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Valentine W.J.,Ossian Health Economics and Communications GmbH | Palmer A.J.,Menzies Research Institute | Lammert M.,Novo Nordisk AS | Langer J.,Novo Nordisk AS | Brandle M.,Kantonsspital St. Gallen
Clinical Therapeutics | Year: 2011

Background: The global clinical and economic burden of type 2 diabetes is substantial. Recently, clinical trials with glucagon-like peptide-1 (GLP-1) receptor agonists (liraglutide and exenatide) have shown a multifactorial clinical profile with the potential to address many of the clinical needs of patients and reduce the burden of disease. Objective: The goal of this study was to evaluate the long-term cost-effectiveness of once-daily liraglutide versus exenatide BID in patients with type 2 diabetes who failed to improve with metformin and/or sulfonylurea, based on the results of a previous clinical trial in 6 European countries (Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria). Methods: A validated computer simulation model of diabetes was used to predict life expectancy, quality-adjusted life years (QALYs), and incidence of diabetes-related complications in patients receiving liraglutide (1.8 mg once daily) or exenatide (10 μg BID). Baseline cohort characteristics and treatment effects were derived from the Liraglutide Effect and Action in Diabetes 6 trial. Country-specific complication costs were taken from published sources. Simulations were run over 40 years from third-party payer perspectives. Future costs and clinical benefits were discounted at country-specific discount rates. Sensitivity analyses were performed. Results: Liraglutide was associated with improvements of 0.12 to 0.17 QALY and a reduced incidence of most diabetes-related complications versus exenatide in all settings. Evaluation of total direct medical costs (treatment plus complication costs) suggest that liraglutide was likely to cost between Euro (€) 1023 and €1866 more than exenatide over patients' lifetimes, leading to incremental cost-effectiveness ratios per QALY gained versus exenatide of: Switzerland, CHF (Swiss francs) 10,950 (€6902); Denmark, Danish krone [kr] 88,160 (€11,805); Norway, Norwegian krone [kr], 111,916 (€13,546); Finland, €8459; the Netherlands, €8119; and Austria, €8516. Conclusions: Long-term projections indicated that liraglutide was associated with benefits in life expectancy, QALYs, and reduced complication rates versus exenatide. Liraglutide was cost-effective from a health care payer perspective in Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria. Clinicaltrials.gov identifier: NCT 00518882. © 2011 Elsevier HS Journals, Inc.

The Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation Study (NICE Study) (NCT00575172) was a 5-year, open-label, randomised controlled trial which compared cardiovascular outcomes in Japanese type 2 diabetes patients intensively treated with regular human insulin or insulin aspart (NovoRapid; Novo Nordisk A/S, Bagsvaerd, Denmark), a rapid-acting insulin analogue. The aim of the present analysis was to evaluate the cost effectiveness of insulin aspart versus regular human insulin from the perspective of a Japanese third-party healthcare payer. A discrete event-simulation model was developed in Microsoft Excel to assess the within-trial cost effectiveness and make longer-term clinical projections in patients treated with regular human insulin or insulin aspart. In addition to severe hypoglycaemia, the model captured myocardial and cerebral infarction events and percutaneous coronary intervention and coronary artery bypass graft procedures. Within-trial mortality, incidence of severe hypoglycaemia and cardiovascular event probabilities were derived from the annual rates observed during the trial period, while post-trial outcomes were calculated using the event rates from the trial, adjusted for increasing patient age. Event costs were accounted from the healthcare payer perspective and expressed in 2008 Japanese yen (JPY), while health-related quality of life (HRQoL) was captured using event and state utilities. Future costs and clinical benefits were discounted at 3% annually. Life expectancy, quality-adjusted life expectancy, cardiovascular event rates and costs were evaluated over 5- and 10-year time horizons and sensitivity analyses were performed to assess variability in model outcomes. Over 5 years of treatment, insulin aspart dominated human insulin both in incremental life expectancy and in incremental quality-adjusted life-years (QALYS). Insulin aspart was associated with a small improvement in discounted life expectancy of 0.005 years (4.688 vs. 4.684 years) and an increase of 0.023 quality-adjusted life-years (QALYs) (3.800 vs. 3.776 QALYs) when compared with regular human insulin. Insulin aspart also incurred lower costs (JPY 481,586 vs. 594,717, difference -113,131) which resulted from the decreased incidence of cardiovascular events with insulin aspart (0.013 events per patient year vs. 0.030 on regular human insulin). Breakdown of costs indicated that pharmacy costs were higher with insulin aspart (JPY 346,608 vs. 278,468), but these costs were more than offset by the reduced costs associated with cardiovascular complications and hypoglycaemia over 5 years of treatment (JPY 134,978 vs. 316,249). Sensitivity analysis showed that insulin aspart was still cost-effective in the case where only 18% of the within-trial cardiovascular and mortality benefit over regular human insulin was captured in the model (assuming a willingness-to-pay threshold of JPY 5,000,000). The NICE study cohort was relatively small (n=325), meaning that caution should be exercised when calculating and interpreting the incremental cost-effectiveness ratio. Also, despite the differences in cardiovascular risk profile between the Japanese and UK populations, UKPDS-derived risk equations were used to project MI outcomes and PCI and CABG procedures and UKPDS HRQoL scores were applied to all health states. While these risk formulas and HRQoL utilities may not be directly applicable to the Japanese population, no equivalent Japanese-specific data are currently available. In a Japanese type 2 diabetes population, prescribing rapid-acting insulin aspart significantly reduced cardiovascular complications over 5- and 10-year time horizons, resulting in increased quality of life and decreased costs when compared with human insulin.

