Prescription-based cost analysis of medicines for cardiovascular risk factors at Indian Council of Medical Research-Rational Use of Medicine Centre Hospitals of India.

OBJECTIVES: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs. MATERIALS AND METHODS: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range). RESULTS: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001). CONCLUSION: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines.

Utilisation patterns and costs of lipid-lowering drugs in Switzerland 2013-2019.

OBJECTIVE: To analyse utilisation patterns of lipid-lowering drugs and the related costs in Switzerland between the years 2013 and 2019. METHODS: We conducted a retrospective descriptive study using administrative claims data of persons aged ≥18 years enrolled with the health insurance company Helsana. To enable statements at the Swiss population level, results were extrapolated according to age, sex and canton of residence. RESULTS: The overall prevalence of patients taking lipid-lowering drugs rose from 8.9% (n = 736,174) in 2013 to 11.6% (n = 841,682) in 2019, but varied markedly across regions, with highest values in Ticino and lowest values in Zurich. More than every third individual aged ≥65 years was treated with a lipid-lowering drug in 2019. Statins were by far the most commonly used drugs (>90% of prescriptions), followed by ezetimibe, fibrates and PCSK9 inhibitors. We observed a trend towards the prescription of more potent statins (atorvastatin, rosuvastatin) in recent years. Total costs of lipid-lowering drugs increased from CHF 222 million in 2013 to CHF 230 million in 2019 (+3.5%), whereas annual per capita costs decreased from CHF 302 in 2013 to CHF 273 in 2019 (-9.4%). CONCLUSION: The increasing use of lipid-lowering drugs reflects current therapeutic guidelines, but results in high costs for the healthcare system.

The Potential Benefits and Costs of an Intensified Approach to Low Density Lipoprotein Cholesterol Lowering in People with Abdominal Aortic Aneurysm.

OBJECTIVE: The aims of this study were to assess the incidence of major vascular events (MVE) and peripheral vascular events (PVE) in people with a small asymptomatic abdominal aortic aneurysm (AAA) and model the theoretical benefits and costs of an intensified low density lipoprotein cholesterol (LDL-C) lowering programme. METHODS: A total of 583 participants with AAAs measuring 30 - 54 mm were included in this study. The control of LDL-C and prescription of lipid lowering drugs were assessed by dividing participants into approximately equal tertiles depending on their year of recruitment into the study. The occurrence of MVE (myocardial infarction, stroke, cardiovascular death, and coronary or non-coronary revascularisation) and PVE (non-coronary revascularisation, AAA repair, and major amputation) were recorded prospectively, and the incidence of these events was calculated using Kaplan-Meier analysis. The relative risk reduction reported for these events in a previous randomised control trial (RCT) was then applied to these figures to model the absolute risk reduction and numbers needed to treat (NTT) that could theoretically be achieved with a mean LDL-C lowering of 1 mmol/L. The maximum allowable expense for a cost effective intensive LDL-C lowering programme was estimated using a cost utility analysis. RESULTS: At entry, only 28.5% of participants had an LDL-C of < 1.8 mmol/L and only 18.5% were prescribed a high potency statin (atorvastatin 80 mg or rosuvastatin 40 mg). The five year incidences of MVE and PVE were 38.1% and 44.7%, respectively. It was estimated that if the mean LDL-C of the cohort had been reduced by 1 mmol/L, this could have reduced the absolute risk of MVE and PVE by 6.5% (95% CI 4.4 - 8.7; NNT 15) and 5.3% (95% CI 1.4 - 7.5; NNT 19), respectively. It was estimated that the maximum allowable expense for a cost effective LDL-C lowering programme would be between $1 239 AUD (€768) and $1 582 AUD (€981) per person per annum over a five year period. CONCLUSION: People with a small asymptomatic AAA are at high risk of MVE and PVE. This study provides evidence of the possible benefits and allowable expense for a cost effective intensive LDL-C lowering programme in this population.

Bempedoic acid for high-risk patients with CVD as adjunct lipid-lowering therapy: A cost-effectiveness analysis.

