CurrentCentenePolicy CP.PHAR.436

Pexidartinib (Turalio) coverage

Defines medical necessity criteria, prior authorization requirements, and coverage conditions for pexidartinib (Turalio) for Centene-affiliated health plans, including TGCT and select off‑label histiocytic neoplasms; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyPexidartinib (Turalio) coverage

Policy CodePolicy CP.PHAR.436

Change TypeMaterial clinical changes and dose/administration updates

Effective Date12.01.19

Next Review Date

Key ActionPrior authorization required; submit supporting documentation and ensure prescribed pexidartinib is single-agent per NCCN when applicable.

SourceLink

POLICY UPDATE CHANGES

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 capsule strength to 125 mg.

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

500 mg/daymaximum daily dose

125 mgcapsule strength

12 monthsapproval duration (Medicaid/HIM)

12 monthsapproval duration (Commercial)

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Coverage and Medical Necessity Criteria

Initial Therapy — TGCT

Covered when ALL of the following are met (Initial Approval Criteria — TGCT):

TGCT Initial: 1. Diagnosis of TGCT (also known as giant cell tumor of the tendon sheath [GCT-TS] or pigmented villonodular synovitis [PVNS]); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is associated with severe morbidity or functional limitations and is not amenable to improvement with surgery; 5. Prescribed as a single agent; 6. For brand Turalio requests, member must use generic pexidartinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Request meets one of the following: (a) Dose does not exceed both: (i) 500 mg per day and (ii) 4 capsules per day; OR (b) 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.

Initial Therapy — Histiocytic Neoplasms (off-label)

Covered when ALL of the following are met (Initial Approval Criteria — Histiocytic Neoplasms — off-label):

Histiocytic Initial: 1. Diagnosis of histiocytic neoplasms (Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans cell histiocytosis); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. Disease is CSF1R mutation positive; 5. Prescribed as a single agent; 6. For brand Turalio requests, member must use generic pexidartinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Dose is within the FDA maximum limit for any FDA-approved indication or 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.

Continued Therapy — Continued Therapy (All Indications in Section I)

Continued Therapy (All Indications in Section I):

Continuation: 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) New dose does not exceed both: (i) 500 mg per day and (ii) 4 capsules per day; OR (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.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance 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 documents.

Uses for indications that are not listed in Section I and that lack sufficient supporting evidence per the applicable off‑label use policies are considered not authorized (not medically necessary) under this policy.

Indication	Regimen	Maximum daily dose	Dosage form / strength	Coverage
Tenosynovial giant cell tumor (TGCT)
250 mg PO twice daily (BID) with a low-fat meal until disease progression or unacceptable toxicity
500 mg/day
Capsules, 125 mg
Covered with criteria

Coding and Dosing Details

Off-label histiocytic neoplasmsmixedCovered

Erdheim-Chester disease	diagnosis listed (no numeric ICD-10 provided)
Rosai-Dorfman disease	diagnosis listed (no numeric ICD-10 provided)
Langerhans cell histiocytosis	diagnosis listed (no numeric ICD-10 provided)

Maximum daily dose

Maximum daily dose500 mg/day

Per-dose regimen (TGCT)250 mg PO twice daily with a low‑fat meal (capsules 125 mg) until disease progression or unacceptable toxicity

Capsule strength125 mg

TGCT / CSF1R definitions

TGCT (tenosynovial giant cell tumor)Also known as giant cell tumor of the tendon sheath (GCT‑TS) or pigmented villonodular synovitis (PVNS); indication for Turalio in adults with symptomatic disease not amenable to surgery

CSF1RColony stimulating factor 1 receptor — target of pexidartinib; pexidartinib is a selective CSF1R tyrosine kinase inhibitor

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Turalio (pexidartinib). Approval durations vary by line of business: Commercial — 12 months or duration of request, whichever is less; Medicaid/HIM — 12 months.

Commercial: 12 months or duration of request, whichever is less
Medicaid/HIM: 12 months

Billing Rule

Generic Substitution Requirement

For brand Turalio requests, the member must use generic pexidartinib if it is available unless the generic is contraindicated or the member has experienced clinically significant adverse effects with the generic formulation.

Line of Therapy Specifications

first-line

First-line use (must meet all):

First-line: Indicated for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery; prescribed by or in consultation with an oncologist; age ≥ 18 years; prescribed as a single agent; dose limits and regimen requirements as specified in initial approval criteria.

Biomarker and Test Requirements

CSF1R mutation

CSF1R mutation requirementDisease must be CSF1R mutation positive for coverage of histiocytic neoplasms (Erdheim‑Chester disease, Rosai‑Dorfman disease, Langerhans cell histiocytosis)

Applies toHistiocytic neoplasms listed in initial approval criteria (Erdheim‑Chester, Rosai‑Dorfman, Langerhans cell)

Prescriber requirementPrescribed by or in consultation with an oncologist or hematologist

Dosing Regimens and Formulations

Dosing instruction	Administration details	Dose modifications / notes	Maximum daily dose	Dosage form
250 mg PO twice daily (BID)
Take with a low-fat meal (approximately 11 to 14 grams of total fat); continue until disease progression or unacceptable toxicity
Reduce dose if used concomitantly with moderate/strong CYP3A inhibitors or UGT inhibitors; dose increases must not exceed 500 mg/day
500 mg/day
Capsules, 125 mg strength

Background and Drug Information

Pexidartinib is a selective colony stimulating factor 1 receptor (CSF1R) tyrosine kinase inhibitor indicated for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The agent also has guideline‑supported off‑label use in certain histiocytic neoplasms when treatment is supported by clinical evidence and compendia recommendations.

Policy Revision History

2025-07-17annual_reviewLatest

Extended initial approval duration for Medicaid and HIM from 6 months to 12 months for maintenance medication (applied to all indications).

2024-08-02annual_review

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

2022-10-27annual_review

Updated maximum daily dose to 500 mg and changed capsule strength to 125 mg; added off‑label criteria for histiocytic neoplasms per NCCN category 2A recommendation.