Atherosclerotic cardiovascular disease thresholds for statin initiation among people living with HIV in Thailand: A cost-effectiveness analysis.
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ABSTRACT: Background
People living with HIV (PLHIV) have an elevated risk of atherosclerotic cardiovascular disease (ASCVD) compared to their uninfected peers. Expanding statin use may help alleviate this burden. We evaluated the cost-effectiveness of reducing the recommend statin initiation threshold for primary ASCVD prevention among PLHIV in Thailand.Methods
Our decision analytic microsimulation model randomly selected (with replacement) individuals from the TREAT Asia HIV Observational Database (data collected between 1/January/2013 and 1/September/2019). Direct medical costs and quality-adjusted life-years were assigned in annual cycles over a lifetime horizon and discounted at 3% per year. We assumed the Thai healthcare sector perspective. The study population included PLHIV aged 35-75 years, without ASCVD, and receiving antiretroviral therapy. Statin initiation thresholds evaluated were 10-year ASCVD risk ≥10% (control), ≥7.5% and ≥5%.Results
A statin initiation threshold of ASCVD risk ≥7.5% resulted in accumulation of 0.015 additional quality-adjusted life-years compared with an ASCVD risk threshold ≥10%, at an extra cost of 3,539 Baht ($US113), giving an incremental cost-effectiveness ratio of 239,000 Baht ($US7,670)/quality-adjusted life-year gained. The incremental cost-effectiveness ratio comparing ASCVD risk ≥5% to ≥7.5% was 349,000 Baht ($US11,200)/quality-adjusted life-year gained. At a willingness-to-pay threshold of 160,000 Baht ($US5,135)/quality-adjusted life-year gained, a 30.8% reduction in the average cost of low/moderate statin therapy led to the ASCVD risk threshold ≥7.5% becoming cost-effective compared with current practice.Conclusions
Reducing the recommended 10-year ASCVD risk threshold for statin initiation among PLHIV in Thailand would not currently be cost-effective. However, a lower threshold could become cost-effective with greater preference for cheaper statins.
SUBMITTER: Boettiger DC
PROVIDER: S-EPMC8428548 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionPeople living with HIV (PLHIV) have an elevated risk of atherosclerotic cardiovascular disease (CVD) compared to their HIV-negative peers. Expanding statin use may help alleviate this burden. However, the choice of statin in the context of antiretroviral therapy is challenging. Pravastatin and pitavastatin improve cholesterol levels in PLHIV without interacting substantially with antiretroviral therapy. They are also more expensive than most statins. We evaluated the cost-effectiveness of pravastatin and pitavastatin for the primary prevention of CVD among PLHIV in Thailand who are not currently using lipid-lowering therapy.MethodsWe developed a discrete-state microsimulation model that randomly selected (with replacement) individuals from the TREAT Asia HIV Observational Database cohort who were aged 40 to 75 years, receiving antiretroviral therapy in Thailand, and not using lipid-lowering therapy. The model simulated each individual's probability of experiencing CVD. We evaluated: (1) treating no one with statins; (2) treating everyone with pravastatin 20mg/day (drug cost 7568 Thai Baht ($US243)/year) and (3) treating everyone with pitavastatin 2 mg/day (drug cost 8182 Baht ($US263)/year). Direct medical costs and quality-adjusted life-years (QALYs) were assigned in annual cycles over a 20-year time horizon and discounted at 3% per year. We assumed the Thai healthcare sector perspective.ResultsPravastatin was estimated to be less effective and less cost-effective than pitavastatin and was therefore dominated (extended) by pitavastatin. Patients receiving pitavastatin accumulated 0.042 additional QALYs compared with those not using a statin, at an extra cost of 96,442 Baht ($US3095), giving an incremental cost-effectiveness ratio of 2,300,000 Baht ($US73,812)/QALY gained. These findings were sensitive to statin costs and statin efficacy, pill burden, and targeting of PLHIV based on CVD risk. At a willingness-to-pay threshold of 160,000 Baht ($US5135)/QALY gained, we estimated that pravastatin would become cost-effective at an annual cost of 415 Baht ($US13.30)/year and pitavastatin would become cost-effective at an annual cost of 600 Baht ($US19.30)/year.ConclusionsNeither pravastatin nor pitavastatin were projected to be cost-effective for the primary prevention of CVD among PLHIV in Thailand who are not currently using lipid-lowering therapy. We do not recommend expanding current use of these drugs among PLHIV in Thailand without substantial price reduction.
