RESUMO
Background: The recent inclusion of polypills-fixed-dose combinations of antihypertensive medicines and a statin with or without aspirin-in the World Health Organization's Essential Medicines List (EML) reiterates the potential of this approach to improve global treatment coverage for cardiovascular diseases (CVDs). Although there exists extensive evidence on the effectiveness, safety and acceptability of polypills, there has been no research to date assessing the real-world availability and affordability of polypills globally. Methods: We conducted a cross-sectional survey, based on the WHO/Health Action International methodology, in 13 countries around the world. In the surveyed countries, we first ascertained whether any polypill was authorised for marketing and/or included in EMLs and clinical guidelines. In each country, we collected retail and price data for polypills from at least one public-sector facility and three private pharmacies using convenience sampling. Polypills were considered unaffordable if the lowest-paid worker spent more than a day's wage to purchase a monthly supply. Results: Polypills were approved for marketing in four of the 13 surveyed countries: Spain, India, Mauritius and Argentina. None of these countries included polypills in national guidelines, formularies, or EMLs. In the four countries, no surveyed public pharmacies stocked polypills. In the private sector, we identified seven unique polypill combinations, marketed by eight different companies. Private sector availability was 100% in Argentina and Spain. Most combinations (n = 5) identified were in India. Combinations found in India and Spain were affordable in the local context. A lowest-paid government worker would spend between 0.2 (India) and 2.8 (Mauritius) days' wages to pay the price for one month's supply of the polypills. Polypills were likely to be affordable if they were manufactured in the same country. Conclusion: Low availability and affordability of polypills in the public sector suggest that implementation remains poor globally. Context-specific multi-disciplinary health system research is required to understand factors affecting polypill implementation and to design and evaluate appropriate implementation strategies.
Assuntos
Doenças Cardiovasculares , Humanos , Estudos Transversais , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/economia , Combinação de Medicamentos , Índia/epidemiologia , Anti-Hipertensivos/economia , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/uso terapêutico , Espanha/epidemiologia , Acessibilidade aos Serviços de Saúde , Aspirina/administração & dosagem , Aspirina/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Saúde Global , Argentina/epidemiologiaRESUMO
BACKGROUND: Puerto Ricans are the Hispanic subgroup with the highest adjusted prevalence of statin-eligible patients. However, no study has described statin utilization and adherence among subjects living on the island of Puerto Rico. OBJECTIVES: To (a) estimate the prevalence of beneficiaries with diabetes aged between 40 and 75 years; (b) estimate the prevalence of statin utilization among beneficiaries with diabetes; and (c) estimate secondary adherence to statins among beneficiaries with diabetes. METHODS: With pharmacy claims data from a commercial pharmacy benefit manager (PBM) in the Commonwealth of Puerto Rico, this study used a retrospective longitudinal design to analyze all pharmacy claims generated by 115,674 beneficiaries aged between 40 and 75 years with continuous enrollment during 2018. Beneficiaries with diabetes were defined by having ≥ 2 pharmacy claims for antidiabetic agents during 2018. Statin utilization was defined by having ≥ 1 pharmacy claim for statins among beneficiaries with diabetes. The proportion of days covered (PDC) was used to measure secondary adherence to statins. Parametric and nonparametric statistics were used to describe statin utilization and adherence. RESULTS: The prevalence of beneficiaries with diabetes was 7.8%. Of the 8,975 beneficiaries with diabetes, 5,129 (57.1%) received ≥ 1 prescription for a statin. Older males with diabetes were more likely to receive prescriptions for statins. The median PDC for the 4,553 beneficiaries with ≥ 2 prescriptions for statins was 63.4%; 3,306 (72.6%) beneficiaries filled their statin prescriptions for a 30-day supply only; and 1,252 (27.5%) beneficiaries had a PDC ≥ 80%. The highest PDC (92.3%) was observed for beneficiaries who received statins for a 90-day supply only. CONCLUSIONS: This is the first study that has measured statin utilization and adherence among patients with diabetes living in Puerto Rico. The utilization and adherence to statins among privately insured beneficiaries with diabetes in Puerto Rico are suboptimal. Future studies should focus on understanding the reasons for the suboptimal use of statins and on potential interventions at the beneficiary and provider level to increase statin utilization. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest or financial disclosures to disclose related to this study.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Adesão à Medicação/estatística & dados numéricos , Adulto , Idoso , Feminino , Humanos , Seguro Saúde , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Porto Rico , Estudos RetrospectivosRESUMO
