Medicare Perspective Research Articles

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Aims Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare). Materials and methods A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM). Results The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population. Conclusions Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

Adverse event costs of systemic therapies for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy and biologics in the US.

Aim: The objective of this study was to compare adverse event (AE) management costs for fruquintinib, regorafenib, trifluridine/tipiracil (T/T) and trifluridine/tipiracil+bevacizumab (T/T+bev) for patients with metastatic colorectal cancer (mCRC) previously treated with at least two prior lines of therapy from the US commercial and Medicare payer perspectives. Materials & methods: A cost-consequence model was developed to calculate the per-patient and per-patient-per-month (PPPM) AE costs using rates of grade 3/4 AEs with incidence ≥5% in clinical trials, event-specific management costs and duration treatment. Anchored comparisons of AE costs were calculated using a difference-in-differences approach with best supportive care (BSC) as a common reference. AE rates and treatment duration were obtained from clinical trials: FRESCO and FRESCO-2 (fruquintinib), RECOURSE (T/T), CORRECT (regorafenib) and SUNLIGHT (T/T, T/T+bev). AE management costs for the commercial and Medicare perspectives were obtained from publicly available sources. Results: From the commercial perspective, the AE costs (presented as per-patient, PPPM) were: $4015, $1091 for fruquintinib (FRESCO); $4253, $1390 for fruquintinib (FRESCO-2); $17,110, $11,104 for T/T (RECOURSE); $9851, $4691 for T/T (SUNLIGHT); $8199, $4823 for regorafenib; and $11,620, $2324 for T/T+bev. These results were consistent in anchored comparisons: the difference-in-difference for fruquintinib based on FRESCO was -$1929 versus regorafenib and -$11,427 versus T/T; for fruquintinib based on FRESCO-2 was -$2257 versus regorafenib and -$11,756 versus T/T. Across all analyses, results were consistent from the Medicare perspective. Conclusion: Fruquintinib was associated with lower AE management costs compared with regorafenib, T/T and T/T+bev for patients with previously treated mCRC. This evidence has direct implications for treatment, formulary and pathways decision-making in this patient population.

A National Mandate for Thermal Fuses for Home Oxygen Users is Cost-Effective in the Prevention of Burn Morbidity, Mortality, and Property Loss.

Smoking while using home oxygen leads to explosions, which cause cutaneous burns, death, and loss of property. Thermal fuses interrupt the propagation of ignited oxygen lines and reduce the risk of injury. Prior to mandating thermal fuses for all home oxygen users in the United States, cost-effectiveness analysis should be performed. A Markov model was constructed for suffering a thermal injury while smoking on home oxygen. Societal and Medicare perspectives were adopted, evaluating the costs of a federal policy, including purchasing/shipping thermal fuses to all home oxygen users. Costs included the healthcare required to treat burn patients and extend lives in advanced chronic obstructive pulmonary disease. Cost savings included the avoided property loss. Effectiveness was measured in gains in quality adjusted life years (QALYs). In the status quo, the 10-year societal cost was $28.67 billion compared to $28.36 billion in the policy mandate (saving $305.40 million at 10 years). 1812 QALYs were gained with the policy mandate, yielding, and incremental cost-effectiveness ratio (ICER) of -$160 317. From the Medicare payor perspective, the ICER was $64 981. Deterministic and probabilistic sensitivity analyses showed little variation in the ICER under multiple scenarios. The discrepancy between the dominant ICER for a societal perspective and the cost-effective ICER for a Medicare perspective reflected savings from averted property loss not realized by Medicare. A national policy mandating and paying for thermal fuses for all home oxygen users is dominant from a societal perspective and cost-effective from a Medicare perspective. The US government should adopt such a policy.

Unveiling the cost-effectiveness of CDK4/6 inhibitors in treating patients with HR+/HER2- metastatic breast cancer: A closer look at nonmedication expenses.