| S-EPMC7305414 | biostudies-literature
Project description:The American College of Cardiology and the American Heart Association (ACC/AHA) cholesterol treatment guidelines have wide-scale implications for treating adults without history of atherosclerotic cardiovascular disease (ASCVD) with statins.To estimate the cost-effectiveness of various 10-year ASCVD risk thresholds that could be used in the ACC/AHA cholesterol treatment guidelines.Microsimulation model, including lifetime time horizon, US societal perspective, 3% discount rate for costs, and health outcomes. In the model, hypothetical individuals from a representative US population aged 40 to 75 years received statin treatment, experienced ASCVD events, and died from ASCVD-related or non-ASCVD-related causes based on ASCVD natural history and statin treatment parameters. Data sources for model parameters included National Health and Nutrition Examination Surveys, large clinical trials and meta-analyses for statin benefits and treatment, and other published sources.Estimated ASCVD events prevented and incremental costs per quality-adjusted life-year (QALY) gained.In the base-case scenario, the current ASCVD threshold of 7.5% or higher, which was estimated to be associated with 48% of adults treated with statins, had an incremental cost-effectiveness ratio (ICER) of $37,000/QALY compared with a 10% or higher threshold. More lenient ASCVD thresholds of 4.0% or higher (61% of adults treated) and 3.0% or higher (67% of adults treated) had ICERs of $81,000/QALY and $140,000/QALY, respectively. Shifting from a 7.5% or higher ASCVD risk threshold to a 3.0% or higher ASCVD risk threshold was estimated to be associated with an additional 161,560 cardiovascular disease events averted. Cost-effectiveness results were sensitive to changes in the disutility associated with taking a pill daily, statin price, and the risk of statin-induced diabetes. In probabilistic sensitivity analysis, there was a higher than 93% chance that the optimal ASCVD threshold was 5.0% or lower using a cost-effectiveness threshold of $100,000/QALY.In this microsimulation model of US adults aged 45 to 75 years [corrected], the current 10-year ASCVD risk threshold (?7.5% risk threshold) used in the ACC/AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (ICER, $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (?4.0% risk threshold) or $150,000/QALY (?3.0% risk threshold). The optimal ASCVD threshold was sensitive to patient preferences for taking a pill daily, changes to statin price, and the risk of statin-induced diabetes.
| S-EPMC4797634 | biostudies-literature
Project description:BackgroundInclisiran is a novel, cholesterol-lowering therapy, with a long duration of effect, administered every 6 months (subcutaneously by a healthcare professional). In the ORION-10 trial in US patients with atherosclerotic cardiovascular disease (ASCVD) in addition to maximum tolerated statins, with or without ezetimibe, inclisiran demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 51%. This is the first peer-reviewed publication to investigate the price at which inclisiran is cost effective in the US.ObjectiveThe aim of this study was to determine the maximum price at which inclisiran is cost effective in addition to standard of care, in US patients with ASCVD, versus standard of care alone, at different willingness-to-pay thresholds.Design, setting and participantsA lifetime Markov model from the US health system perspective, including 15 health states, was used to evaluate the cost effectiveness of inclisiran. The following states were separated by time from a previous cardiovascular event (0-1 years, 1-2 years, 2+ years ['stable']): initial, unstable angina, myocardial infarction, and stroke. Additional states included revascularization and death (cardiovascular or non-cardiovascular causes). Baseline risk of cardivoascular events were from US database sources or published literature. Reductions in LDL-C from inclisiran were from the ORION-10 trial. LDL-C reduction was used to adjust baseline risk of cardiovascular events, based on established relationships between 1 mmol/L reduction in LDL-C and decreases in cardiovascular events, from the Cholesterol Treatment Trialists studies. The population included adults with a history of ASCVD, and LDL-C ≥ 70 mg/dL, despite maximum tolerated doses of statin therapy.InterventionsInclisiran as an adjunct to standard of care, compared with standard of care alone.Main outcomes and measuresThe threshold price of inclisiran.ResultsInclisiran as an adjunct to standard of care resulted in threshold annual inclisiran prices of $6383, $9973, and $13,563 at willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per quality-adjusted life-year, respectively. Probabilistic sensitivity analysis showed that at a threshold of $100,000 per QALY, inclisiran had a 100% probability of being cost effective, with an annual price below $9000. At the publicly available price of $3250 per dose, inclisiran was found to have an incremental cost-effectiveness ratio just above the $50,000 per QALY threshold, of $51,686.Conclusions and relevanceThis study identified the price at which inclisiran is cost effective for the US health system, at generally accepted willingness-to-pay thresholds.
