Subject: Tibsovo SGM 2635-A P2026

Drug

TIBSOVO  (ivosidenib)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

Newly Diagnosed Acute Myeloid Leukemia

Tibsovo is indicated in combination with azacitidine or as monotherapy for the treatment of newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Relapsed or Refractory Acute Myeloid Leukemia

Tibsovo is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Relapsed or Refractory Myelodysplastic Syndromes

Tibsovo is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Locally Advanced or Metastatic Cholangiocarcinoma

Tibsovo is indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Compendial Uses²

·        AML with an IDH1 mutation

·        Myelodysplastic Syndromes (MDS) with an IDH1 mutation

·        Cholangiocarcinoma with an IDH1 mutation

·        Conventional (grades 1-3) or dedifferentiated chondrosarcoma with a susceptible IDH-1 mutation

·        Central Nervous System (CNS) Cancers:

§  IDH mutant Astrocytoma

§  IDH mutant Oligodendroglioma

§  High-grade gliomas

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: medical record documentation of isocitrate dehydrogenase-1 (IDH1) mutation.

Coverage Criteria

Acute Myeloid Leukemia (AML)^1,2

Authorization of 12 months may be granted for treatment of newly diagnosed AML with a susceptible IDH1 mutation, when used as a single agent or in combination with azacitidine, in members who are either at least 75 years old or are ineligible or declines intensive induction therapy.

Authorization of 12 months may be granted for post-induction therapy for AML with a susceptible IDH1 mutation when all of the following criteria are met:

·        The requested medication will be used as a single agent or in combination with azacitidine

·        Member has experienced response to Tibsovo therapy

Authorization of 12 months may be granted for treatment of relapsed or refractory AML with a susceptible IDH1 mutation, as a single agent.

Myelodysplastic Syndromes (MDS)^1,2

Authorization of 12 months may be granted for subsequent treatment of MDS in members with a susceptible IDH1 mutation.

Cholangiocarcinoma^1,2

Authorization of 12 months may be granted for subsequent treatment of unresectable, resected gross residual (R2), locally advanced or metastatic cholangiocarcinoma as a single agent in members with an IDH1 mutation.

Chondrosarcoma²

Authorization of 12 months may be granted for treatment of conventional (grades 1-3) or dedifferentiated chondrosarcoma, as a single agent, in members with a susceptible IDH1 mutation.

Central Nervous System (CNS) Cancers²

Authorization of 12 months may be granted for treatment as a single agent in members who are unable to tolerate vorasidenib with the following types of IDH1 mutant CNS cancers:

·        Astrocytoma (WHO grade 2) and either of the following criteria is met:

§  Member has recurrent or progressive disease, or

§  The requested medication will be used as adjuvant treatment

·        Oligodendroglioma (WHO grade 2 or 3) and member has recurrent or progressive disease

·        Oligodendroglioma (WHO grade 2) and the requested medication will be used as adjuvant treatment

·        Recurrent or progressive high grade gliomas of the following histologies:

§  H3-mutated high-grade glioma

§  High-grade astrocytoma with piloid features (HGAP)

§  Pleomorphic xanthoastrocytoma (PXA) WHO grade 3

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Tibsovo [package insert]. Boston, MA: Servier Pharmaceuticals LLC; October 2023.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 29, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 14, 2026