ModifiedUnitedHealthcarePolicy N/A

Calquence (acalabrutinib) prior authorization

UnitedHealthcare prior authorization/notification program criteria for coverage of Calquence (acalabrutinib) across indications including mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphomas, and Waldenström macroglobulinemia, including initial and reauthorization rules, duration, and reference to NCCN/Compendium recommendations.

Policy Summary

PayerUnitedHealthcare

PolicyCalquence (acalabrutinib) prior authorization

Policy CodePolicy N/A

Change TypeAdded FDA indicationexpanded NCCN-based indications

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Calquence; coverage only when policy clinical criteria are met; pediatric members <19 automatically process without coverage review.

SourceLink

POLICY UPDATE CHANGES

Effective 6/1/2025 program updated to include FDA indication for previously untreated MCL patients ineligible for HSCT.

Added criteria for B-cell lymphomas and Waldenström macroglobulinemia per NCCN guidelines (5/2021).

Changed classification of gastric and nongastric MALT lymphoma to Extranodal Marginal Zone Lymphoma of the stomach and of nongastric sites per NCCN (5/2023).

Multiple annual reviews with no change to clinical criteria recorded (12/2019, 5/2022, 5/2024).

6Covered Indications listed

12 monthsAuthorization duration

Members <19

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Pediatric auto-approval

Coverage Summary

UnitedHealthcare’s prior authorization/notification program for Calquence (acalabrutinib) applies to the listed hematologic malignancies and related pathways described in the policy and is covered_with_criteria when the clinical criteria are met. The scope includes mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), nodal, splenic and extranodal marginal zone lymphomas, and Waldenström macroglobulinemia, with initial and reauthorization rules and durations specified.

UnitedHealthcare references the NCCN and Biologics Compendium when recognizing indications and regimens for automated approval pathways, and notes that state mandates, federal regulatory requirements, and member-specific benefit plans may supersede or otherwise affect coverage determinations.

Calquence — quick policy attributes

Covered IndicationsMCL (previously treated), MCL (previously untreated ineligible for HSCT, with bendamustine + rituximab), CLL/SLL, Nodal marginal zone lymphoma, Splenic marginal zone lymphoma, Extranodal marginal zone lymphoma (stomach and nongastric non-cutaneous), Waldenström macroglobulinemia

Authorization duration12 months for initial and reauthorization approvals

Pediatric auto-approvalPrescriptions for members <19 years automatically process without coverage review; authorization issued for 12 months

Effective date2025-06-01

Last review2025-03-01

P&T / Package insert notesPolicy updated to reflect FDA label change (includes previously untreated MCL ineligible for HSCT) and references NCCN/Biologics Compendium; package insert revision January 2025; multiple P&T reviews listed including 3/2025

Initial Therapy Criteria

Mantle Cell Lymphoma (MCL) - Initial Authorization

Calquence will be approved when ALL of the following are met:

ALL of the following

ALL of the following
- Diagnosis of mantle cell lymphoma (MCL)
- ONE of the following
  - Either
    Patient is ineligible for autologous hematopoietic stem cell transplantation (HSCT)
    Patient has not received therapy for MCL prior (e.g., bortezomib, rituximab)

Continuation / Reauthorization Criteria

Mantle Cell Lymphoma (MCL) - Reauthorization

Calquence will be approved when ALL of the following are met:

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

Authorization will be issued for 12 months

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

Calquence will be approved when ALL of the following are met:

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

Authorization will be issued for 12 months

Marginal Zone Lymphomas - Reauthorization

Calquence will be approved when ALL of the following are met:

Pediatric Automatic Approval

General exception for patients <19 years

Patient is less than 19 years of age

Prescription will automatically process without a coverage review; authorization issued for 12 months

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Calquence; coverage is provided only when the policy clinical criteria are met. Note: prescriptions for members under age 19 will automatically process without a coverage review.

Documentation Required

Reauthorization evidence requirement

For reauthorization, documentation must show the patient does not have evidence of progressive disease while on Calquence therapy; approvals are issued for 12 months.

Applicable Codes & Diagnosis Logic

Referenced diagnosis logic (examples in text)ICD-10

No codes listed

Background & Clinical Evidence

Calquence (acalabrutinib) is FDA‑indicated for: treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; in combination with bendamustine plus rituximab for previously untreated MCL patients who are ineligible for autologous hematopoietic stem cell transplantation (HSCT); and for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

The National Comprehensive Cancer Network (NCCN) recommends Calquence for multiple B‑cell lymphomas, including splenic and nodal marginal zone lymphoma, extranodal marginal zone lymphoma (EMZL) of the stomach and nongastric sites (noncutaneous), and Waldenström macroglobulinemia/lymphoplasmacytic lymphoma.