| S-EPMC9468070 | biostudies-literature
Project description:ImportanceThe proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab has been demonstrated to reduce the composite of myocardial infarction, stroke, or cardiovascular death in patients with established atherosclerotic cardiovascular disease. To our knowledge, long-term cost-effectiveness of this therapy has not been evaluated using clinical trial efficacy data.ObjectiveTo evaluate the cost-effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease when added to standard background therapy.Design, setting, and participantsA Markov cohort state-transition model was used, integrating US population-specific demographics, risk factors, background therapy, and event rates along with trial-based event risk reduction. Costs, including price of drug, utilities, and transitional probabilities, were included from published sources.ExposuresAddition of evolocumab to standard background therapy including statins.Main outcomes and measuresCardiovascular events including myocardial infarction, ischemic stroke and cardiovascular death, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), and net value-based price.ResultsIn the base case, using US clinical practice patients with atherosclerotic cardiovascular disease with low-density lipoprotein cholesterol levels of at least 70 mg/dL (to convert to millimoles per liter, multiply by 0.0259) and an annual events rate of 6.4 per 100 patient-years, evolocumab was associated with increased cost and improved QALY: incremental cost, $105 398; incremental QALY, 0.39, with an ICER of $268 637 per QALY gained ($165 689 with discounted price of $10 311 based on mean rebate of 29% for branded pharmaceuticals). Sensitivity and scenario analyses demonstrated ICERs ranging from $100 193 to $488 642 per QALY, with ICER of $413 579 per QALY for trial patient characteristics and event rate of 4.2 per 100 patient-years ($270 192 with discounted price of $10 311) and $483 800 if no cardiovascular mortality reduction emerges. Evolocumab treatment exceeded $150 000 per QALY in most scenarios but would meet this threshold at an annual net price of $9669 ($6780 for the trial participants) or with the discounted net price of $10 311 in patients with low-density lipoprotein cholesterol levels of at least 80 mg/dL.Conclusions and relevanceAt its current list price of $14 523, the addition of evolocumab to standard background therapy in patients with atherosclerotic cardiovascular disease exceeds generally accepted cost-effectiveness thresholds. To achieve an ICER of $150 000 per QALY, the annual net price would need to be substantially lower ($9669 for US clinical practice and $6780 for trial participants), or a higher-risk population would need to be treated.
| S-EPMC5710446 | biostudies-literature
Project description:Purpose of reviewTo highlight mechanisms of elevated risk of atherosclerotic cardiovascular disease (ASCVD) among people living with HIV (PLWH), discuss therapeutic strategies, and opportunities for primary prevention.Recent findingsHIV-associated ASCVD risk is likely multifactorial and due to HIV-specific factors and traditional risk factors even in the setting of treated and suppressed HIV disease. Although a growing body of evidence suggests that inflammation and immune activation are key drivers of atherogenesis, therapies designed to lower inflammation including colchicine and low-dose methotrexate have not improved secondary cardiovascular endpoints among PLWH. Statins continue to be the mainstay of management of hyperlipidemia in HIV, but the impact of newer lipid therapies including proprotein convertase subtilisin/kexin type 9 inhibitors on ASCVD risk among PLWH is under investigation. Aside from the factors mentioned above, healthcare disparities are particularly prominent among PLWH and thus likely contribute to increased ASCVD risk.SummaryOur understanding of mechanisms of elevated ASCVD risk in HIV continues to evolve, and the optimal treatment for CVD in HIV aside from targeting traditional risk factors remains unknown. Future studies including novel therapies to lower inflammation, control of risk factors, and implementation science are needed to ascertain optimal ways to treat and prevent ASCVD among PLWH.
