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UnitedHealthcare Tibsovo Prior Auth Coverage | OpenPayer

CurrentUnitedHealthcarePolicy 2025 P 1257-9

Prior Authorization/Notification - Tibsovo (ivosidenib) coverage criteria

UnitedHealthcare prior authorization criteria for coverage of Tibsovo (ivosidenib) for specified malignancy indications and patient populations; applies to members whose benefit requires prior authorization for this medication.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Notification - Tibsovo (ivosidenib) coverage criteria

Policy CodePolicy 2025 P 1257-9

Key ActionObtain prior authorization and document IDH1 mutation positivity and indication-specific criteria before submitting the request.

Change TypeAnnual review / operational updates

Effective DateApr 1, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Annual review updated criteria for oligodendroglioma and astrocytoma per NCCN guidelines and updated references.

Updated background and criteria to include new indication for relapsed or refractory MDS with a susceptible IDH1 mutation.

Added criteria for oligodendroglioma and astrocytoma per NCCN guidelines.

Notwithstanding Coverage Criteria, approvals may be granted based solely on previous claim/medication history, diagnosis codes, and/or claim logic; automated processes vary by program.

12 monthsauthorization duration for approved requests

Multiple tumor typesindications covered

2018-2025documented program updates

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Coverage Criteria for Tibsovo (ivosidenib)

Initial Authorization — Acute Myeloid Leukemia (AML)

Covered when ALL of the following are met

AML initial authorization: Diagnosis of acute myeloid leukemia (AML); AML is IDH1 mutation-positive; and one of the following: disease is relapsed or refractory; OR new diagnosis with BOTH: (i) new diagnosis of AML AND (ii) one of: patient ≥75 years old; patient has comorbidities that preclude use of intensive induction chemotherapy; patient ≥60 years old and not a candidate for or declines intensive induction therapy; patient ≥60 years old and receiving post-induction therapy following response to previous lower intensity therapy

Reauthorization — AML

Covered when ALL of the following are met

AML reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Initial Authorization — Chondrosarcoma (Bone Cancer)

Covered when ALL of the following are met

Chondrosarcoma initial: Diagnosis of chondrosarcoma; susceptible IDH1 mutation-positive; and disease is one of: conventional (grades 1-3) OR dedifferentiated

Reauthorization — Chondrosarcoma

Chondrosarcoma reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Initial Authorization — Cholangiocarcinoma

Covered when ALL of the following are met

Cholangiocarcinoma initial: Diagnosis of cholangiocarcinoma; susceptible IDH1 mutation-positive; disease is locally advanced, unresectable, or metastatic; and disease has progressed on or after systemic treatment

Reauthorization — Cholangiocarcinoma

Cholangiocarcinoma reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Initial Authorization — Oligodendroglioma

Covered when ALL of the following are met

Oligodendroglioma initial: Diagnosis of oligodendroglioma; disease is recurrent or progressive; presence of both IDH1 mutation and 1p19q codeletion; and disease is WHO grade 2 or 3

Reauthorization — Oligodendroglioma

Oligodendroglioma reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Initial Authorization — Astrocytoma

Covered when ALL of the following are met

Astrocytoma initial: Diagnosis of astrocytoma; disease is recurrent or progressive; presence of IDH1 mutation; and disease is WHO grade 2, 3, or 4

Reauthorization — Astrocytoma

Astrocytoma reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Initial Authorization — Myelodysplastic Syndrome (MDS)

Covered when ALL of the following are met

MDS initial: Diagnosis of myelodysplastic syndrome (MDS); disease is relapsed or refractory; presence of IDH1 mutation

Reauthorization — MDS

MDS reauthorization: Patient does not show evidence of progressive disease while on Tibsovo therapy

Pediatrics

Pediatric authorization: Member is less than 19 years of age

Coverage criteria in this document are the standard prior authorization requirements for Tibsovo (ivosidenib). Members under the age of 19 will have the prescription processed without a coverage review. Some states have laws that mandate coverage for off‑label medication use or require use of alternate compendia; when such state mandates apply, they supersede the language in this benefit document or the notification criteria.

