Centene ivosidenib (Tibsovo) Coverage Prior Auth

Coverage Criteria for Ivosidenib (Tibsovo)

inv-01: Initial Approval Criteria — AML

Covered when ALL of the following are met

AML initial therapy criteria: 1) Diagnosis of acute myeloid leukemia (AML); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Disease is newly diagnosed and prescribed in combination with azacitidine or as monotherapy for patients not eligible for intensive induction OR disease is relapsed or refractory; 5) Medical justification supports inability to use intensive induction chemotherapy when applicable (see appendices); 6) Presence of an IDH1 mutation; 7) Dose does not exceed 500 mg per day (2 tablets); 8) Prescribed regimen must be FDA‑approved or recommended by NCCN; if used off‑label, dose must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence.

Generic ivosidenib must be used if available unless contraindicated

inv-02: Initial Approval Criteria — Cholangiocarcinoma

Covered when ALL of the following are met

Cholangiocarcinoma criteria: 1) Diagnosis of locally advanced or metastatic cholangiocarcinoma; 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) Disease is positive for an IDH1 mutation; 5) Prescribed as a single agent for disease progression on or after systemic treatment; 6) Dose does not exceed 500 mg per day (2 tablets); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN; if used off‑label, dose must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence.

Generic ivosidenib must be used if available unless contraindicated

inv-03: Initial Approval Criteria — MDS

Covered when ALL of the following are met

MDS criteria: 1) Diagnosis of myelodysplastic syndromes (MDS); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Disease is relapsed or refractory, or there is disease progression or intolerance to systemic treatment; 5) Presence of an IDH1 mutation; 6) Dose does not exceed 500 mg per day (2 tablets); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN; if used off‑label, dose must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence.

Generic ivosidenib must be used if available unless contraindicated

inv-04: Initial Approval Criteria — Selected Off‑Label Indications

Covered when ALL of the following are met

Chondrosarcoma criteria: 1) Diagnosis of conventional (grade 1-3) or dedifferentiated chondrosarcoma; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Disease is positive for an IDH1 mutation; 5) Dose does not exceed 500 mg per day (2 tablets); 6) Prescribed regimen must be FDA‑approved or recommended by NCCN; if used off‑label, the dose and use must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence.

Generic ivosidenib must be used if available unless contraindicated

Glioma criteria: 1) Diagnosis of oligodendroglioma or astrocytoma (glioma); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Disease is positive for an IDH1 mutation; 5) Prescribed as a single agent; 6) Dose does not exceed 500 mg per day (2 tablets); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN; if used off‑label, the dose and use must be supported by practice guidelines or peer‑reviewed literature and prescriber must submit supporting evidence.

Generic ivosidenib must be used if available unless contraindicated

inv-05: Continued Therapy — Covered when ALL of the following are met (renewal/continuation conditions)

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving ivosidenib via the Centene benefit, or documentation supports current receipt and at least 30 days of therapy; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed 500 mg per day or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 4) Generic ivosidenib must be used if available unless contraindicated.

Prescribed regimen must be FDA‑approved or recommended by NCCN for off‑label uses

inv-06: Routing for indications and off‑label requests — general coverage limitations and routing

General coverage limitations and routing

Formulary/non‑formulary routing: Coverage requests must follow the applicable formulary or non‑formulary policy for the member's line of business (commercial, marketplace, Medicaid), or follow the off‑label use policy when the indication is not listed in this policy.

References: CP.CPA.190, HIM.PA.33, CP PMN.255, HIM.PA.103, CP PMN.16, CP CPA.09, HIM.PA.154, CP.PMN.53

inv-07: Dose, duration, and boxed warning — dosing, continuation guidance, boxed warning mention

Dosing and continuation guidance

Dose and duration: Recommended dosing: 500 mg PO once daily (tablet available as 250 mg); maximum dose 500 mg/day. For patients with AML or MDS without disease progression or unacceptable toxicity, continue ivosidenib for a minimum of 6 months to allow time for clinical response.500 mg/day; minimum 6 months

Tablet available as 250 mg

Safety warning: Differentiation syndrome is a boxed warning applicable to AML and MDS treatment with ivosidenib.