1532 Background: Cyclin-dependent kinase (CDK)4/6 inhibitors have significantly enhanced survival outcomes in postmenopausal patients diagnosed with HR+ MBC. Their integration with endocrine therapy (ET) has become the standard of care in MBC treatment lines. There are limited economic evaluations of these innovative, yet costly, therapies. This study assesses the cost-effectiveness of these drugs using EHR derived data and administrative claims to estimate cost. Methods: We used the nationwide EHR-derived Flatiron Health (FH) de-identified database to identify 3,879 patients receiving 1st line (1L) treatment for HR+ MBC (2,137 received CDK4/6i+ET and 1,742 received ET alone) between Feb 2015 and Nov 2021. SEER-Medicare claims data was used to supplement the missing cost info in the FH database to quantify monthly medication costs, drawing data from Medicare patients continuously enrolled in PARTs A, B, and D between 2015 to 2021 for at least 24 months and specific to therapeutic approaches for MBC and overall healthcare costs. The costs were adjusted by the patient characteristic: age, race, specific ET or CDK4/6i drug, and Medicare dual eligibility. The effectiveness was measured as progression-free duration in months. All costs were adjusted for inflation. The Incremental Cost Effectiveness Ratio (ICER) analysis was conducted to examine the cost-effectiveness of CDK4/6i as compared with ET alone. Results: Average estimated monthly medication costs were $12,524 and $322 for CDK4/6i+ET and ET alone, respectively. On average, CDK4/6i+ET increased the estimated medication costs by $235,564 over the time to first progression and was associated with a gain of 3.2 months of progression-free survival as compared to ET alone, resulting in an ICER of $73,098 per month without progression. At a willingness-to-pay of $65,000 per month without progression, both groups have 50% probability of being considered cost-effective. Notably, the average estimated monthly non-medication costs (total costs-medication costs) for the CDK4/6i+ET group were $2,278 compared to $4,265 for the ET alone group (p<0.001). On average, CDK4/6i+ET decreased the estimated non-medication costs by $ 22,427. For non-medication costs, the ICER drops to $7,178 per month without progression making the CDK4/6i+ET the dominant cost-effective choice over ET alone. Conclusions: Cost-effectiveness of treating HR+ MBC patients is primarily driven by the cost of CDK4/6i drug prices. However, findings highlight significantly lower overall non-medication healthcare costs using CDK4/6i+ET compared to ET alone in 1L treatment. These cost savings, however, are offset by the high medication costs of CDK4/6i. Thus, lowering the market cost of CDK4/6i drugs or targeting those who can benefit the most could shift the balance in favor of a cost-effective benefit from Medicare perspective.

Cost-effectiveness of medication therapy management among Medicare population and across racial/ethnic groups.

Inappropriate medication utilization among older adults is a pressing concern in the United States, owing to its high prevalence and the consequential detrimental impact it engenders. The adverse effects stemming from the inappropriate use of medication may be unequally borne by racial/ethnic minority populations, calling for greater efforts towards promoting equity in healthcare. The study objective was to assess the cost-effectiveness of Medication Therapy Management (MTM) services among Medicare beneficiaries and across racial/ethnic groups. Medicare administrative data from 2016 to 2017 linked to Area Health Resources Files were used to analyze Medicare fee-for-service patients aged 65 or above with continuous Parts A/B/D coverage. The intervention group included new MTM enrollees in 2017; the control group referred to patients who met the general MTM eligible criteria but did not enroll in 2016 or 2017. The 2 groups were matched using a propensity score method. Effectiveness was evaluated as the proportion of appropriate medication utilization based on performance measures developed by the Pharmacy Quality Alliance. Costs were computed as total healthcare costs from Medicare perspective. A multivariable net benefit regressions with a classic linear model and Bayesian analysis were utilized. Net benefit was calculated based on willingness-to-pay thresholds at various multiples of the gross domestic product in 2017. Three-way interaction terms among dummy variables for MTM enrollment, 2017, and racial/ethnic minority groups were incorporated in a difference-in-differences study design. After adjusting for patient characteristics, the findings indicate that MTM receipt was associated with incremental net benefit among each race and ethnicity. For instance, the net benefit of MTM among the non-Hispanic White patients was $2498 (95% confidence interval = $1609, $3386) at a willingness-to-pay value of $59,908. The study found no significant difference in net benefits for MTM services between minority and White patients. The study provides evidence that MTM is a cost-effective tool for managing medication utilization among the Medicare population. However, MTM may not be cost-effective in reducing racial/ethnic disparities in medication utilization in the short term. Further research is needed to understand the long-term cost-effectiveness of MTM on racial/ethnic disparities.