BACKGROUND: Bempedoic acid is a novel adenosine triphosphate citrate lyase inhibitor shown to reduce low density lipoprotein cholesterol when used as an adjunct lipid-lowering therapy in patients with high cardiovascular disease (CVD) risk. OBJECTIVE: Our analysis aimed to determine the price at which bempedoic acid would be cost-effective from the Australian health care perspective. METHODS: A Markov model was designed using data from the Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Harmony trial, to model the clinical outcomes and costs of 1000 patients treated with bempedoic acid over a lifetime horizon. Relevant health states were "Alive with CVD," "Alive with recurrent CVD," and "Dead." With annual cycles, patients were at risk of a nonfatal myocardial infarction, coronary revascularization, and death from CVD or non-CVD causes. Costs and utilities were obtained from published sources. Outcomes of interest were the incremental cost-effectiveness ratios in terms of cost per quality-adjusted life year (QALY) gained and cost per year of life saved. Outcomes were discounted at 5% per annum. RESULTS: Among 1000 individuals, bempedoic acid in addition to statin therapy was estimated to save 122 (discounted) years of life and 103 (discounted) QALYs compared with statin therapy alone. At an acquisition cost of AU$584.40 per year (USD$397.01), bempedoic acid would be considered cost-effective within the Australian setting, with an incremental cost-effectiveness ratio of AU$49,890 per QALY gained (USD$33,893) and AU$42,433 per year of life saved (USD$28,827). CONCLUSIONS: Bempedoic acid may be cost-effective within the Australian health care setting at an annual acquisition price less than $600.

Changes in nationwide Medicare and Medicaid expenditures on lipid-lowering therapies after proprotein convertase/subtilisin type 9 inhibitor availability.

BACKGROUND: Several advances in lipid-lowering pharmacotherapy and changes in generic formulation availability occurred between 2013 and 2017. OBJECTIVE: We sought to examine nationwide trends in Medicare Part D and Medicaid expenditures on lipid-lowering therapies from 2013 to 2017. METHODS: We aggregated 662.2 million Medicare Part D and Medicaid prescription claims with associated expense data for 2013 to 2017 from the Medicare and Medicaid Drug Spending Dashboards for nine therapeutic classes of lipid-lowering therapies. RESULTS: Total Medicare Part D expenditures on lipid-lowering therapies was $7.01 billion in 2013 and $5.07 billion in 2017. Total Medicaid lipid-lowering therapy expenditures decreased from $440.9 million in 2013 to $398.7 million in 2017. Annual Medicare expenditures on Crestor were $2.2 billion in 2013 and $0.31 billion in 2017. Annual Medicaid Crestor expenditures decreased from $92.4 million in 2013 to $30.1 million in 2017. From 2013 to 2016, Medicare expenditures on Zetia decreased from $0.89 billion to $0.70 billion, whereas Medicaid Zetia expenditures decreased from $38.6 million in 2013 to $25.4 million in 2017. In 2017, PCSK9 inhibitors accounted for $317.3 million and $14.2 million in Medicare and Medicaid expenditures, respectively. CONCLUSIONS: Overall Medicare and Medicaid expenditures on lipid-lowering therapies decreased by $2.5 billion from 2013 to 2017.

Implications of cost-effectiveness analyses of lipid-lowering therapies: From the policy-maker's desk to the patient's bedside.

In our increasingly cost-conscious health system, patients, clinicians, hospitals, and payers all agree about the urgent need to rein in runaway healthcare costs. High pharmaceutical costs make drugs unaffordable to many patients who may benefit from them, including some insured patients who face prohibitive out-of-pocket costs. Health systems and payers can use the systematic framework of cost-effectiveness analysis and estimated budgetary impact to prioritize the adoption of new therapies and technologies. In this review article, we discuss basic principles of cost-effectiveness research for practicing clinicians, the concept of cost-effectiveness versus affordability, other considerations relevant to resource allocation, and limitations of cost-effectiveness research. We use the example of lipid lowering therapies to discuss application of cost-effectiveness research in informing health care policy, its use for health care systems and in the development of clinical practice guidelines, and its implications for clinicians and patients. As clinicians and patients become more cognizant of the cost-implications of new therapies, professional societies can help improve the quality of decision-making by incorporating unbiased value statements into their expert guidelines.

Assessment and Management of Patients with Hyperlipidemia Referred for Initiation of PCSK9 Inhibitor Therapy: A Lipid Clinic Experience.

