CALQUENCE (acalabrutinib)

CALQUENCE (acalabrutinib)

SELF-ADMINISTRATION - ORAL

Indications for Prior Authorization:

• Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Coverage Criteria:

1.    For treatment of MCL:

• Dose does not exceed 200 mg (two 100 mg tablets) daily; AND

• Prescribed by or in consultation with an oncologist; AND

• Patient is 18 years of age or older; AND

• Member has mantle cell lymphoma and has had at least 1 prior therapy; AND

• Patient is not concurrently taking a CYP3A inhibitor or inducer; AND

• Patient is not concurrently taking a proton pump inhibitor (PPI)

  • (stagger dosing with H2-receptor antagonists and antacids)

2.    For treatment of CLL/SLL:

• Dose does not exceed 200 mg (two 100 mg tablets) daily; AND

• The drug is being used to treat CLL/SLL as approved by the Food and Drug Administration (FDA)

Coverage Duration:

• 1 year

Authorization is not covered for the following: 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

Dosage and Administration:

• Dose modifications are recommended for non-hematologic toxicities, thrombocytopenia with bleeding, thrombocytopenia, or neutropenia lasting longer than 7 days.
• Take Calquence 2 hours before taking a H2-receptor antagonist (e.g. famotidine, cimetidine, ranitidine) and separate Calquence dosing by at least 2 hours with antacids.

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Policy Updates:

• 2017 – Initial FDA approval.
• 12/17/2018 – New policy.
• 11/30/2020 – Updated FDA-approved indications to include CLL/SLL. Updated formatting.
• 06/01/2023 - Updated policy to include dosing/prescriber requirements and formatting.

References:

• Calquence [package insert], Wilmington, DE: AstraZeneca Pharmaceuticals, Inc.; November 2019.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – B-Cell Lymphomas, version 4.2020 – August 13, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed November 30, 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, version 1.2021 – September 28, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed November 30, 2020.