Denosumab for Elderly Men with Osteoporosis: A Cost-Effectiveness Analysis from the US Payer Perspective.
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ABSTRACT:
SUBMITTER: Silverman S
PROVIDER: S-EPMC4689973 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Osteoporosis affects many men, with significant morbidity and mortality. However, the best osteoporosis screening strategies for men are unknown. We developed an individual-level state-transition cost-effectiveness model with a lifetime time horizon to identify the cost-effectiveness of different osteoporosis screening strategies for US men involving various screening tests (dual-energy X-ray absorptiometry [DXA]; the Osteoporosis Self-Assessment Tool [OST]; or a fracture risk assessment strategy using age, femoral neck bone mineral density [BMD], and Vertebral Fracture Assessment [VFA]); screening initiation ages (50, 60, 70, or 80 years); and repeat screening intervals (5 years or 10 years). In base-case analysis, no screening was a less effective option than all other strategies evaluated; furthermore, no screening was more expensive than all strategies that involved screening with DXA or the OST risk assessment instrument, and thus no screening was "dominated" by screening with DXA or OST at all evaluated screening initiation ages and repeat screening intervals. Screening strategies that most frequently appeared as most cost-effective in base-case analyses and one-way sensitivity analyses when assuming willingness-to-pay of $50,000/quality-adjusted life-year (QALY) or $100,000/QALY included screening initiation at age 50 years with the fracture risk assessment strategy and repeat screening every 10 years; screening initiation at age 50 years with fracture risk assessment and repeat screening every 5 years; and screening initiation at age 50 years with DXA and repeat screening every 5 years. In conclusion, expansion of osteoporosis screening for US men to initiate routine screening at age 50 or 60 years would be expected to be effective and of good value for improving health outcomes. A fracture risk assessment strategy using variables of age, femoral neck BMD, and VFA is likely to be the most effective of the evaluated strategies within accepted cost-effectiveness parameters. DXA and OST are also reasonable screening options, albeit likely slightly less effective than the evaluated fracture risk assessment strategy. © 2016 American Society for Bone and Mineral Research.
| S-EPMC4891297 | biostudies-literature
Project description:IntroductionGolimumab is a tumor necrosis factor-? (TNF-?) inhibitor for treatment of patients with severe, active ankylosing spondylitis. This study evaluated the cost-effectiveness of golimumab compared with conventional care and other TNF-? inhibitors in treatment of AS from the UK National Health Service perspective.MethodsA long-term Markov model (with initial decision tree) was developed to simulate the progression of a hypothetical cohort of patients with active AS over a lifetime. The effectiveness outcome was quality-adjusted life-years (QALYs). Utilities were estimated by mapping Bath Ankylosing Spondylitis Functional Index scores, and the primary response measure was ?50% improvement on the Bath Ankylosing Spondylitis Disease Activity Index at 12 weeks. Direct, medication, and AS management costs were included. Costs and outcomes were discounted at 3.5%.ResultsAll TNF-? inhibitors were comparable to each other and superior to conventional care. The incremental cost-effectiveness ratios (ICERs) for TNF-? inhibitors were £19,070-42,532 per QALY gained compared with conventional care. Analyses of the ICERs for each TNF-? inhibitor compared with conventional care demonstrated that golimumab was the most cost-effective treatment, and that adalimumab and etanercept were dominated by golimumab. Sensitivity analyses confirmed the robustness of these analyses.ConclusionsGolimumab may be considered a cost-effective treatment alternative for patients with active AS. With comparable costs and efficacy among TNF-? inhibitors, the choice of TNF-? inhibitor to treat AS is likely to be driven by patient and physician choice.FundingMerck & Co., Inc.
| S-EPMC5696295 | biostudies-literature
Project description:BackgroundOsteoporosis is a progressive skeletal disease associated with an increased risk of bone fracture. This study aimed to estimate the cost-effectiveness of denosumab for osteoporotic fracture prevention compared to bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate) and selective estrogen receptor modulators (raloxifene) in a cohort of postmenopausal women with osteoporosis.MethodsA Markov model was used to evaluate the cost and effectiveness of denosumab versus comparators. The model had a cycle length of 6 months and was run from the age of 68 years to individual patients' lifetime or the age of 100 years. The health states considered in the model were well, hip fracture, vertebral fracture, wrist fracture, other osteoporotic fracture, post-hip fracture, post-vertebral fracture, and death. Recent local data were used as inputs for the model parameters. A discount rate of 4.5% was applied to both costs and outcomes.ResultsFrom the perspective of the healthcare system, denosumab was cost-effective or cost-saving compared to all comparators, considering one unit of Korea's gross domestic product per capita, USA dollar (USD) 34,870. Denosumab was cost-saving compared to ibandronate (oral) and raloxifene. Compared to alendronate, denosumab was cost-effective with an incremental cost-effectiveness ratio (ICER) of USD 767.10 per quality-adjusted life year (QALY). The ICER of denosumab vs. ibandronate IV, risedronate, and zoledronate was USD 685.63, USD 1,469.71, USD 4,668.53 per QALY, respectively.ConclusionsThe findings of this analysis suggest that denosumab is a cost-effective therapeutic option for preventing fractures in postmenopausal women with osteoporosis in South Korea.
