Cost-effectiveness of digital therapeutics for essential hypertension.
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ABSTRACT:
SUBMITTER: Nomura A
PROVIDER: S-EPMC9474296 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
Publications
Cost-effectiveness of digital therapeutics for essential hypertension.
Nomura Akihiro A Tanigawa Tomoyuki T Kario Kazuomi K Igarashi Ataru A
Hypertension research : official journal of the Japanese Society of Hypertension 20220620 10
Hypertension increases the risk of cardiovascular and other diseases. Lifestyle modification is a significant component of nonpharmacological treatments for hypertension. We previously reported the clinical efficacy of digital therapeutics (DTx) in the HERB-DH1 trial. However, there is still a lack of cost-effectiveness assessments evaluating the impact of prescription DTx. This study aimed to analyze the cost-effectiveness of using prescription DTx in treating hypertension. We developed a month ...[more]
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Project description:Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real-world blood pressure (BP) control rate remains poor. To improve BP target achievement, we developed a novel digital therapeutic-the HERB software system -to manage hypertension. Here, we performed a randomized pilot study to assess the safety and efficacy of the HERB system for hypertension. We recruited 146 patients with essential hypertension from March 2018 to March 2019. We allocated eligible patients to the intervention group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary outcome was the mean change from baseline to 24 weeks in 24-hour systolic BP (SBP) measured by ambulatory blood pressure monitoring (ABPM). The baseline characteristics in each group were well balanced; the mean age was approx. 57 years, and 67% were male. In the primary end point at 24 weeks, HERB intervention did not lower the mean change of 24-hour SBP by ABPM compared with the controls (adjusted difference: -0.66 mmHg; p = .78). In an exploratory analysis focusing on antihypertensive drug-naïve patients aged <65, the effects of the HERB intervention were significantly greater than the control for reducing 24-hour SBP by ABPM at 16 weeks (adjusted difference: -7.6 mmHg; p = .013; and morning home SBP at 24 weeks (adjusted difference - 6.0 mmHg; p = .012). Thus, the HERB intervention did not achieve a primary efficacy end point. However, we observed that antihypertensive drug-naïve adult hypertensive patients aged <65 years could be a potential HERB system-effective target for further investigations of the efficacy of the system.
| S-EPMC8678748 | biostudies-literature
Project description:AimsDigital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication.Methods and resultsThis prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group (n = 199) or control (n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were -2.4 (95% confidence interval -4.5 to -0.3), -4.3 (-6.7 to -1.9), and -3.6 (-6.2 to -1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks.ConclusionThe HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.
| S-EPMC8530534 | biostudies-literature
Project description:BackgroundHypertension is China's leading cardiovascular disease risk factor. Improved hypertension control in China would result in result in enormous health gains in the world's largest population. A computer simulation model projected the cost-effectiveness of hypertension treatment in Chinese adults, assuming a range of essential medicines list drug costs.Methods and findingsThe Cardiovascular Disease Policy Model-China, a Markov-style computer simulation model, simulated hypertension screening, essential medicines program implementation, hypertension control program administration, drug treatment and monitoring costs, disease-related costs, and quality-adjusted life years (QALYs) gained by preventing cardiovascular disease or lost because of drug side effects in untreated hypertensive adults aged 35-84 y over 2015-2025. Cost-effectiveness was assessed in cardiovascular disease patients (secondary prevention) and for two blood pressure ranges in primary prevention (stage one, 140-159/90-99 mm Hg; stage two, ≥160/≥100 mm Hg). Treatment of isolated systolic hypertension and combined systolic and diastolic hypertension were modeled as a reduction in systolic blood pressure; treatment of isolated diastolic hypertension was modeled as a reduction in diastolic blood pressure. One-way and probabilistic sensitivity analyses explored ranges of antihypertensive drug effectiveness and costs, monitoring frequency, medication adherence, side effect severity, background hypertension prevalence, antihypertensive medication treatment, case fatality, incidence and prevalence, and cardiovascular disease treatment costs. Median antihypertensive costs from Shanghai and Yunnan province were entered into the model in order to estimate the effects of very low and high drug prices. Incremental cost-effectiveness ratios less than the per capita gross domestic product of China (11,900 international dollars [Int$] in 2015) were considered cost-effective. Treating hypertensive adults with prior cardiovascular disease for secondary prevention was projected to be cost saving in the main simulation and 100% of probabilistic simulation results. Treating all hypertension for primary and secondary prevention would prevent about 800,000 cardiovascular disease events annually (95% uncertainty