CurrentBlue Cross Blue Shield - IowaPolicy 05.02.81

Turalio (pexidartinib) drug coverage

Defines prior authorization, coverage criteria, dosing limits, and authorized indications for Turalio (pexidartinib) for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTuralio (pexidartinib) drug coverage

Policy CodePolicy 05.02.81

Change TypeNo material changes

Effective DateSep 25, 2025

Next Review Date

Key ActionObtain prior authorization; authorizations of 12 months may be granted for TGCT and PVNS and 6 months for histiocytic neoplasms with a CSF1R mutation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTGCT / PVNS auth

6 monthsHistiocytic auth

400 mg BIDFDA initial dose

120/mo125 mg limit

Coverage Criteria for Turalio (pexidartinib)

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TGCT initial therapy: Patient is an adult with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Authorization may be granted for 12 months as single-agent therapy

TGCT continuation: No evidence of unacceptable toxicity or disease progression while on current regimen

Authorization of 12 months may be granted for continued treatment

Pigmented Villonodular Synovitis (PVNS)

Covered when ALL of the following are met

PVNS initial therapy: Diagnosis of pigmented villonodular synovitis (PVNS)

Authorization may be granted for 12 months as single-agent therapy

PVNS continuation: No evidence of unacceptable toxicity or disease progression while on current regimen

Authorization of 12 months may be granted for continued treatment

Histiocytic Neoplasms

Covered when ALL of the following are met

Histiocytic neoplasms covered types: Symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD), Rosai-Dorfman Disease (RDD), or Langerhans Cell Histiocytosis (LCH)

CSF1R mutation requirement for some neoplasms: Member has documentation of a CSF1R (colony stimulating factor 1 receptor) mutation where applicable

Authorization of 6 months will be granted for histiocytic neoplasm subtypes in members with a CSF1R mutation

Histiocytic continuation: No evidence of unacceptable toxicity or disease progression while on current regimen

Authorization may be granted for continued treatment

Initial Therapy

Initial therapy

Initial authorization durations and indications

TGCT initial: Adult patient with symptomatic TGCT not amenable to surgery

Authorization may be granted for 12 months as single-agent therapy

PVNS initial: Diagnosis of PVNS

Authorization may be granted for 12 months as single-agent therapy

Histiocytic neoplasm initial: Symptomatic or relapsed/refractory ECD, RDD, or LCH with documentation of CSF1R mutation where applicable

Authorization of 6 months will be granted for histiocytic neoplasm subtypes in members with a CSF1R mutation

Continuation Therapy

Continuation therapy

Continuation therapy is eligible for reauthorization when there is no evidence of unacceptable toxicity or disease progression.

TGCT continuation: No unacceptable toxicity or progression

12 month reauthorization may be granted

PVNS continuation: No unacceptable toxicity or progression

12 month reauthorization may be granted

Histiocytic neoplasms continuation: No unacceptable toxicity or progression

Reauthorization duration per case; typical initial continuation authorized per clinical judgment

Quantity Limits for Turalio

inv-16: Turalio 125 mg capsules — 120

ProductTuralio (pexidartinib) 125 mg capsules

Standard quantity limit120 per 30 days

FDA-recommended initial dosing (125 mg formulation)Initial dose: 250 mg (two 125 mg capsules) twice daily; dose reductions described in policy

inv-17: Turalio 200 mg capsules — (blank value; see source)

ProductTuralio (pexidartinib) 200 mg capsules

Standard quantity limit(no standard limit listed in policy)

FDA-recommended initial dosing (200 mg formulation)Initial dose: 400 mg (two 200 mg capsules) twice daily; dose adjustments described in policy

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Turalio (pexidartinib). Authorization durations: 12 months may be granted for Tenosynovial Giant Cell Tumor (TGCT) and Pigmented Villonodular Synovitis (PVNS) when used as single-agent therapy. For histiocytic neoplasms (symptomatic or relapsed/refractory Erdheim‑Chester Disease, Rosai‑Dorfman Disease, or Langerhans Cell Histiocytosis) in members with a CSF1R mutation, authorizations of 6 months may be granted when used as a single agent.

Authorization duration: 12 months — Tenosynovial Giant Cell Tumor (TGCT) as single-agent therapy
Authorization duration: 12 months — Pigmented Villonodular Synovitis (PVNS) as single-agent therapy
Authorization duration: 6 months — Histiocytic neoplasms (ECD, RDD, LCH) with documented CSF1R mutation as single-agent therapy

Step Therapy

No Step Therapy Specified

No step therapy requirements are specified in this policy for Turalio (pexidartinib).

Documentation Required

Required Documentation

Submit documentation necessary to initiate prior authorization review: documentation of the presence of a colony stimulating factor 1 receptor (CSF1R) mutation where applicable.

Required: Documentation of CSF1R mutation (when applicable)

Denial Risk

Not Medically Necessary If Criteria Not Met

Turalio (pexidartinib) is considered not medically necessary for members who do not meet the criteria set forth in this policy.

Background

Turalio (pexidartinib) is an oral colony stimulating factor 1 receptor (CSF1R) inhibitor indicated for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. The policy also includes compendial uses such as pigmented villonodular synovitis (PVNS) and certain histiocytic neoplasms and aligns coverage with FDA labeling, accepted compendia, and evidence-based guidelines.

Definitions

inv-13: TGCT / PVNS / Histiocytic neoplasms — Definitions and short descriptions

TGCT (Tenosynovial Giant Cell Tumor)Symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery

PVNS (Pigmented Villonodular Synovitis)Listed as a compendial use for Turalio; pigmented villonodular synovitis is included under compendial indications in the policy

Histiocytic neoplasmsCompendial uses include Erdheim-Chester Disease (ECD), Langerhans Cell Histiocytosis (LCH), and Rosai-Dorfman Disease (RDD)

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTuralio (pexidartinib) drug coverage

Policy CodePolicy 05.02.81

Change TypeNo material changes

Effective DateSep 25, 2025

Next Review Date

Key ActionObtain prior authorization; authorizations of 12 months may be granted for TGCT and PVNS and 6 months for histiocytic neoplasms with a CSF1R mutation.

SourceLink

On This Page

OpenPayer

Turalio (pexidartinib) drug coverage

Coverage Criteria for Turalio (pexidartinib)

Initial Therapy

Continuation Therapy

Billing, Codes and Quantity Limits

Quantity Limits for Turalio

Provider Actions and Prior Authorization

Background

Definitions

Site of Care and Dosing Constraints