CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tibsovo (ivosidenib)

Defines accepted indications, clinical criteria, exclusions, coding, and utilization management expectations for Tibsovo (ivosidenib) for Commercial, Exchange/Marketplace, and Medicaid lines of business. Includes FDA-approved and select off-label/compendia-supported uses and limits on dosing and duration.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTibsovo (ivosidenib)

Policy CodePolicy N/A

Change TypeAdministrative / Reference updates

Effective Date

Next Review Date

Key ActionSubmit documentation of IDH1 gene-mutation positivity detected by an FDA-approved test (example: Abbott RealTime IDH1 Assay) for approval.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced previous UM ONC_1340 Tibsovo (ivosidenib).

Added Evolent disclaimer language and coding information with HCPCS code; updated verbiage and references.

3Covered Indications

3Lines of Business

2Dose Limits noted

Coverage Summary

Coverage stance: covered_with_criteria for Tibsovo (ivosidenib) when specified clinical criteria are met, including documented IDH1 mutation and indication-specific requirements.

Scope summary: Defines accepted indications, clinical criteria, exclusions, coding, and utilization management expectations for Tibsovo (ivosidenib) for Commercial, Exchange/Marketplace, and Medicaid lines of business. Includes FDA-approved and select compendia-supported uses, dose limits, and continuation rules.

Payer and policy metadata: Payer = Neighborhood Health Plan of Rhode Island; Drug = Tibsovo (ivosidenib). Coding: HCPCS/J-code J8999 for ivosidenib. Policy updated and administratively converted to a new Evolent guideline template in December 2025 with prior administrative updates in December 2024.

Initial Therapy Criteria — Indications

Indications - Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS)

Covered when ALL of the following are met:

ALL of the following

Documented IDH1 gene-mutation as detected by an FDA approved test (e.g., Abbott RealTime IDH1 Assay)
ONE of the following clinical settings
- Newly diagnosed AML: Tibsovo (ivosidenib) used as monotherapy
- Newly diagnosed AML: Tibsovo (ivosidenib) used in combination with Vidaza (azacitidine)
- Relapsed or refractory AML: Tibsovo (ivosidenib) used as monotherapy

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Indication - Myelodysplastic Syndromes (MDS)

Covered when ALL of the following are met:

ALL of the following

Member has relapsed or refractory MDS
Documented IDH1 mutation
Use of Tibsovo (ivosidenib) as therapy for relapsed/refractory MDS (monotherapy implied)

Unproven / Exclusions and Safety Warnings

Differentiation syndrome: A potentially fatal adverse reaction characterized by fever, respiratory symptoms (dyspnea, hypoxia, pulmonary infiltrates), pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic/renal/multi-organ dysfunction; requires prompt corticosteroid therapy and hemodynamic monitoring until symptom resolution.

Sufficient evidence definition: Evidence meeting the policy standard is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that addresses whether patient and disease characteristics and the regimen are adequately represented, reports clinically meaningful outcomes (ASCO-recommended thresholds, e.g., HR < 0.80 or ≥3 months survival benefit for OS/PFS where applicable), and uses appropriate study design; case reports and abstracts without full peer-reviewed articles are generally insufficient.

Provider Actions and Utilization Management

Prior Authorization

Prior authorization / Evolent processing required

Evolent must process and authorize medication requests for Tibsovo (ivosidenib). Medications that are not authorized by Evolent may be deemed not approvable and not reimbursable.

J8999

Documentation Required

IDH1 mutation documentation required

Submit documentation showing a documented IDH1 gene‑mutation detected by an FDA‑approved test (example: Abbott RealTime IDH1 Assay).

Documentation Required

Continuation authorization documentation

For continuation (maintenance) requests, submit documentation that the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Billing Rule

Dose and monthly quantity limits enforceable

Single‑dose and monthly tablet limits are enforced and claims exceeding these limits may be rejected or denied.

Single dose limit: <= 500 mg
Monthly tablet limit: <= 60 (250 mg) tablets per month

Denial Risk

Denial for investigational/off-label without sufficient evidence

Requests for investigational or off‑label use lacking sufficient evidence or not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature (per the policy's evidentiary standards) may be denied.

Clinical Evidence

ClarIDHyPhase 3 ClarIDHy trial (JAMA Oncol. 2021) — reported overall survival efficacy results in IDH1‑mutant cholangiocarcinoma

NEJM 2022Ivosidenib + azacitidine in newly diagnosed IDH1‑mutated AML — NEJM 2022 supportive trial

CCR 2024FDA approval summary and evidence for ivosidenib + azacitidine in AML — Clin Cancer Res. 2024

ClarIDHy trial (cholangiocarcinoma): The phase 3 ClarIDHy randomized clinical trial reported final overall survival efficacy results for ivosidenib in advanced IDH1-mutant cholangiocarcinoma (JAMA Oncology 2021).

AML combination evidence: Clinical Cancer Research (2024) and the New England Journal of Medicine (2022) publications describe trials supporting the use of ivosidenib in combination with azacitidine for newly diagnosed IDH1-mutated AML.

Additional AML evidence and durability: Prior peer-reviewed work (e.g., N Engl J Med 2018) describes durable remissions with single-agent ivosidenib in relapsed/refractory IDH1-mutated AML, supporting monotherapy use in that setting.

Alignment with labeling/guidelines/compendia: The policy requires that use be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards; references include prescribing information and compendia listings.

Background

Background: Tibsovo (ivosidenib) is an IDH1 inhibitor indicated for IDH1-mutated malignancies; the policy aligns coverage with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, and peer-reviewed evidence.

Evolent responsibilities and scope: Evolent processes medication requests for the payer and medications not authorized by Evolent may be deemed not approvable and not reimbursable. The scope_summary and clinical criteria apply to Commercial, Exchange/Marketplace, and Medicaid lines of business.

Clinical applicability: Policy details accepted indications (cholangiocarcinoma, AML, MDS), required documentation of IDH1 mutation (e.g., Abbott RealTime IDH1 Assay), dose and monthly tablet limits, continuation criteria, and boxed warning precautions (differentiation syndrome).

Revision History

2025-12administrativeLatest

Converted to new Evolent guideline template and replaced previous UM ONC_1340 Tibsovo (ivosidenib); updated references. (Administrative conversion; non-material change.)

2024-12administrative

Added Evolent disclaimer language and coding information with HCPCS code; updated verbiage and references. (Administrative/reference updates; non-material change.)