Subject: Tibsovo 2635-A SGM P2023a
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
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 has comorbidities that preclude the use of
intensive induction therapy and the requested
medication will be used as a single agent or in
combination with azacitidine
c. Member is 60 years of age or older, declines 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
b. Member is 60 years of age or older
c. 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, 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.
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® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 9, 2023.
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.
November 09, 2023