PURPOSE: Previous studies have reported that monoclonal antibodies against proprotein convertase subtilisin/kexin type 9 (PCSK9) in clinical practice have been underutilized due to several barriers, including high cost, stringent insurance authorization, patient cost-sharing and insufficient documentation of a patient's medical history. The purpose of our study was to determine if prescribing PCSK9 inhibitors only to patients meeting the established indications would significantly improve the approval rate and utilization. METHODS: We conducted a review and analysis of the medical records of patients referred by their physician to a hospital-based lipid clinic over a 20-month period specifically for initiation of a PCSK9 inhibitor. RESULTS: There were 180 patients referred to our lipid clinic by their cardiologist or internist specifically for initiation of a PCSK9 inhibitor. Only 76 (42%) of these patients met the approved indications for this therapy and were provided PCSK9 inhibitor prescriptions. All received insurance approval within 3 weeks. Three did not initiate therapy due to excessive out-of-pocket cost, three discontinued therapy after two injections because of intolerable side effects (rhinorrhea), with the remaining 70 patients starting and continuing therapy, long-term. The remaining 104 patients were not given a PCSK9 inhibitor prescription and were treated with oral lipid-lowering medications. CONCLUSION: Our findings suggest that those physicians who referred patients to our lipid clinic specifically for initiation of a PCSK9 inhibitor were not aware of the established indications. By prescribing a PCSK9 inhibitor to only those patients meeting the established indications, 100% obtained approval. Therefore, to achieve higher insurance approval rates and utilization, it is essential that physicians understand the indications for PCSK9 inhibitor therapy and prescribe them only to patients meeting the established indications.

Access to and price trends of antidiabetic, antihypertensive, and antilipidemic drugs in outpatient settings of the Universal Coverage Scheme in Thailand.

Under the Universal Coverage Scheme (UCS) with payment per capita for outpatient (OP) services, hospitals' financial risks will rise if access to essential drugs increases. This study examined trends in access to and price of essential drugs for noncommunicable diseases (NCDs) and an overall purchasing price index (PPI) for an OP drug basket from public hospitals. To examine drug access, OP prescription data from 2010-2012 were obtained from the UCS. Access to thirteen drugs for diabetes, hypertension, and dyslipidemia was examined for trend using a time-series analysis. To calculate the PPI, drugs in the same dataset in 2010 that each contributed at least 0.2% of the total OP drug expenditure (N = 118 items) were selected together with drugs expected for near future growth (N = 48 items). The PPI was constructed from purchasing prices in 16 hospitals using a standard method developed by the International Labour Organization. Based on 166 drug items accounting for 75% of OP drug expenditures, the overall PPI continually declined by 6.8% from 2010 to 2012. Access to the 13 selected NCD drugs, accounting for 22% of the total OP drug expenditure increased from 22 to 30 per 1,000 population for antidiabetics, 27 to 47 for antihypertensive agents, and 32 to 53 for antilipidemics from 2010-2012. Growth in the study drug recipients was relatively higher than that in the population and diagnosed patients. Due to generic market competition, metformin, glipizide, amlodipine, losartan, simvastatin, atorvastatin, and fenofibrate prices decreased by 6-22%. Antiretrovirals and risperidone prices decreased by more than 10% due to price negotiation by the UCS. Access to essential drugs for diabetes, hypertension and dyslipidemia has increased. A decline in the PPI could contain essential drug expenditure when the demand for the drugs increased. Generic market competition and price negotiation by the UCS led to price reduction.

Coste-efectividad e impacto presupuestario del tratamiento con evolocumab frente a estatinas y ezetimiba para la hipercolesterolemia en España / Cost-effectiveness and budget impact of treatment with evolocumab versus statins and ezetimibe for hypercholesterolemia in Spain

