CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tibsovo (ivosidenib) coverage

Defines accepted indications, requirements, and limits for coverage of Tibsovo (ivosidenib) for members of the plan; applies to providers submitting medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business listed.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTibsovo (ivosidenib) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of IDH1 mutation positivity and indication-specific clinical information; continuation requests require evidence of no disease progression and an active prior authorization within the last year without >30-day lapse.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

IDH1biomarker for coverage

500 mgsingle dose maximum

60 tabs/momonthly supply limit

J8999HCPCS

Commercial, Medicaid, Exchangelines of business

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Coverage Criteria for Tibsovo (ivosidenib)

inv-01: AML / MDS Coverage Criteria

Covered when ALL of the following are met for AML or MDS:

AML-IDH1-newly_diagnosed_or_RR: Member has acute myeloid leukemia (AML) with a documented IDH1 gene mutation detected by an FDA-approved or appropriate test (e.g., Abbott RealTime IDH1 Assay); ivosidenib (Tibsovo) may be used as monotherapy or in combination with azacitidine for newly diagnosed AML, or as monotherapy for relapsed/refractory AML.

For MDS: ivosidenib may be used for relapsed/refractory MDS with a documented IDH1 mutation.

inv-02: Cholangiocarcinoma Coverage Criteria

Covered when ALL of the following are met for cholangiocarcinoma:

CCA-IDH1-recurrent_unresectable_metastatic: Member has recurrent unresectable or metastatic cholangiocarcinoma with documented IDH1 mutation and disease has progressed after at least one prior line of therapy; ivosidenib (Tibsovo) may be used as monotherapy.

Confirmation of IDH1 mutation positivity by an appropriate test is required.

Use of Tibsovo (ivosidenib) is excluded when the requested indication is investigational or an off-label use that lacks sufficient supporting evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature. The policy defines sufficient evidence by multiple factors including whether the patient and cancer characteristics match the published evidence, whether the tested regimen is adequately represented, whether study outcomes are clinically meaningful (for example, ASCO-recommended thresholds such as a hazard ratio < 0.80 or survival benefit of at least 3 months for OS or PFS), and whether the study design is appropriate for the question being asked.

Use of Tibsovo (ivosidenib) is considered not medically necessary when the evidence is insufficient for off-label indications based on the criteria above, or when dosing and supply limits are exceeded. Specifically, requests will be not medically necessary if they exceed the single-dose limit of 500 mg or the maximum monthly supply of 60 (250 mg) tablets/month, or when there is lack of documentation of IDH1 mutation positivity or prior disease progression on ivosidenib or an ivosidenib-containing regimen.

Coding and Quantity Limits

HCPCS codeHCPCS

J8999

ivosidenib

inv-06: Single dose limit — 500 mg

Single dose limit500 mg per single dose — dosing that exceeds 500 mg is excluded

Source policy guidanceRequests with dosing >500 mg will be excluded/denied per exclusion criteria

Relevance to authorizationPrior authorizations must ensure single-dose does not exceed 500 mg

inv-07: Maximum monthly supply — 60 (250 mg) tablets/month

Maximum monthly supply60 (250 mg) tablets per month — treatment exceeding this limit is excluded

Equivalent total monthly mgEquivalent to 15,000 mg/month if using 250 mg tablets

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Continuation requests are eligible only if the member has not experienced disease progression on the requested medication, the prior authorization remained active within the last year without a lapse of >30 days, and no additional medications are being added to the continuation request.

Continuation requests allowed only when no disease progression on Tibsovo
Authorization must have been active within the last year with ≤30 day lapse
No new medications may be added on continuation requests

Step Therapy

No explicit step-therapy sequencing is mandated for Tibsovo; coverage is determined by indication-specific criteria (e.g., IDH1-mutant AML, relapsed/refractory MDS, IDH1-mutant cholangiocarcinoma after ≥1 prior line).

Coverage is guided by diagnosis and documented IDH1 mutation rather than a required trial of alternative agents

Background

Ivosidenib (Tibsovo) is an IDH1-targeted inhibitor used for tumors with documented IDH1 mutations. Coverage for Tibsovo in this policy is contingent on evidence of an IDH1 mutation and adherence to dosing and supply limits; exclusions include prior progression on ivosidenib and investigational or unsupported off-label uses as described in the exclusion criteria.

Definitions

inv-13: IDH1 mutation positivity — Presence of an IDH1 gene mutation documented by an FDA-approved or appropriate laboratory test.

DefinitionPresence of an IDH1 gene mutation documented by an FDA-approved or appropriate laboratory test

Example testAbbott RealTime IDH1 Assay is cited as an FDA-approved test

Requirement for coverageIDH1 mutation confirmation is required for AML, MDS, and cholangiocarcinoma indications

inv-14: Continuation request — A request to continue an existing authorization where member has not progressed; prior authorization was active within the last year.

DefinitionA request to continue an existing authorization where the member has not experienced disease progression

Timing requirementPrior authorization must have been active within the last year without a lapse of more than 30 days

Line of Therapy

inv-15: first-line | second-line

newly_diagnosed_AML: Ivosidenib can be used as monotherapy or in combination with azacitidine for newly diagnosed AML with a documented IDH1 mutation.

relapsed_refractory_AML_or_MDS: Ivosidenib may be used as monotherapy for relapsed or refractory AML and for relapsed or refractory MDS with a documented IDH1 mutation.

cholangiocarcinoma_after_prior_therapy: Ivosidenib is covered as monotherapy for IDH1‑mutated recurrent unresectable or metastatic cholangiocarcinoma that has progressed after at least one prior line of therapy.

Confirmation of IDH1 mutation positivity is required.

Biomarker Requirements

inv-16: IDH1 — Documented mutation detected by FDA-approved or appropriate test (e.g., Abbott RealTime IDH1 Assay).

Biomarker requirementDocumented IDH1 mutation detected by an FDA-approved or appropriate test (e.g., Abbott RealTime IDH1 Assay)

Indication linkageRequired for coverage in AML (newly diagnosed and relapsed/refractory), MDS (relapsed/refractory), and cholangiocarcinoma

Test acceptabilityCoverage accepts FDA-approved tests or other appropriate laboratory tests for IDH1 confirmation

Covered Regimens and Indications

Regimen	Indication	Coverage status
Ivosidenib monotherapy or in combination with azacitidine
Newly diagnosed acute myeloid leukemia (AML) with documented IDH1 mutation
Covered

Regimen	Indication	Coverage status
Ivosidenib monotherapy
Relapsed or refractory AML, or relapsed/refractory myelodysplastic syndromes (MDS) with documented IDH1 mutation
Covered

Regimen	Indication	Coverage status
Ivosidenib monotherapy
IDH1‑mutation positive recurrent unresectable or metastatic cholangiocarcinoma after progression on ≥1 prior line of therapy (IDH1 confirmation required)
Covered with criteria