| S-EPMC9208907 | biostudies-literature
Project description:Aim: The cost-effectiveness of treatment options (anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, sacral nerve stimulation and percutaneous tibial stimulation [the latter two including new rechargeable neurostimulators]) for the management of overactive bladder (OAB) were compared with best supportive care (BSC) using a previously published Markov model. Materials & methods: Cost-effectiveness was evaluated over a 15-year time horizon, and sensitivity analyses were performed using 2- and 5-year horizons. Discontinuation rates, resource utilization, and costs were derived from published sources. Results: Using Medicare and commercial costs over a 15-year time period, onabotulinumtoxinA 100U had incremental cost-effectiveness ratios (ICERs) gained of $39,591/quality-adjusted life-year (QALY) and $42,255/QALY, respectively, versus BSC, which were the lowest ICERs of all assessed treatments. The sensitivity analyses at 2- and 5-year horizons also showed onabotulinumtoxinA to be the most cost-effective of all assessed treatments versus BSC. Conclusion: OnabotulinumtoxinA 100U is currently the most cost-effective treatment for OAB.
| S-EPMC10288955 | biostudies-literature
Project description:IntroductionThis study aims to evaluate the cost-effectiveness of remdesivir compared to other existing therapies (SoC) in Turkey to treat COVID-19 patients hospitalized with < 94% saturation and low-flow oxygen therapy (LFOT) requirement.MethodsWe compared remdesivir as the treatment for COVID-19 with the treatments in the Turkish treatment guidelines. Analyses were performed using data from 78 hospitalized COVID-19 patients with SpO2 < 94% who received LFOT in a tertiary healthcare facility. COVID-19 episode costs were calculated for 78 patients considering the cost of modeled remdesivir treatment in the same group from the payer's perspective. The incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) was calculated for remdesivir versus the SoC for the population identified. For Turkey, a reimbursement threshold value between USD 8599 (1 × per capita gross domestic product-GDP) and USD 25.797 (3 × GDP) per QALY was used.ResultsIn the remdesivir arm, the length of hospital stay (LOS) was 3 days shorter than the SOC. The low ventilator requirement in the remdesivir arm was one factor that decreased the QALY disutility value. In patients who were transferred to intensive care unit (ICU) from the ward, the mean LOS was 17.3 days (SD 13.6), and the mean cost of stay was USD 155.3/day (SD 168.0), while in patients who were admitted to ICU at baseline, the mean LOS was 13.1 days (SD 13.7), and the mean cost of stay was USD 207.9/day (SD 133.6). The mean cost of episode per patient was USD 3461.1 (SD 2259.8) in the remdesivir arm and USD 3538.9 (SD 3296.0) in the SOC arm. Incremental QALYs were estimated at 0.174. Remdesivir treatment was determined to be cost saving vs. SoC.ConclusionsRemdesivir, which results in shorter LOS and lower rates of intubation requirements in ICU patients than existing therapies, is associated with higher QALYs and lower costs, dominating SoC in patients with SpO2 < 94% who require oxygen support.
| S-EPMC8355577 | biostudies-literature
Project description:BackgroundInsurance reimbursement provisions in South Korea limit osteoporosis medication availability for patients with T-scores exceeding - 2.5. This study aimed to evaluate the financial impact and fracture prevention of continuous denosumab therapy until a T-score>-2.0 (Dmab-C strategy), versus discontinuation of denosumab after reaching T-score>-2.5 (Dmab-D strategy) in osteoporosis patients.MethodsA cost-consequence analysis from a Korean healthcare system perspective was performed using a newly developed Markov model. The incidence of vertebral and non-vertebral fracture, fracture-related deaths, drug costs, and fracture-treatment costs were estimated and compared between Dmab-C and Dmab-D strategy over a lifetime in eligible patients aged 55 years.ResultsBase-case analysis revealed that Dmab-C prevented 32.21 vertebral fracture (VF) and 12.43 non-VF events per 100 patients over a lifetime, while reducing 1.29 fracture-related deaths. Lifetime direct healthcare cost saving per patient was KRW 1,354,655 if Dmab-C replaces Dmab-D. When productivity losses were considered, Dmab-C saved KRW 29,025,949 per patient compared to Dmab-D. The additional treatment costs of Dmab-C could be offset by the higher subsequent treatment costs and fracture treatment costs of Dmab-D. The sensitivity analysis showed consistent patterns with results of the base-case analysis.ConclusionContinuous treatment using denosumab until osteoporosis patients achieve and maintain a T-score of -2.0 would provide greater clinical and economic benefits in terms of fracture prevention and reduced mortality risks compared to outcomes from discontinuing treatment at a T-score of -2.5 or above. This new treatment strategy would effectively lower the risk of fractures and fracture-related mortality, ultimately leading to lower medical expenses.