Introducción y objetivos: Analizar la razón de coste-efectividad y el impacto presupuestario del tratamiento con evolocumab (inhibidor de la PCSK9) para pacientes en prevención secundaria en el Sistema Nacional de Salud español. Métodos: Se realizaron, desde la perspectiva del sistema sanitario público, análisis de impacto presupuestario, modelos de árbol de decisión y Markov, basándose en el único ensayo clínico con datos de morbimortalidad (FOURIER). Las alternativas comparadas fueron evolocumab frente a estatinas y un 5% ezetimiba conjuntamente. La medida de eficacia utilizada fue el número de eventos cardiovasculares evitados. Se realizaron análisis de sensibilidad univariable y probabilístico. Resultados: El coste sanitario promedio de los pacientes tratados a 26 meses con evolocumab fue de 11.134,78 euros y de 393,83 euros con el estándar (estatinas + ezetimiba). El coste-efectividad incremental superó los 600.000 euros por evento cardiovascular evitado en las 2 variables (primera: muerte cardiovascular, infarto de miocardio, accidente cerebrovascular, hospitalización por angina inestable o revascularización coronaria; segunda: incluye los 3 primeros eventos). A 10 años, el modelo de Markov mostró un coste promedio de 471.417,37 frente a 13.948,45 euros con evolocumab y estándar respectivamente. El tratamiento con evolocumab en hipercolesterolemia familiar supondría anualmente entre 3 y 6,1 millones de euros, lo que supone una diferencia de 2,5-5,1 millones de euros con el tratamiento estándar (2017). Para el año 2021, en hipercolesterolemia no familiar (prevención secundaria), la diferencia osciló entre 204,3 y 1.364,7 millones de euros. Conclusiones: El evolocumab se asocia con menor frecuencia de eventos cardiovasculares, pero resulta ineficiente para los pacientes susceptibles de recibirlo en el Sistema Nacional de Salud

Introduction and objectives: To analyze the cost-effectiveness ratio and budget impact of treatment with evolocumab (PCSK9 inhibitor) for patients in secondary prevention in the Spanish National Health System. Methods: A budget impact analysis, decision tree and Markov models were designed under the public health system perspective, based on the only study with morbidity and mortality data (FOURIER). The alternatives compared were evolocumab vs statins, and dual therapy with ezetimibe in 5% of the population. The measure of effectiveness used was the number of cardiovascular events avoided. Univariate and probabilistic sensitivity analyses were performed. Results: The average annual cost of patients receiving evolocumab was 11 134.78€ and 393.83€ for standard treatment (statins plus ezetimibe). The incremental cost-effectiveness ratio was > 600 000 € per avoided cardiovascular event for both assessed outcomes (first: cardiovascular death, myocardial infarction, stroke, and hospitalization due to unstable angina or coronary revascularization; second: includes the first 3 events). To perform the 10-year Markov model, the average cost of standard treatment was 13 948.45€ vs 471 417.37€ with evolocumab. Treatment with evolocumab for patients with familial hypercholesterolemia would cost between 3 and 6.1 million euros, assuming a difference of 2.5 and 5.1 million euros with the standard treatment (2017). This difference would be between 204.3 and 1364.7 million euros (2021) for those with nonfamiliar hypercholesterolemia (secondary prevention). Conclusions: Treatment with evolocumab is associated with a lower frequency of cardiovascular events, but is inefficient for patients suitable to receive this drug in the Spanish National Health System

Coste-efectividad del evolocumab / Cost-effectiveness of evolocumab

No disponible

Coste-efectividad del evolocumab. Respuesta / Cost-effectiveness of evolocumab. Response

No disponible

Hyperlipidemia: Management with Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors.

Coronary artery disease is the leading cause of death in United States. Hyperlipidemia is an independent and potentially reversible risk factor for coronary artery disease. The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, collectively known as statins, have been the mainstay of pharmacologic therapy. Their availability, ease of administration, low cost, and strong evidence behind safety and efficacy makes them one of the most widely prescribed lipid-lowering agents. However, some patients may be intolerant to statins, and few others suffer from very high serum levels of cholesterol in which statin therapy alone or in combination with other cholesterol-lowering agents is insufficient in reducing serum lipid levels to achieve desired levels. In 2015, the Food and Drug Administration approved a new family of lipid-lowering agents, collectively known as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.PCSK9 inhibitors are biologically active molecules that decrease serum low-density lipoprotein cholesterol compared with statin therapy alone. They serve as an alternative to statins for patients who are intolerant to statin or as supplemental therapy in those patients for whom lower levels in serum low-density lipoprotein cholesterol are not achieved by statins alone. This article discusses PCSK9 inhibitors, their mechanism of action, indications, efficacy, safety, costs and limitations.

