Abstract
PURPOSE
Real-world evidence comparing health care resource use (HRU) and costs between novel targeted therapies among patients with chronic lymphocytic leukemia (CLL) is lacking. We compared all-cause and CLL-specific HRU and costs between patients initiated on B-cell lymphoma 2 inhibitor (venetoclax)– or Bruton tyrosine kinase inhibitor (BTKi)–based regimens in the second-line (2L) setting.
METHODS
This is a retrospective observational study using Optum Clinformatics Data Mart of adult patients with CLL/small lymphocytic lymphoma who received 2L venetoclax- or BTKi-based regimens (January 2018-December 2021) for the first time and had ≥one CLL diagnostic claim after 2L initiation and ≥two claims for venetoclax or BTKi. Baseline characteristics were balanced using stabilized inverse probability of treatment weights. Mean monthly cost difference (MMCD) between cohorts for all-cause and CLL-specific per patient per month (PPPM) costs was estimated. Rates of PPPM-HRU were compared between cohorts using rate ratios (RRs).
RESULTS
Of 280 patients, median age 75.5 years, 64.6% and 35.4% received BTKi- versus venetoclax-based regimens, respectively. Most BTKi-treated patients received monotherapy (88.4%), whereas 62.3% of venetoclax-treated patients received combination therapy with anti-CD20 agents. The median duration of 2L therapy was 11.6 and 11.0 months for BTKi versus venetoclax cohorts, respectively. All-cause total costs were lower for venetoclax versus BTKi (MMCD [SE], $–2,497.64 [$1,006.77] in US dollars (USD); P = .01), driven by lower medication costs offsetting medical costs; trends were similar for CLL-specific estimates. Outpatient HRU was higher for venetoclax versus BTKi (RR all-cause: 1.22 versus CLL-specific: 1.64).
CONCLUSION
Venetoclax was associated with total monthly cost savings versus BTKis, illustrating the economic value of time-limited venetoclax-based regimens in the 2L setting.
INTRODUCTION
Chronic lymphocytic leukemia (CLL) is the most common leukemia among adults in Western countries.1 CLL is particularly prominent among older patients, as evidenced by the median age of 72 years at diagnosis.2 The longstanding treatment options for patients with CLL have been cytotoxic chemotherapy (CT) regimens as monotherapy or combined with anti-CD20 agents (chemoimmunotherapy [CIT]).3,4 In recent years, the treatment paradigm for CLL has evolved and shifted away from traditional CT/CIT with the approval of novel targeted agents, providing more effective and better-tolerated treatment choices for patients.3-5 These novel agents include targeted CT-free treatment until progression regimens, such as Bruton tyrosine kinase inhibitors (BTKis) and, more recently, fixed-duration B-cell lymphoma 2 inhibitors such as venetoclax which has been demonstrated to be efficacious in treatment-naïve and relapsed/refractory settings.6,7
CONTEXT
Key Objective
This study aimed to compare costs and health care resource utilization between patients with chronic lymphocytic leukemia (CLL) initiated on venetoclax-based versus Bruton tyrosine kinase inhibitor (BTKi)–based regimens in the second-line (2L) setting.
Knowledge Generated
In patients treated with venetoclax, the estimated all-cause and CLL-specific total cost savings were $29,970.68 in US dollars (USD) and $16,944.96 USD, respectively, compared with BTKi-based regimens. This difference was driven by lower medication costs in venetoclax-based regimens, which offset medical costs. Venetoclax-based regimens in the 2L CLL setting resulted in higher utilization of all-case and CLL-specific outpatient services compared with BTKi-based regimens, whereas all-cause and CLL-specific inpatient admissions and emergency department visits were similar between cohorts.
Relevance
Given the evolution in CLL treatment in the era of targeted therapies, CLL-related spending is expected to increase significantly by 2025. Results from this study highlight the economic benefit of time-limited therapies, such as venetoclax, in the 2L CLL setting.
