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      Cost-Effectiveness and Budget Impact of Emerging Minimally Invasive Surgical Treatments for Benign Prostatic Hyperplasia

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          Abstract

          Background: Benign prostatic hyperplasia (BPH) is one of the most prevalent and costly chronic conditions among middle-aged and elderly men. Prostatic urethral lift (PUL) and convective water vapor thermal therapy (WVTT) are emerging minimally invasive surgical treatments as an alternative to traditional treatment options for men with moderate-to-severe BPH. This study evaluated the cost-effectiveness and budget impact of PUL and WVTT for men with BPH using long-term clinical outcomes.

          Methods: The cost-effectiveness and budget impact models were developed from a US Medicare perspective over a 4-year time horizon. The models were populated with males with a mean age of 63 and an average International Prostate Symptom Score (IPSS) of 22. Clinical inputs were extracted from the LIFT and Rezum II randomized controlled trials at 4 years. Utility values were assigned using IPSS and BPH severity levels. Procedural, adverse event, retreatment, follow-up, and medication costs were based on 2019 Medicare payment rates and Medicare Part D drug spending. One-way and probabilistic sensitivity analyses (PSAs) were performed.

          Results: At 4 years, PUL was associated with greater retreatment rates (24.6% vs 10.9%), lower quality-adjusted life-years (QALYs) (3.490 vs 3.548) and higher total costs (US$7393 vs US$2233) compared with WVTT, making WVTT the more effective and less costly treatment strategy. The 70% total cost difference of PUL and WVTT was predominantly driven by higher PUL procedural (US$5617 vs US$1689) and retreatment (US$976 vs US$257) costs. The PSA demonstrated that relative to PUL, WVTT yielded higher QALYs and lower costs 99% and 100% of the time, respectively.

          Conclusions: Compared to PUL, WVTT was a cost-effective and cost-saving treatment of moderate-to-severe BPH. These findings provide evidence for clinicians, payers, and health policy makers to help further define the role of minimally invasive surgical treatments for BPH.

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          Most cited references23

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          Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force.

          Budget impact analyses (BIAs) are an essential part of a comprehensive economic assessment of a health care intervention and are increasingly required by reimbursement authorities as part of a listing or reimbursement submission. The objective of this report was to present updated guidance on methods for those undertaking such analyses or for those reviewing the results of such analyses. This update was needed, in part, because of developments in BIA methods as well as a growing interest, particularly in emerging markets, in matters related to affordability and population health impacts of health care interventions. The Task Force was approved by the International Society for Pharmacoeconomics and Outcomes Research Health Sciences Policy Council and appointed by its Board of Directors. Members were experienced developers or users of BIAs; worked in academia and industry and as advisors to governments; and came from several countries in North America and South America, Oceania, Asia, and Europe. The Task Force solicited comments on the drafts from a core group of external reviewers and, more broadly, from the membership of the International Society for Pharmacoeconomics and Outcomes Research. The Task Force recommends that the design of a BIA for a new health care intervention should take into account relevant features of the health care system, possible access restrictions, the anticipated uptake of the new intervention, and the use and effects of the current and new interventions. The key elements of a BIA include estimating the size of the eligible population, the current mix of treatments and the expected mix after the introduction of the new intervention, the cost of the treatment mixes, and any changes expected in condition-related costs. Where possible, the BIA calculations should be performed by using a simple cost calculator approach because of its ease of use for budget holders. In instances, however, in which the changes in eligible population size, disease severity mix, or treatment patterns cannot be credibly captured by using the cost calculator approach, a cohort or patient-level condition-specific model may be used to estimate the budget impact of the new intervention, accounting appropriately for those entering and leaving the eligible population over time. In either case, the BIA should use data that reflect values specific to a particular decision maker's population. Sensitivity analysis should be of alternative scenarios chosen from the perspective of the decision maker. The validation of the model should include at least face validity with decision makers and verification of the calculations. Data sources for the BIA should include published clinical trial estimates and comparator studies for the efficacy and safety of the current and new interventions as well as the decision maker's own population for the other parameter estimates, where possible. Other data sources include the use of published data, well-recognized local or national statistical information, and, in special circumstances, expert opinion. Reporting of the BIA should provide detailed information about the input parameter values and calculations at a level of detail that would allow another modeler to replicate the analysis. The outcomes of the BIA should be presented in the format of interest to health care decision makers. In a computer program, options should be provided for different categories of costs to be included or excluded from the analysis. We recommend a framework for the BIA, provide guidance on the acquisition and use of data, and offer a common reporting format that will promote standardization and transparency. Adherence to these good research practice principles would not necessarily supersede jurisdiction-specific BIA guidelines but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Published by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved.
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            Health outcomes in economic evaluation: the QALY and utilities.

            The quality-adjusted life year (QALY) is routinely used as a summary measure of health outcome for economic evaluation, which incorporates the impact on both the quantity and quality of life. Key studies relating to the QALY and utility measurement are the sources of data. Areas of agreement include the need for a standard measure of health outcome to enable comparisons across different disease areas and populations, and the methods used for valuing health states in utility measurement. Areas of controversy include the limitation of the QALY approach in terms of the health benefits it can capture, its blindness towards equity concerns, the underlying theoretical assumptions and the most appropriate generic preference-based measure of utility. There is growing debate relating to whether a QALY is the same regardless of who accrues it, and also the issue as to who should value health states. Research is required to further enhance the QALY approach to deal with challenges relating to equity-weighted utility maximization and testing the validity of underlying assumptions. Issues around choosing between condition-specific measures and generic instruments also merit further investigation.
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              Assessing cost-effectiveness in healthcare: history of the $50,000 per QALY threshold.

              Cost-effectiveness analyses, particularly in the USA, commonly use a figure of $50,000 per life-year or quality-adjusted life-year gained as a threshold for assessing the cost-effectiveness of an intervention. The history of this practice is ill defined, although it has been linked to the end-stage renal disease kidney dialysis cost-effectiveness literature from the 1980s. The use of $50,000 as a benchmark for assessing the cost-effectiveness of an intervention first emerged in 1992 and became widely used after 1996. The appeal of the $50,000 figure appears to lie in the convenience of a round number rather than in the value of renal dialysis. Rather than arbitrary thresholds, estimates of willingness to pay and the opportunity cost of healthcare resources are needed.
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                Author and article information

                Journal
                J Health Econ Outcomes Res
                J Health Econ Outcomes Res
                1694
                Journal of Health Economics and Outcomes Research
                Columbia Data Analytics, LLC
                2326-697X
                2327-2236
                6 May 2021
                2021
                : 8
                : 1
                : 42-50
                Affiliations
                [1 ] Weill Cornell Medicine, New York, NY, USA
                [2 ] Boston Scientific, Marlborough, MA, USA
                [3 ] Certara Germany GmbH, Loerrach, BW, Germany
                [4 ] Carolina Urologic Research Center, Myrtle Beach, SC, USA
                Author notes

                *Corresponding author:

                E-mail address: sirikan.rojanasarot@bsci.com, sirikan.rojanasarot@gmail.com

                Article
                22256
                10.36469/jheor.2021.22256
                8102068
                33987450
                66767580-d54b-4e7f-a0e3-ae9473e2a07d

                This is an open access article distributed under the terms of the Creative Commons Attribution License (4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 15 March 2021
                : 12 April 2021
                Funding
                This study was funded by Boston Scientific.
                Categories
                Urological/Gynecological Diseases

                cost-effectiveness analysis,minimally invasive surgical treatments,budget impact analysis,prostatic urethral lift,water vapor thermal therapy,benign prostatic hyperplasia

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