The cost-effectiveness of PCSK9 inhibitors - The Australian healthcare perspective.

BACKGROUND: For patients in whom statins are not tolerated or effective as monotherapy, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a new class of lipid lowering therapies that may reduce low-density lipoprotein cholesterol (LDL-C) levels by up to 50% and lower cardiovascular events. While an important treatment option, the cost-effectiveness of PCSK9i in Australia remains unknown. This study aimed to determine the cost-effectiveness of PCSK9i compared to placebo in the prevention of atherosclerotic cardiovascular disease (CVD). METHODS AND RESULTS: A Markov cohort state-transition model was developed in Microsoft Excel. A hypothetical sample of 1000 individuals based on subjects in the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial populated the model. With each five-year cycle, model subjects could have non-fatal CVD events (myocardial infarction and/or stroke), or die from CVD or other causes. Follow-up was simulated for 25 years. CVD risk reduction, cost and utility data were gathered from published sources. At current acquisition prices (AU$8174 per person per year), the incremental cost effectiveness ratio (ICER) was AU$308,558 per quality-adjusted life year (QALY) saved. Acquisition prices would need to be reduced to approximately AU$1500 per person per annum for PCSK9i to reach the arbitrary cost-effectiveness threshold of AU$50,000 per QALY saved. CONCLUSION(S): PCSK9i are an effective alternative for those with existing CVD or at high risk of CVD in whom statin therapy alone is ineffective, but are not cost-effective to the Australian healthcare system based on current prices.

Polypill: an affordable strategy for cardiovascular disease prevention in low-medium-income countries.

The simplification of fixed dose medications by using a single 'polypill' is an attractive strategy to improve adherence to medications which has shown benefit to cardiovascular risk factor control and cardiovascular disease prevention or delay in the progression of these diseases. We review the evidence obtained from a series of clinical trials demonstrating an improvement in adherence to the polypill compared to the use of each compound separately, and found similar or better control of the classical cardiovascular risk factors and a similar safety profile. These results suggest that the use of the polypill could have a beneficial impact in cardiovascular morbidity and mortality. Furthermore, the polypill has the potential to improve cost effectiveness and is simple to use. However, before recommending the implementation of the polypill in programs aimed at primary and secondary cardiovascular prevention, we are awaiting the results of several current clinical trials aimed at measuring the impact on the frequency of major cardiovascular outcomes, particularly in low-medium-income countries.

Clinical characteristics, patterns of lipid-lowering medication use, and health care resource utilization and costs among patients with atherosclerotic cardiovascular disease.

PURPOSE: The aim of this study was to investigate real-world patient characteristics, medication use, and health care resource utilization (HCRU) and costs among patients with clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, to examine burden of disease and unmet needs, such as potential undertreatment. PATIENTS AND METHODS: This retrospective cohort study utilized a nationally representative managed care database to identify newly diagnosed ASCVD patients between January 1, 2007, and November 30, 2012 (index = first ASCVD diagnosis date) in the USA. Patients had ≥12-month pre-index (baseline) and ≥12-month post-index (follow-up) health plan enrollment and no baseline lipid-lowering medication (LLM). Patient characteristics, LLM utilization patterns, HCRU, and costs were examined for all patients and by subgroups based on LLM use pattern and/or follow-up low-density lipoprotein cholesterol (LDL-C) levels. RESULTS: A total of 128,017 ASCVD patients were identified with a mean (SD) age of 59 (13) years, 43.1% female, and 48.8% with ≥36-month follow-up. Within 12-month follow-up, 10.6% had high-intensity statins and 56.9% had no LLM fills. Baseline mean (SD) all-cause costs were $8,852 ($25,608). At 12-month follow-up, mean (SD) all-cause and ASCVD-related costs were $31,443 ($54,040) and $20,289 ($45,159), respectively. The 36-month analyses showed similar distributions. Multivariable analyses showed that age, gender, region, health insurance type, baseline comorbidities, baseline use of specific medications, baseline lipid profiles, and index ASCVD type were significantly associated with all-cause and ASCVD-related health care costs. CONCLUSION: Patients have nonoptimal treatment for ASCVD and substantial HCRU and costs associated with residual risk. Unmet needs and cost burdens of ASCVD patients merit additional investigation.