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

Cost-utility of Initial Management of High-grade T1 Bladder Cancer With Intravesical BCG vs Immediate Radical Cystectomy

ObjectivesTo compare the cost-utility of initial management of high-grade T1 non-muscle invasive bladder cancer (HGT1 NMIBC) with intravesical BCG versus immediate radical cystectomy. High risk NMIBC patients may climb a costly ladder of treatments, culminating in radical cystectomy for oncologic or symptomatic benefit in up to one-third. This high healthcare resource utilization presents a challenging dilemma in balancing sufficiently aggressive management with cost, toxicity, and quality-of-life. MethodsCost-utility of initially managing HGT1 with intravesical BCG and early radical cystectomy with ileal conduit urinary diversion was compared using decision-analytic Markov models. Five-year oncologic outcomes, adverse event rates, and published utility values were extracted from literature. Costs were calculated from a US Medicare perspective in 2021 US dollars. Sensitivity analysis identified drivers of cost and break-even points for recurrence and progression. ResultsMean costs were $26,093 for intravesical BCG and $39,720 for immediate radical cystectomy, though cystectomy generated a gain of 2.2 QALYs compared to intravesical BCG. Immediate cystectomy was a more cost-effective management strategy for HGT1 NMIBC with an ICER of $7120/QALY.The costs associated with cystectomy, TURBT, and BCG toxicity had the greatest impact on ICER. One-way sensitivity analysis demonstrated that intravesical BCG became a cost-effective management strategy if the five-year recurrence rate of HG T1 was less than 56% or the five-year progression rate to MIBC was less than 4%. ConclusionsAt current prices, treatment of high-grade T1 NMIBC with early radical cystectomy is more cost-effective management strategy than initial treatment with intravesical BCG.

Cost-Effectiveness of Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation for Older Patients With High-Risk Myelodysplastic Syndrome: Analysis of BMT CTN 1102.

BMT CTN 1102 was a phase III trial comparing reduced-intensity allogeneic hematopoietic cell transplantation (RIC alloHCT) to standard of care for persons with intermediate- or high-risk myelodysplastic syndrome (MDS). We report results of a cost-effectiveness analysis conducted alongside the clinical trial. Three hundred eighty-four patients received HCT (n = 260) or standard of care (n = 124) according to availability of a human leukocyte antigen-matched donor. Cost-effectiveness was calculated from US commercial and Medicare perspectives over a 20-year time horizon. Health care utilization and costs were estimated using propensity score-matched cohorts of HCT recipients in the OptumLabs Data Warehouse (age 50-64 years) and Medicare (age 65 years and older). EuroQol 5 Dimension (EQ-5D) surveys of trial participants were used to derive health state utilities. Extrapolated 20-year overall survival for those age 50-64 years was 29% for HCT (n = 105) versus 13% for usual care (n = 44) and 31% for HCT (n = 155) versus 12% for non-HCT (n = 80) for those age 65 years and older. HCT was more effective (+2.36 quality-adjusted life-years [QALYs] for age 50-64 years and +2.92 QALYs for age 65 years and older) and more costly (+$452,242 in US dollars (USD) for age 50-64 years and +$233,214 USD for age 65 years and older) than usual care, with incremental cost-effectiveness ratios of $191,487 (USD)/QALY and $79,834 (USD)/QALY, respectively. For persons age 50-64 years, there was a 29% chance that HCT was cost-effective using a willingness-to-pay (WTP) threshold of $150K (USD)/QALY and 51% at a $200K (USD)/QALY. For persons age 65 years and older, the probability was 100% at a WTP >$150K (USD)/QALY. Among patients age 65 years and older with high-risk MDS, RIC HCT is a high-value strategy. For those age 50-64 years, HCT is a lower-value strategy but has similar cost-effectiveness to other therapies commonly used in oncology.

