ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Evolent Clinical Guideline 3005 for Calquence (acalabrutinib)

Evolent Clinical Guideline defining accepted indications, exclusions, and utilization management requirements for acalabrutinib (Calquence) including FDA-approved and accepted off-label uses; applies to medication requests processed by Evolent for multiple commercial and Medicaid lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3005 for Calquence (acalabrutinib)

Policy CodePolicy N/A

Change TypeTemplate conversion; new indication(s); references updated

Effective Date

Next Review Date

Key ActionPrescribing must be supported by FDA labeling, CMS compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1331 Calquence guideline.

Added new indication (unspecified) and updated references; updated NCH verbiage to Evolent.

2Covered primary indications (CLL/SLL, MCL)

3Hard exclusion types listed

1HCPCS drug code

Coverage Summary

Medical-Necessity Criteria

General Evidence Requirements

Use of this drug must be supported by one of the following sources:

ANY of the following

FDA approved product labeling
CMS-approved compendia
National Comprehensive Cancer Network (NCCN)
American Society of Clinical Oncology (ASCO) clinical guidelines
Peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Continuation Therapy Exception

Continuation requests for a not-approvable medication shall be exempt if ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Continuation request exemption: A process where continuation of a not-approvable medication is allowed if patient meets the three specified conditions (no progression, recent use without >30-day lapse, no added meds).

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)

Calquence (acalabrutinib) coverage for CLL/SLL:

Covered uses

May be used as a single agent for first-line therapy of CLL/SLL
May be used as a single agent for subsequent-line therapy of CLL/SLL

Exclusion for CLL: Concurrent use with an anti-CD20 antibody including any rituximab products or Gazyva (obinutuzumab) is excluded (Calquence + Gazyva not supported)

Mantle Cell Lymphoma (MCL)

Calquence (acalabrutinib) coverage for mantle cell lymphoma:

ANY of the following

May be used as monotherapy in relapsed/refractory mantle cell lymphoma in members who have received one prior chemoimmunotherapy, including a rituximab-containing regimen (e.g., RCHOP, RDHAP, BR)
May be used in combination with bendamustine and rituximab/rituximab biosimilar for adult members with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)

Exclusion / Not medically acceptable uses

Do not authorize when ANY of the following exclusion criteria are present:

ANY of the following

Disease progression while receiving an acalabrutinib-containing regimen or while receiving another BTK inhibitor (e.g., ibrutinib, zanubrutinib)
Concurrent use with an anti-CD20 antibody including any rituximab products or Gazyva (obinutuzumab) for the treatment of CLL
Dose limit: Dosing exceeds single dose limit of Calquence (acalabrutinib) 100 mg100 mg
See policy thresholds for single dose limit.
Quantity limit: Treatment exceeds the maximum limit of 60 (100 mg) tablets per month

Provider Actions & Requirements

Prior Authorization

Prior authorization required for medication requests

Evolent is responsible for processing all medication requests. Prior authorization is required for medication requests for acalabrutinib (J8999); medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J8999

Documentation Required

Evidence source requirement

Prescribing must be supported by one of the following sources.

FDA approved product labeling
CMS‑approved compendia
National Comprehensive Cancer Network (NCCN)
American Society of Clinical Oncology (ASCO) clinical guidelines
Peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Denial for excluded combinations

Claims will not be supported for excluded concurrent regimens in CLL.

Affected code: J8999
Concurrent use with anti‑CD20 antibodies (e.g., rituximab products or Gazyva/obinutuzumab) for CLL is not supported and will be denied.

Billing Rule

Dose and quantity limits enforcement

Do not exceed the specified single dose and monthly tablet limits; exceeding these limits is an exclusion criterion and claims may be denied.

Single dose limit: 100 mg
Maximum: 60 (100 mg) tablets per month

Documentation Required

Continuation exception documentation

For continuation of a medication that would otherwise be not approvable, documentation must include all of the following:

No disease progression while on the requested medication
The medication was used within the last year without a lapse of more than 30 days of active authorization
No additional medications are being added to the continuation request

Background & Evidence

Background: The guideline’s purpose is to define and describe accepted uses of Calquence (acalabrutinib), including FDA-approved and accepted off-label indications, and to require that use be supported by FDA labeling, CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

The guidance includes a specific continuation exception allowing continuation of a not-approvable medication when the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Referenced pivotal trials and compendia include ELEVATE-TN and ACE-LY-004, randomized trials comparing acalabrutinib to ibrutinib, the Calquence prescribing information, Clinical Pharmacology, Micromedex, NCCN guidelines/drugs and biologics compendium, and other cited peer-reviewed literature supporting the recommendations.

Supporting evidence

Key trial referencesELEVATE-TN; ACE-LY-004; randomized trials comparing acalabrutinib to ibrutinib (references spanning 2024-2025)

OpenPayer

Evolent Clinical Guideline 3005 for Calquence (acalabrutinib)

Coverage Summary

Medical-Necessity Criteria

Provider Actions & Requirements

Coding

Background & Evidence

Revision History