Real-World Comparative Effectiveness and Cost Comparison of Thromboprophylactic Use of Enoxaparin versus Unfractionated Heparin in 376,858 Medically Ill Hospitalized US Patients.

BACKGROUND: Venous thromboembolism (VTE) is a serious complication in medically ill inpatients. Enoxaparin or unfractionated heparin (UFH) thromboprophylaxis has been shown to reduce VTE in clinical trials; however, comparative effectiveness and differences in hospital costs are unknown in US hospital practice. OBJECTIVE: This study compared clinical and economic outcomes between enoxaparin and UFH thromboprophylaxis in medically ill inpatients. METHODS: A retrospective cohort study was conducted using the Premier Healthcare Database between 1 January 2010 and 30 September 2016. Inpatients aged ≥ 18 years with a ≥ 6-day hospital stay for serious medical conditions were included. Two patient groups receiving thromboprophylaxis were identified during hospitalization: one receiving enoxaparin and other receiving UFH. Regression models were constructed to compare VTE events, in-hospital mortality, pulmonary embolism (PE)-related mortality, major bleeding, and total hospital costs during both the index hospitalization and the 90-day readmission period between the two groups. RESULTS: A total of 242,474 and 134,384 inpatients received enoxaparin or UFH for thromboprophylaxis, respectively. Compared with UFH prophylaxis, enoxaparin was significantly associated with 15%, 9%, 33%, and 41% reduced odds of VTE, in-hospital mortality, PE-related mortality, and major bleeding, respectively, during index hospitalization, and 10% and 19% reduced odds of VTE and bleeding, respectively, during the readmission period. Mean total hospital costs were significantly lower in patients receiving enoxaparin prophylaxis than in those given UFH. CONCLUSIONS: Thromboprophylaxis with enoxaparin was associated with significantly reduced in-hospital VTE events, death, and major bleeding and lower hospital costs compared with UFH in hospitalized medically ill patients.

Comparative Effectiveness and Costs of Enoxaparin Monotherapy Versus Unfractionated Heparin Monotherapy in Treating Acute Coronary Syndrome.

BACKGROUND: Enoxaparin and unfractionated heparin (UFH) are guideline-recommended anticoagulants for patients with acute coronary syndrome (ACS), including unstable angina (UA) and myocardial infarction with (STEMI) or without ST-segment elevation (NSTEMI). Prior efficacy and safety evidence are mainly from clinical trials. Economic data are insufficient. This study examined the differences in utilization, effectiveness, safety, and costs in treating ACS between enoxaparin and UFH monotherapy using real-world data. METHODS: Using data from 859 US hospitals, inpatients ≥ 18 years of age with a diagnosis of an initial episode of ACS between 2010 and 2016 were identified. Outcomes included 30-day risk of non-fatal myocardial infarction (MI), recurrent angina, in-hospital mortality, composite ischemic complication (having MI/recurrent angina/death), major bleeding, and costs. Multivariable regression was used to compare outcomes between enoxaparin and UFH monotherapy. RESULTS: Among 1,048,053 eligible patients (UA: 219,259; NSTEMI: 582,134; STEMI: 246,660), the prevalence of enoxaparin monotherapy was 12.0%, 13.9%, and 5.1%, and the prevalence of UFH monotherapy was 45.1%, 43.1% and 59.8%, for UA, NSTEMI, and STEMI patients, respectively. Enoxaparin was associated with a lower risk of ischemic complications and death among NSTEMI, but not in UA or STEMI patients, and with a lower risk of major bleeding in all patients. Cost savings per patient during index admission and 30-day follow-up for enoxaparin over UFH was $2972 for UA, $2475 for NSTEMI, and $3050 for STEMI. CONCLUSIONS: Enoxaparin was associated with a lower risk of ischemic complications (including death), lower costs, and better safety than UFH among NSTEMI patients. Improving upstream selection of anticoagulants in appropriate populations may help optimize clinical outcomes and costs.

Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway.

BACKGROUND: Lixisenatide is a potent, selective and short-acting once daily prandial glucagon-like peptide-1 receptor agonist which lowers glycohemoglobin and body weight by clinically significant amounts in patients with type 2 diabetes treated with basal insulin, with limited risk of hypoglycemia. OBJECTIVE: To assess the cost-effectiveness of lixisenatide versus bolus insulin, both in combination with basal insulin, in patients with type 2 diabetes in Norway. METHODS: The IMS CORE Diabetes Model, a non-product-specific and validated simulation model, was used to make clinical and cost projections. Transition probabilities, risk adjustments and the progression of complication risk factors were derived from the UK Prospective Diabetes Study, supplemented with Norwegian data. Patients were assumed to receive combination treatment with basal insulin, lixisenatide or bolus insulin therapy for 3 years, followed by intensification of a basal-bolus insulin regimen for their remaining lifetime. Simulated healthcare costs, taken from the public payer perspective, were derived from microcosting and diagnosis related groups, discounted at 4% per annum and reported in Norwegian krone (NOK). Productivity costs were also captured based on extractions from the Norwegian Labor and Welfare Administration. Health state utilities were derived from a systematic literature review. Sensitivity and scenario analyses were performed. RESULTS: Lixisenatide in combination with basal insulin was associated with increased quality-adjusted life years (QALYs) and reduced lifetime healthcare costs compared to bolus insulin in combination with basal insulin in patients with Type 2 diabetes, and can be considered dominant. The net monetary benefit of lixisenatide versus bolus insulin was NOK 39,369 per patient. Results were sensitive to discounting, the application of excess body weight associated disutility and uncertainty surrounding the changes in HbA1c. CONCLUSIONS: Lixisenatide may be considered an economically efficient therapy in combination with basal insulin in the Norwegian setting, due to cost savings, weight loss and associated gains in health-related quality of life.

