The rising cost of commonly used emergency department medications (2006-15).

OBJECTIVE: We determine how aggregate costs have changed for commonly used emergency department (ED) medications, and assess drivers of cost increases. METHODS: Using the National Hospital Ambulatory Medical Care Survey (NHAMCS), we identified the top 150 ED medications administered and prescribed at discharge in 2015. We used average wholesale prices (AWP) for each year from 2006 to 15 from the Red Book (Truven Health Analytics Inc.). Average wholesale price per patient (AWPP) was calculated by dividing AWP by drug uses. This was then multiplied by the total drug administrations or prescriptions to estimate the total cost in a given the year. All prices were converted to 2015 dollars. RESULTS: Aggregate costs of drugs administered in the ED increased from $688.7 million in 2006 to $882.4 million in 2015. For discharge prescriptions, aggregate costs increased from $2.031 billion in 2006 to $4.572 billion in 2015. AWPP for drugs administered in the ED in 2015 was 14.5% higher than in 2006 and 24.3% higher at discharge. The largest absolute increase in AWPP for drugs administered was for glucagon, which increased from $111 in 2006 to $235 in 2015. The largest AWPP increase at discharge was for epinephrine auto-injector, which increased from $124 in 2006 and to $481 in 2015. CONCLUSION: Over the course of the study period, the aggregate costs of the most common medications administered in the ED increased by 28% while the costs of medications prescribed at discharge increased 125%.

Long-term impact on healthcare resource utilization of statin treatment, and its cost effectiveness in the primary prevention of cardiovascular disease: a record linkage study.

AIMS: To assess the impact on healthcare resource utilization, costs, and quality of life over 15 years from 5 years of statin use in men without a history of myocardial infarction in the West of Scotland Coronary Prevention Study (WOSCOPS). METHODS: Six thousand five hundred and ninety-five participants aged 45-54 years were randomized to 5 years treatment with pravastatin (40 mg) or placebo. Linkage to routinely collected health records extended follow-up for secondary healthcare resource utilization to 15 years. The following new results are reported: cause-specific first and recurrent cardiovascular hospital admissions including myocardial infarction, heart failure, stroke, coronary revascularization and angiography; non-cardiovascular hospitalization; days in hospital; quality-adjusted life years (QALYs); costs of pravastatin treatment, treatment safety monitoring, and hospital admissions. RESULTS: Five years treatment of 1000 patients with pravastatin (40 mg/day) saved the NHS £710 000 (P < 0.001), including the cost of pravastatin and lipid and safety monitoring, and gained 136 QALYs (P = 0.017) over the 15-year period. Benefits per 1000 subjects, attributable to prevention of cardiovascular events, included 163 fewer admissions and a saving of 1836 days in hospital, with fewer admissions for myocardial infarction, stroke, heart failure and coronary revascularization. There was no excess in non-cardiovascular admissions or costs (or in admissions associated with diabetes or its complications) and no evidence of heterogeneity of effect over sub-groups defined by baseline cardiovascular risk. CONCLUSION: Five years' primary prevention treatment of middle-aged men with a statin significantly reduces healthcare resource utilization, is cost saving, and increases QALYs. Treatment of even younger, lower risk individuals is likely to be cost-effective.

Clinical consequences following regulatory changes in respect to reimbursement of statins cost by the Icelandic Social Insurance Administration.

INTRODUCTION: On 1 March 2009, a new reimbursement system was introduced by the Ministry of Health of Iceland regarding drugs to treat hyperlipidaemia. The Social Insurance Administration was only authorised to reimburse 10 and 20 mg simvastatin unless patients were eligible to receive a medical card from the Social Insurance Administration. The purpose of this study was to evaluate the influence of this reimbursement regulation on the clinical outcome. MATERIALS AND METHODS: Patients that received hyperlipidaemia treatment and were admitted to the cardiac ward were enrolled. The criteria were that the patients had been admitted 1 year prior to the regulation change and were using other statins than simvastatin. RESULTS: Out of 233 eligible patients 170 (73%) reached the treatment goal before the switch. After the switch, only 126 (54%) reached their goal (p<0.05). Total cholesterol was found to be increased after the switch by a mean of 0.48 mmol/l (range 3.90-5.53 mmol/l, p<0.001). Low-density lipoprotein cholesterol increased by a mean of 0.48 mmol/l (range 1.62-3.11, p<0.001). The level of triglycerides did not change significantly. Before the introduction of the new regulations, 73% of subjects were well controlled, but after 1 March 2009, this figure dropped to 46% (37% decrease). CONCLUSIONS: In order to lower costs for subsidising drugs, a switch to simvastatin from other cholesterol-lowering drugs was implemented (by the Ministry of Health of Iceland). The result was a significant and unwanted increase in cholesterol levels among patients with heart disease. The reason seems to be inaccurate prescriptions due to lack of competence among physicians and pharmacists. The use of "one drug fits all" does not comply here.