Prior authorization is required for Tibsovo and determinations may be made using clinical documentation or administrative data. UnitedHealthcare may approve initial or reauthorization requests based on prior claim/medication history, ICD‑10 diagnosis codes, and/or claim logic; program‑level automation and supply limits may also affect approvals. Annual reviews and periodic updates to align criteria with the NCCN and label are documented in the change history.

Initial Therapy Criteria by Indication

Initial therapy — Initial authorization criteria vary by indication and require IDH1 mutation positivity and additional disease-specific conditions.

Initial authorization criteria vary by indication and require IDH1 mutation positivity and additional disease-specific conditions.

Initial therapy nodes: See indication-specific initial authorization criteria for AML, chondrosarcoma, cholangiocarcinoma, oligodendroglioma, astrocytoma, and MDS

Reauthorization and Continuation Criteria

Reauthorization/Continuation — Reauthorization is contingent on absence of progressive disease while on therapy.

Reauthorization is contingent on absence of progressive disease while on therapy.

Continuation criteria: Patient does not show evidence of progressive disease while on Tibsovo therapy

Provider Actions, Prior Authorization, and Administrative Notes

Prior Authorization

Prior Authorization Required

Prior authorization required for Tibsovo. Prior authorization and clinical criteria vary by indication; specific criteria sets for AML, chondrosarcoma, cholangiocarcinoma, oligodendroglioma, astrocytoma, and MDS must be met for approval.

Initial and re-authorization decisions require meeting indication-specific clinical criteria (see criteria sets for AML, chondrosarcoma, cholangiocarcinoma, oligodendroglioma, astrocytoma, MDS).
Authorization will be issued for 12 months when criteria are met for covered indications.
For members under 19 years of age, prescriptions will automatically process without a coverage review; tibsovo will be approved for 12 months if member is < 19 years.

Note

Prior Authorization Determination

Prior authorization and re-authorization decisions may be made using prior claim/medication history, ICD-10 diagnosis codes, and/or automated claim logic. UnitedHealthcare may approve requests based solely on these data elements where allowed.

Background

Tibsovo (ivosidenib) is an isocitrate dehydrogenase‑1 (IDH1) inhibitor indicated for treatment of adult patients with a susceptible IDH1 mutation in several tumor types. Indications referenced in this policy and in the program change log include relapsed/refractory acute myeloid leukemia (AML) and certain newly diagnosed AML patients not candidates for intensive induction, relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation, previously treated locally advanced or metastatic cholangiocarcinoma, and IDH1‑mutant central nervous system and bone tumors (including oligodendroglioma, astrocytoma, and chondrosarcoma) per label and NCCN guidance.

Definitions and Reference Materials

Susceptible IDH1 mutation-positive

DefinitionPresence of an isocitrate dehydrogenase-1 (IDH1) mutation as identified by an appropriate test and consistent with indications listed in the labeling and NCCN recommendations.

Test requirementMutation must be identified by an appropriate diagnostic test (per labeling/NCCN guidance).

RelevanceRequired for all covered indications of Tibsovo (e.g., AML, MDS, cholangiocarcinoma, chondrosarcoma, oligodendroglioma, astrocytoma).

NCCN Compendium

SourceThe NCCN Drugs and Biologics Compendium (NCCN Compendium™) is referenced as a guideline source for recommended use criteria and alignment.

AccessNCCN Compendium available at www.nccn.org (access date noted in references).

Quantity Limits and Supply Constraints

Tibsovo (ivosidenib)

Quantity limitsSupply limits may be in place for Tibsovo; utilization management programs may enforce limits.

Approval logicUnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated processes vary by program.

Program variabilityUse of automated approval and re-approval processes varies by program and therapeutic class.

Policy Revision History and Changes

2025-01annual_reviewLatest

Annual review updated criteria for oligodendroglioma and astrocytoma per NCCN guidelines and updated references.

2024-01criteria_update

Updated background and criteria to include new indication for relapsed or refractory MDS with a susceptible IDH1 mutation and updated references.

2023-10annual_review

Annual review added criteria for oligodendroglioma and astrocytoma per NCCN guidelines and updated references.