CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Calquence (acalabrutinib) coverage guideline

Defines accepted indications, continuation and exclusion criteria, dosing limits, billing code, and evidence requirements for coverage of acalabrutinib (Calquence) for members processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island across multiple lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCalquence (acalabrutinib) coverage guideline

Policy CodePolicy N/A

Change TypeTemplate conversion; indication added; verbiage update

Effective Date

Next Review Date

Key ActionMedication requests must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior guideline UM ONC_1331; added new indication and updated references (February 2025).

Updated organizational verbiage from NCH to Evolent (October 2024).

2Primary covered indications listed (CLL/SLL, MCL)

1HCPCS drug code listed

3Lines of business applicable

60Max tablets per month (100 mg)

Coverage Summary

Policy stance: covered_with_criteria. This guideline defines accepted indications for Calquence (acalabrutinib) including FDA‑approved uses and select off‑label uses supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Evolent is responsible for processing and authorizing all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation and exclusion rules (e.g., progression while on a BTK inhibitor, concurrent anti‑CD20 use in CLL, dosing and monthly supply limits) are enforced by Evolent.

Scope summary: Applies to members managed by Evolent on behalf of Neighborhood Health Plan of Rhode Island across multiple lines of business (CHIP, Commercial, Exchange/Marketplace, Medicaid, Medicare Advantage).

Lead / administrative details: dates.last_review = 2025-02; status = CURRENT.

General Coverage Requirements

Covered when ALL of the following are met:

ALL of the following

General coverage requirements: Use is supported by one of the following: FDA approved product labeling, CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements
Medication request is processed and authorized by Evolent (requests not authorized by Evolent may be deemed not approvable and not reimbursable)

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

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

Covered when ANY of the following use cases apply and general coverage requirements are met:

ANY of the following

CLL/SLL monotherapy - first-line: Calquence (acalabrutinib) used as a single agent for first-line therapy of CLL/SLL
General Coverage Requirements (b0_1) must also be met.
CLL/SLL monotherapy - subsequent line: Calquence (acalabrutinib) used as a single agent for subsequent line therapy of CLL/SLL
General Coverage Requirements (b0_1) must also be met.

Exclusion for combination with anti‑CD20 in CLL: Concurrent use with an anti‑CD20 antibody including any rituximab products or Gazyva (obinutuzumab) for treatment of CLL is excluded (Evolent does not support Calquence + Gazyva in CLL)

Refer to ELEVATE-TN trial basis; single-agent acalabrutinib is considered as effective per policy.

Denial Risk

Denial if exclusion criteria met

Claims will be denied when exclusion criteria are met, including disease progression on acalabrutinib or another BTK inhibitor, concurrent anti‑CD20 therapy in CLL, or dosing/supply over established limits.

Dosing limits: single dose limit 100 mg; maximum 60 (100 mg) tablets per month (claims may be denied if exceeded).
Concurrent anti‑CD20 exclusion in CLL: concurrent use with any rituximab product or Gazyva (obinutuzumab) is excluded and may result in denial.
Progression on BTK inhibitors: disease progression while receiving an acalabrutinib‑containing regimen or while receiving another BTK inhibitor (e.g., ibrutinib, zanubrutinib) is a denial criterion.
Billing code: J8999 (acalabrutinib) referenced for claims processing and denial determination.

Indication — Mantle Cell Lymphoma (MCL)

Indication: Mantle Cell Lymphoma (MCL)

Covered when ALL of the following specific to each use case are met (General Coverage Requirements apply):

Relapsed/Refractory MCL: Calquence used as monotherapy in relapsed/refractory mantle cell lymphoma in members who have received one prior chemoimmunotherapy, including a rituximab-containing regimen (e.g., R-CHOP, R-DHAP, BR)

General Coverage Requirements (b0_1) must also be met.

Previously untreated MCL (ineligible for autologous HSCT): Calquence used in combination with bendamustine and rituximab or rituximab biosimilar for adult members with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)

General Coverage Requirements (b0_1) must also be met.