Acceptable incremental cost effectiveness ratio for use of new drugs, cases in statin therapies.

As it is an urgent issue to contain increasing healthcare expenditures, unlimited reimbursement of pharmaceuticals continues to be controversial. The objective of this study is to identify acceptable incremental cost effectiveness ratios between new and conventional therapies. Clinical study data for five statin therapies were used to indicate treatment effectiveness and incremental costs were indicated by price premiums at price listing. The incremental cost effectiveness ratios to pravastatin were 0 yen/patient with response, 1,475.1 yen/patient with response, 3,033.3 yen/patient with response, and 3,032.4 yen/patient with response. By conducting further analyses in various pharmaceuticals and categorizing acceptable incremental cost effectiveness ratios based on the disease severity and expected level of improvement in disease condition, drug prices that reflect the value of new pharmaceuticals and that are reasonable to be reimbursed can be suggested.

Statins for atherosclerotic cardiovascular disease prevention in people living with HIV in Thailand: a cost-effectiveness analysis.

INTRODUCTION: People 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. METHODS: We 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. RESULTS: Pravastatin 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. CONCLUSIONS: Neither 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.

Cost-effectiveness analysis of rosuvastatin versus atorvastatin, simvastatin, and pravastatin from a Canadian health system perspective.

OBJECTIVE: The primary objective of this study was to assess the cost-effectiveness of the most commonly prescribed doses of rosuvastatin, atorvastatin, simvastatin, and pravastatin for managing various lipid parameters in patients with hypercholesterolemia over a 1-year time horizon from a Canadian health care perspective. METHODS: Incremental cost-effectiveness ratios (ICERs) were estimated for branded rosuvastatin compared with branded atorvastatin, generic simvastatin, and generic pravastatin in patients with hypercholesterolemia in terms of percent reduction in low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio, as well as in TC, HDL-C, triglycerides (TG), apolipoprotein (Apo) B, the ApoB/ApoA-I ratio, and attainment of the Canadian LDL-C goal. The pharmacoeconomic model was constructed for a 1-year time horizon using efficacy data from a randomized, open-label trial including 2268 adults and the wholesale acquisition costs of branded rosuvastatin and atorvastatin and generic simvastatin and pravastatin in British Columbia. RESULTS: The most commonly prescribed doses of each of the 4 statins in British Columbia were as follows: rosuvastatin 10 mg (75.8% of all rosuvastatin doses); atorvastatin 10 and 20 mg (46.4% and 35.3%, respectively, of all atorvastatin doses); simvastatin 20 and 40 mg (42.5% and 31.8%, respectively, of all simvastatin doses); and pravastatin 20 and 40 mg (55.0% and 34.1%, respectively, of all pravastatin doses). Rosuvastatin 10 mg was dominant (ie, was more effective at a lower cost) relative to atorvastatin 10 and 20 mg, simvastatin 20 and 40 mg, and pravastatin 40 mg in terms of reductions in LDL-C, TC/ HDL-C ratio, TC, ApoB, and ApoB/ApoA-I ratio, increases in HDL-C, and attainment of the LDL-C goal. Compared with pravastatin 20 mg, the ICER per percent reduction in LDL-C, TC/HDL-C ratio, TC, TG, ApoB, or ApoB/ApoA-I or increase in HDL-C ranged from $3.89 to $26.07; the value for 1 additional patient achieving the LDL-C goal was $419.75. When the statin doses were aggregated based on the Canadian statin-utilization pattern, rosuvastatin was dominant relative to atorvastatin on all effectiveness measures evaluated. When rosuvastatin was compared with generic simvastatin and pravastatin, the annual costs for 1 additional patient achieving the LDL-C goal were $144.51 and $373.91, respectively. Based on the sensitivity analysis, rosuvastatin was associated with the highest probability of cost-effectiveness compared with the other statins over a broad range of monetary values per unit of clinical effect. CONCLUSION: When percent changes in lipid parameters and rates of LDL-C goal attainment were considered in patients with hypercholesterolemia in British Columbia, rosuvastatin 10 mg was more cost-effective than the most frequently used doses of atorvastatin (10 and 20 mg), generic simvastatin (20 and 40 mg), and generic pravastatin (20 and 40 mg).