EPH94 Comparative Analysis of Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus: A Nationwide US Medicare Perspective

EPH94 Comparative Analysis of Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus: A Nationwide US Medicare Perspective

Sequential intravesical gemcitabine-docetaxel vs. bacillus Calmette-Guerin (BCG) in the treatment of non-muscle invasive bladder cancer: A preliminary cost-effectiveness analysis.

Treatment naïve patients with high-risk non-muscle invasive bladder cancer (NMIBC) are treated with bacillus Calmette-Guérin (BCG) therapy as the standard of care. Recently, intravesical sequential gemcitabine-docetaxel in the BCG-naïve setting was shown to be well-tolerated and effective, raising the possibility of a new first line intravesical therapy. Cost effectiveness of this intervention remains unknown; therefore, we designed a cost effectiveness study evaluating BCG vs. sequential gemcitabine-docetaxel in patients with high risk NMIBC. Using TreeAgePro 2019 software, we developed a Markov model to evaluate BCG vs. gemcitabine-docetaxel from the U.S. Medicare perspective with a 2-year time horizon. Model probabilities and utilities were derived from published literature. Direct costs were obtained from Medicare cost databases. Our primary outcomes were effectiveness (measured in quality adjusted life years [QALYs]), cost and the incremental cost-effectiveness ratio with a willingness to pay threshold of $100,000. Our results indicate that while both treatments resulted in similar QALYs of 1.76, the mean costs per patient at 2 years were $12,363 and $7,090 for BCG and gemcitabine-docetaxel, respectively. Therefore, the BCG strategy was dominated by the gemcitabine-docetaxel strategy as it was equally effective and less costly. One way sensitivity analyses were completed and gemcitabine-docetaxel remained a cost-effective strategy. The findings of this preliminary cost-effectiveness analysis are novel in that they highlight a well tolerated, efficacious drug that is less expensive than the traditional gold standard therapy. In modern medicine, we are more often challenged by agents with marginally increased efficacy but at significantly higher costs; gemcitabine-docetaxel represents a rare entity which is a success for both patients and healthcare systems alike.

An economic evaluation of first-line cryoballoon ablation vs antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation from a U.S. Medicare perspective.

Three recent randomized controlled trials have demonstrated that, as an initial rhythm control strategy, first-line cryoballoon ablation (cryoablation) reduces atrial arrhythmia recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). The study sought to evaluate the cost-effectiveness of first-line cryoablation compared with first-line AADs for treating symptomatic PAF from a U.S. Medicare payer perspective. Individual patient-level data from 703 participants with PAF enrolled into the Cryo-FIRST (NCT01803438), STOP AF First (NCT03118518), and EARLY-AF (NCT02825979) trials were used to derive parameters for the cost-effectiveness model. The cost-effectiveness model used a hybrid decision tree and Markov structure. The decision tree had a 1-year time horizon and was used to inform the initial health state allocation in the first cycleof the Markov model. The Markov model used a 40-year time horizon (3-month cycle length). Health benefits were expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Cryoablation was estimated to yield higher QALYs (+0.17) and higher costs (+$4274) per patient over a 40-year time horizon than AADs. Ultimately, this produced an average incremental cost-effectiveness ratio of $24,637 per QALY gained. Independent of initial treatment, individuals were expected to receive ∼1.2 ablations over a lifetime. There was a 45% relative reduction in time spent in atrial fibrillation health states for those initially treated with cryoablation compared with AADs. Initial rhythm control with first-line cryoballoon ablation is highly cost-effective compared with first-line AADs from a U.S. Medicare payer perspective.

