Calquence (acalabrutinib)

Indications for Prior Authorization

Calquence (acalabrutinib)
  • For diagnosis of Mantle Cell Lymphoma (MCL)
    1) Indicated in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 2) Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

  • For diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
    Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Criteria

Calquence

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Mantle Cell Lymphoma (MCL)

  • Diagnosis of mantle cell lymphoma (MCL)
  • AND
  • One of the following:
    • All of the following:
      • Patient has received no prior therapy for MCL (e.g., bortezomib, rituximab)
      • AND
      • Patient is ineligible for autologous hematopoietic stem cell transplantation (HSCT)
      • AND
      • Used in combination with bendamustine and rituximab
      OR
    • Patient has received at least one prior therapy for MCL
Calquence

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

  • Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma
Calquence

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2025-02-05, 2024-01-25, 2023-07-03, 2023-02-28, 2022-09-06, 2022-01-10, 2021-04-14, 2021-01-28, 2020-01-09

  1. Calquence Tablet Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. January 2025.

  • 2025-02-05: 2025 Annual Review. Added new indication for previously untreated Mantle Cell Lymphoma. Updated to full approval the existing indication for Mantle Cell Lymphoma, in previously treated patients. Removed obsolete product Calquence capsule (GPI 21532103000120) as target drug. Consolidated Reauthorization section.
  • 2024-01-25: Annual review - no criteria changes
  • 2023-07-03: Removed specialist requirement
  • 2023-02-28: Annual Review - no criteria changes
  • 2022-09-06: Added Calquence tablet formulation. Updated references.
  • 2022-01-10: Annual Review - No criteria changes
  • 2021-04-14: Updated GPIs
  • 2021-01-28: annual review no updates to clinical criteria
  • 2020-01-09: added new indication