Cost-effectiveness of cholesterol-lowering therapy with pravastatin in patients with previous acute coronary syndromes aged 65 to 74 years compared with younger patients: results from the LIPID study.

BACKGROUND: We compared cost-effectiveness of pravastatin in a placebo-controlled trial in 5500 younger (31-64 years) and 3514 older patients (65-74 years) with previous acute coronary syndromes. METHODS: Hospitalizations and long-term medication within the 6 years of the trial were estimated in all patients . Drug dosage, nursing home, and ambulatory care costs were estimated from substudies. Incremental costs per life saved of pravastatin relative to placebo were estimated from treatment effects and resource use. RESULTS: Over 6 years, pravastatin reduced all-cause mortality by 4.3% in the older patients and by 2.3% in the younger patients. Older patients assigned pravastatin had marginally lower cost of pravastatin and other medication over 6 years (A dollar 4442 vs A dollar 4637), but greater cost offsets (A dollar 2061 vs A dollar 897) from lower rates of hospitalizations. The incremental cost per life saved with pravastatin was A dollar 55500 in the old and A dollar 167200 in the young. Assuming no treatment effect beyond the study period, the life expectancy to age 82 years of additional survivors was 9.1 years in the older and 17.3 years in the younger. Estimated additional life-years saved from pravastatin therapy were 0.39 years for older and 0.40 years for younger patients. Incremental costs per life-year saved were A dollar 7581 in the older and A dollar 14944 in the younger, if discounted at 5% per annum. CONCLUSIONS: Pravastatin therapy was more cost-effective among older than younger patients, because of their higher baseline risk and greater cost offsets, despite their shorter life expectancy.

Cost-effectiveness analysis of cholesterol-lowering therapies in Spain.

OBJECTIVE: To assess the cost efficacy of atorvastatin, simvastatin, lovastatin, fluvastatin, pravastatin, and colestyramine in the reduction of low-density lipoprotein-cholesterol (LDL-C) levels and the cost per patient to achieve the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) therapeutic objectives in Spain. METHOD: The following treatments were evaluated: atorvastatin, simvastatin, and pravastatin 10-40 mg/day; lovastatin and fluvastatin 20-80 mg/day; and colestyramine 12-24 g/day. The cost effectiveness of these treatments was evaluated, in terms of cost per percentage of LDL-C reduction, by comparing annual treatment costs versus the efficacy of LDL-C reduction. Treatment costs included medication costs (2003 wholesale prices), control measures, and the treatment of adverse affects. The efficacy of HMG-CoA reductase inhibitors (statins) was obtained from a meta-analysis of results obtained from clinical trials published between 1993 and 2003 that met the following criteria: monotherapy; >16 weeks of treatment; randomized allocation of individuals to the intervention and comparator groups; dietary treatment for > or =3 months before administration of medication; and double-blind measurement of outcomes. Average and incremental cost-effectiveness ratios were calculated to assess the efficiency of cholesterol-lowering treatments. RESULTS: Efficacy, in terms of percentage of LDL-C reduction, ranged from 10% for colestyramine 12 g/day to 49% for atorvastatin 40 mg/day. Total annual treatment costs ranged from euro 321 for fluvastatin 20 mg/day to euro 1151 for atorvastatin 40 mg/day. Cost-effectiveness ratios, in terms of cost per percentage of LDL-C reduced, were: euro 11-23 for atorvastatin; euro 12-21 for simvastatin; euro 14-22 for lovastatin; euro 15-24 for fluvastatin; euro 21-42 for pravastatin; and euro 35-46 for colestyramine. Atorvastatin 10 mg/day was the most cost-effective treatment, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. Atorvastatin was the most cost-effective treatment in the achievement of the NCEP ATP III LDL-C reduction objectives in patients with high (<100 mg/dL) and moderate (<130 mg/dL) risk of coronary heart disease (CHD), with a cost per patient of euro 747 and euro 405 per year, respectively. Fluvastatin was the most cost-effective treatment in the achievement of the NCEP ATPIII therapeutic objective in patients with low-risk of CHD (LDL-C <160 mg/dL), with a cost per patient of euro 321. CONCLUSION: Atorvastatin 10 mg/day was the most cost-effective cholesterol-lowering drug, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. The preferred statin should be atorvastatin in patients with moderate-to-high CHD risk and fluvastatin in patients with low risk for CHD.