Continuation Therapy Criteria

Continuation Therapy Exemption

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

No disease progression: Member has not experienced disease progression on the requested medication
Recent prior use without lapse: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 days lapse
No new medications added: No additional medication(s) are being added to the continuation request

Exclusions / Investigational Uses

Exclusion Criteria (General)

Not covered when ANY of the following exclusion criteria apply:

ANY of the following

Progression on BTK inhibitor: Disease progression while receiving an acalabrutinib-containing regimen or while receiving another BTK inhibitor (e.g., ibrutinib, zanubrutinib)
CLL anti-CD20 combination exclusion: For treatment of CLL: concurrent use with an anti‑CD20 antibody including any rituximab products or Gazyva (obinutuzumab)
Single dose limit: Dosing exceeds single dose limit of Calquence (acalabrutinib) 100 mg100 mg single dose
Monthly supply limit: Treatment exceeds the maximum limit of 60 (100 mg) tablets per month60 (100 mg) tablets/month
Investigational/off-label insufficient evidence: Investigational use for an off‑label indication that is not sufficient in evidence or not generally accepted by the medical community as defined by CMS compendia or acceptable peer‑reviewed literature
See Evidence Sufficiency Criteria (b4_1) for required evidence elements.

Evidence Sufficiency Criteria (for off‑label/investigational uses)

Off‑label/investigational use is considered insufficient unless documentation addresses ALL of the following considerations (sufficient evidence requires CMS compendia or acceptable peer‑reviewed literature):

Evidence Sufficiency Criteria

Patient representation: Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
Regimen representation: Whether the administered chemotherapy/biologic/immune/targeted/other oncologic therapy regimen is adequately represented in the published evidence
Clinically meaningful outcomes: Whether reported study outcomes represent clinically meaningful outcomes experienced by patients (ASCO definitions: e.g., hazard ratio < 0.80 and recommended survival benefit for OS and PFS should be at least 3 months)HR < 0.80; OS/PFS >= 3 months

Provider Actions & Requirements

Prior Authorization

Evolent authorization required

Evolent authorization is required for medication requests. Requests not processed and authorized by Evolent may be deemed not approvable and not reimbursable.

Medication requests must be authorized by Evolent prior to approval. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.
Include HCPCS code J8999 (acalabrutinib) on requests and claims to facilitate authorization and billing.

Documentation Required

Supportive evidence required for off‑label use

Supportive documentation is required for off‑label or investigational uses. Provide sources showing FDA labeling, CMS‑recognized compendia, guideline support, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards, and demonstrate that the patient and the regimen are represented in the published evidence.

Evidence sources accepted: FDA product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Chapter 15 requirements.
Required documentation must address whether the patient's clinical characteristics are adequately represented in the published evidence.
Required documentation must address whether the administered regimen/therapy is adequately represented in the published evidence.
Peer‑reviewed literature must meet CMS Chapter 15 standards (study design, clinically meaningful outcomes per ASCO definitions, etc.).

Denial Risk

Denial if exclusion criteria met

Supplemental denial and billing considerations: in addition to exclusion criteria, denials or claim problems can occur for dosing or supply overage and when claims lack appropriate coding.

Single dose must not exceed 100 mg; treatment supply must not exceed 60 (100 mg) tablets per month — exceeding these limits can lead to denial or billing rejection.
Use HCPCS code J8999 (acalabrutinib) on claims; missing or incorrect coding may affect reimbursement.

Clinical Evidence / References

Key trials / references: ELEVATE‑TN (Sharman et al.), ACE‑LY‑004 (Wang et al.), phase 2 and comparative trials including acalabrutinib versus ibrutinib (Byrd et al.), and additional phase 2/3 trial data cited in the guideline references.

Other supporting sources: Calquence prescribing information (AstraZeneca) and multiple compendia and resources (NCCN, ASCO/ASCO perspective on clinically meaningful outcomes, Clinical Pharmacology, Micromedex, AHFS).

Off‑label acceptance: Off‑label uses are accepted only when supported by CMS‑recognized compendia or acceptable peer‑reviewed literature that meet the Evidence Sufficiency Criteria (per Medicare Benefit Policy Manual Chapter 15 and ASCO thresholds for clinically meaningful outcomes).

Background

Background: This policy defines accepted indications for acalabrutinib (Calquence) including FDA‑approved and select off‑label indications supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Evolent processes all medication requests and authorizations and enforces continuation and exclusion rules (for example, disease progression on a BTK inhibitor precludes coverage; concurrent use with anti‑CD20 agents in CLL is not supported).

Covered indications summarized: single‑agent use for first‑line or subsequent therapy of CLL/SLL (but acalabrutinib + obinutuzumab is not supported for CLL based on ELEVATE‑TN), monotherapy for relapsed/refractory mantle cell lymphoma after one prior chemoimmunotherapy, and combination with bendamustine + rituximab for previously untreated MCL in patients ineligible for autologous HSCT.

Scope applicability: Policy is applied by Evolent for Neighborhood Health Plan of Rhode Island across the listed lines of business (CHIP, Commercial, Exchange/Marketplace, Medicaid, Medicare Advantage).