Partly driven by the high prevalence of CLL and the longer survival of patients with CLL,8 the economic burden to both patients and payers is substantial. Previously, mean monthly per-patient all-cause costs were estimated at $17,442 for patients with CLL receiving systemic therapy.9 Furthermore, financial toxicity is a documented source of stress for patients and caregivers, which is prominent in patients with hematologic malignancies. A recent review determined that as many as 20%-50% of patients with hematologic malignancies experience financial toxicity.10 In patients with CLL specifically, financial burden has been shown to affect treatment decisions and patients' quality of life.11 In the era of novel targeted therapies, CLL treatment costs are expected to rise.12 More research is needed to quantify the health care and economic burden of treating CLL with novel targeted agents.
Recent studies have evaluated the benefits of the fixed treatment duration of venetoclax in the context of clinical trials6,7 or total cost of care.13 However, there is a paucity of data characterizing the real-world benefits regarding cost and health care resource utilization (HRU) of venetoclax and BTKis. This study aimed to compare all-cause and CLL-specific costs and HRU between patients with CLL initiated on venetoclax-based versus BTKi-based regimens in the second-line (2L) setting. This study represents one of the first economic analyses to include venetoclax, which is important to fully assess the benefits of a newer treatment given the competitive CLL landscape.
METHODS
Study Design and Data Source
This was a retrospective observational study using Optum Clinformatics Data Mart data of patients with confirmed CLL/small lymphocytic lymphoma (SLL) who received 2L therapy with either (1) venetoclax-based (venetoclax cohort) or (2) BTKi-based (BTKi cohort) regimens between January 2018 and December 2021. A confirmed CLL diagnosis was defined as two claims at least 30 days apart or one inpatient admission with an International Classification of Diseases, Tenth Revision (ICD-10) code for CLL (C91.1x) or SLL (C83.0x). Included patients were 18 years and older, had ≥one claim with CLL diagnosis codes after 2L therapy initiation, and had evidence of ≥two claims for venetoclax- or BTKi-based regimens. No use of venetoclax (venetoclax cohort) or BTKi (BTKi cohort) was permitted in 1L to ensure that patients initiating either therapy in 2L were new users. Patients who received venetoclax-based or BTKi-based regimens were identified with National Drug Codes (NDC). To identify usage of combination therapies with anti-CD20 regimens, NDC and Healthcare Common Procedure Coding System codes were used.
Patients were excluded if they had the presence of end-stage renal disease, participated in a clinical trial, had missing data on race and sex, or had ≥one claim with diagnosis codes for mantle cell lymphoma, marginal zone lymphoma, or Waldenstrom macroglobulinemia (BTKi cohort) or acute myeloid leukemia (venetoclax cohort) before initiation of 2L therapy. These conditions, in which venetoclax- and/or BTKi-based regimens are also approved as treatments, were excluded from the respective cohort population to ensure the selection of only patients with CLL. Patients who participated in a clinical trial were evaluated using ICD codes: ICD-10: Z00.6; ICD-9: V70.7 within 12 months before the index date, which serves as a proxy for participation in a clinical trial. This approach has been used elsewhere previously.14,15
A claims-based line of therapy algorithm was used to identify patients initiating 2L. First, line of therapy was defined as all CLL medications used within the first 35 days of the first identified medication. The first service date of a qualifying agent served as the start date of the line of therapy. Line advancement occurred if there was an addition of a new therapeutic agent any time after the 35-day window, the entire regimen was switched, or treatment was reinitiated with the same agent after a gap of 90 days. Once these lines were derived, patients receiving venetoclax- or BTKI-based regimens were identified and included in the study as per eligibility criteria.
The index date was defined as the start of 2L therapy in both cohorts. Baseline characteristics of eligible patients, measured on or 12 months before the index date, were balanced using stabilized inverse probability of treatment weights (S-IPTW) to ensure comparable cohorts. Patients were continuously enrolled from at least 2 years before 1L therapy until the start of 2L therapy and followed from the start of 2L until the end of continuous enrollment or study period.
Study Outcomes
Outcomes included in this study were the mean monthly cost difference (MMCD) for all-cause and CLL-related per patient per month (PPPM) costs, inclusive of medication and medical costs. All-cause and CLL-specific total cost savings at 12 months were estimated. Costs represented the allowable amount by the health plan and do not represent the amount paid by the patient nor the health plan. In addition, rates of all-cause and CLL-specific PPPM-HRU were calculated.