INTRODUCTION: In Argentina, the national guidelines for lipid control emphasize the use of relatively inexpensive low- or moderate-potency statins by patients at high risk (>20 %) of a cardiovascular event. The objective of this study was to compare the impact and costs of the current national CVD prevention guidelines with regard to morbidity and mortality in Argentina with the impact and costs of three strategies that incorporate high-potency statins. METHODS: We used the CVD Policy Model-Argentina to model the proposed interventions. This model is a national-scale, state-transition (Markov) computer simulation model of the CVD incidence, prevalence, mortality, and costs in adults 35-84 years of age. We modeled three scenarios: scenario 1 lowers the risk threshold for treatment to >10 % according the Framingham Risk Score (FRS); scenario 2 intensifies statin potency under current treatment thresholds; and scenario 3 combines both scenarios by lowering the treatment threshold to ≥10 % FRS and intensifying statin potency. RESULTS: Scenario 1 would translate into 1400 fewer MIs and 500 fewer CHD deaths every year, a 3 % and 2 % reduction, respectively. Scenario 2 would lead to 2000 fewer MIs and 1000 fewer CHD deaths every year. Scenario 3 would result in the greatest reduction in MIs and CHD deaths, with 3400 fewer MIs and 1400 fewer CHD deaths every year, which translates to a 7 % and 6 % reduction, respectively. All scenarios were cost-effective if the cost of a high-potency statin pill was under US$0.25. CONCLUSION: Incorporating those individuals with greater than 10 % cardiovascular risk and the use of high-potency statins into Argentina's national lipid guidelines could result in fewer CHD deaths and events at a reasonable cost.
Assuntos
Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/tratamento farmacológico , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Argentina/epidemiologia , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Análise Custo-Benefício/métodos , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto/normas , Prevenção Primária/economia , Prevenção Primária/métodos , Fatores de RiscoAssuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Adulto Jovem , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Aterosclerose/tratamento farmacológico , Estados Unidos , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/prevenção & controle , Risco , Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Tomada de Decisão CompartilhadaRESUMO
BACKGROUND: Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost-sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. METHOD AND RESULTS: Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi-experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference-in-difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low-income subsidies [non-LIS] and had generic-only gap coverage) to those of a control group (LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand-name statin use (-0.24 30-day fills, P<0.001). This was only partially offset by increased monthly generic statin use (+0.06 30-day fill, P<0.001), with an overall drop in any monthly statin use (-0.18 30-day fills, P<0.001). Overall adherence with statins declined (OR 0.81, P<0.001), and statin discontinuation increased (OR 1.62, P<0.001) in the study group as compared to the control group. CONCLUSIONS: Increases in cost-sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia.
Assuntos
Atorvastatina/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/tratamento farmacológico , Rosuvastatina Cálcica/uso terapêutico , Idoso , Atorvastatina/economia , Custo Compartilhado de Seguro , Custos de Medicamentos , Substituição de Medicamentos , Medicamentos Genéricos , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Modelos Logísticos , Masculino , Medicare Part D/economia , Adesão à Medicação , Razão de Chances , Pontuação de Propensão , Rosuvastatina Cálcica/economia , Estados UnidosRESUMO
BACKGROUND: WHO has targeted that medicines to prevent recurrent cardiovascular disease be available in 80% of communities and used by 50% of eligible individuals by 2025. We have previously reported that use of these medicines is very low, but now aim to assess how such low use relates to their lack of availability or poor affordability. METHODS: We analysed information about availability and costs of cardiovascular disease medicines (aspirin, ß blockers, angiotensin-converting enzyme inhibitors, and statins) in pharmacies gathered from 596 communities in 18 countries participating in the Prospective Urban Rural Epidemiology (PURE) study. Medicines were considered available if present at the pharmacy when surveyed, and affordable if their combined cost was less than 20% of household capacity-to-pay. We compared results from high-income, upper middle-income, lower middle-income, and low-income countries. Data from India were presented separately given its large, generic pharmaceutical industry. FINDINGS: Communities were recruited between Jan 1, 2003, and Dec 31, 2013. All four cardiovascular disease medicines were available in 61 (95%) of 64 urban and 27 (90%) of 30 rural communities in high-income countries, 53 (80%) of 66 urban and 43 (73%) of 59 rural communities in upper middle-income countries, 69 (62%) of 111 urban and 42 (37%) of 114 rural communities in lower middle-income countries, eight (25%) of 32 urban and one (3%) of 30 rural communities in low-income countries (excluding India), and 34 (89%) of 38 urban and 42 (81%) of 52 rural communities in India. The four cardiovascular disease medicines were potentially unaffordable for 0·14% of households in high-income countries (14 of 9934 households), 25% of upper middle-income countries (6299 of 24,776), 33% of lower middle-income countries (13,253 of 40,023), 60% of low-income countries (excluding India; 1976 of 3312), and 59% households in India (9939 of 16,874). In low-income and middle-income countries, patients with previous cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04-0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04-0·55). INTERPRETATION: Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025. FUNDING: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.