| S-EPMC10799461 | biostudies-literature
Project description:BackgroundOsteoporosis is often considered to be a disease of women. Over the last few years, owing to the increasing clinical and economic burden, the awareness and imperative for identifying and managing osteoporosis in men have increased substantially. With the approval of agents to treat men with osteoporosis, more economic evaluations have been conducted to assess the potential economic benefits of these interventions. Despite this concern, there is no specific overview of cost-effectiveness analyses for the treatment of osteoporosis in men.ObjectivesThis study aims (1) to systematically review economic evaluations of interventions for osteoporosis in men; (2) to critically appraise the quality of included studies and the source of model input data; and (3) to investigate the comparability of results for studies including both men and women.MethodsA literature search mainly using MEDLINE (via Ovid) and Embase databases was undertaken to identify original articles published between 1 January, 2000 and 30 June, 2022. Studies that assessed the cost effectiveness of interventions for osteoporosis in men were included. The Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases and the International Osteoporosis Foundation osteoporosis-specific guideline was used to assess the quality of design, conduct, and reporting of included studies.ResultsOf 2973 articles identified, 25 studies fulfilled the inclusion criteria, classified into economic evaluations of active drugs (n = 8) or nutritional supplements (n = 4), intervention thresholds (n = 5), screening strategies (n = 6), and post-fracture care programs (n = 2). Most studies were conducted in European countries (n = 15), followed by North America (n = 9). Bisphosphonates (namely alendronate) and nutritional supplements were shown to be generally cost effective compared with no treatment in men over 60 years of age with osteoporosis or prior fractures. Two other studies suggested that denosumab was cost effective in men aged 75 years and older with osteoporosis compared with bisphosphates and teriparatide. Intervention thresholds at which bisphosphonates were found to be cost effective varied among studies with a 10-year probability of a major osteoporotic fracture that ranged from 8.9 to 34.2% for different age categories. A few studies suggested cost effectiveness of screening strategies and post-fracture care programs in men. Similar findings regarding the cost effectiveness of drugs and intervention thresholds in women and men were captured, with slightly greater incremental cost-effectiveness ratios in men. The quality of the studies included had an average score of 18.8 out of 25 (range 13-23.5). Hip fracture incidence and mortality risk were mainly derived from studies in men, while fracture cost, treatment efficacy, and disutility were commonly derived from studies in women or studies combining both sexes.ConclusionsAnti-osteoporosis drugs and nutritional supplements are generally cost effective in men with osteoporosis. Screening strategies and post-fracture care programs also showed economic benefits for men. Cost-effectiveness and intervention thresholds were generally similar in studies conducted in both men and women, with slightly greater incremental cost-effectiveness ratios in men.
| S-EPMC10020287 | biostudies-literature
Project description:BackgroundTrastuzumab improves survival in HER2+ breast cancer patients, with some evidence of adverse cardiac side effects. Current recommendations are to give adjuvant trastuzumab for one year or until recurrence, although trastuzumab treatment for only 9 or 10 weeks has shown similar survival rates to 12-month treatment. We present here a multi-arm joint analysis examining the relative cost-effectiveness of different durations of adjuvant trastuzumab.Methods and findingsNetwork meta-analysis (NMA) was used to examine which trials' data to include in the cost-effectiveness analysis (CEA). A network using FinHer (9 weeks vs. zero) and BCIRG006 (12 months vs. zero) trials offered the only jointly randomisable network so these trials were used in the CEA. The 3-arm CEA compared costs and quality-adjusted life-years (QALYs) associated with zero, 9-week and 12-month adjuvant trastuzumab durations in early breast cancer, using a decision tree followed by a Markov model that extrapolated the results to a lifetime time horizon. Pairwise incremental cost-effectiveness ratios (ICERs) were also calculated for each pair of regimens and used in budget impact analysis, and the Bucher method was used to check face validity of the findings. Addition of the PHARE trial (6 months vs. 12 months) to the network, in order to create a 4-arm CEA including the 6-month regimen, was not possible as late randomisation in this trial resulted in recruitment of a different patient population as evidenced by the NMA findings. The CEA results suggest that 9 weeks' trastuzumab is cost-saving and leads to more QALYs than 12 months', i.e. the former dominates the latter. The cost-effectiveness acceptability frontier (CEAF) favours zero trastuzumab at willingness-to-pay levels below £2,500/QALY and treatment for 9 weeks above this threshold. The combination of the NMA and Bucher investigations suggests that the 9-week duration is as efficacious as the 12-month duration for distant-disease-free survival and overall survival, and safer in terms of fewer adverse cardiac events.ConclusionsOur CEA results suggest that 9-week trastuzumab dominates 12-month trastuzumab in cost-effectiveness terms at conventional thresholds of willingness to pay for a QALY, and the 9-week regimen is also suggested to be as clinically effective as the 12-month regimen according to the NMA and Bucher analyses. This finding agrees with the results of the E2198 head-to-head study that compared 10 weeks' with 14 months' trastuzumab and found no significant difference. Appropriate trial design and reporting is critical if results are to be synthesisable with existing evidence, as selection bias can lead to recruitment of a different patient population from existing trials. Our analysis was not based on head-to-head trials' data, so the results should be viewed with caution. Short-duration trials would benefit from recruiting larger numbers of participants to reduce uncertainty in the synthesised results.
