ≤ 4 times per day

Initial titrationInitially apply once every other day for first week, then increase weekly to reach target frequency as tolerated

Product concentrationGel concentration: 1% (600 mg per 600 g)

Denial Risk

Generic Product Requirement

Generic bexarotene is required when available. For Targretin capsule or gel requests, members must use generic bexarotene products unless the prescriber documents a contraindication or clinically significant adverse effect to the generic.

Generic bexarotene required unless contraindicated or adverse effects occur
Prescriber must document rationale if branded product is requested

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. For dose increases or off‑label uses, submit supporting practice guideline or peer‑reviewed literature evidence.

Office notes, labs, or other clinical information required
For off‑label dosing, include supporting guidelines or peer‑reviewed literature
For continuation: documentation of current therapy ≥ 30 days and positive response

Billing Rule

Branded-to-Generic Redirection

Branded Targretin requests may be redirected to equivalent generic bexarotene products for initiation or continuation of therapy. If a branded product is requested, the prescriber must document medical necessity for branded over generic.

Redirection to generic bexarotene capsules or gel may occur
Prescriber documentation required to keep branded product

Renewal considerationRequested increases must be supported by guidelines or peer-reviewed literature with prescriber evidence

Prescribing informationProduct prescribing information for Targretin cited in references (capsules and gel)

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

2026-03-30annual_reviewLatest

Modified Medicaid/HIM initial approval duration from 6 to 12 months per standard oncology approach and added ICHRA line of business.