EE246 Cognitive Behavioral Therapy (CBT) Vs. Oral Antidepressants for Treatment of Depression in Older Adults: A Cost-Effectiveness Analysis

Older adults under treatment with oral antidepressants (ADs) experience an increased risk of falls compared to non-users. Cognitive behavioral therapy (CBT) is an appropriate first-line alternative for the treatment of depression in older adults. There are currently no economic evaluations conducted comparing the two treatments. This research aims to explore the cost-effectiveness of CBT compared with oral ADs for depression in older adults, considering the risk of falls, fall-related emergency room visits (ERV) and their related consequences from a US Medicare perspective.

EPH38 Burden of Psychiatric Health in Elderly Myasthenia Gravis Patients: A Nationwide Medicare Perspective

Myasthenia gravis (MG) is a chronic autoimmune disease marked by heterogeneous presentations of progressive muscle weakness with a typical age of onset between 20-40 years. Treatment advancements have increased the lifespan of people with MG, but disease burden in older populations is not well-characterized. The objective of this analysis was to characterize the burden of MG among elderly Medicare beneficiaries in terms of the prevalence and association between muscle weakness and psychiatric health.

Cost-effectiveness of acalabrutinib regimens in treatment-naïve chronic lymphocytic leukemia in the United States

ABSTRACT Background Clinical outcomes in chronic lymphocytic leukemia (CLL) have improved with targeted therapy, including Bruton tyrosine kinase inhibitors such as acalabrutinib. Methods A semi-Markov model with three health states (progression-free, progressed disease, and death) estimated cost per quality-adjusted life-year (QALY) gained for acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab in treatment-naive CLL (based on ELEVATE-TN). The model used direct costs and resource utilization from the US Medicare perspective and utility values sourced from literature. Sensitivity analyses tested the robustness of the model. Results Over a 30-year lifetime horizon, the model base case analysis suggested that acalabrutinib monotherapy had an incremental cost of $206,329 and 2.52 QALYs gained versus chlorambucil + obinutuzumab, resulting in an incremental cost-effectiveness ratio (ICER) of $81,960/QALY. Acalabrutinib + obinutuzumab had an incremental cost of $423,747 and 2.79 QALYs gained (ICER: $152,153/QALY). Probabilistic sensitivity analysis showed the probability of acalabrutinib monotherapy being cost-effective as 59% to 73% at a $100,000-to-150,000/QALY willingness-to-pay threshold; the probability of acalabrutinib + obinutuzumab being cost-effective ranged from 34% to 51%. Conclusions Although the analysis is limited by uncertainty in postprogression survival outcomes, acalabrutinib monotherapy is likely cost-effective vs chlorambucil + obinutuzumab in treatment-naive CLL in the US Medicare setting.

PD13-01 COST-EFFECTIVENESS OF INITIAL MANAGEMENT OF HIGH-GRADE T1 BLADDER CANCER WITH INTRAVESICAL BCG VS IMMEDIATE RADICAL CYSTECTOMY

