CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tibsovo (ivosidenib) — Coverage Criteria

Defines coverage, medical necessity criteria, and utilization management requirements for tibsovo (ivosidenib) for members across Commercial, Exchange, and Medicaid lines of business. Applies to provider medication requests processed by the payer's UM program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTibsovo (ivosidenib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 27, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation of IDH1 mutation positivity and indication-specific evidence per the policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Applicable lines

500 mgSingle dose limit

60 tabsMonthly max

C9399Billing code

2024-12-27Effective

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 and Medical Necessity Criteria

Indication-specific coverage criteria

Covered when ALL of the following are met for the specified indication

AML - newly diagnosed: Member has newly diagnosed acute myeloid leukemia (AML) with documented IDH1 mutation; ivosidenib (Tibsovo) used as monotherapy OR in combination with azacitidine (Vidaza); documentation of an appropriate validated test for IDH1 mutation (e.g., Abbott RealTime IDH1 Assay)

Supported by policy statements on permitted uses

AML - relapsed/refractory: Member has relapsed or refractory AML with documented IDH1 mutation; ivosidenib (Tibsovo) used as monotherapy

MDS - relapsed/refractory: Member has relapsed or refractory myelodysplastic syndromes (MDS) with documented IDH1 mutation; ivosidenib (Tibsovo) may be used

Policy references use in relapsed/refractory MDS with documented IDH1 mutation

Cholangiocarcinoma - recurrent/metastatic: Member has IDH1‑mutation positive recurrent unresectable or metastatic cholangiocarcinoma that progressed on at least one prior line of therapy; ivosidenib (Tibsovo) used as monotherapy; confirmation of IDH1 mutation required

Supported by cholangiocarcinoma-specific policy language

Continuation Therapy

Continuation therapy covered when ALL of the following are met

Continuation therapy general: The requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; and no additional medication(s) are being added to the continuation request

Continuation exemption criteria per policy section on continuation requests

Coverage is excluded when any of the following apply: disease progression on or following Tibsovo (ivosidenib) or an ivosidenib-containing regimen; lack of documentation of IDH1 mutation positivity (see definitions for acceptable testing); dosing that exceeds the single-dose limit of 500 mg; or treatment that exceeds the monthly maximum of 60 (250 mg) tablets. Additionally, requests for ivosidenib intended for investigational or off‑label indications that lack sufficient evidence or are not generally accepted by the medical community are excluded. The policy defines insufficient evidence as failures in one or more of these domains: inadequate representation of the patient or cancer characteristics in published evidence; inadequate representation of the regimen under study; outcomes that are not clinically meaningful; inappropriate experimental design for the question; reliance solely on uncontrolled case reports or abstracts without full peer‑reviewed publication. Documentation of these exclusion criteria will be used to deny coverage when applicable.

Use of Tibsovo (ivosidenib) for off‑label or investigational indications will be considered not medically necessary when the requested indication is not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy specifies elements used to judge sufficiency of evidence: whether study populations and tumor characteristics match the member’s situation; whether the therapy/regimen evaluated corresponds to the requested use; whether reported outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as hazard ratios < 0.80 or survival benefits of at least 3 months); and whether the study design and publication type provide robust evidence (randomized trials preferred; case reports and meeting abstracts without full peer‑reviewed articles are generally inadequate). Requests for investigational/off‑label use lacking these evidentiary elements are considered not medically necessary.

Initial Therapy — Medical Necessity Logic

Initial therapy criteria

Initial therapy is allowed when indication-specific criteria and documentation are provided:

Initial therapy AML: Documented IDH1 mutation; indication corresponds to either newly diagnosed AML (ivosidenib as monotherapy or in combination with azacitidine) or relapsed/refractory AML (monotherapy); appropriate validated test documentation provided (e.g., Abbott RealTime IDH1 Assay)

Initial therapy MDS: Relapsed or refractory MDS with documented IDH1 mutation; appropriate test documentation provided

Initial therapy cholangiocarcinoma: IDH1‑mutant recurrent unresectable or metastatic cholangiocarcinoma that has progressed on ≥1 prior line of therapy; confirmation of IDH1 mutation required

Continuation Therapy — Ongoing Use Conditions

Continuation therapy rules

Continuation requests for previously used, non-approvable medication are exempt when all conditions are met:

Continuation exemption: Medication was used within the last year AND member has not experienced disease progression or intolerance to the medication AND no additional medications are being added to the continuation request

From policy section on continuation requests (Exemption conditions)

Provider Requirements and Actionable Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tibsovo (ivosidenib). Requests must demonstrate indication-specific criteria and meet the documentation and dosing limits outlined below. Evolent (on behalf of the payer) must authorize medication requests; medications not authorized may be denied and not reimbursable.

Prior authorization required for all new starts and non-exempt continuation requests
Continuation exemption: medication used within the last year, no disease progression or intolerance, and no additional medications added to the continuation request

Note

Permitted Uses / Sequencing

Tibsovo (ivosidenib) is permitted in the following uses and sequencing when supported by documentation of an IDH1 mutation and other policy criteria: as monotherapy or in combination with azacitidine (Vidaza) for newly diagnosed AML; as monotherapy for relapsed/refractory AML; for relapsed/refractory MDS with documented IDH1 mutation; and as monotherapy for IDH1‑mutation positive recurrent unresectable or metastatic cholangiocarcinoma after progression on at least one prior line of therapy.