Statistical Analysis
The S-IPTW for balancing cohort baseline characteristics was created using trimmed propensity scores (min = 0.01; max = 0.99) and calculated by assigning weights equal to the reciprocal of propensity scores to the venetoclax cohort and the reciprocal of the complement of the propensity score to the BTKi cohort. The derived weights were subsequently stabilized using the proportion of patients in the respective treatment groups. S-IPTW was chosen over conventional IPTW to limit the influence of extreme weights, minimize the variance of calculated effect sizes, and permit the estimation of these estimates directly from conventional statistical models.16 Variables included in the propensity score model were age at 2L initiation; sex; race; type of previous line of therapy; insurance type; geographical region; the presence of congestive heart failure, myocardial infarction, diabetes, renal disease, hypertension, atrial fibrillation, or acute kidney failure; year of 2L initiation; Charlson comorbidity score; time to 2L initiation; and baseline all-cause medication costs. Sex and race were determined by the health insurance plan. A standardized difference of ≤10% signified balance between cohorts.
The MMCD and SEs for all-cause and CLL-specific PPPM costs were estimated using weighted regression models with an identity link and normal distribution and reported for total direct health care costs (inclusive of medication and medical costs), medication costs (inclusive of oral medications and injectables), and medical costs (inclusive of inpatient, outpatient, and emergency department [ED] costs). PPPM was calculated by dividing the total costs by the duration of 2L therapy, where duration was defined as the time between 2L initiation and the earliest of third-line initiation or end of continuous enrollment. Mean 12-month total cost savings were estimated by multiplying the MMCD estimate by 12, which approximated the duration of 2L therapy. A sensitivity analysis to confirm the MMCD estimates was conducted for all-cause and CLL-specific costs using weighted gamma regression models; cost ratios and 95% CIs comparing the cohorts are reported for total, medication, and medical costs. Rate ratios (RRs) and corresponding CIs comparing all-cause and CLL-specific PPPM-HRU during 2L therapy between cohorts were estimated using weighted negative binomial regression with a log link. All analyses were conducted in SAS 9.4, and P values < .05 were considered statistically significant.
RESULTS
Patient Population
A total of 280 patients were included with a median age of 75.5 years, where 64.6% and 35.4% received BTKi-based and venetoclax-based regimens in the 2L setting, respectively (Table 1). Most patients were male (68.7% and 65.2% for the venetoclax and BTKi cohorts, respectively), and over 84% were White among both cohorts. The most frequently observed comorbidities across both cohorts were hypertension (68.9%), renal disease (29.6%), and diabetes (25.0%). A majority of patients had Medicare as their insurance (76.8% and 75.1% for the venetoclax and BTKi cohorts, respectively), which is expected given the prevalence of CLL in older patients. The most common first-line therapy used was BTKi-based regimens among the venetoclax cohort (59.6%) and CT/CIT regimens among the BTKi cohort (61.9%).
TABLE 1.
