CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Targretin (oral bexarotene) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and utilization management requirements for oral bexarotene (Targretin) for treating cancer (notably cutaneous T-cell lymphoma) for members whose medication requests are processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTargretin (oral bexarotene) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionSubmit prior authorization requests to Evolent's UM department for review and final approval by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 mg/m2single dose maximum

300 tablets/momaximum monthly limit

refractory ≥1CTCL requirement

CMS/compendiaevidence sources

Coverage Criteria for Targretin (oral bexarotene)

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Initial therapy for CTCL

Covered when ALL of the following are met

Primary coverage criteria: Member has a diagnosis of cutaneous T-cell lymphoma with cutaneous manifestations; Targretin (oral bexarotene) is requested for treatment; member is refractory to at least one prior systemic therapy; use is supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS requirements.

Per policy, off-label uses require adequate supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature).

Continuation therapy

Continuation requests are approved when ALL of the following are true

Continuation criteria: The requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; no additional medications are being added to the continuation request.

Continuation requests for a not-approvable medication may be exempt from Evolent policy when these conditions are met.

Requests for Targretin (oral bexarotene) will be excluded when any of the following apply: use after documented disease progression while on the same regimen; dosing that exceeds the single dose limit of 400 mg/m2 (oral); or treatment that exceeds the maximum limit of 300 (75 mg) tablets per month. These limits are enforced to align dosing with the policy's safety and utilization expectations.

Use of Targretin for investigational purposes or for off-label indications that lack sufficient supporting evidence will be considered not medically necessary. The policy defines sufficient evidence as inclusion in CMS-recognized compendia or acceptable peer-reviewed literature; when those are absent, the policy evaluates whether published evidence adequately represents the patient and regimen, reports clinically meaningful outcomes (for example, ASCO-recommended thresholds such as hazard ratio < 0.80 or at least 3 months survival benefit for OS/PFS), and uses appropriate study design. Case reports and meeting abstracts without full peer-reviewed articles generally do not provide adequate evidence.

Coding and Quantity Limits

inv-05: Single dose limit — 400 mg/m2

Single dose limit400 mg/m2

Applies toTargretin (oral bexarotene) single oral dose

Consequence of exceedanceRequest excluded per exclusion criteria

inv-06: Maximum monthly tablets — 300 (75 mg) tablets per month

Maximum monthly tablets300 (75 mg) tablets per month

Applies toTargretin (oral bexarotene) 75 mg tablets

Consequence of exceedanceRequest excluded per exclusion criteria

inv-16: Targretin (oral bexarotene) — quantity limit 300

Quantity limit (per policy)300 (per month)

Unit75 mg tablets

DrugTargretin (oral bexarotene)

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization and approver

Medication requests are processed by Evolent Utilization Management and require review and final approval by the Utilization Management Committee.

All medication requests must be submitted to Evolent UM for prior authorization and final approval by the Utilization Management Committee.

Step Therapy

Step requirement for CTCL

Authorization for Targretin (oral bexarotene) for cutaneous T‑cell lymphoma (CTCL) is limited to members who are refractory to at least one prior systemic therapy.

Step requirement: member must have failed ≥1 prior systemic therapy for CTCL before authorization will be considered.

Documentation Required

Required supporting documentation

Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS standards.

Acceptable supporting documentation includes FDA product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that satisfies CMS Medicare Benefit Policy Manual Chapter 15 evidentiary standards.

Denial Risk

Denial triggers / Exclusion criteria

Authorization will be denied when any of the following exclusion criteria or denial triggers are present.

Use after disease progression on the same regimen.
Single dose exceeds 400 mg/m2 (oral).
Monthly dispensing exceeds 300 tablets (75 mg strength).
Investigational or off‑label use lacking sufficient supporting evidence (not supported by CMS compendia, NCCN/ASCO, FDA labeling, or acceptable peer‑reviewed literature).
Insufficient evidence examples include: inadequate representation of patient/cancer characteristics in published evidence; regimen not represented; outcomes not clinically meaningful (per ASCO thresholds, e.g., HR <0.80 or survival benefit ≥3 months); weak experimental design; reliance on uncontrolled case reports or abstracts without full peer‑reviewed publication.

Initial Therapy Criteria

Initial therapy for CTCL

Initial therapy: Targretin (oral bexarotene) is requested for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in a member who is refractory to at least one prior systemic therapy.

Use must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature per CMS requirements.

Step	Requirement
1	Member must have failed or been refractory to ≥1 prior systemic therapy before Targretin (oral bexarotene) is authorized for cutaneous T‑cell lymphoma (CTCL).

Continuation Criteria

Continuation

Continuation authorization conditions

Continuation: Medication was used within the last year; member has not experienced disease progression and/or intolerance to the medication; no additional medications are being added to the continuation request.

Continuation requests that meet these conditions are exempt from the requirement to re-evaluate as a new initiation per Evolent policy.

inv-12: Definition — Continuation requests

DefinitionContinuation requests are renewals for medications used within the last year where the member has not experienced disease progression or intolerance and no additional medications are being added.

TimeframeMedication used within the last year

Clinical conditionNo disease progression or intolerance to the requested medication

Request scopeNo additional medications added to the continuation request

Background

Targretin (oral bexarotene) is indicated for the treatment of cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL). This policy defines coverage for Targretin when used for CTCL in members who are refractory to at least one prior systemic therapy and when the requested use is supported by FDA labeling or accepted oncology compendia/guidelines or acceptable peer‑reviewed literature. The policy also clarifies continuation requests (renewals) may be approved if the medication was used within the last year without disease progression or intolerance and no additional therapies are being added. Exclusion criteria and dosing limits—such as the 400 mg/m2 single dose limit and the 300 (75 mg) tablets per month maximum—apply as described in the policy.

Revision History

2024-11-13committee_approval

Clinical guideline reviewed and approved by the Evolent Specialty Services Clinical Guideline Review Committee (committee approval recorded 11/13/24).

2024-11-29effective_dateLatest

Policy effective date established for Targretin (oral bexarotene).

2023-11-08committee_review