Subject: Iclusig 2173-A SGM P2021
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. Adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors
2. Adult patients with accelerated phase (AP) or blast phase (BP) chronic myeloid leukemia (CML) or Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated
3. Adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL
Limitation of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
B. Compendial Uses
1. Primary treatment of patients with advanced phase CML (accelerated phase or blast phase)
2. Follow-up therapy for CML patients after hematopoietic stem cell transplant (HSCT)
3. Component of a treatment induction regimen, consolidation therapy regimen, or maintenance therapy regimen
for Ph+ acute lymphoblastic leukemia (ALL)
4. Maintenance therapy for Ph+ ALL patients after hematopoietic stem cell transplant (HSCT)
5. Therapy for relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) with T315I mutations
and/or for patients for whom no other TKI is indicated
6. Myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or ABL1 rearrangements in chronic phase
7. Lymphoid, myeloid or mixed lineage neoplasms with eosinophilia and FGFR1 or ABL1 rearrangements in blast phase
All other indications are considered experimental/investigational and not medically necessary.
II. REQUIRED DOCUMENTATION
The following information is necessary to initiate the prior authorization review:
A. Prior to initiation of therapy for treatment of CML or Ph+ ALL/LL: results of cytogenetic and/or molecular testing for
detection of the Ph chromosome or the BCR-ABL gene
B. For members requesting initiation of therapy with the requested medication for treatment of T315I-positive CML:
results of BCR-ABL1 mutation testing for T315I mutation
C. For members requesting initiation of therapy with the requested medication for treatment of myeloid and/or lymphoid
neoplasms with eosinophilia: results of testing or analysis confirming FGFR1 or ABL1 rearrangement
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Myeloid Leukemia (CML)
Authorization of 12 months may be granted for treatment of CML that has been confirmed by detection of the Ph chromosome
or BCR-ABL gene by cytogenetic and/or molecular testing when any of the following criteria are met:
1. Member has T315I-positive CML
2. Member has chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least
two prior kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
3. Member has accelerated phase (AP) or blast phase (BP) CML and treatment with any other kinase inhibitors
(e.g., bosutinib, dasatinib, imatinib, nilotinib) are not indicated
B. Ph+ Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL)
Authorization of 12 months may be granted for treatment of Ph+ ALL or LL that has been confirmed by detection of the Ph chromosome
or BCR-ABL gene by cytogenetic and/or molecular testing.
C. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid neoplasms with eosinophilia and
FGFR1 or ABL1 rearrangement in the chronic phase or blast phase.
IV. CONTINUATION OF THERAPY
A. CML
Authorization of 12 months may be granted for continued treatment of CML that has been confirmed by detection
of Ph chromosome or BCR-ABL gene by cytogenetic and/ or molecular testing when there is no evidence of unacceptable
toxicity or disease progression while on the current regimen.
B. Ph+ ALL/LL
Authorization of 12 months may be granted for continued treatment of Ph+ ALL or LL that has been confirmed by detection
of Ph chromosome or BCR-ABL gene by cytogenetic and/ or molecular testing when there is no evidence of unacceptable
toxicity or disease progression while on the current regimen.
C. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization 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:
- Iclusig [package insert]. Cambridge, MA: Ariad Pharmaceuticals, Inc.; December 2020.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 30, 2021.
- NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 3.2021). © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 30, 2021.
- NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 2.2020).
© 2020 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 30, 2021.
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.
October 01, 2021
