Pharmacy Prior Authorization Criteria

Calquence (acalabrutinib)

Indications for Prior Authorization

Calquence (acalabrutinib)

• For diagnosis of Mantle Cell Lymphoma (MCL)
  Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• 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
• Patient has received at least one prior therapy for MCL

Calquence

Prior Authorization (Reauthorization)

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

• Patient does not show evidence of progressive disease while on therapy

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 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

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

References

1. Calquence Capsule Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. March 2022.
2. Calquence Tablet Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. August 2022.

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Revision History

• 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

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