Subject: Calquence 2397-A SGM P2023a
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CALQUENCE
(acalabrutinib)
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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. Mantle Cell Lymphoma
Calquence is indicated for the treatment of adult patients
with mantle cell lymphoma (MCL) who have received at
least one prior therapy.
2. Chronic Lymphocytic Leukemia or Small Lymphocytic
Lymphoma
Calquence is indicated for the treatment of adult patients
with chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL).
B. Compendial Uses
1. Waldenström Macroglobulinemia/Lymphoplasmacytic
Lymphoma
2. Gastric MALT Lymphoma (Extranodal Marginal Zone
Lymphoma of the Stomach)/Non-gastric MALT Lymphoma
(Extranodal Marginal Zone Lymphoma of Nongastric
Sites)
3. Nodal Marginal Zone Lymphoma
4. Splenic Marginal Zone Lymphoma
5. CLL/SLL
6. Mantle Cell Lymphoma
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Mantle cell lymphoma
Authorization of 12 months may be granted for treatment of
mantle cell lymphoma when any of the following criteria are
met:
1. The requested medication will be used as a single agent
for subsequent therapy.
2. The requested medication will be used in combination
with rituximab for induction therapy.
3. The requested medication will be used in combination
with rituximab as pre-treatment to limit the number of
cycles of induction therapy with RHyperCVAD (rituximab,
cyclophosphamide, vincristine, doxorubicin and
dexamethasone) regimen.
B. Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
CLL/SLL as a single agent or in combination with
obinutuzumab.
C. Waldenström Macroglobulinemia/Lymphoplasmacytic
Lymphoma
Authorization of 12 months may be granted for subsequent
treatment of Waldenström Macroglobulinemia
/Lymphoplasmacytic Lymphoma as a single agent.
D. Gastric MALT Lymphoma (Extranodal Marginal Zone
Lymphoma of the Stomach)/Non-gastric MALT
Lymphoma (Extranodal Marginal Zone Lymphoma of
Nongastric Sites)/Nodal Marginal Zone
Lymphoma/Splenic Marginal Zone Lymphoma
Authorization of 12 months may be granted for treatment of
gastric MALT lymphoma (extranodal marginal zone
lymphoma of the stomach), non-gastric MALT lymphoma
(extranodal marginal zone lymphoma of nongastric sites),
nodal marginal zone lymphoma and splenic marginal zone
lymphoma when used as subsequent therapy.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II 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:
- Calquence [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2022.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 22, 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.
February 23, 2024
