CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Turalio (pexidartinib) — coverage criteria

Defines clinical and utilization management criteria for coverage of Turalio (pexidartinib) including approved and supported off‑label uses, and who may approve requests within the UM program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Turalio (pexidartinib) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 08, 2024

Key ActionSubmit prior authorization requests to Evolent/UM with supporting evidence that aligns with FDA labeling, CMS compendia, or accepted guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250 mgsingle dose limit

120 capsmaximum monthly limit

May 31, 2024effective date

UM Committeefinal approval authority

Coverage Criteria for Turalio (pexidartinib)

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Continuation Therapy

Continuation coverage exemption conditions

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression and/or no intolerance to the requested medication AND additional medication(s) are not being added to the continuation request

Applies to continuation requests for a not-approvable medication

Coverage exclusions for Turalio (pexidartinib) include any of the following: disease progression while receiving Turalio or failure to experience symptom improvement after 3 months of treatment (examples of symptoms include joint pain and stiffness). Use is not permitted for members with pre‑existing increased serum transaminases, total or direct bilirubin above the upper limit of normal, or active liver or biliary tract disease (including increased alkaline phosphatase). Requests will also be excluded when dosing exceeds the single dose limit of 250 mg or when treatment would exceed the maximum limit of 120 (200 mg) capsules per month.

Turalio use for off‑label or investigational indications will be excluded when the indication lacks sufficient evidence or is not generally accepted by the medical community. Sufficient evidence is defined by whether the published literature adequately represents the patient and cancer characteristics, the therapy regimen studied, and whether outcomes are clinically meaningful (for example ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months for OS/PFS). The design of the studies and the feasibility of randomized or controlled methods are also considered; non‑randomized trials with substantial subject numbers may be supportive but case reports, abstracts without peer‑reviewed publication, or evidence that does not meet CMS‑recognized compendia or acceptable peer‑reviewed literature standards will generally be insufficient.

Initial Therapy

Initial therapy

Initial TGCT therapy: Symptomatic TGCT with severe morbidity/functional limitations not amenable to surgery OR member is not a surgical candidate AND Turalio (pexidartinib) will be used as a single agent for non-metastatic TGCT

Supports initiation when criteria met

Continuation Therapy

Continuation requests

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression and/or no intolerance AND no additional medications are being added

Continuation requests for not-approvable medications may be exempt

Coding and Quantity Limits

Maximum monthly supply

Maximum monthly supply120 (200 mg) capsules per month

Applies toTuralio (pexidartinib) quantity limits

EnforcementRequests exceeding this monthly limit will be excluded (denied)

Single dose limit

Single dose limit250 mg

EnforcementDosing above this single dose will be excluded (denied)

ContextIncluded in exclusion criteria for Turalio (pexidartinib)

Turalio (pexidartinib) — quantity limits

ProductTuralio (pexidartinib)

Quantity limit stated120 (200 mg) capsules per month

Exclusion if exceededTreatment exceeding this maximum monthly limit will be excluded (denied)

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required; Evolent/UM processing

Prior authorization is required for Turalio (pexidartinib). Both initiation and continuation requests must meet the policy's inclusion and exclusion criteria and be processed by Evolent/Utilization Management per this policy.

Step Therapy

Continuation exemption conditions for previously used medication

Continuation (exemption) requests for a previously used medication may be exempt from this policy only if the medication was used within the last year, the member has not experienced disease progression and/or intolerance, and no additional medications are being added to the continuation request.

Requested medication used within the last year
No disease progression and/or no intolerance to the requested medication
No additional medications added to the continuation request

Documentation Required

Required supporting evidence

Documentation supporting use must consist of FDA-approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial triggers: dosing, quantity, and progression

Requests will be denied if they meet specified exclusion criteria including dosing or quantity limits, or disease progression/no symptom improvement as described in the policy.

Dosing exceeds single dose limit of 250 mg
Treatment exceeds maximum limit of 120 (200 mg) capsules per month
Disease progression while receiving Turalio or continued lack of symptom improvement after 3 months

Definitions

TGCT indication

IndicationTenosynovial Giant Cell Tumor (TGCT)

Clinical criteriaMember has symptomatic TGCT associated with severe morbidity/functional limitations not amenable to improvement with surgery, or member is not a surgical candidate

Use caseTuralio must be used as a single agent for non-metastatic TGCT

Coverage stanceCovered when all TGCT criteria are met

Background

Turalio (pexidartinib) is a targeted CSF1R inhibitor indicated for treatment of tenosynovial giant cell tumor (TGCT) when the disease is symptomatic and causes severe morbidity or functional limitation that is not amenable to improvement with surgery, or when the patient is not a surgical candidate. Use must align with FDA labeling and accepted compendia/guidelines and is intended as single‑agent therapy for non‑metastatic TGCT.