You have accessJournal of UrologyCME1 Apr 2023PD13-01 COST-EFFECTIVENESS OF INITIAL MANAGEMENT OF HIGH-GRADE T1 BLADDER CANCER WITH INTRAVESICAL BCG VS IMMEDIATE RADICAL CYSTECTOMY Heather Huelster, Neil Mason, Kyle Rose, Andrew Chang, Mahrukh Naqvi, Robert Gore, Youngchul Kim, Scott Gilbert, and Facundo Davaro Heather HuelsterHeather Huelster More articles by this author , Neil MasonNeil Mason More articles by this author , Kyle RoseKyle Rose More articles by this author , Andrew ChangAndrew Chang More articles by this author , Mahrukh NaqviMahrukh Naqvi More articles by this author , Robert GoreRobert Gore More articles by this author , Youngchul KimYoungchul Kim More articles by this author , Scott GilbertScott Gilbert More articles by this author , and Facundo DavaroFacundo Davaro More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003260.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Recurrent, BCG-refractory, or progressive high-grade T1 non-muscle invasive bladder cancer (HGT1) patients are exposed to costly treatments and toxicity from repeated transurethral resections and intravesical treatments. Escalation of therapy culminates in radical cystectomy in up to one-third. High healthcare resource utilization for this group of bladder cancer patients presents a challenging dilemma defined by balancing sufficiently aggressive management with the cost, toxicity, and quality-of-life implications of treatment. METHODS: A Markov model was constructed to compare the cost-effectiveness of HGT1 cancers managed initially with intravesical BCG with delayed radical cystectomy for NMIBC progression or recurrence versus immediate radical cystectomy with ileal conduit urinary diversion. The base case was represented by a 70 year old potent man with a new diagnosis of HG T1 bladder cancer, ECOG 0-1 performance status, and renal function acceptable for cisplatin-based chemotherapy. Five-year oncologic outcomes, adverse event rates, and published utility values were extracted from current literature. Drug and procedural costs were calculated from a US Medicare perspective and converted to 2021 US dollars. A willingness-to-pay threshold of $150,000 per quality adjusted life year (QALY) was considered cost-effective. One-way sensitivity analysis was then performed to identify correlates with overall cost and identify break-even points for recurrence and progression risk. RESULTS: The mean five-year costs for initial management of HGT1 were $43,197 (SD $3847) for intravesical BCG and $39,502 (SD $5434) for immediate radical cystectomy. Immediate cystectomy generated a gain of 1.7 QALYs and dominated intravesical BCG, generating an ICER of -$2238/QALY. Costs associated with cystectomy, TURBT, and BCG toxicity had the greatest impact on ICER. One-way sensitivity analysis demonstrated that intravesical BCG became a cost-effective management strategy if the 5-year recurrence rate of HG T1 was less than 56% or the five-year progression rate to MIBC was less than 4%. CONCLUSIONS: At current costs, treatment of HG T1 bladder cancer with immediate radical cystectomy achieves better oncologic and quality of life outcomes at lower cost over five years, and therefore is a more cost-effective management strategy than initial treatment with intravesical BCG. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e405 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Heather Huelster More articles by this author Neil Mason More articles by this author Kyle Rose More articles by this author Andrew Chang More articles by this author Mahrukh Naqvi More articles by this author Robert Gore More articles by this author Youngchul Kim More articles by this author Scott Gilbert More articles by this author Facundo Davaro More articles by this author Expand All Advertisement PDF downloadLoading ...

MP39-17 SEQUENTIAL INTRAVESICAL GEMCITABINE-DOCETAXEL VERSUS BACILLUS CALMETTE-GUERIN (BCG) IN THE TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER: A PRELIMINARY COST-EFFECTIVENESS ANALYSIS

