CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Turalio (pexidartinib) coverage criteria

Defines medical necessity, inclusion and exclusion criteria, and utilization management authority for Turalio (pexidartinib) for treatment of Tenosynovial Giant Cell Tumor (TGCT) and other potential oncologic uses when supported by FDA labeling or accepted compendia/guidelines. Applies to medication requests processed by Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTuralio (pexidartinib) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionDocument symptomatic TGCT severity or non-surgical candidacy and submit supporting evidence; all requests are reviewed by Evolent/Utilization Management for final approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Primary FDA-accepted clinical indication explicitly addressed (TGCT)

3Core continuation requirements listed

4Explicit exclusion criteria categories

Turalio (pexidartinib) — Medical Necessity Criteria

Inclusion Criteria — Continuation requests exemption

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Inclusion Criteria — Tenosynovial Giant Cell Tumor (TGCT)

Turalio (pexidartinib) is covered when ALL of the following are met:

ALL of the following

Member has symptomatic TGCT associated with severe morbidity/functional limitations not amenable to improvement with surgery, OR member is not a surgical candidate
This is an OR within a single bullet — interpreted as the member must have symptomatic TGCT with either severe morbidity/functional limitations not correctable by surgery OR be a non-surgical candidate
Turalio (pexidartinib) will be used as a single agent for non-metastatic TGCT

What Providers Must Do

Prior Authorization

UM review required for Turalio requests

All requests for pexidartinib (Turalio) are processed by Evolent/Utilization Management and require review; final approval is provided by the Utilization Management Committee as applicable.

Documentation Required

Document surgical candidacy and symptom severity for TGCT

Document that the member has symptomatic TGCT with severe morbidity or functional limitations not amenable to improvement with surgery, or document that the member is not a surgical candidate, and confirm pexidartinib will be used as single‑agent therapy for non‑metastatic disease.

Denial Risk

Denial if liver dysfunction or over-dosing

Requests will be denied if baseline liver tests are above the upper limit of normal, active liver or biliary tract disease is present, or if requested dosing exceeds the policy limits (single‑dose limit 250 mg or the stated monthly capsule maximum).

Do not approve for members with pre‑existing increased serum transaminases or total/direct bilirubin above the upper limit of normal.
Do not approve for active liver or biliary tract disease, including increased alkaline phosphatase.
Do not approve if dosing exceeds single dose limit of 250 mg or exceeds the maximum monthly capsule limit (120 capsules/month as listed).

Documentation Required

Evidence requirement for off-label use

Off‑label uses must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards per the Medicare Benefit Policy Manual Chapter 15; the provider must supply references demonstrating adequate evidence.

Evidence should address whether the patient and cancer are represented in the published evidence, whether the regimen is adequately represented, and whether outcomes are clinically meaningful (ASCO standards referenced).
Case reports or abstracts without full peer‑reviewed articles are inadequate; non‑randomized trials require sufficient subject numbers per policy guidance.

Clinical Background

Pexidartinib (Turalio) is a targeted oral therapy approved for the treatment of symptomatic Tenosynovial Giant Cell Tumor (TGCT) that is not amenable to surgical resection. The policy requires documentation that the member has symptomatic TGCT with severe morbidity or functional limitations not correctable by surgery, or that the member is not a surgical candidate, and that pexidartinib will be used as single‑agent therapy for non‑metastatic disease.

Use of pexidartinib requires careful consideration of hepatic safety. The policy specifies that members with pre‑existing increased serum transaminases, or with total or direct bilirubin above the upper limit of normal, or with active liver or biliary tract disease (including increased alkaline phosphatase) are excluded from treatment. These liver function abnormalities constitute contraindications to therapy under this coverage criteria.

The policy also notes that evidence for off‑label oncology uses is limited: investigational or off‑label indications will not be approved unless supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or adequate peer‑reviewed literature that meets CMS standards. Requests for off‑label use must demonstrate that published evidence appropriately represents the patient population, regimen, and clinically meaningful outcomes per ASCO guidance.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTuralio (pexidartinib) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionDocument symptomatic TGCT severity or non-surgical candidacy and submit supporting evidence; all requests are reviewed by Evolent/Utilization Management for final approval.

SourceLink

On This Page

OpenPayer

Turalio (pexidartinib) coverage criteria

Turalio (pexidartinib) — Medical Necessity Criteria

What Providers Must Do

Codes and Billing References

Numeric and Clinical Thresholds

Clinical Background

Defined Terms

Policy Dates & Review