Unweighted Baseline Patient Demographics and Clinical Characteristics
| Characteristic | Venetoclax Cohort (n = 99) | BTKi Cohort (n = 181) |
|---|---|---|
| Age at 2L initiation, years, median (IQR) | 74.0 (66-80) | 76.0 (68-81) |
| Sex,a No. (%) | ||
| Female | 31 (31.3) | 63 (34.8) |
| Male | 68 (68.7) | 118 (65.2) |
| Race,a No. (%) | ||
| Asian | 0 (0.0) | 1 (0.6) |
| Black | 10 (10.1) | 15 (8.3) |
| Hispanic | 5 (5.1) | 12 (6.6) |
| White | 84 (84.8) | 153 (84.5) |
| Geographical region, No. (%) | ||
| South | 35 (35.4) | 74 (40.9) |
| Midwest | 32 (32.3) | 43 (23.8) |
| West | 25 (25.3) | 48 (26.5) |
| Northeast | 7 (7.1) | 16 (8.8) |
| Type of insurance, No. (%) | ||
| Commercial | 23 (23.2) | 45 (24.9) |
| Medicare | 76 (76.8) | 136 (75.1) |
| Comorbidities, No. (%) | ||
| Myocardial infarction | 9 (9.1) | 10 (5.5) |
| Congestive heart failure | 20 (20.2) | 27 (14.9) |
| Diabetes | 22 (22.2) | 48 (26.5) |
| Renal disease | 27 (27.3) | 56 (30.9) |
| Hypertension | 72 (72.7) | 121 (66.9) |
| Atrial fibrillation | 29 (29.3)** | 24 (13.3) |
| Acute kidney failure | 22 (22.2) | 29 (16.0) |
| CCI score, median (IQR) | 3.0 (2-4) | 3.0 (2-4) |
| First line of therapy, No. (%) | ||
| BTKi-based regimen | 59 (59.6)*** | 0 (0.0) |
| CT/CIT regimen | 24 (24.2) | 112 (61.9) |
| IT monotherapy | 16 (16.2) | 64 (35.4) |
| Venetoclax-based regimen | 0 (0.0) | 5 (2.8) |
| Year of 2L initiation, No. (%) | ||
| 2018 | 12 (12.1) | 32 (17.7) |
| 2019 | 26 (26.3) | 53 (29.3) |
| 2020 | 35 (35.4) | 55 (30.4) |
| 2021 | 26 (26.3) | 41 (22.7) |
| Time to 2L, months, median (IQR) | 42.9 (26.3-71.5) | 46.7 (24.4-69.4) |
| All-cause medication cost PPPM, USD, mean (SD) | $4,828 ($5,295)*** | $2,200 ($3,224) |
Abbreviations: 2L, second-line; BTKi, Bruton tyrosine kinase inhibitor; CCI, Charleston Comorbidity Index; CT/CIT, chemotherapy/chemoimmunotherapy; IQR, interquartile range; IT, immunotherapy; PPPM, per patient per month; SD, standard deviation; USD, US dollars.
As determined by insurance plan.
**P < .001.
***P < .0001.
After weighting, all variables were balanced with an effective sample size of n = 279 (Data Supplement, Figs S1A and S1B).
Treatment Patterns and Duration of Therapy
The overall median follow-up time was approximately 15 months with an overall median 2L duration of therapy of 11.5 months. Most BTKi-based patients were treated with monotherapy (88.4%), whereas most venetoclax-based patients were treated in combination with anti-CD20 agents (62.3%). The proportion of patients with subsequent therapy was 19.4% and 24.9% for venetoclax- and BTKi-based patients, respectively. The median duration of 2L therapy was 11.0 and 11.6 months for venetoclax- and BTKi-based patients, respectively (Table 2).
TABLE 2.
Type and Duration in Months of Therapy
| Regimen | After Weighting Cohort |
|---|---|
| BTKi Cohort (n = 181) | |
| Regimen name, No. (%) | |
| BTKi monotherapy | 160 (88.4) |
| BTKi + anti-CD20 | 17 (9.4) |
| Other BTKi regimens | 4 (2.2) |
| Subsequent therapy, % | 24.9 |
| Duration of treatment,a months, median (IQR) | 8.6 (4.3-16.6) |
| Duration of 2L,b months, median (IQR) | 11.6 (6.5-21.1) |
| Duration of follow-up,c months, median (IQR) | 16.0 (8.1-24.7) |
| Venetoclax Cohort (n = 98) | |
|---|---|
| Regimen name, No. (%) | |
| Venetoclax monotherapy | 36 (36.7) |
| Venetoclax + G | 38 (38.8) |
| Venetoclax + R | 23 (23.5) |
| Other venetoclax regimens | 1 (1.0) |
| Subsequent therapy, % | 19.4 |
| Duration of treatment,a months, median (IQR) | 8.2 (3.7-13.8) |
| Duration of 2L,b months, median (IQR) | 11.0 (5.9-21.6) |
| Duration of follow-up,c months, median (IQR) | 14.9 (7.9-24.6) |
Abbreviations: 2L, second-line; 3L, third-line; anti-CD20, monoclonal antibody directed against human CD20 antigen; BTKi, Bruton tyrosine kinase inhibitor; venetoclax + G, venetoclax + obinutuzumab; venetoclax + R, venetoclax + rituximab.