You have accessJournal of UrologyCME1 Apr 2023MP39-17 SEQUENTIAL INTRAVESICAL GEMCITABINE-DOCETAXEL VERSUS BACILLUS CALMETTE-GUERIN (BCG) IN THE TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER: A PRELIMINARY COST-EFFECTIVENESS ANALYSIS Laura Bukavina, Spencer Bell, Vignesh Packiam, Marc Smaldone, Phillip Abosh, Robert Uzzo, Alexander Kutikov, Andres Correa, and Diana Magee Laura BukavinaLaura Bukavina More articles by this author , Spencer BellSpencer Bell More articles by this author , Vignesh PackiamVignesh Packiam More articles by this author , Marc SmaldoneMarc Smaldone More articles by this author , Phillip AboshPhillip Abosh More articles by this author , Robert UzzoRobert Uzzo More articles by this author , Alexander KutikovAlexander Kutikov More articles by this author , Andres CorreaAndres Correa More articles by this author , and Diana MageeDiana Magee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003277.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Treatment naïve patients with high-risk non-muscle invasive bladder cancer (NMIBC) are treated with bacillus Calmette-Guérin (BCG) therapy as the standard of care. Recently, intravesical sequential gemcitabine-docetaxel in the BCG-naïve setting was shown to be well-tolerated and effective at two years, raising the possibility of a new first line intravesical therapy for high risk NMIBC in over 40 years. The cost effectiveness of this intervention remains unknown; therefore, we designed a cost effectiveness study evaluating BCG versus sequential gemcitabine-docetaxel in patients with high-risk NMIBC. METHODS: Using TreeAgePro 2019 (Williamstown, MA) software, we developed a Markov model to evaluate BCG versus gemcitabine-docetaxel from the U.S. Medicare perspective with a 2-year time horizon. Model probabilities and utilities were derived from published literature. Direct costs were obtained from Medicare cost databases. Our primary oucomes were effectiveness (measured in quality adjusted life years (QALYs)), cost and the incremental cost-effectiveness ratio with a willingness to pay threshold of $100,000. Model schematic is depicted in Figure 1. RESULTS: Our results indicate that while both treatments resulted in similar QALYs of 1.76, the mean costs per patient at 2 years were $12,363 and $7,090 for BCG and gemcitabine-docetaxel, respectively. Therefore, the BCG strategy was dominated by the gemcitabine-docetaxel strategy as it was equally effective and less costly. One way sensitivity analyses were completed to evaluate the model’s robustness to changes in the data inputs and throughout the scenarios assessed gemcitabine-docetaxel remained a cost-effective strategy as the BCG strategy continued to be dominated. CONCLUSIONS: The findings of this preliminary cost-effectiveness analysis are novel in that they highlight a well tolerated, efficacious drug that is less expensive than the traditional gold standard therapy. In modern medicine, we are more often challenged by agents with marginally increased efficacy but at significantly higher costs; gemcitabine-docetaxel represents a rare entity which is a success for both patients and healthcare systems alike. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e542 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laura Bukavina More articles by this author Spencer Bell More articles by this author Vignesh Packiam More articles by this author Marc Smaldone More articles by this author Phillip Abosh More articles by this author Robert Uzzo More articles by this author Alexander Kutikov More articles by this author Andres Correa More articles by this author Diana Magee More articles by this author Expand All Advertisement PDF downloadLoading ...

Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening

Human papillomavirus (HPV) self-sampling addresses barriers to cervical cancer screening, and mailed self-sampling kits have been reported to increase screening uptake. International research suggests mailed kits are cost-effective in certain settings. However, the cost-effectiveness of mailing HPV self-sampling kits for increasing screening uptake has not been evaluated in the US. To conduct an economic evaluation of a mailed HPV self-sampling intervention among underscreened women enrolled in an integrated US health care system. This economic evaluation involved a cost-effectiveness analysis of results from a randomized clinical trial of 19 851 women aged 30 to 64 years enrolled in a health plan from Kaiser Permanente Washington (KPWA), a US-based integrated health care system. Women were identified through electronic medical records, and eligible participants were enrolled in a health plan for at least 3 years and 5 months, had a primary care clinician, had not received a Papanicolaou test for at least 3 years and 5 months, and had not received a hysterectomy. Enrollment occurred from February 25, 2014, to August 29, 2016, with follow-up through February 25, 2018. The current economic evaluation was conducted between August 2, 2021, and July 30, 2022. Intervention delivery costs were calculated from both the KPWA and Medicare perspectives and were based on either wellness visit or Papanicolaou test-only visit costs. Participants in the control group received usual care, which comprised patient reminders and ad hoc outreach for screening. Participants in the intervention group received usual care plus a mailed HPV self-sampling kit. The primary economic outcome was the incremental cost-effectiveness ratio (ICER) for increased screening uptake, defined as the incremental difference in cost (intervention group minus control group) divided by the difference in the number of participants completing screening (intervention group minus control group) within 6 months of randomization. Among 19 851 women (mean [SD] age, 50.1 [9.5] years; 76.7% White), 9960 were randomized to the intervention group, and 9891 were randomized to the control group. Baseline ICERs ranged from $85.84 (95% CI, $85.68-$85.99) using KPWA wellness visits as the cost basis to $146.29 (95% CI, $146.20-$146.38) using Medicare Papanicolaou test-only visits as the cost source. Subgroups of participants aged 50 to 64 years and participants most recently overdue for screening achieved cost-effectiveness at lower levels of willingness to pay for an additional completed screening than other subgroups. In this economic evaluation, mailing HPV self-sampling kits to women overdue for cervical cancer screening was cost-effective for increased screening uptake relative to usual care. These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates among eligible women in US health care systems.