Assuntos
Fármacos Cardiovasculares/provisão & distribuição , Doenças Cardiovasculares/tratamento farmacológico , Países Desenvolvidos , Países em Desenvolvimento , Custos de Medicamentos , Renda , Farmácias , Antagonistas Adrenérgicos beta/economia , Antagonistas Adrenérgicos beta/provisão & distribuição , Antagonistas Adrenérgicos beta/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/economia , Inibidores da Enzima Conversora de Angiotensina/provisão & distribuição , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Argentina , Aspirina/economia , Aspirina/provisão & distribuição , Aspirina/uso terapêutico , Bangladesh , Brasil , Canadá , Fármacos Cardiovasculares/economia , Fármacos Cardiovasculares/uso terapêutico , Chile , China , Colômbia , Características da Família , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/provisão & distribuição , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Índia , Irã (Geográfico) , Malásia , Paquistão , Inibidores da Agregação Plaquetária/economia , Inibidores da Agregação Plaquetária/provisão & distribuição , Inibidores da Agregação Plaquetária/uso terapêutico , Polônia , População Rural , Prevenção Secundária , África do Sul , Suécia , Turquia , Emirados Árabes Unidos , População Urbana , ZimbábueRESUMO
Background: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. Objective: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. Methods: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40mg), intermediate dose; and above 40% (atorvastatin 20-80mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. Results: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. Conclusions: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil. .
Fundamento: Estatinas tem eficácia comprovada na redução de eventos cardiovasculares, mas o impacto financeiro de seu uso disseminado pode ser substancial. Objetivo: Conduzir análise de custo-efetividade de três esquemas de doses de estatinas na perspectiva do SUS. Métodos: Foi desenvolvido modelo de Markov para avaliar a razão de custo-efetividade incremental (RCEI) de regimes de dose baixa, intermediária e alta, em prevenção secundária e quatro cenários de prevenção primária (risco em 10 anos de 5%, 10%, 15% e 20%). Regimes com redução de LDL abaixo de 30% (ex: sinvastatina 10mg) foram considerados dose baixa; entre 30-40% (atorvastatina 10mg, sinvastatina 40mg), dose intermediária; e acima de 40% (atorvastatina 20-80 mg, rosuvastatina 20 mg), dose alta. Dados de efetividade foram obtidos de revisão sistemática com aproximadamente 136.000 pacientes. Dados nacionais foram usados para estimar utilidades e custos (expressos em dólares internacionais - Int$). Um limiar de disposição a pagar (LDP) igual ao produto interno bruto per capita nacional (aproximadamente Int$11.770) foi utilizado. Resultados: A dose baixa foi dominada por extensão nos cenários de prevenção primária. Nos cinco cenários, a RCEI da dose intermediária ficou abaixo de Int$10.000 por QALY. A RCEI de dose alta ficou acima de Int$27.000 por QALY em todos os cenários. Nas curvas de aceitabilidade de custo-efetividade, dose intermediária teve probabilidade de ser custo-efetiva acima de 50% com RCEIs entre Int$9.000-20.000 por QALY em todos os cenários. Conclusões: Considerando um LDP razoável, uso de estatinas em doses intermediárias é economicamente atrativo, e deveria ser intervenção prioritária na redução de eventos cardiovasculares no Brasil. .
Assuntos
Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Custo-Benefício , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Programas Nacionais de Saúde/economia , Atorvastatina , Brasil , Fluorbenzenos/administração & dosagem , Fluorbenzenos/economia , Ácidos Heptanoicos/administração & dosagem , Ácidos Heptanoicos/economia , Modelos Econômicos , Prevenção Primária/economia , Pirimidinas/administração & dosagem , Pirimidinas/economia , Pirróis/administração & dosagem , Pirróis/economia , Medição de Risco , Fatores de Risco , Rosuvastatina Cálcica , Prevenção Secundária/economia , Sinvastatina/administração & dosagem , Sinvastatina/economia , Sulfonamidas/administração & dosagem , Sulfonamidas/economiaRESUMO
BACKGROUND: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. OBJECTIVE: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. METHODS: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40 mg), intermediate dose; and above 40% (atorvastatin 20-80 mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. RESULTS: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. CONCLUSIONS: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil.