Difference in months between the index date and last claim for 2L plus days supplied.
Difference in months between the index date and earliest of 3L treatment or end of continuous enrollment.
Difference in months between the index date and the end of continuous enrollment.
MMCD Cost Burden
The all-cause total health care costs were significantly lower for the venetoclax cohort compared with that for the BTKi cohort (MMCD [SE]: $–2,497.64 [$1,006.77] USD; P = .01). This difference was driven by lower medication costs ($−3,645.96 [$736.68] USD) that fully offset the medical costs ($1,148.31 [$691.42] USD) for the venetoclax versus BTKi cohorts (Fig 1; Data Supplement, Table S1). Similar trends were observed in the CLL-specific estimates. On the basis of the MMCD, the estimated 12-month all-cause and CLL-specific total cost savings were $29,970.68 USD and $16,944.96 USD, respectively, among patients treated with venetoclax compared with BTKi-based regimens.
FIG 1.
MMCDs comparing venetoclax with BTKi cohorts in second-line setting. *P < .05; ***P < .0001. BTKi, Bruton tyrosine kinase inhibitor; CLL, chronic lymphocytic leukemia; MMCD, mean monthly cost difference; PPPM, per patient per month; SE, standard error; USD, US dollars.
The sensitivity analysis confirmed the primary results, with cost ratios comparing venetoclax versus BTKi cohorts of 0.85, 0.73, and 1.33 for all-cause total, medication, and medical costs, respectively (Data Supplement, Table S2).
PPPM-HRU
Overall, the utilization of all-cause and CLL-specific outpatient services was higher for venetoclax-based patients compared with that for BTKi-based patients (RR [95% CI], all-cause 1.22 [1.05 to 1.42] and CLL-specific 1.64 [1.35 to 2.01]). Rates of all-cause and CLL-specific inpatient admissions and ED visits were similar between cohorts (Fig 2).
FIG 2.
RRs comparing HRU between venetoclax and BTKi cohorts in second-line setting. *P < .05; ***P < .0001. BTKi, Bruton tyrosine kinase inhibitor; CI, confidence intervals; CLL, chronic lymphocytic leukemia; ED, emergency department; HRU, health care resource utilization; PPPM, per patient per month; RR, rate ratio.
DISCUSSION
The CLL treatment paradigm has evolved in the past decade with the approval of novel targeted agents, moving from traditional CT/CIT to treat until progression and fixed-duration therapies, providing more treatment choices for patients.3-5 Specifically, with the cost to patients and payers expected to increase over time in the era of targeted therapies,12 comparative studies indicative of contemporary clinical practice are warranted. Given that targeted therapies vary in duration of treatment, administration, and their benefit-risk profiles, these factors carry economic implications. In addition, fixed-duration therapies administered for a finite period present an opportunity for possible cost-savings in a competitive CLL landscape. However, there is a paucity of literature characterizing real-world benefits regarding cost and HRU of a fixed-duration therapy such as venetoclax, compared with BTKi. This analysis was one of the first to quantify real-world HRU and the economic benefit of venetoclax as well as the first to compare HRU and costs between novel targeted agents.
Previous economic analyses in CLL have centered around total cost of care of one drug, such as venetoclax,13 comparative HRU and cost between novel targeted therapies and CT/CIT,9,17,18 or comparative HRU and cost by patient clinical characteristics and adverse events.19,20 These studies have demonstrated that the HRU and economic burden of CLL are substantial and vary by treatment regimens, adherence to treatment, outcomes, and duration of therapy.9,13,17-20 The current analysis, comparing economic outcomes between venetoclax and BTKi-based regimens, demonstrates that all-cause and CLL-specific total monthly costs were lower in the venetoclax cohort as compared with the BTKi cohort. The lower monthly costs resulted in the estimated 12-month all-cause and CLL-specific total cost savings of $29,970.68 USD and $16,944.96 USD, respectively. The lower total costs of care were largely driven by lower medication costs that fully offset the higher medical costs among venetoclax-treated patients relative to BTKi-treated. The lower medication costs in the venetoclax cohort may be attributable to the fixed duration of venetoclax-based regimens, whereas the higher medical costs in this cohort may be driven by outpatient and inpatient use relative to the BTKi cohort. The total cost of venetoclax may be further reduced by optimization of algorithms of inpatient management and improving the resources that enable management of potential adverse events in the outpatient setting. These findings highlight the economic benefit of time-limited therapies, such as venetoclax, in 2L CLL setting.