Monitor and manage per prescribing information

Non‑FDA approved (off‑label) indications that are not specifically listed in this policy are not authorized for coverage unless the provider submits sufficient documentation supporting efficacy and safety in accordance with the applicable off‑label use policies or formulary/no‑coverage pathways. Refer to the off‑label use policies for the member's line of business: CP CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid), or follow the applicable formulary/no‑coverage and non‑formulary policies noted below.

When a requested use is not on the formulary/PDL or is not listed in this policy, providers must follow the referenced formulary/no‑coverage or non‑formulary policies for the member's line of business. Applicable references include CP.CPA.190 (Commercial no‑coverage/formulary), HIM.PA.33 (Marketplace no‑coverage/formulary), CP PMN.255 (Medicaid PDL/no‑coverage), and for non‑formulary routing HIM.PA.103 (Marketplace non‑formulary) and CP PMN.16 (Medicaid non‑formulary). If the indication is not listed and the formulary pathways do not apply, the off‑label use policies cited above should be used to support coverage consideration.

Requests for non‑FDA approved indications that lack sufficient evidence of efficacy and safety as defined by the referenced off‑label use policies (CP CPA.09, HIM.PA.154, CP PMN.53) or applicable evidence‑of‑coverage documents are considered not authorized / not medically necessary and may be denied.

Uses that are non‑FDA approved and not supported by documentation per the off‑label or formulary/non‑formulary policies may be considered not medically necessary. Providers should submit supporting peer‑reviewed literature, practice guidelines (e.g., NCCN), or other evidence as specified by the applicable off‑label policy for the member's line of business; otherwise, the request should be routed per the formulary/non‑formulary policies referenced above.

Initial Therapy Authorization Requirements

inv-29: Initial Therapy — top-level group; criteria vary by diagnosis but require IDH1 mutation positivity and prescriber specialty

Initial authorization criteria vary by diagnosis; all require IDH1 mutation positivity and prescriber specialty.

Initial therapy general: 1) Prescribed by or in consultation with an oncologist or hematologist (as specified by diagnosis); 2) Age ≥ 18 years; 3) Presence of a susceptible IDH1 mutation documented; 4) Dose does not exceed 500 mg per day (2 tablets); 5) Use generic ivosidenib if available unless contraindicated; 6) Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label uses require supporting evidence from practice guidelines or peer‑reviewed literature provided by the prescriber.

inv-30: Initial therapy — single top-level node summary

Initial dosing: Dosing regimen: 500 mg PO once daily until disease progression or unacceptable toxicity. Tablet available as 250 mg.500 mg PO QD

Prescribing information referenced

Continuation / Renewal Criteria

inv-31: Continuation Therapy — renewal requirements and response assessment

Continuation/renewal requirements

Continuation therapy: 1) Member must have been receiving ivosidenib via the Centene benefit or provide documentation of current receipt for at least 30 days; 2) Member is responding positively to therapy; 3) Any requested dose increase must not exceed the 500 mg/day maximum or must be supported by practice guidelines or peer‑reviewed literature; 4) Generic ivosidenib must be used if available unless contraindicated.

inv-32: Continuation therapy — continuation for responding patients (minimum durations)

Continue therapy: For AML or MDS patients without disease progression or unacceptable toxicity, continue ivosidenib for a minimum of 6 months to allow time for clinical response.minimum 6 months

Maximum dose 500 mg/day

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must document diagnosis and IDH1 mutation status, prescriber specialty, patient age, and dosing limits. For requests involving dose increases, the new dose must not exceed 500 mg (2 tablets) per day unless supported by practice guidelines or peer‑reviewed literature; prescriber must submit supporting evidence for off‑label dosing.

Diagnosis and IDH1 mutation status required
Prescribed by or in consultation with an oncologist or hematologist
Patient age ≥ 18 years for adult indications (per indication specifics)
Dose limit: ≤ 500 mg (2 tablets) per day unless guideline-supported

Note

Formulary / Routing Guidance

Providers must follow the applicable formulary/no‑coverage/non‑formulary/off‑label policies for the member's line of business when routing prior authorization requests. For formulary or PDL drugs follow CP.CPA.190 (Commercial), HIM.PA.33 (Marketplace) or CP PMN.255 (Medicaid). For non‑formulary drugs follow CP.CPA.190 (Commercial), HIM.PA.103 (Marketplace) or CP PMN.16 (Medicaid). For off‑label uses refer to CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace) or CP.PMN.53 (Medicaid).