[Statin therapy: cost-effectiveness and evaluation of evidence as criterium for improving expenditure within the National Health Program]. / Terapia medica con le statine: valutazione costo/efficacia e della migliore evidenza clinica per razionalizzare la spesa del Servizio Sanitario Nazionale.

The choice is difficult in medicine. But individual physicians and patients must make medical decisions rather than organizations or pharmaceutical companies. The choice concerns the transparency of the decision-making process (evidence based medicine), and mistrust of the methods used in cost-effectiveness analysis. Medicare's policy of paying for any medical advance that has positive benefits, regardless of its costs, is un-sustainable. Cost-effectiveness information may assume a more important role in future coverage decisions with regard to outpatient prescription drugs, but at the private level, rather than at the national one. Functional equivalence of drugs reflects a reference-pricing technique applied to a therapeutic category--reimbursement for compounds of similar efficacy within a therapeutic class set to the lowest-priced product in the class. Essentially, a standard of functional equivalence applies a cost-effectiveness principle: assuming that alternative interventions are equivalent, one should not pay more for one of them.

Cost effectiveness of rosuvastatin in treating patients to low-density lipoprotein cholesterol goals compared with atorvastatin, pravastatin, and simvastatin (a US Analysis of the STELLAR Trial).

Statin therapy decreases low-density lipoprotein cholesterol levels and the risk of coronary heart disease but has a considerable short-term effect on health care budgets. The cost effectiveness of rosuvastatin (Crestor) has been compared with those of atorvastatin, pravastatin, and simvastatin in lowering low-density lipoprotein cholesterol levels and achieving National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. The analysis was conducted from the perspective of health care payers in the United States. Clinical data were obtained from the Statin Therapies for Elevated Lipid Levels Compared Across Doses to Rosuvastatin (STELLAR) trial. Drug costs were based on wholesale acquisition costs. Cost effectiveness was assessed with the net monetary benefit approach and a 1-year time horizon. Rosuvastatin at 10 mg, the recommended starting dose, was the most cost-effective statin over a large range of "willingness-to-pay" values for a unit of clinical effect (i.e., a 1% decrease in low-density lipoprotein cholesterol or a patient achieving the goal).

Cost-effectiveness of pravastatin for primary prevention of coronary artery disease in Japan.

OBJECTIVE: This analysis was designed to estimate the cost-effectiveness of pravastatin for the primary prevention of coronary heart disease in Japan. METHODS: A state-transition model was used to compare the cost-effectiveness of pravastatin therapy with no intervention. Hypothetical cohorts were assumed according to patients' age, sex, initial serum total cholesterol (TC) levels, and other cardiac risk factors. For the baseline analysis, 20 mg/day of pravastatin was used for people aged 60 years who had an initial TC level of 240 mg/dl. Epidemiological, clinical, and economic data were collected from published articles. Incremental cost-effectiveness ratios (ICERs) in yen per quality-adjusted life year (QALY) were calculated. To confirm the effects of different variables, a sensitivity analysis was performed. The assumptions of our model were in accordance with the Japan Atherosclerosis Society Guidelines for the Diagnosis and Treatment of Atherosclerotic Cardiovascular disease. RESULTS: ICERs were respectively 44 million and 76 million yen/QALY for men and women at low cardiac risk (i.e., the risks of hypercholesterolemia and old age) and 7.5 million and 4.3 million yen/QALY for those at high cardiac risk (i.e., the risks of hypercholesterolemia, old age, cigarette smoking, hypertension, and hyperglycemia). CONCLUSIONS: The cost-effectiveness of pravastatin therapy differs substantially according to the level of cardiac risk. At present, pravastatin therapy is not cost-effective for persons at low cardiac risk.

