CurrentNeighborhood Health Plan of Rhode IslandPolicy 2397-A

acalabrutinib (Calquence) coverage for lymphoid malignancies

Defines coverage, authorization duration, and approval criteria for acalabrutinib (Calquence) for FDA-approved indications and select compendial uses for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyacalabrutinib (Calquence) coverage for lymphoid malignancies

Policy CodePolicy 2397-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit authorization requests documenting indication, prior therapies when required, regimen details, and evidence of benefit or absence of progression for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period

FDA + compendiacoverage condition

1+MCL prior therapy

Document refreference

Coverage Criteria for Acalabrutinib (Calquence)

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MCL FDA indication: Acalabrutinib is indicated for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.at least one prior therapy

Reference: FDA indication.

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

FDA indication for frontline combination.

CLL/SLL indication: Acalabrutinib is indicated for treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).NA

FDA indication.

Compendial indications

Covered compendial uses (when ALL approval criteria are met):

Compendial lymphoma indications: Uses supported by compendia including Waldenström macroglobulinemia/lymphoplasmacytic lymphoma; gastric and non-gastric MALT lymphoma; nodal and splenic marginal zone lymphoma; CLL/SLL; and mantle cell lymphoma.NA

See NCCN Drugs & Biologics Compendium and NCCN B-Cell Lymphomas guideline.

Authorization rules

Authorization and continuation:

Initial authorization duration: Authorization of 12 months may be granted for listed indications as specified (MCL, CLL/SLL, Waldenström, marginal zone and MALT lymphomas).12 months

Authorization duration per policy.

Continuation criteria: Reauthorization may be granted for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.no unacceptable toxicity or progression

Continuation of Therapy section.

Regimens and Indications Covered

Regimen	Indication	Coverage
acalabrutinib + bendamustine + rituximab
Previously untreated mantle cell lymphoma (MCL) in patients ineligible for autologous HSCT
Covered when criteria met; authorization may be granted for up to 12 months

Regimen	Indication / Use	Coverage
acalabrutinib as single agent or with rituximab
Mantle cell lymphoma (MCL) — induction or subsequent single‑agent therapy (including rituximab combination or pre‑treatment to limit RHyperCVAD cycles)
Covered when criteria met; authorization may be granted for up to 12 months

Regimen	Indication	Coverage
acalabrutinib as single agent or in combination with obinutuzumab
Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL)
Covered when criteria met; authorization may be granted for up to 12 months

Provider Requirements and Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months for covered indications. Requests for reauthorization must follow continuation criteria and demonstrate no unacceptable toxicity or disease progression while on the current regimen.

Prior authorization duration: up to 12 months; reauthorization requires documentation per continuation of therapy criteria

Step Therapy

Mantle Cell Lymphoma (MCL) Therapy Sequencing

For mantle cell lymphoma (MCL), authorization of 12 months may be granted when the medication is used as a subsequent single-agent therapy, in combination with rituximab for induction therapy, as pre-treatment to limit R-HyperCVAD induction cycles when used with rituximab, or in combination with bendamustine and rituximab for previously untreated disease when the member is ineligible for transplant.

MCL sequencing: single-agent subsequent therapy
MCL sequencing: combination with rituximab for induction
MCL sequencing: rituximab pre-treatment to limit R-HyperCVAD cycles
MCL sequencing: combination with bendamustine + rituximab for untreated, transplant-ineligible patients

Step Therapy

CLL/SLL Sequencing

Authorization of 12 months may be granted for treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when used as a single agent or in combination with obinutuzumab.

Step Therapy

Waldenström Macroglobulinemia Sequencing

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

Step Therapy

MALT and Marginal Zone Lymphomas Sequencing

Authorization of 12 months may be granted for treatment of gastric and non-gastric MALT lymphoma, nodal marginal zone lymphoma, and splenic marginal zone lymphoma when used as subsequent therapy. All other indications are considered experimental/investigational and not medically necessary.

Line of Therapy Criteria

first-line and subsequent

MCL subsequent therapy: For MCL, acalabrutinib is covered for adult patients who have received at least one prior therapy when used as single-agent subsequent therapy.at least one prior therapy

Covered as subsequent single-agent therapy per FDA indication and authorization rules.

MCL frontline transplant-ineligible: For previously untreated MCL in patients ineligible for autologous HSCT, acalabrutinib in combination with bendamustine and rituximab is covered.ineligible for autologous HSCT

Frontline combination indication.

first-line and subsequent

CLL/SLL use: Acalabrutinib is covered for CLL/SLL as a treatment option; authorization of 12 months may be granted for single-agent use or in combination with obinutuzumab.NA

FDA indication and authorization criteria.

salvage

Waldenström and marginal zone subsequent therapy: Authorization of 12 months may be granted for subsequent treatment of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma and for subsequent therapy in gastric/non-gastric MALT and nodal or splenic marginal zone lymphomas when used as subsequent therapy.subsequent therapy

Compendial uses with 12-month authorization.

Definitions and Compendial Uses

Compendial uses (defined)

Waldenström macroglobulinemia / lymphoplasmacytic lymphomaListed as a compendial use supported by recognized compendia (e.g., NCCN).

Gastric and non-gastric MALT lymphomaIncluded as compendial indications (extranodal marginal zone lymphoma of the stomach and nongastric sites).

Nodal and splenic marginal zone lymphomaSpecified compendial uses for nodal and splenic marginal zone lymphoma.

Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL)Listed among compendial uses in addition to its FDA indication for CLL/SLL.

Mantle cell lymphoma (MCL)Included in compendial uses; note MCL is also an FDA‑approved indication (single-agent after ≥1 prior therapy and combination in frontline transplant‑ineligible patients).

Background on Acalabrutinib (Calquence)

Acalabrutinib (Calquence) is a Bruton tyrosine kinase (BTK) inhibitor used in lymphoid malignancies. The policy aligns coverage with the drug’s FDA-approved indications and a set of specified compendial uses, which include disorders such as Waldenström macroglobulinemia/lymphoplasmacytic lymphoma, gastric and non-gastric MALT lymphoma, nodal and splenic marginal zone lymphoma, CLL/SLL, and mantle cell lymphoma. Coverage is provided only for those FDA-approved and listed compendial uses when the approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyacalabrutinib (Calquence) coverage for lymphoid malignancies

Policy CodePolicy 2397-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit authorization requests documenting indication, prior therapies when required, regimen details, and evidence of benefit or absence of progression for reauthorization.

SourceLink

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