UnitedHealthcare explicitly references the NCCN Compendium and the Biologics Compendium for coverage recognition (Category of Evidence and Consensus 1, 2A, or 2B) and documents periodic updates reflecting FDA label changes and guideline-based additions; state mandates and plan‑specific rules may supersede the policy.

Evidence and references

P&T approval dates12/2017, 12/2018, 12/2019, 4/2020, 5/2021, 5/2022, 5/2023, 5/2024, 3/2025

Package insert revisionJanuary 2025

Revision History

2025-06-01effective_updateLatest

Program updated effective 6/1/2025 to include FDA indication for previously untreated mantle cell lymphoma (MCL) patients who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

2025-03-01policy_reviewLatest

3/2025 P&T update: background and references updated to reflect FDA label change for previously untreated MCL ineligible for HSCT.

Definitions

Authorization: Approval of therapy for a specified duration; in this policy authorizations are issued for 12 months.

HSCT: Autologous hematopoietic stem cell transplantation.

NCCN Compendium: The National Comprehensive Cancer Network drug compendium used to recognize recommended regimens (Categories 1, 2A, 2B) and may be used to support automated or compendium‑based approvals; state mandates may also apply and supersede policy language.

Policy Summary

PayerUnitedHealthcare

PolicyCalquence (acalabrutinib) prior authorization

Policy CodePolicy N/A

Change TypeAdded FDA indicationexpanded NCCN-based indications

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Calquence; coverage only when policy clinical criteria are met; pediatric members <19 automatically process without coverage review.

SourceLink

On This Page

Used in combination with bendamustine and rituximab

Patient has received at least one therapy for MCL (e.g., bortezomib, rituximab) prior

title': 'Mantle Cell Lymphoma (MCL) - Initial Authorization

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) - Initial Authorization

Calquence will be approved when ALL of the following are met:

ALL of the following

Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Authorization will be issued for 12 months

ref": "b1_1

title": "Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) - Initial Authorization

ref

Marginal Zone Lymphomas (Nodal, Splenic, Extranodal EMZL of stomach and non-gastric non-cutaneous) - Initial Authorization

Calquence will be approved when ALL of the following are met:

ALL of the following

Diagnosis of one of the following: Nodal marginal zone lymphoma; Splenic marginal zone lymphoma; Extranodal marginal zone lymphoma (EMZL) of the stomach; Extranodal marginal zone lymphoma of nongastric sites (non-cutaneous)
Disease is recurrent, relapsed, refractory, or progressive
Authorization will be issued for 12 months

ref": "b1_2

title": "Marginal Zone Lymphomas (Nodal, Splenic, Extranodal EMZL of stomach and non-gastric non-cutaneous) - Initial Authorization

ref

Waldenström Macroglobulinemia / Lymphoplasmacytic Lymphoma - Initial Authorization

Calquence will be approved when ALL of the following are met:

ALL of the following

Diagnosis of Waldenström macroglobulinemia (lymphoplasmacytic lymphoma)
ONE of the following
- Patient did not respond to primary therapy
- Disease is relapsed or progressive

ref": "b1_3

title": "Waldenström Macroglobulinemia / Lymphoplasmacytic Lymphoma - Initial Authorization

ref

NCCN/Biologics Compendium recognition

Automatic coverage pathway when recognized by compendia

Indication is recognized for treatment of the cancer by the NCCN and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months; state mandates and benefit plan may supersede

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

Authorization will be issued for 12 months

Waldenström Macroglobulinemia - Reauthorization

Calquence will be approved when ALL of the following are met:

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

Authorization will be issued for 12 months

Billing Rule

Duration of authorization

Authorizations, both initial and reauthorization, are issued for a duration of 12 months.

Billing Rule

Automated approvals permitted

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claims or medication history, diagnosis codes and/or claim logic using automated approval processes; use of these automated processes varies by program and therapeutic class.

Documentation Required

Use of compendia/state mandates

The policy recognizes NCCN and the Biologics Compendium (Categories 1, 2A, 2B) for coverage decisions; where state mandates or benefit-plan specific requirements apply, they may supersede this policy.

5/2021: Added criteria for B-cell lymphomas and Waldenström macroglobulinemia per NCCN guidelines (expanded covered indications).

2023-05terminology_revision

5/2023: Terminology updated to align with NCCN — gastric and nongastric MALT lymphoma reclassified as Extranodal Marginal Zone Lymphoma (EMZL) of the stomach and EMZL of nongastric sites (non-cutaneous).

2019-12administrative_review

12/2019: Annual review recorded with no changes to clinical criteria.

2022-05administrative_review

5/2022: Annual review with no change to clinical criteria; background and references updated.

2024-05administrative_review

5/2024: Annual review with no change to clinical criteria; references updated.