As the CLL treatment paradigm continues to evolve and spending related to CLL is expected to increase,12 health care burden on payers and financial toxicity for patients become a growing and relevant concern. In recent years, spending on cancer health care expenditures overall has risen by 38%, increasing health care burden.21,22 The annual cost of CLL management specifically is expected to increase nearly 600% by 2025 from 2014, partly because of the increased use of novel targeted therapies.12,21 Specific to payers, the rising cost coupled with varying efficacy and adverse events between targeted therapies have highlighted the need to establish optimal treatment sequencing and clinical and economic values (ie, cost-effectiveness) to alleviate the cost burden.21,23 Recent studies looking at cost-effectiveness and budget impact from the payer perspective have determined that frontline use of treat-to-progression therapies may not be cost-effective,24 whereas fixed-duration therapies may be cost-effective within accepted US willingness-to-pay thresholds.24-27 Overall, fixed-duration therapies may be cost-saving to US payers because of lower treatment costs if initiated early during the course of CLL treatment.23,25 Further studies to understand long-term costs and full budget impacts of treatment sequences of novel targeted therapies to payers are warranted. Specific to patients, previous studies suggest that patients with cancer frequently experience financial and associated psychological burdens, further leading to treatment nonadherence.28 The CLL-specific financial burden has been documented to affect patients' quality of life and treatment decisions, including the postponement of care and prescription fills.11,12 In addition, a recent study found that cost ranked as one of the most important attributes influencing selection of CLL treatment by patients,29 further highlighting the need to not only quantify the economic impact of novel targeted therapies but also include it as part of shared decision making.
The US pharmaceutical policy landscape is also becoming increasingly complex and acutely focused on cost containment strategies. Here, understanding the economic impact of novel targeted therapies and moving toward sustainable pricing strategies is essential as high costs could lead to financial toxicity and suboptimal adherence and outcomes. To encourage negotiations and sustainable pricing, Congress recently signed the Inflation Reduction Act into law.11 Key provisions of this act will affect various stakeholders, including patients, payers, and pharmaceutical companies. The out-of-pocket spending cap for Medicare will potentially lower costs for patients, such as those with CLL who are frequently on Medicare given the high median age at diagnosis, and help to ensure access to treatments and reduce financial toxicity.30 For the first time, Health and Human Services will be able to negotiate prices for part B and part D drugs that constitute the highest Medicare spending, affecting reimbursement and revenue growth for pharmaceutical companies.11,30 Understanding the budget impact, cost-effectiveness, and overall economic and clinical value of a drug will be critical in supporting these negotiations.
This study is not without limitations. As with any administrative claims-based study, coding errors are possible. There may be differences between patients who received venetoclax-based versus BTKi-based regimens, and while inverse probability weighting was used to control for observable confounders, there could be unobserved confounders that could affect the HRU and cost outcomes of this real-world study. Given these known limitations, we have used robust methods to address them accordingly. Costs were not separated out by combination therapies (ie, anti-CD20) within each cohort. Finally, financial values in Optum are derived using Optum's proprietary algorithm and may not reflect the actual allowable amount from the health plan. However, this is unlikely to disproportionately affect a specific cohort and should have a negligible impact on our conclusions.
In conclusion, this study demonstrated that treatment with venetoclax is associated with a reduction in total monthly all-cause and CLL-specific costs relative to BTKi-based treatments in the 2L setting. This was largely driven by lower monthly medication costs, which may be attributable to the fixed duration of venetoclax-based regimens, that offset higher monthly medical costs for venetoclax-based versus BTKi-based treatments. Thus, our study demonstrates the economic value of fixed-duration venetoclax-based regimens in the 2L CLL setting. In a competitive CLL landscape where costs of treatments are expected to rise, financial toxicity experienced by patients and health care burden on payers are important considerations in treatment selection.