Assuntos
Doenças Cardiovasculares/economia , Doenças Cardiovasculares/prevenção & controle , Análise Custo-Benefício , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Programas Nacionais de Saúde/economia , Idoso , Idoso de 80 Anos ou mais , Atorvastatina , Brasil , Feminino , Fluorbenzenos/administração & dosagem , Fluorbenzenos/economia , Ácidos Heptanoicos/administração & dosagem , Ácidos Heptanoicos/economia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Prevenção Primária/economia , Pirimidinas/administração & dosagem , Pirimidinas/economia , Pirróis/administração & dosagem , Pirróis/economia , Medição de Risco , Fatores de Risco , Rosuvastatina Cálcica , Prevenção Secundária/economia , Sinvastatina/administração & dosagem , Sinvastatina/economia , Sulfonamidas/administração & dosagem , Sulfonamidas/economiaRESUMO
OBJECTIVE: To examine how enrollees' statin compliance responds to expected prices in Medicare Part D, which features a nonlinear price schedule due to a coverage gap. DATA SOURCES/STUDY SETTING: Prescription Drug Event data for a 5 percent random sample of Medicare Advantage Prescription Drug Plan enrollees in 2008 who did not receive a low-income subsidy. STUDY DESIGN: We analyze statin compliance prior to the coverage gap, where the "effective price" is higher than the actual copayment for drugs because consumers anticipate that more spending will make them more likely to reach the gap. We construct each enrollee's effective price as her expected price at the end of the year, which is the weighted average between pre-gap and in-gap copayments with the weight being the predicted probability of hitting the gap. Compliance is defined as at least 80 percent of days covered. PRINCIPAL FINDINGS: Part D enrollees' pre-gap statin compliance decreases by 3.7-4.7 percentage points for a $10 increase in the effective price. CONCLUSION: The presence of a coverage gap decreases statin compliance prior to the gap, suggesting that incorporating expected future prices is important to assess the full impact of cost sharing on drug compliance under nonlinear price schedules.
Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Medicare Part D , Adesão à Medicação/estatística & dados numéricos , Medicamentos sob Prescrição/economia , Idoso , Custos e Análise de Custo , Feminino , Humanos , Masculino , Estados UnidosRESUMO
OBJECTIVE: The objective of this study is to perform an economic evaluation analyzing the treatment with atorvastatin and simvastatin in comparison to placebo treatment, within the Brazilian Public Healthcare System (SUS) scenario, for patients with high risk of cardiovascular disease; analyzing if the additional cost related to statin treatment is justified by the clinical benefits expected, in terms of cardiovascular event and mortality reduction. METHODS: Cardiovascular event risk and mortality risk were used as outcomes. Statin efficacy at LDL-c and cardiovascular events levels lowering data was obtained from a systematic review of literature. A decision analytic model was developed to perform a cost-effectiveness analysis comparing atorvastatin 10mg/day and simvastatin 40 mg/day to placebo treatment in patients with dyslipidemia in Brazil. The target population of this study was a hypothetic cohort of men and women with a mean age of 50 years old and high risk of cardiovascular disease. The model includes only direct costs obtained from Ambulatory and Hospital Information System and Price Database of Brazilian Ministry of Health. The comparative cost-effectiveness analysis itself was done through Excel spreadsheets covering a 5 -years time horizon. RESULTS: The result shows that atorvastatin 10mg/day in comparison to placebo has higher cost with higher effectiveness in the time horizon of 5 years (Incremental Cost Effectiveness Ratio of R$ 433.065,05 per life year gained). In this scenario atorvastatin is not cost effective in comparison to placebo. The simvastatin 40 mg/day appears to be a strategy with lower cost and higher effectiveness in comparison to placebo, in the time horizon analyzed (5 years). In the multivariate probabilistic sensitivity analysis, simvastatin showed 53% of the results in the quadrant with greater effectiveness and lower cost. CONCLUSIONS: This study is an important tool for public decision makers. The study can be used in the decision process of increasing cardiovascular disease treatment access with budgetary sustainability for Ministry of Health. In comparison to placebo, the results show that sinvastatin is a cost saving strategy while atorvastatin is not cost effective.