interval, 0.6 to 1.0 million) and was borderline cost-effective incremental to treating only cardiovascular disease and stage two patients (2015 Int$13,000 per QALY gained [95% uncertainty interval, Int$10,000 to Int$18,000]). Of all one-way sensitivity analyses, assuming adherence to taking medications as low as 25%, high Shanghai drug costs, or low medication efficacy led to the most unfavorable results (treating all hypertension, about Int$47,000, Int$37,000, and Int$27,000 per QALY were gained, respectively). The strengths of this study were the use of a recent Chinese national health survey, vital statistics, health care costs, and cohort study outcomes data as model inputs and reliance on clinical-trial-based estimates of coronary heart disease and stroke risk reduction due to antihypertensive medication treatment. The limitations of the study were the use of several sources of data, limited clinical trial evidence for medication effectiveness and harms in the youngest and oldest age groups, lack of information about geographic and ethnic subgroups, lack of specific information about indirect costs borne by patients, and uncertainty about the future epidemiology of cardiovascular diseases in China.ConclusionsExpanded hypertension treatment has the potential to prevent about 800,000 cardiovascular disease events annually and be borderline cost-effective in China, provided low-cost essential antihypertensive medicines programs can be implemented.
| S-EPMC4524696 | biostudies-literature
Project description:BackgroundWhile a population-wide strategy involving lifestyle changes and a high-risk strategy involving pharmacological interventions have been described, the recently proposed personalized medicine approach combining both strategies for the prevention of hypertension has increasingly gained attention. However, a cost-effectiveness analysis has been hardly addressed. This study was set out to build a Markov analytical decision model with a variety of prevention strategies in order to conduct an economic analysis for tailored preventative methods.MethodsThe Markov decision model was used to perform an economic analysis of four preventative strategies: usual care, a population-based universal approach, a population-based high-risk approach, and a personalized strategy. In all decisions, the cohort in each prevention method was tracked throughout time to clarify the four-state model-based natural history of hypertension. Utilizing the Monte Carlo simulation, a probabilistic cost-effectiveness analysis was carried out. The incremental cost-effectiveness ratio was calculated to estimate the additional cost to save an additional life year.ResultsThe incremental cost-effectiveness ratios (ICER) for the personalized preventive strategy versus those for standard care were -USD 3317 per QALY gained, whereas they were, respectively, USD 120,781 and USD 53,223 per Quality-Adjusted Life Year (QALY) gained for the population-wide universal approach and the population-based high-risk approach. When the ceiling ratio of willingness to pay was USD 300,000, the probability of being cost-effective reached 74% for the universal approach and was almost certain for the personalized preventive strategy. The equivalent analysis for the personalized strategy against a general plan showed that the former was still cost-effective.ConclusionsTo support a health economic decision model for the financial evaluation of hypertension preventative measures, a personalized four-state natural history of hypertension model was created. The personalized preventive treatment appeared more cost-effective than population-based conventional care. These findings are extremely valuable for making hypertension-based health decisions based on precise preventive medication.
| S-EPMC10302947 | biostudies-literature
Project description:The Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID) trial demonstrated that adding aliskiren, an oral direct renin inhibitor, at a dosage of 300 mg/d to the highest approved dosage of losartan and optimal antihypertensive therapy reduces albuminuria over 6 mo among patients with type 2 diabetes, hypertension, and albuminuria. The cost-effectiveness of this therapy, however, is unknown. Here, we used a Markov model to project progression to ESRD, life years, quality-adjusted life years, and lifetime costs for aliskiren plus losartan versus losartan. We used data from the AVOID study and the Irbesartan in Diabetic Nephropathy Trial (IDNT) to estimate probabilities of progression of renal disease. We estimated probabilities of mortality for ESRD and other comorbidities using data from the US Renal Data System, US Vital Statistics, and published studies. We based pharmacy costs on wholesale acquisition costs and based costs of ESRD and transplantation on data from the US Renal Data System. We found that adding aliskiren to losartan increased time free of ESRD, life expectancy, and quality-adjusted life expectancy by 0.1772, 0.1021, and 0.0967 yr, respectively. Total expected lifetime health care costs increased by $2952, reflecting the higher pharmacy costs of aliskiren and losartan ($7769), which were partially offset by savings in costs of ESRD ($4860). We estimated the cost-effectiveness of aliskiren to be $30,500 per quality-adjusted life year gained. In conclusion, adding aliskiren to losartan and optimal therapy in patients with type 2 diabetes, hypertension, and albuminuria may be cost-effective from a US health care system perspective.