[Physicians' experience with increased use of individual reimbursement for pharmaceuticals]. / Legers erfaringer med individuell refusjon for legemidler.

BACKGROUND: Implementation of a more restrictive reimbursement policy in Norway (in June 2003) has led to an increased use of individual reimbursement (patient application ) rather than general reimbursement (based on a positive list) of important pharmaceuticals. This study investigates physicians' attitudes to and experience with increased use of individual reimbursement one year after implementation of the new directive. MATERIAL AND METHODS: Questions concerning individual reimbursement were included in a questionnaire to the Research Institute of the Norwegian Medical Association's reference panel in November 2004. RESULTS: 993 (71 %) of 1399 physicians responded to the questionnaire and 605 (61 %) of these reported that they had referred patients to a specialist or applied for individual reimbursement within the last year. About half (48 %) reported that the scheme contributes to rational use of pharmaceuticals, but more than 70 % were dissatisfied with the scheme and 87 % reported the scheme to be complicated and resource demanding. Only 37 % reported that all individual reimbursement applications were granted approval. 57 % reported that the scheme prevented them from prescribing the pharmaceutical they considered best for a patient, and 52 % reported that patients rather choose to pay for a pharmaceutical so treatment could start immediately. Administrative time for individual reimbursement applications was estimated to an average of 2.6 hours per month per physician. INTERPRETATION: The results indicate that physicians are considerably dissatisfied with the practical implications of this scheme. Comprehensive analyses of the total health consequences, costs and distributional effects of the increased use of individual reimbursement for important pharmaceuticals are needed.

Lipid management and cholesterol goal attainment in Norway.

OBJECTIVE: To document prescribing patterns of lipid-modifying therapies in hypercholesterolemic patients, cholesterol goal attainment, and factors associated with cholesterol goal attainment in Norway. METHOD: This was a retrospective, observational study using existing computerized patient records at 11 primary healthcare centers in Norway and the Norwegian Patient Register of hospital data. The study population was 3111 patients identified in the primary care database who were prescribed a lipid-modifying therapy between the dates of July 1987 and May 2003 and who were > or = 18 years of age at the time of the first prescription. Of these patients, 1337 patients had uncontrolled lipid measures at baseline. In the analysis of goal attainment, data were available for 877 (28% of the total study population) and 1144 (37%) patients with baseline and follow-up total cholesterol (TC) and/or low-density lipoprotein-cholesterol (LDL-C) levels after 4 and 12 months' treatment, respectively. OUTCOME MEASURES: Initial lipid-modifying therapy (drug and dosage), changes in initial lipid-modifying therapy, cholesterol goal attainment, and factors related to cholesterol goal attainment. Cholesterol treatment goals were defined as LDL-C <3.0 mmol/L and/or TC <5.0 mmol/L (as per the Second Joint Task Force of European Societies on the Prevention of Cardiovascular Disease). RESULTS: The initial lipid-modifying therapy was a HMG-CoA reductase inhibitor (statin) in 98% of patients, most often simvastatin (42%; mean initial dosage = 18.4 mg/day) or atorvastatin (34%; 12.7 mg/day). The median year of treatment initiation was 1999 and the mean duration of follow-up was 39 months. The initial prescription remained unchanged at year 1 for most patients (69%), whereas 17% discontinued drug treatment. Mean TC levels decreased from 7.36 mmol/L at baseline (n = 1337) to 5.31 mmol/L at 12 months (n = 1144; p < 0.05), whereas mean LDL-C levels decreased from 4.98 (n = 847) to 3.08 mmol/L at 12 months (n = 713; p < 0.05). These mean reductions occurred within 3 months of the initial prescription and did not change subsequently. A total of 32.9% of patients who were not at goal at baseline achieved cholesterol goal 12 months after initiating treatment. The factors related to cholesterol goal attainment at 12 months were: baseline TC level (odds ratio [OR] 0.64; 95% CI 0.58, 0.71), treatment with a statin (OR 8.60; 95% CI 1.13, 65.4), diagnosis of diabetes mellitus (OR 2.91; 95% CI 2.01, 4.21), and age (OR 1.02; 95% CI 1.01, 1.03). CONCLUSIONS: Lipid-modifying therapy in Norway is dominated by statin monotherapy. In this analysis of primary-care patients, maximal reductions in cholesterol levels were seen within the first 3-4 months after therapy initiation. After 12 months of treatment, 67% of patients remained above recommended cholesterol levels. More effective and well tolerated treatment strategies are needed to improve the probability of patients achieving cholesterol treatment goals.