Maximizing the cost-effectiveness of lipid-lowering therapy.

Cardiovascular disease, including coronary heart disease, is the leading cause of death both in men and in women in the United States. The purpose of this review is to describe the effectiveness of lipid-lowering therapy in reducing cardiovascular morbidity and mortality, which has recently been extended to patients with mild to moderate hypercholesterolemia, and the cost of providing therapy, which would be prohibitive if all persons with hypercholesterolemia received treatment. Cost-effectiveness analysis provides a rational means of allocating limited health care resources by allowing the comparison of the costs of lipid-lowering therapy, in particular, therapy with beta-hydroxy-beta-methylglutaryl-CoA (coenzyme A) reductase inhibitors (statins), with the costs of atherosclerosis that could be prevented by lowering cholesterol. To extend the benefits of treatment to the large number of persons not receiving therapy, we need to implement more cost-effective treatment by improving risk assessment, increasing treatment effectiveness, and reducing the cost of therapy.

Cost effectiveness of statin therapy for the primary prevention of major coronary events in individuals with type 2 diabetes.

OBJECTIVE: To assess the cost and cost effectiveness of hydroxymethylglutaryl (HMG)-CoA reductase inhibitor (statin) therapy for the primary prevention of major coronary events in the U.S. population with diabetes and LDL cholesterol levels > or =100 mg/dl, especially in the population with LDL cholesterol levels 100-129 mg/dl. RESEARCH DESIGN AND METHODS: Analyses were performed using population estimates from National Health and Nutrition Examination Survey (NHANES)-III, cost estimates from a health system perspective, statin LDL-lowering effectiveness from pivotal clinical trials, and treatment effectiveness from the diabetic subgroup analysis of the Heart Protection Study. RESULTS: -There are approximately 8.2 million Americans with diabetes, LDL cholesterol levels > or =100 mg/dl, and no clinical evidence of cardiovascular disease. Each year, statin therapy could prevent approximately 71,000 major coronary events in this population. In the subgroup with LDL cholesterol levels 100-129 mg/dl, the annual cost of statin treatment ranges from 600 to 1,000 US dollars per subject. In the population with LDL cholesterol levels > or =130 mg/dl, the annual cost ranges from 700 to 2,100 US dollars. Annual incremental cost per subject, defined as the cost of statin treatment plus the cost of major coronary events with statin treatment minus the cost of major coronary events without statin treatment, ranges from 480 to 950 US dollars in the subgroup with LDL cholesterol levels 100-129 mg/dl and from 590 to 1,920 US dollars in the population with LDL cholesterol levels > or =130 mg/dl. CONCLUSIONS: Statin therapy for the primary prevention of major coronary events in subjects with type 2 diabetes and LDL cholesterol levels 100-129 mg/dl is affordable and cost effective relative to statin therapy in subjects with higher LDL cholesterol levels.

Cost-effectiveness of pravastatin in secondary prevention of coronary heart disease: comparison between Belgium and the United States of a projected risk model.

Methodological differences and variations in health care regulations among countries often preclude direct comparisons of cost-effectiveness studies. A projected risk model was applied, designed to determine the economic value in the United States of pravastatin in the secondary prevention of coronary heart disease (CHD), to Belgium using local health care costs. A Markov process was used to model the effectiveness of treatment for 3 years with pravastatin versus placebo in 1000 male CHD patients aged 60 years and clinically similar to those in the pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I) and pravastatin, lipids and atherosclerosis in the carotid arteries (PLAC II) studies. The PLAC I and II trials have shown that pravastatin treatment for 3 years at a weighted mean dose of 36.64 mg daily significantly reduced the incidence of non-fatal myocardial infarction in patients with CHD. Framingham data were used to project the risk of mortality 10 years post-myocardial infarction. The incremental cost per life year gained (LYG), after discounting costs and benefits by 5% annually, in the setting of Belgian health care regulations, was Belgian francs (BEF) 720794 (US$ 24359) for CHD patients with one additional risk factor; BEF 526464 (US$ 17792) for those with two additional risk factors; and BEF 392765 (US$ 13274) for those with three or more additional risk factors. The cost per LYG in Belgium appeared to be more sensitive to drug acquisition cost than to costs of medical interventions. The cost-effectiveness ratios of pravastatin monotherapy for 3 years in secondary prevention of CHD, obtained with the same projected risk model, are from 86 to 92% higher in Belgium than in the United States, due to differences in medical patterns of practice and in intervention costs.