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Project description:BackgroundIn LABBPS (Los Angeles Barbershop Blood Pressure Study), pharmacist-led hypertension care in Los Angeles County Black-owned barbershops significantly improved blood pressure control in non-Hispanic Black men with uncontrolled hypertension at baseline. In this analysis, 10-year health outcomes and health care costs of 1 year of the LABBPS intervention versus control are projected.MethodsA discrete event simulation of hypertension care processes projected blood pressure, medication-related adverse events, fatal and nonfatal cardiovascular disease events, and noncardiovascular disease death in LABBPS participants. Program costs, total direct health care costs (2019 US dollars), and quality-adjusted life-years (QALYs) were estimated for the LABBPS intervention and control arms from a health care sector perspective over a 10-year horizon. Future costs and QALYs were discounted 3% annually. High and intermediate cost-effectiveness thresholds were defined as <$50 000 and <$150 000 per QALY gained, respectively.ResultsAt 10 years, the intervention was projected to cost an average of $2356 (95% uncertainty interval, -$264 to $4611) more per participant than the control arm and gain 0.06 (95% uncertainty interval, 0.01-0.10) QALYs. The LABBPS intervention was highly cost-effective, with a mean cost of $42 717 per QALY gained (58% probability of being highly and 96% of being at least intermediately cost-effective). Exclusive use of generic drugs improved the cost-effectiveness to $17 162 per QALY gained. The LABBPS intervention would be only intermediately cost-effective if pharmacists were less likely to intensify antihypertensive medications when systolic blood pressure was ≥150 mm Hg or if pharmacist weekly time driving to barbershops increased.ConclusionsHypertension care delivered by clinical pharmacists in Black barbershops is a highly cost-effective way to improve blood pressure control in Black men.
| S-EPMC8206005 | biostudies-literature
Project description:BackgroundMore than half of all heart disease and stroke are attributable to hypertension, which is associated with approximately 10% of direct medical costs globally. Clinical trial evidence has demonstrated that the benefits of pharmacist intervention, including education, consultation and/or prescribing, can help to reduce blood pressure; a recent Canadian trial found an 18.3 mmHg reduction in systolic blood pressure associated with pharmacist care and prescribing. The objective of this study was to evaluate the economic impact of such an intervention in a Canadian setting.MethodsA Markov cost-effectiveness model was developed to extrapolate potential differences in long-term cardiovascular and renal disease outcomes, using Framingham risk equations and other published risk equations. A range of values for systolic blood pressure reduction was considered (7.6-18.3 mmHg) to reflect the range of potential interventions and available evidence. The model incorporated health outcomes, costs and quality of life to estimate an overall incremental cost-effectiveness ratio. Costs considered included direct medical costs as well as the costs associated with implementing the pharmacist intervention strategy.ResultsFor a systolic blood pressure reduction of 18.3 mmHg, the estimated impact is 0.21 fewer cardiovascular events per person and, discounted at 5% per year, 0.3 additional life-years, 0.4 additional quality-adjusted life-years and $6,364 cost savings over a lifetime. Thus, the intervention is economically dominant, being both more effective and cost-saving relative to usual care.DiscussionAcross a range of one-way and probabilistic sensitivity analyses of key parameters and assumptions, pharmacist intervention remained both effective and cost-saving.ConclusionComprehensive pharmacist care of hypertension, including patient education and prescribing, has the potential to offer both health benefits and cost savings to Canadians and, as such, has important public health implications.
