Economic Analysis of Alliance A041202 CLL Study

Study Overview
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Brief Summary
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The prospective cost-effectiveness (cost-utility) analysis from the perspective of the Canadian public healthcare system was completed in 2021. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tarrifs applied to calculate quality-adjusted life-years (QALYs). Costs were applied to resource utilization data (expressed in 20196 US dollars). We examined costs and outcomes (QALYs) associated with ibrutinib with rituximab (IR) and BR therapy.

Official Title
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Prospective Economic Analysis: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib + Rituximab vs Ibrutinib Alone in Untreated Older Patients (≥65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Conditions
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Chronic Lymphocytic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be eligible for the core CLC.2/A041202 protocol. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. However, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure cost-utility ratio | , as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-alone compared to bendamustine-rituximab in elderly patients with CLL |  | 5 years | 
| Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-rituximab compared to ibrutinib alone in elderly patients with CLL |  | 5 years | 
| Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL |  | 5 years | 
| Measure the incremental cost-effectiveness, as measured in cost per life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL |  | 5 years |