CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

acalabrutinib (Calquence) coverage for lymphoid malignancies

Defines coverage criteria and authorization durations for Calquence (acalabrutinib) for FDA-approved and compendial indications (MCL, CLL/SLL, various marginal zone lymphomas, Waldenstrom macroglobulinemia) and continuation/reauthorization rules for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyacalabrutinib (Calquence) coverage for lymphoid malignancies

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization must be obtained prior to treatment; initial and continuation authorizations are typically granted for 12 months when criteria are met.

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria

2FDA-approved indications listed

5Compendial/other indications listed

12Typical authorization duration (months)

Coverage Summary

Calquence (acalabrutinib) is a Bruton tyrosine kinase (BTK) inhibitor with FDA approvals for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The policy defines covered indications to include these FDA-approved uses as well as compendial indications when all approval criteria are met and the member has no exclusions to the prescribed therapy.

Covered Indications and Authorization Durations

Calquence is covered for the following indications when all approval criteria are met and no member exclusions apply:

ALL of the following

FDA-approved indications (A)
- Mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy
  Authorization of 12 months may be granted for treatment of mantle cell lymphoma as a single agent when the member has received at least one prior therapy
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients
  Authorization of 12 months may be granted for treatment of CLL/SLL as a single agent or in combination with obinutuzumab
Compendial uses (B)
- Gastric MALT lymphoma (extranodal marginal zone lymphoma of the stomach)
  Authorization of 12 months may be granted when used as subsequent therapy
- Non-gastric MALT lymphoma (extranodal marginal zone lymphoma of nongastric sites)
  Authorization of 12 months may be granted when used as subsequent therapy
- Nodal marginal zone lymphoma
  Authorization of 12 months may be granted when used as subsequent therapy
- Splenic marginal zone lymphoma
  Authorization of 12 months may be granted when used as subsequent therapy
- Waldenström macroglobulinemia / lymphoplasmacytic lymphoma
  Authorization of 12 months may be granted for subsequent treatment as a single agent
Member has no exclusions to the prescribed therapy
General eligibility requirement

Initial and Continuation Therapy Criteria

FDA-approved / Initial Therapy

FDA-approved (initial-therapy focused)

Mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy
Authorization of 12 months may be granted for treatment of mantle cell lymphoma as a single agent when the member has received at least one prior therapy
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients
Authorization of 12 months may be granted for treatment of CLL/SLL as a single agent or in combination with obinutuzumab

Continuation / Reauthorization Criteria

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Member requests reauthorization for an indication listed in the covered indications
There is no evidence of unacceptable toxicity while on the current regimen
There is no evidence of disease progression while on the current regimen

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required

Authorization must be obtained prior to treatment; initial and continuation authorizations are typically granted for 12 months when criteria are met.

Documentation Required

Document lack of toxicity or progression for reauthorization

For continuation/reauthorization, provider must document no unacceptable toxicity and no disease progression on current regimen.

Background

Background: Calquence (acalabrutinib) is a BTK inhibitor indicated for adult patients with mantle cell lymphoma (MCL) after at least one prior therapy and for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Compendial uses supported in the policy include various marginal zone lymphomas (gastric and non-gastric MALT, nodal, splenic) and Waldenström macroglobulinemia/lymphoplasmacytic lymphoma.

The policy references and relies on the product label (Calquence package insert, AstraZeneca; August 2022) and the NCCN Drugs & Biologics Compendium (2023) for compendial support and details of covered indications and authorization guidance.