Cost-effectiveness of statins.

Currently, 6 hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are marketed in the United States (US). Given the wide variation in the prices and efficacy of statins, formal cost-effectiveness analysis may improve drug selection decisions. To assess the cost-effectiveness of statin therapy in primary and secondary prevention of coronary heart disease, we developed a model of the costs and consequences of lipid-regulating therapy and estimated the incremental cost-effectiveness of 5 statins (atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin) at usual starting doses versus no therapy. Drug effects on serum lipids were assessed using data approved by the US Food and Drug Administration for product labeling. Annual risks of coronary event occurrence were estimated using Framingham Heart Study coronary risk equations developed for use in this model. Current estimates of direct medical costs of coronary heart disease were used to assign costs to health states and acute coronary events. Main outcome measurements were net cost (statin therapy minus savings in coronary heart disease treatment), gain in life expectancy, and cost per life-year saved. The maximum gain in life expectancy was achieved with atorvastatin, which also had a lower net cost than lovastatin, pravastatin, and simvastatin. Compared with fluvastatin, atorvastatin's greater effectiveness is attained at a lower cost per life-year saved. The cost-effectiveness of HMG-CoA reductase inhibition in primary and secondary prevention of coronary heart disease has been improved with the introduction of atorvastatin.

Preventing coronary artery disease in the West of Scotland: implications for primary prevention.

The effectiveness of plasma cholesterol reduction therapy is no longer in question. Recent studies of cholesterol-lowering drug therapy demonstrate significant reductions in risks of mortality and coronary events in patients with existing coronary artery disease. The West of Scotland Coronary Prevention Study (WOSCOPS) demonstrated the therapy's effectiveness as primary prevention in patients without demonstrated coronary artery disease. Now that the efficacy of lipid reduction has been demonstrated conclusively, we face the difficult question of deciding what the treatment goals should be, whom to treat, and how to make those decisions cost effectively. These questions have complex social and ethical components and will lead to considerable discussion about how lipid-decreasing drugs will be used.

Pravastatin alone and in combination with low-dose cholestyramine in patients with primary hypercholesterolemia and coronary artery disease.

This randomized, open-label study compared the cost efficiency of low-dose pravastatin combined with low-dose cholestyramine with high-dose pravastatin monotherapy in 59 patients with moderate hypercholesterolemia and coronary disease. Both regimes were effective in improving lipid profiles in these patients; however, low-dose combination therapy enhanced achievement in therapeutic goals and cost efficiency.

Cost-effectiveness of pravastatin in secondary prevention of coronary artery disease.

This study analyzed the cost-effectiveness of pravastatin in secondary prevention of coronary artery disease (CAD). The projected risk model in 445 male patients with established CAD and moderately elevated serum low-density lipoprotein cholesterol used results data from 2 placebo-controlled plaque regression trials: Pravastatin Limitation of Atherosclerosis in the Coronary Arteries and Pravastatin, Lipids, and Atherosclerosis in the Carotids. Framingham Heart Study data were used to project the risk of mortality 10 years after myocardial infarction (MI) for incremental male patients in the placebo group who had MI. A Markov process was used to estimate life-years saved, and decision analysis was used to estimate cost. Depending on the patient-risk profile, the midrange estimated cost per life-year saved with pravastatin in secondary prevention of CAD varied from $7,124 to $12,665, which is favorable compared with other widely accepted medical interventions.

Cerivastatin versus branded pravastatin in the treatment of primary hypercholesterolemia in primary care practice in Canada: a one-year, open-label, randomized, comparative study of efficacy, safety, and cost-effectiveness.

