Subject: Tibsovo 2635-A SGM P2024
Policy:
I. 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.
A. FDA-Approved Indications
1. 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.
2. 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.
3. 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.
4. 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.
B. Compendial Uses
1. AML with an IDH1 mutation
2. Cholangiocarcinoma with an IDH1 mutation
3. Conventional (grades 1-3) or dedifferentiated chondrosarcoma with a susceptible IDH-1
mutation
4. Myelodysplastic Syndromes (MDS)
5. Central Nervous System (CNS) Cancers:
a. IDH mutant Astrocytoma WHO Grade 2
b. IDH mutant Oligodendroglioma WHO Grade 2 or 3
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
medical record documentation of isocitrate dehydrogenase-1 (IDH1) mutation
III. CRITERIA FOR INITIAL APPROVAL
A. Acute Myeloid Leukemia (AML)
1. Authorization of 12 months may be granted for treatment of newly diagnosed AML with a
susceptible IDH1 mutation when any of the following criteria is met:
a. Member is 75 years of age or older and the requested medication will be used as a
single agent or in combination with azacitidine
b. Member is not a candidate for intensive induction therapy and the requested
medication will be used as a single agent or in combination with azacitidine
2. 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:
a. The requested medication will be used as a single agent or in combination with
azacitidine
b. Member has experienced response to Tibsovo therapy
3. Authorization of 12 months may be granted for treatment of relapsed or refractory AML
with a susceptible IDH1 mutation
B. Myelodysplastic Syndromes (MDS)
Authorization of 12 months may be granted for treatment of relapsed or refractory MDS in
members with a susceptible IDH1 mutation.
C. Cholangiocarcinoma
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.
D. Chondrosarcoma
Authorization of 12 months may be granted for treatment of conventional (grades 1-3) or
dedifferentiated chondrosarcoma in members with a susceptible IDH1 mutation.
E. CNS Cancers
Authorization of 12 months may be granted for treatment as a single agent of the following
types of CNS cancer:
1. Recurrent or progressive IDH1 mutant astrocytoma (WHO Grade 2)
2. Recurrent or progressive IDH1 mutant oligodendroglioma (WHO Grade 2 or 3)
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section III 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:
- Tibsovo [package insert]. Boston, MA: Servier Pharmaceuticals LLC; October 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 9, 2024.
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 20, 2024