| S-EPMC8064238 | biostudies-literature
Project description:BackgroundRisk evaluation of atherosclerotic cardiovascular disease (ASCVD) remains the cornerstone of primary prevention. The cardiovascular risk assessment can guide the decision-making on various preventive measures such as initiating or deferring statin therapy. Thus, our study aimed to assess the physicians' knowledge, attitude, and practices regarding atherosclerotic cardiovascular diseases risk assessment. Also, we evaluated the physician-patient discussion and counseling practices before statin therapy initiation in concordance with recommendations from the latest clinical practice guideline.MethodsA cross-sectional study was conducted between November 2020 and January 2021. A self-administered questionnaire was distributed to 350 physicians (GPs, residents, specialists, and consultants). Two trained pharmacists distributed the questionnaires in 5 major tertiary governmental hospitals and more than ten private hospitals. Also, private clinics were targeted so that we get a representative sample of physicians at different workplaces.ResultsA total of 270 physicians filled the questionnaire out of 350 physicians approached, with 14 being excluded due to high missing data, giving a final response rate of 73%. Participants had suboptimal knowledge and practices with a high positive attitude toward atherosclerotic cardiovascular diseases risk assessment. The knowledge and practices were higher among consultants, participants from the cardiology department, those with experience years of more than nine years, and those who reported following a specific guideline for cholesterol management or using a risk calculator in their practice. Notably, the risk assessment and counseling practices were lower among physicians who reported seeing more patients per day.ConclusionPhysicians had overall low knowledge, suboptimal practices, and a high positive attitude toward cardiovascular risk assessment. Therefore, physicians' training and continuing medical education regarding cholesterol management and primary prevention clinical practice guidelines are recommended. Also, the importance of adherence to clinical practice guidelines and their impact on clinical outcomes should be emphasized.
| S-EPMC9135296 | biostudies-literature
Project description:IntroductionTo evaluate the cost-effectiveness of evolocumab when added to standard of care lipid-lowering treatment (LLT) for patients with atherosclerotic cardiovascular disease (ASCVD) who cannot adequately control their low-density lipoprotein cholesterol (LDL-C) despite optimized LLT in Canada.MethodsAn incremental cost-utility analysis was conducted using a Markov cohort state transition model adapted to the Canadian setting. Analyses were conducted from a public health and societal perspective using a lifetime time horizon for Canada. Scenario analyses were conducted on the basis of recommendations from the 2021 Canadian Cardiovascular Society (CCS) dyslipidemia guidelines.ResultsIn ASCVD patients with prior myocardial infarction (MI) and baseline LDL-C ≥ 1.8 mmol/L, adding evolocumab to optimized statin therapy with or without ezetimibe is associated with an incremental cost per quality-adjusted life year (QALY) gained of $66,453 CAD. Furthermore, for every 100 patients treated with evolocumab for lifetime, adding evolocumab to optimized LLT will prevent approximately 52 cardiovascular (CV) events, of which seven would be fatal. The results are generally robust using univariate and simultaneous variation in model input parameters. Scenario analyses for patient populations as per the CCS guidelines suggest that evolocumab added to optimized LLT may be considered cost-effective, given an incremental cost-effectiveness ratio (ICER) threshold of CAD$100,000 per QALY gained. Limitations associated with this analysis should be interpreted in the context of data and modeling assumptions used.ConclusionOverall, this analysis supports reimbursement of evolocumab by payers in patients with ASCVD who cannot reach LDL-C thresholds despite optimized LLT to reduce unnecessary fatal and non-fatal CV events.
| S-EPMC9239938 | biostudies-literature
Project description:BACKGROUND:Chronic pain is a common, disabling, and costly comorbidity, particularly in people living with HIV (PLWH). This study developed and pilot tested a pain self-management intervention for chronic pain tailored to PLWH called Skills TO Manage Pain (STOMP). OBJECTIVES:Given the additional resources needed to deliver STOMP in HIV clinical settings, an important objective of the pilot study was to assess not only STOMP's preliminary efficacy, but also its cost-effectiveness. RESEARCH DESIGN AND SUBJECTS:The present study draws from a 44-participant, 2-arm randomized pilot trial of the STOMP intervention vs usual care among PLWH and at least moderate chronic pain (Clinicaltrials.gov: NCT02824562). Cost-effectiveness is presented as the incremental cost-effectiveness ratio (ICER). Costs were considered from the clinic perspective over a 1-year time horizon using real costs from the pilot trial. It was conservatively assumed there would be no costs savings. The Standard Gamble (SG) method was used to directly measure utilities. RESULTS:Thirty-six participants met inclusion criteria for the present analyses. Mean age was 52 years; 61% were female and 86% were black. The total cost of STOMP was $483.83 per person. Using the SG method, the change in QALYs was 0.15, corresponding to an ICER of $3,225. CONCLUSIONS:STOMP's cost/QALY is substantially lower than the $50,000 to $100,000/QALY benchmark often used to indicate cost-effectiveness. Although based on a pilot trial and, therefore, preliminary, these findings are promising, and suggest the importance of cost analyses in future STOMP trials.