| S-EPMC5383006 | biostudies-literature
Project description:ImportanceFalls and osteoporosis share the potential clinical end point of fractures among older patients. To date, few fall prevention guidelines incorporate screening for osteoporosis to reduce fall-related fractures.ObjectiveTo assess the cost-effectiveness of screening for osteoporosis using dual-energy x-ray absorptiometry (DXA) followed by osteoporosis treatment in older men with a history of falls.Design, setting, and participantsIn this economic evaluation, a Markov model was developed to simulate the incidence of major osteoporotic fractures in a hypothetical cohort of community-dwelling men aged 65 years who had fallen at least once in the past year. Data sources included literature published from January 1, 1946, to July 31, 2020. The model adopted a societal perspective, a lifetime horizon, a 1-year cycle length, and a discount rate of 3% per year for both health benefits and costs. The analysis was designed and conducted from October 1, 2019, to September 30, 2020.InterventionsScreening with DXA followed by treatment for men diagnosed with osteoporosis compared with usual care.Main outcomes and measuresIncremental cost-effectiveness ratio (ICER), measured by cost per quality-adjusted life-year (QALY) gained.ResultsAmong the hypothetical cohort of men aged 65 years, the screening strategy had an ICER of $33 169/QALY gained and was preferred over usual care at the willingness-to-pay threshold of $100 000/QALY gained. The number needed to screen to prevent 1 hip fracture was 1876; to prevent 1 major osteoporotic fracture, 746. The screening strategy would become more effective and less costly than usual care for men 77 years and older. The ICER for the screening strategy did not substantially change across a wide range of assumptions tested in all other deterministic sensitivity analyses. At a willingness-to-pay threshold of $50 000/QALY gained, screening was cost-effective in 56.0% of simulations; at $100 000/QALY gained, 90.8% of simulations; and at $200 000/QALY gained, 99.6% of simulations.Conclusions and relevanceThese findings suggest that for older men who have fallen at least once in the past year, screening with DXA followed by treatment for those diagnosed with osteoporosis is a cost-effective use of resources. Fall history could be a useful cue to trigger assessment for osteoporosis in men.
| S-EPMC7708999 | biostudies-literature
Project description:BackgroundWith limited healthcare resources available, cost-effective provision of dialysis to patients with end-stage renal disease (ESRD) is important.ObjectivesTo assess the cost-effectiveness of varying levels of peritoneal dialysis (PD) use versus current practice among incident ESRD patients requiring dialysis.MethodsA Markov model was developed to investigate the cost-effectiveness of increasing uptake of PD to 39 and 50 % versus current practice of 22 % PD from a UK National Health Service perspective for the year of 2013-2014. A scenario with 5 % PD was also considered. Sensitivity analyses were performed.ResultsFive- and 10-year discounted total costs and quality-adjusted life years (QALYs) per patient for the current scenario (22 % PD) were £96,307 and 2.104, and £133,339 and 3.301, respectively. Use of PD in 39 % of patients resulted in 5- and 10-year total per-patient cost savings of £3,180 and £4,102 versus current usage alongside total per-patient QALY increases of 0.017 and 0.020. Use of PD in 50 % of patients resulted in 5- and 10-year per-patient cost savings of £5,238 and £6,758 versus current usage alongside per-patient QALY increases of 0.029 and 0.033. Thus, increasing use of PD was associated with marginally better outcomes and lower costs. Cost savings were driven by lower treatment costs and reduced transport requirements for PD versus haemodialysis. Reducing PD use was associated with higher costs and a small reduction in QALYs.ConclusionsThese findings suggest increasing PD use among incident dialysis patients would be cost-effective, associated with reduced costs and potential modest improvements in quality of life.
| S-EPMC4110409 | biostudies-literature