OMNI® surgical system versus iStent inject® with concomitant cataract surgery for the treatment of mild-to-moderate primary open-angle glaucoma in the United States: a cost utility analysis

ABSTRACT Background A Markov model was developed to investigate the cost utility of the OMNI® Surgical System (OMNI®) versus iStent inject® in patients with mild to moderate primary open angle glaucoma (POAG) during concomitant cataract surgery from a US Medicare perspective. Methods For patients aged 65 years and older with mild to moderate POAG and visually significant cataract, we simulated progression through four glaucoma states (mild, moderate, advanced, severe) and death, using 6-month cycles and a lifetime horizon. A systematic literature review identified effectiveness data to calculate health state transition probabilities. Direct costs included surgical procedures, physician fees, and intraocular pressure (IOP)-lowering medications using Medicare 2022 rates. Utilities were sourced from published literature. Model structure and inputs were validated by a panel of ophthalmologists in the US and UK. Main outcome measures were incremental cost/QALY gained and net monetary benefit (NMB). Results OMNI® dominated iStent inject® with $552 lower costs and a gain of 0.02 quality-adjusted life-years. Model robustness was tested through deterministic and probabilistic sensitivity analyses, with OMNI® being dominant or cost-effective. NMB was $1,422 using a $50,000 willingness-to-pay threshold. Conclusion OMNI® was less costly and more effective than iStent inject® over a lifetime perspective for mild-to-moderate POAG Medicare patients in need of cataract extraction.

An economic evaluation of vagus nerve stimulation as an adjunctive treatment to anti-seizure medications for the treatment of drug resistant epilepsy in the United States

IntroductionPeople with recurrent epileptic seizures are typically treated with anti-seizure medications (ASMs). Around a third of epilepsy patients fail to achieve an adequate response to ASMs and may be eligible to receive vagus nerve stimulation (VNS) therapy for their drug-resistant epilepsy (DRE) if they are unsuited to surgery. VNS received approval from the United States (US) Food and Drug Administration agency. However, there has to date been no comprehensive cost effectiveness evaluation of VNS within the US setting. This study was designed, using a US Medicare perspective, to estimate costs and quality-adjusted life years (QALYs) associated with VNS as an adjunct to ongoing ASM therapy, compared to ASMs alone.MethodsWe developed a cohort state transition model in Microsoft Excel, with four health states defined by different percentage reductions in seizure frequency, with a 3-month cycle and transition probabilities derived from published clinical trials and registry data. Sensitivity analyses were conducted to understand the impact of parameter uncertainty. Costs included the VNS device, placement, programming, battery changes, and removal; ASM therapy; adverse events associated with VNS (dyspnea, hoarseness, and cough); and costs associated with seizure burden (i.e. hospitalizations, emergency department visits, neurologist visits).ResultsUnder base case assumptions, treatment with VNS was associated with a 0.385 QALY gain and a $109,678 saving per patient, when compared with ASM therapy alone. The incremental net monetary benefit (iNMB) was $128,903 at a threshold of $50,000 per QALY, with the positive iNMB indicating that VNS is a highly cost effective treatment. This result is explained by the modeled reduction in relative seizure frequency and associated reduction in healthcare resource use that the VNS group experienced. Sensitivity analyses supported this conclusion.ConclusionsVNS was evaluated as a cost effective addition to the current standard of care in the treatment of DRE in the US Medicare context.

Cost-effectiveness of Compression Therapy With Early Endovenous Ablation in Venous Ulceration for a Medicare Population

Venous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context. To evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective. This economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022. Direct medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results. This model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold. In this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.