Subject: Calquence SGM 2397-A P2024a_R

Drug

CALQUENCE  (acalabrutinib)

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 Indications

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.
• Calquence in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplant (HSCT).

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).

Compendial Uses

• Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
• 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
• CLL/SLL
• Mantle Cell Lymphoma

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

Coverage Criteria

Mantle Cell Lymphoma

Authorization of 12 months may be granted for treatment of mantle cell lymphoma when any of the following criteria are met:

• The requested medication will be used as a single agent for subsequent therapy.
• The requested medication will be used in combination with rituximab for induction therapy.
• 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.
• The requested medication will be used in combination with bendamustine and rituximab for previously untreated disease and the member is ineligible for transplant.

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.

Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Authorization of 12 months may be granted for subsequent treatment of Waldenström Macroglobulinemia /Lymphoplasmacytic Lymphoma as a single agent.

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.

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. Calquence [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2025.
2. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 29, 2024.
3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): B-Cell Lymphomas. Version 2.2024. Accessed May 29, 2024. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf.

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.

March 09, 2025