BACKGROUND: Potential cost differences between statins are driven primarily by drug costs, differential lowering effects on low-density lipoprotein cholesterol (LDL-C) levels, and adverse drug interactions and reactions. OBJECTIVE: The purpose of this study was to compare the efficacy, safety, and direct treatment costs of cerivastatin and branded pravastatin in adult patients with primary hypercholesterolemia over a 1-year period. METHODS: This was a multicenter (48 sites), randomized, open-label, parallel-group, optional dose-titration study conducted in Canada. Patients aged 18 to 75 years with documented primary hypercholesterolemia (mean LDL-C > or = 160 mg/dL [> or = 4.5 mmol/L] and at least 1 fasting triglyceride measurement < or = 400 mg/dL [< or = 4.5 mmol/L]) that did not respond adequately to dietary intervention were enrolled. Patients who were on a diet at study entry were instructed to continue that diet for the duration of the study. Patients not following a diet were also entered into the study provided they had received previous dietary counseling and were unwilling or unable to comply with this dietary advice. Before randomization, treating physicians were required to record a target lipid level for each patient and then instructed to randomize patients to treatment with any dose and any titration schedule of cerivastatin or branded pravastatin according to their normal practice. Physicians were not required to titrate the study drug dose if the patient did not achieve the predefined target goal. Lipid analyses were conducted at baseline/randomization and at months 3, 6, 9, and 12. All samples drawn for lipid analyses were collected after a fast of > or = 10 hours. A cost-minimization approach was used to compare the direct treatment costs between cerivastatin and branded pravastatin. Since the analysis was from the perspective of the third-party payer (Ministries of Health), only costs attributed to the third-party payer were included. RESULTS: A total of 417 patients were randomized to once-daily treatment with cerivastatin 0.1 mg to 0.4 mg (n = 209) or branded pravastatin 10 mg to 40 mg (n = 208); 39 (9.4%) of patients discontinued prematurely, 19 (4.6%) because of an adverse event. The incidence of adverse events was similar for cerivastatin (73.6%) and branded pravastatin (74.9%). The majority of adverse events were mild or moderate and included headache, nausea, pain, and dizziness. Both cerivastatin and pravastatin were effective in lowering LDL-C to target levels (mean reduction 29.8% and 27.5%, respectively, P = 0.35). An LDL-C decrease of > or = 20% from baseline to end point was achieved in 74.2% of cerivastatin patients and 74.0% of pravastatin patients. The annualized direct hyperlipidemia treatment cost was 19% higher in the branded pravastatin group compared with the cerivastatin group. A sensitivity analysis designed to examine the impact of generic pricing on the cost-minimization analysis indicated that the cost difference between cerivastatin and generic pravastatin was not significant. CONCLUSIONS: Both cerivastatin and branded pravastatin were well tolerated and effective in lowering LDL-C by > or = 20% versus baseline. A cost savings in favor of cerivastatin was a reflection of the lower drug acquisition cost of cerivastatin compared with branded pravastatin.

Use of diagnostic cluster methodology for therapeutic costing and drug surveillance of HMG-CoA reductase-inhibitor therapy.

Diagnostic cluster methodology groups patients having similar medical conditions according to their International Classification of Diseases, 9th Revision codes. Episodes of care related to the diagnostic cluster can then be tracked from the claims data to determine the total charges associated with patient management. A retrospective claims analysis using an episode registry database was conducted to determine the 1-year (July 1, 1995, to June 30, 1996) covered charge for statin therapy, the overall cost of treating related cardiovascular (CV) disease, and the cost impact of coadministration of drugs that potentially compete for hepatic metabolism. The three statin treatment groups (lovastatin, pravastatin, and simvastatin) were similar with respect to age, gender, mean number of prescription refills, rate of refill compliance, and prevalence of the coadministration of potentially interacting agents. Before adjustment for severity of illness, there were no significant differences between groups in prescription drugs/services (statin Rx/Svc) or total CV charges. After adjustment for severity of illness, the pravastatin group had the lowest statin Rx/Svc and total CV charges. Within the group with the greatest severity of illness, statin Rx/Svc charges were significantly lower with pravastatin than with lovastatin and simvastatin. The statin Rx/Svc charges were not significantly different between lovastatin and simvastatin. Coadministration of a potentially interacting agent significantly increased both the statin Rx/Svc and total CV charges within the simvastatin-treated group but did not significantly influence costs in the lovastatin- or pravastatin-treated groups. The estimates of direct costs derived from this analysis are consistent with findings in the published literature and demonstrate that pravastatin has cost advantages compared with lovastatin and simvastatin. Diagnostic cluster methodology also generated valuable information regarding drug surveillance and the health care cost impact of potential drug-drug interactions with selected statins.