Bita Fakhri
Consulting or Advisory Role: AbbVie/Genentech, AbbVie, Genentech, AstraZeneca, Pharmacyclics, Bristol Myers Squibb/Celgene/Juno, BeiGene, Loxo/Lilly, tg ther, Adaptive Biotechnologies
Speakers' Bureau: Loxo/Lilly, AbbVie
Research Funding: Loxo (Inst), Genmab (Inst), Genentech (Inst), Bristol Myers Squibb/Celgene/Juno (Inst), AbbVie (Inst), BeiGene (Inst)
Nnadozie Emechebe
Employment: AbbVie
Stock and Other Ownership Interests: AbbVie
Beenish S. Manzoor
Employment: AbbVie
Stock and Other Ownership Interests: AbbVie
Dureshahwar Jawaid
Employment: AbbVie
Hasan Alhasani
Stock and Other Ownership Interests: AbbVie
Honoraria: AbbVie
Melanie Edwards
Employment: Lowell General Hospital
Hande H. Tuncer
Honoraria: AbbVie, Curio Science
Consulting or Advisory Role: AbbVie, Intellisphere, OncLive/MJH Life Sciences, Lilly
No other potential conflicts of interest were reported.
PRIOR PRESENTATION
Presented at the meeting of the Academy of Managed Care Pharmacy (AMCP) 2023, San Antonio, TX, March 21-24, 2023.
SUPPORT
Venetoclax is developed in a collaboration between AbbVie Inc and Genentech Inc. Supported by AbbVie; AbbVie funded the study and participated in the study design, research, analysis, data collection, interpretation of the data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Brandy Menges, PhD, of Fishawack Facilitate Ltd, part of Avalere Health, and funded by AbbVie.
DATA SHARING STATEMENT
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://protect-eu.mimecast.com/s/xFozCVPyqik3DvVCGUrxZ? domain=vivli.org/https://vivli.org/ourmember/abbvie/ then select “Home”.
AUTHOR CONTRIBUTIONS
Conception and design: Nnadozie Emechebe, Beenish S. Manzoor, Hasan Alhasani, Dureshahwar Jawaid, Hande H. Tuncer, Bita Fakhri
Provision of study materials or patients: Beenish S. Manzoor, Hasan Alhasani
Collection and assembly of data: Beenish S. Manzoor, Nnadozie Emechebe
Data analysis and interpretation: All authors
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Real-World Health Care Resource Use and Costs Among Patients With Chronic Lymphocytic Leukemia Treated With Venetoclax-Based and Bruton Tyrosine Kinase Inhibitor–Based Regimens in the Second-Line Setting
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.
Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).
Bita Fakhri
Consulting or Advisory Role: AbbVie/Genentech, AbbVie, Genentech, AstraZeneca, Pharmacyclics, Bristol Myers Squibb/Celgene/Juno, BeiGene, Loxo/Lilly, tg ther, Adaptive Biotechnologies
Speakers' Bureau: Loxo/Lilly, AbbVie
Research Funding: Loxo (Inst), Genmab (Inst), Genentech (Inst), Bristol Myers Squibb/Celgene/Juno (Inst), AbbVie (Inst), BeiGene (Inst)
Nnadozie Emechebe
Employment: AbbVie
Stock and Other Ownership Interests: AbbVie
Beenish S. Manzoor
Employment: AbbVie
Stock and Other Ownership Interests: AbbVie
Dureshahwar Jawaid
Employment: AbbVie
Hasan Alhasani
Stock and Other Ownership Interests: AbbVie
Honoraria: AbbVie
Melanie Edwards
Employment: Lowell General Hospital
Hande H. Tuncer
Honoraria: AbbVie, Curio Science
Consulting or Advisory Role: AbbVie, Intellisphere, OncLive/MJH Life Sciences, Lilly
No other potential conflicts of interest were reported.
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Data Availability Statement
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