| S-EPMC5415065 | biostudies-literature
Project description:BackgroundThe SingHypertension primary care clinic intervention, which consisted of clinician training in hypertension management, subsidized single-pill combination medications, nurse-delivered motivational conversations and telephone follow-ups, improved blood pressure control and cardiovascular disease (CVD) risk scores relative to usual care among patients with uncontrolled hypertension in Singapore. This study quantified the incremental cost-effectiveness, in terms of incremental cost per unit reduction disability-adjusted life years, of SingHypertension relative to usual care for patients with hypertension from the health system perspective.Methods and resultsWe developed a Markov model to simulate CVD events and associated outcomes for a hypothetical cohort of patients over a 10-year period. Costs were measured in US dollars, and effectiveness was measured in disability-adjusted life years averted. We present base-case results and conducted deterministic and probabilistic sensitivity analyses. Based on a willingness-to-pay threshold of US $55 500 per DALY averted, SingHypertension was cost-effective for patients with hypertension (incremental cost-effectiveness ratio: US $24 765 per disability-adjusted life year averted) relative to usual care. This result held even if risk reduction was assumed to decline linearly to 0 over 10 years but not sooner than 7 years. Incremental cost-effectiveness ratios were most sensitive to the magnitude of the reduction in CVD risk; at least a 0.13% to 0.16% point reduction in 10-year CVD risk is required for cost-effectiveness. Probabilistic sensitivity analysis indicates that SingHypertension has a 78% chance of being cost-effective at the willingness-to-pay threshold.ConclusionsSingHypertension represents good value for the money for reducing CVD incidence, morbidity, and mortality and should be considered for wide-scale implementation in Singapore and possibly other countries.Registration informationREGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02972619.
| S-EPMC11262484 | biostudies-literature
Project description:ImportanceEvolving breast cancer treatments have led to improved outcomes but carry a substantial financial burden. The association of treatment costs with the cost-effectiveness of screening mammography is unknown.ObjectiveTo determine the cost-effectiveness of population-based breast cancer screening in the context of current treatment standards.Design, setting, and participantsIn this economic evaluation, the Canadian Partnership Against Cancer/Statistics Canada OncoSim-Breast microsimulation model was used to estimate the impact of various screening schedules in terms of clinical outcomes and treatment costs. Breast cancer treatment costs were derived from activity-based costing published in 2023 specific to a publicly funded health system in Ontario, Canada. A single birth cohort of individuals assigned female at birth in 1975 was modeled until death or age 99 years (whichever came first).ExposuresFive screening scenarios were modeled: no screening, biennial (ages 50-74 years and 40-74 years), hybrid (biennial ages 40-49 years and annual ages 50-74 years), and annual screening (ages 40-74 years).Main outcomes and measuresIncremental cost-effectiveness ratios for deaths averted, life-years (LYs) gained, and incremental cost-utility ratios for quality-adjusted life-years (QALYs) gained were determined for screening scenarios. Sensitivity analyses were conducted by varying screening participation rates and reducing recall rates to 5% and the estimated mortality benefits of screening.ResultsEarlier initiation of breast cancer screening at age 40 years (vs age 50 years) was associated with improved clinical outcomes (deaths averted, LYs saved, and QALYs gained) and reduced health care spending on breast cancer treatment. From a health system perspective, incremental cost-effectiveness ratios for biennial screening at ages 40 to 74 years compared with biennial screening at ages 50 to 74 years were cost saving, with CAD$49 759 saved per death averted, $1558 per LY saved, and $2007 saved per QALY gained. Annual screening at ages 40 to 74 years was cost-effective while achieving the best breast cancer outcomes, with costs of $25 501 per death averted, $1100 per LY saved, and $1447 per QALY gained compared with the current Canadian standard of biennial screening at ages 50 to 74 years.Conclusions and relevanceIn this economic analysis, although screening costs increased according to the number of lifetime screens, they were completely or largely offset by reduced breast cancer therapy costs. Digital mammography was a highly cost-effective tool to reduce breast cancer mortality. These results have important policy implications for all single-payer health systems and call for greater investment in screening programs.
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