CurrentmhnPolicy CP.PHAR.436

Pexidartinib (Turalio) coverage policy

Defines medical necessity, prior authorization, and coverage criteria for pexidartinib (Turalio) for commercial, HIM, and Medicaid lines of business, including FDA-approved TGCT indication and select off-label histiocytic neoplasms.

Policy Summary

Payermhn

PolicyPexidartinib (Turalio) coverage policy

Policy CodePolicy CP.PHAR.436

Change TypeMaterial clinical and dosing updates

Effective Date12.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets initial or continuation criteria (diagnosis, prescriber specialty, age, dosing limits, single‑agent use).

SourceLink

POLICY UPDATE CHANGES

Added requirement that for TGCT and histiocytic neoplasms, pexidartinib be prescribed as a single agent per NCCN compendium.

Updated maximum daily dose to 500 mg and changed product availability to 125 mg capsule (from prior 200 mg capsule).

Extended initial approval duration for Medicaid and HIM from 6 months to 12 months for maintenance therapy.

Added off-label criteria for histiocytic neoplasms per NCCN category 2A recommendation.

500 mg/daymaximum allowed daily dose

125 mgcapsule strength available

≥ 18minimum age for coverage

12 moinitial approval duration

Policy Summary

Payermhn

PolicyPexidartinib (Turalio) coverage policy

Policy CodePolicy CP.PHAR.436

Change TypeMaterial clinical and dosing updates

Effective Date12.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets initial or continuation criteria (diagnosis, prescriber specialty, age, dosing limits, single‑agent use).

SourceLink

On This Page

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.

Coverage Criteria

Continuation (Renewal) Criteria — All Indications in Section I (must meet all)

Continued coverage when ALL of the following are met

Continuation criteria: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Turalio for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. For brand Turalio requests, member must use generic pexidartinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed both of the following: (i) 500 mg per day; and (ii) 4 capsules per day; b. New 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

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Requests for pexidartinib (Turalio) for indications that are not FDA‑approved and are not specifically addressed by this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage.

Uses of pexidartinib that are outside of FDA‑approved indications and are not supported by adequate documentation per the referenced off‑label policies are considered not authorized (not medically necessary) under this policy.

Regimen	Indication	Notes
250 mg PO BID with a low-fat meal
Tenosynovial giant cell tumor (TGCT)
Continue until disease progression or unacceptable toxicity; maximum 500 mg/day. Reduce dose if used with moderate/strong CYP3A or UGT inhibitors; low‑fat meal ~11–14 g total fat.

Coding

No billing codes listed in policy headermixed

No codes listed

inv-07: Maximum daily dose — 500 mg/day

Maximum daily dose500 mg per day (maximum) — dose must not exceed both 500 mg/day and 4 capsules per day for TGCT; dose reductions may be required with interacting agents

TGCT dosing regimen250 mg PO twice daily with a low‑fat meal until disease progression or unacceptable toxicity (see dosing adjustments for CYP3A/UGT inhibitors)

Capsule limitMaximum of 4 capsules per day when following the 500 mg/day limit

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requirement — Prior authorization is required. Requests must meet the listed initial or continuation criteria in the policy.

Step Therapy

Generic Trial Required

Generic trial requirement — For brand Turalio requests, member must use generic pexidartinib if available unless contraindicated or clinically significant adverse effects are experienced.

Documentation Required

Required clinical documentation — Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

Background

Pexidartinib is a selective CSF1R tyrosine kinase inhibitor indicated for symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The agent has a boxed warning for hepatotoxicity and is available only through a REMS program.

Definitions

inv-13: TGCT definition — Tenosynovial giant cell tumor description and synonyms

DefinitionTenosynovial giant cell tumor (TGCT): a neoplasm also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS)

FDA indicationPexidartinib (Turalio) is indicated for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Alternative names/synonymsGCT-TS; PVNS; giant cell tumor of the tendon sheath

Line of Therapy

first-line | other

Policy does not specify a required line; coverage depends on meeting diagnosis and prescriber criteria

Line of therapy guidance: Policy does not specify explicit line of therapy; requires prescriber specialty and disease meeting criteria; for histiocytic neoplasms CSF1R mutation positivity is required.

Biomarker Requirements

inv-15: CSF1R — biomarker requirement (mutation positive)

Required biomarkerCSF1R mutation positive is required for coverage of histiocytic neoplasms (Erdheim-Chester disease, Rosai‑Dorfman disease, Langerhans cell histiocytosis)

Marker descriptionCSF1R = colony stimulating factor 1 receptor

Context of requirementCSF1R mutation positivity is a coverage criterion for off‑label histiocytic neoplasms and must be documented

Covered Regimens & Dosing

Dosing Schedule	Maximum Daily Dose	Administration Notes
250 mg PO BID with a low-fat meal
500 mg/day
Administer with a low‑fat meal (approximately 11 to 14 grams of total fat). Continue until disease progression or unacceptable toxicity. Reduce dose when coadministered with moderate/strong CYP3A inhibitors or UGT inhibitors.