| S-EPMC6028014 | biostudies-literature
Project description:BackgroundThere is little evidence to date of the potential impact of vegetable gardens on people living with HIV (PLHIV), who often suffer from social and economic losses due to the disease. From 2008 through 2011, Action Contre la Faim France (ACF) implemented a project in Chipinge District, eastern Zimbabwe, providing low-input vegetable gardens (LIGs) to households of PLHIV. Program partners included Médecins du Monde, which provided medical support, and Zimbabwe's Agricultural Extension Service, which supported vegetable cultivation. A survey conducted at the end of the program found LIG participants to have higher Food Consumption Scores (FCS) and Household Dietary Diversity Scores (HDDS) relative to comparator households of PLHIV receiving other support programs. This study assessed the incremental cost-effectiveness of LIGs to improve FCS and HDDS of PLHIV compared to other support programs.MethodsThis analysis used an activity-based cost model, and combined ACF accounting data with estimates of partner and beneficiary costs derived using an ingredients approach to build an estimate of total program resource use. A societal perspective was adopted to encompass costs to beneficiary households, including their opportunity costs and an estimate of their income earned from vegetable sales. Qualitative methods were used to assess program benefits to beneficiary households. Effectiveness data was taken from a previously-conducted survey.ResultsProviding LIGs to PLHIV cost an additional 8,299 EUR per household with adequate FCS and 12,456 EUR per household with HDDS in the upper tertile, relative to comparator households of PLHIV receiving other support programs. Beneficiaries cited multiple tangible and intangible benefits from LIGs, and over 80% of gardens observed were still functioning more than one year after the program had finished.ConclusionsCost outcomes were 20-30 times Zimbabwe's per capita GDP, and unlikely to be affordable within government services. This analysis concludes that LIGs are not cost-effective or affordable relative to other interventions for improving health and nutrition status of PLHIV. Nonetheless, given the myriad benefits acquired by participant households, such programs hold important potential to improve quality of life and reduce stigma against PLHIV.
| S-EPMC4022439 | biostudies-literature
Project description:BackgroundWith advances in antiretroviral therapy, most deaths in people with HIV are now attributable to noncommunicable illnesses, especially cardiovascular disease. We determine the association between HIV and cardiovascular disease, and estimate the national, regional, and global burden of cardiovascular disease attributable to HIV.MethodsWe conducted a systematic review across 5 databases from inception to August 2016 for longitudinal studies of cardiovascular disease in HIV infection. A random-effects meta-analysis across 80 studies was used to derive the pooled rate and risk of cardiovascular disease in people living with HIV. We then estimated the temporal changes in the population-attributable fraction and disability-adjusted life-years (DALYs) from HIV-associated cardiovascular disease from 1990 to 2015 at a regional and global level. National cardiovascular DALYs associated with HIV for 2015 were derived for 154 of the 193 United Nations member states. The main outcome measure was the pooled estimate of the rate and risk of cardiovascular disease in people living with HIV and the national, regional, and global estimates of DALYs from cardiovascular disease associated with HIV.ResultsIn 793 635 people living with HIV and a total follow-up of 3.5 million person-years, the crude rate of cardiovascular disease was 61.8 (95% CI, 45.8-83.4) per 10 000 person-years. In comparison with individuals without HIV, the risk ratio for cardiovascular disease was 2.16 (95% CI, 1.68-2.77). Over the past 26 years, the global population-attributable fraction from cardiovascular disease attributable to HIV increased from 0.36% (95% CI, 0.21%-0.56%) to 0.92% (95% CI, 0.55%-1.41%), and DALYs increased from 0.74 (95% CI, 0.44-1.16) to 2.57 (95% CI, 1.53-3.92) million. There was marked regional variation with most DALYs lost in sub-Saharan Africa (0.87 million, 95% CI, 0.43-1.70) and the Asia Pacific (0.39 million, 95% CI, 0.23-0.62) regions. The highest population-attributable fraction and burden were observed in Swaziland, Botswana, and Lesotho.ConclusionsPeople living with HIV are twice as likely to develop cardiovascular disease. The global burden of HIV-associated cardiovascular disease has tripled over the past 2 decades and is now responsible for 2.6 million DALYs per annum with the greatest impact in sub-Saharan Africa and the Asia Pacific regions.Clinical trial registrationURL: https://www.crd.york.ac.uk/prospero . Unique identifier: CRD42016048257.
| S-EPMC6221183 | biostudies-literature