CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Targretin (oral bexarotene)

Defines accepted indications, continuation and exclusion criteria, dosing limits, evidence requirements, and utilization management/approval authority for oral bexarotene (Targretin) for members under the payer's drug policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTargretin (oral bexarotene)

Policy CodePolicy N/A

Change Typeclarified

Effective DateNov 29, 2024

Next Review Date

Key ActionEvolent Specialty Services must process medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Committee review dates updated through 11/13/24 and effective date set to November 29, 2024.

1Covered Indication (CTCL)

2Hard Limits (single dose, monthly)

4Evidence sufficiency criteria items listed

Coverage Summary

Coverage: Targretin (oral bexarotene) is covered with criteria for the treatment of the cutaneous manifestations of cutaneous T‑cell lymphoma (CTCL) when the member is refractory to at least one systemic therapy. Authorization and utilization management are handled by Evolent Specialty Services (Utilization Management), which reviews requests against the policy criteria.

Medically Necessary - Cutaneous T-Cell Lymphoma (CTCL)

Targretin (oral bexarotene) is covered when ALL of the following are met:

ALL of the following

Indication: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL)
Prior therapy: Member is refractory to at least one systemic therapy

Continuation Therapy Criteria

Continuation Therapy Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

Used within last year: The requested medication was used within the last year
No progression/intolerance: The member has not experienced disease progression and/or no intolerance to the requested medication
No additional meds: Additional medication(s) are not being added to the continuation request

Denial Risk

Continuation denial risk

Continuation requests are exempt only if all of the following are met: the requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; and no additional medications are being added to the continuation request. If disease progression or intolerance has occurred, or additional medications are being added, continuation requests will not qualify for the exemption and are subject to denial.

Exclusions / Not Medically Necessary

Exclusion / Not Medically Necessary Criteria

Targretin (oral bexarotene) is excluded when ANY of the following apply:

Post-progression: Targretin is being used after disease progression with the same regimen
Single dose limit: Dosing exceeds single dose limit of Targretin (oral bexarotene) 400 mg400 mg
Monthly tablet limit: Treatment exceeds the maximum limit of 300 (75 mg) tablets per month300 (75 mg) tablets per month
Investigational/off-label insufficient evidence: Investigational use for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community
Sufficient evidence must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per policy

Evidence Sufficiency Components (for off-label use)

When evaluating sufficiency of evidence for off-label/experimental use, consider ALL of the following:

Clinical representation: Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
Regimen representation: Whether the administered chemotherapy/biologic/immune/targeted/other oncologic therapy regimen is adequately represented in the published evidence
Clinically meaningful outcomes: Whether the reported study outcomes represent clinically meaningful outcomes (ASCO-recommended; e.g., Hazard Ratio < 0.80 and OS/PFS benefit at least 3 months)HR < 0.80; OS/PFS ≥ 3 months

Provider Actions & Prior Authorization

Prior Authorization

Authorization required

Evolent Specialty Services (Evolent) is responsible for processing all medication requests for this therapy. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Support for off-label use

Off-label indications must be supported by appropriate documentation demonstrating sufficient evidence. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Billing Rule

Dose and quantity limits enforced

Single dose and monthly quantity limits are enforced. Dosing that exceeds the single dose limit of 400 mg or the monthly maximum of 300 (75 mg) tablets per month is excluded and claims exceeding these limits are subject to denial.

Background & Scope

Policy background: This policy defines accepted indications for oral bexarotene (Targretin), including FDA‑approved and off‑label uses supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per the CMS Medicare Benefit Policy Manual. Evolent Specialty Services is responsible for processing medication requests and performs authorization and utilization management; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Single dose limit400 mg

Monthly tablet limit300 (75 mg) tablets per month

Coverage stancecovered_with_criteria

SubjectTargretin (oral bexarotene)

Clinical Evidence & References

Evidence references: Policy sources include the Targretin prescribing information (FDA), NCCN, ASCO, Clinical Pharmacology, Micromedex, AHFS, and the Medicare Benefit Policy Manual (Chapter 15) — these are the references the policy relies on when assessing evidence sufficiency.

Definitions

Definition — Continuation request exemption: An exemption that applies when the requested medication was used within the past year, the member has not experienced disease progression or intolerance to the medication, and no additional medications are being added to the continuation request.