Coding and Billing

No explicit billing codes listed in this partmixed

No codes listed

Prior Auth / Formulary routingmixed

affected codes

referenced prior authorization/formulary routing affects PA codes (exact codes not listed in this part)

Maximum daily dose — key value displaying ≤ 500 mg per day

Maximum daily dose≤ 500 mg per day (maximum 500 mg/day)

Tablet equivalence2 tablets per day (250 mg tablet) corresponds to 500 mg/day

Applies to indicationsDose limit specified for AML, cholangiocarcinoma, MDS, and listed off‑label indications

Continuation duration — minimum 6 months

Minimum continuation duration (AML/MDS)Minimum 6 months for AML or MDS if no disease progression or unacceptable toxicity

PurposeAllow time to assess clinical response

Step Therapy and Related Policies

Step	Requirement / routing	Reference policy
1	For uses not specifically listed in this policy (non‑FDA approved indications, age/dosing not listed, or drugs on/off formulary), follow the applicable no‑coverage, non‑formulary, or off‑label use policy for the member's line of business; prior authorization must route per those policies	CP.CPA.190; HIM.PA.33; CP PMN.255; HIM.PA.103; CP PMN.16; CP CPA.09; HIM.PA.154; CP.PMN.53

Date (policy history)	Change made	Notes / evidence
4Q 2020 (08.17.20 / P&T 11.20.20)	Added criteria for biliary tract (cholangiocarcinoma) as an NCCN 2A off‑label indication	References reviewed and updated per 4Q 2020 annual review
4Q 2021 (07.14.21 / P&T 11.21)	Added coverage for older patients (age ≥60) not candidates for induction or as post‑induction therapy per NCCN; updated biliary tract indication to FDA‑labeled for locally advanced/metastatic cholangiocarcinoma previously treated	Also added requirement to use generic if available; references reviewed and updated

Quantity and Dosing Limits

Ivosidenib (Tibsovo) quantity limit — ≤ 500 mg

Quantity limit≤ 500 mg total per day

Per-prescription unitExpressed as mg/day (2 × 250 mg tablets = 500 mg)

Applies toIvosidenib (Tibsovo) for all covered indications in this policy

Ivosidenib (Tibsovo) — maximum dose 500 mg/day and available formulations

Maximum dose500 mg/day (maximum 500 mg per day)

Available formulationTablet: 250 mg

Dosing regimen

Definitions and Abbreviations

Ivosidenib (Tibsovo) — key definition: IDH1 inhibitor

Drug classIDH1 inhibitor (isocitrate dehydrogenase‑1 inhibitor)

Common nameIvosidenib (Tibsovo)

Primary useTreatment of malignancies harboring susceptible IDH1 mutations (e.g., AML, cholangiocarcinoma, MDS)

IDHI — isocitrate dehydrogenase‑1 abbreviation definition

AbbreviationIDHI = isocitrate dehydrogenase‑1

Context of useUsed in policy to denote presence of an IDH1 mutation required for coverage

Referenced in appendices

Background

Ivosidenib (Tibsovo) is an IDH1 inhibitor whose coverage under this policy requires documented IDH1 mutation positivity and prescriber justification. For indications not specifically listed in this document, coverage is contingent on meeting the documentation and routing requirements set forth in the applicable formulary, non‑formulary, or off‑label use policies referenced in this policy.

Site‑of‑Care

Note

Office / site‑of‑care — no site‑of‑care restrictions stated

There are no specific site‑of‑care restrictions stated in this policy; office administration or other settings are not restricted by this document portion.

Refer to the full policy and plan benefit documents for any additional site‑of‑care billing or administration rules.

OpenPayer

Ivosidenib (Tibsovo) coverage

Coverage Criteria for Ivosidenib (Tibsovo)

Initial Therapy Authorization Requirements

Continuation / Renewal Criteria

Provider Requirements and Submission Instructions

Coding and Billing

Step Therapy and Related Policies

Quantity and Dosing Limits

Definitions and Abbreviations

Background

Site‑of‑Care