AML: monotherapy OR in combination with azacitidine for newly diagnosed AML
AML: monotherapy for relapsed/refractory AML
MDS: relapsed/refractory MDS with documented IDH1 mutation
Cholangiocarcinoma: monotherapy for IDH1‑mutation positive recurrent unresectable or metastatic disease after ≥1 prior line of therapy

Documentation Required

Required Documentation

Documentation must include confirmation of IDH1 mutation positivity by an appropriate test (for example, Abbott RealTime IDH1 Assay or equivalent) and relevant prior therapy history to support the requested indication. For continuation requests, include evidence the medication was used within the last year and that the member has not experienced disease progression or intolerance. Provide clinical notes, pathology/genomic test reports, and prior treatment records as applicable.

Confirmatory IDH1 mutation test result (e.g., Abbott RealTime IDH1 Assay or equivalent)
Prior therapy documentation (lines of therapy, dates, response/progression status)
For continuation: evidence of prior use within 12 months and absence of progression or intolerance

Denial Risk

Triggers for Denial

Requests may be denied for the following triggers: documented disease progression on or after ivosidenib or an ivosidenib-containing regimen; lack of documentation of IDH1 mutation positivity; dosing that exceeds single-dose or monthly tablet limits; or investigational/off-label use lacking sufficient evidence or support from recognized compendia or peer‑reviewed literature.

Disease progression on or following Tibsovo (ivosidenib) or an ivosidenib-containing regimen
No documentation of IDH1 mutation positivity
Dosing exceeds single dose limit of 500 mg
Monthly dosing exceeds maximum limit of 60 (250 mg) tablets/month
Investigational or unsupported off-label indications without adequate evidence from CMS‑recognized compendia or acceptable peer‑reviewed literature

Billing, Codes, and Quantity Limits

Billing HCPCSHCPCS

C9399

ivosidenib

inv-06: Single dose limit — 500 mg

Single dose limit500 mg

Applies toTibsovo (ivosidenib) dosing: any single administered dose

Denial triggerRequests exceeding this single-dose limit may be excluded per policy

inv-07: Monthly supply limit — 60 (250 mg) tablets per month

Monthly supply limit60 (250 mg) tablets per month

Equivalent maximum monthly mg15,000 mg per month (60 tablets x 250 mg)

Denial triggerTreatment exceeding this monthly maximum may be excluded per policy

Quantity and Dosing Limits

inv-17: ivosidenib — 60 (250 mg) tablets

DrugIvosidenib (Tibsovo) — 60 (250 mg) tablets

Quantity definitionQuantity limit entry specifies 60 tablets per month for 250 mg strength

Associated rulesMust meet indication-specific coverage criteria and prior authorization requirements

inv-18: ivosidenib — 500 mg (single dose limit)

Single-dose cap500 mg per single dose

ContextListed as the single-dose limit for ivosidenib; exceeding this is an exclusion criterion

Relation to quantity limitsSingle-dose cap operates alongside the monthly tablet limit (60 x 250 mg)

Sequencing and Step Therapy Rules

Indication	Required sequencing / prior therapies	Permitted regimen (per policy)	Notes
Acute Myeloid Leukemia (AML) — newly diagnosed	No prior therapy required (policy allows as initial therapy)	Ivosidenib as monotherapy OR in combination with azacitidine (Vidaza)	Documented IDH1 mutation required (e.g., Abbott RealTime IDH1 Assay) — aligns with FDA label and policy initial therapy criteria
Acute Myeloid Leukemia (AML) — relapsed/refractory	Relapsed or refractory disease (no specific prior-line required beyond relapsed/refractory status)	Ivosidenib monotherapy	Documented IDH1 mutation required
Myelodysplastic Syndromes (MDS) — relapsed/refractory	Relapsed or refractory MDS (no specific prior-line required beyond relapsed/refractory status)	Ivosidenib monotherapy	Documented IDH1 mutation required; policy references FDA approval for MDS use
IDH1‑mutant recurrent unresectable or metastatic cholangiocarcinoma	Progression on at least one prior line of therapy (must have progressed on ≥1 prior systemic therapy)	Ivosidenib monotherapy	Confirmation of IDH1 mutation positivity by an appropriate test is required

Key Definitions

inv-13: IDH1 mutation positivity documented by an appropriate validated test (e.g., Abbott RealTime IDH1 Assay)

DefinitionIDH1 mutation positivity documented by an appropriate validated test (e.g., Abbott RealTime IDH1 Assay)

Accepted test exampleAbbott RealTime IDH1 Assay

Required forCoverage of ivosidenib in AML, MDS, and cholangiocarcinoma as specified in policy

Background and Drug Information

Ivosidenib (Tibsovo) is an oral targeted inhibitor of mutant IDH1 used to treat IDH1‑mutated malignancies. Coverage decisions and permitted uses should align with FDA labeling, accepted compendia, and peer‑reviewed literature; insufficient or investigational uses that are not generally accepted by the medical community will be denied per the policy’s evidence standards.

Prescribing and Monitoring / Site of Care Guidance