Pollock R.F.,Ossian Health Economics and Communications GmbH
Journal of medical economics | Year: 2013

To evaluate the financial consequences of using laparoscopic adjustable gastric banding (LAGB) in place of standard medical management (SMM) in obese patients with type 2 diabetes from a UK healthcare payer perspective. A budget impact model was constructed to evaluate the budgetary implications of LAGB in obese patients with type 2 diabetes in the UK. For patients undergoing LAGB, the model captured pre-, peri-, and post-operative costs including consultations with physicians, psychologists, nurses, and dieticians, the cost of surgery, and costs associated with post-surgical complications. The model also captured costs associated with medication for diabetes, asthma, hypertension, and hyperlipidemia, costs of diabetes complications, sleep apnea, and asthma, and costs of diagnostic tests. The SMM arm also captured costs associated with very low calorie diet products. Costs were modeled in a simulated UK cohort of 100 obese patients with newly-diagnosed diabetes. Future costs were discounted at 3.5% per annum and all costs were reported in 2010 pounds sterling. Over the 5-year time horizon, the cohort of 100 patients who underwent LAGB incurred costs £91,287 lower than an equivalent cohort receiving SMM (£818,668 and £909,955, respectively). Costs of surgery and post-surgical complications (£254,000 and £40,981, respectively) were more than offset by savings arising from reduced diabetes, asthma, and sleep apnea medication costs, reduced incidence of diabetes complications, and fewer healthcare professional contacts. Sensitivity analysis (SA) showed that the model was most sensitive to assumptions around diabetes medication use, although none of the SA findings showed LAGB to be more costly than SMM. In order to capture the diverse resource use and medical care costs arising in obese patients with type 2 diabetes, the analysis made use of a range of heterogeneous data sources. While the vast majority of data were applicable to obese patients with recently-diagnosed diabetes in the UK setting, some surrogate data (e.g. from different geographies) were used in cases where data in the target population were unavailable. Additionally, given the largely uncharacterized long-term risk profile in patients with remission of type 2 diabetes, remission was captured using a transparent and highly conservative approach. Based on the findings of the present analysis, the high initial costs of performing LAGB are offset within 5 years after surgery when compared with SMM in a population of obese patients with type 2 diabetes. The high up-front costs associated with surgery should not therefore be a barrier to its reimbursement in this patient group.

Pollock R.F.,Ossian Health Economics and Communications GmbH | Kappelgaard A.-M.,Novo Nordisk AS | Seitz L.,Novo Nordisk AS
Expert Opinion on Drug Delivery | Year: 2015

Objective: Human growth hormone (hGH) delivery systems differ in the size of the dose increments that can be set by the patient, affecting proximity to the target (i.e., prescribed) dose which can be attained. We investigated differences in dosing increment granularity in NordiFlex®, FlexPro®, NordiPen® (all multiple dose devices) and MiniQuick® (single dose) delivery systems.Methods: A simulation model was developed to project hGH dosing in pediatric patients with growth hormone deficiency, small for gestational age or Turner syndrome, calculating the nearest dose above the target dose administrable by each device in typical EU and US cohorts and projecting the excess dose (hGH wastage) over 1 year of typical use.Results: The device with the smallest dosing increment (FlexPro 5 mg; 0.025 mg dosing increment) was projected to administer doses < 1% above the target across all indications. MiniQuick (0.2 mg dosing increment) was projected to deliver between 5 and 6% above the target dose. None of the sensitivity analyses changed the conclusion that larger dosing increments result in more hGH wastage.Conclusions: In addition to increasing dosing accuracy, finer dosing increments may result in reductions in unnecessary hGH usage, which may in turn result in reductions in the cost of hGH treatment borne by the health-care payer. © 2014 Informa UK, Ltd.

Smith-Palmer J.,Ossian Health Economics and Communications GmbH | Cerri K.,Janssen Pharmaceutical | Valentine W.,Ossian Health Economics and Communications GmbH
BMC Infectious Diseases | Year: 2015

Background: The goal of chronic hepatitis C treatment is to remove the virus to avoid progression of HCV-related disease. Sustained virologic response (SVR) is the most widely used efficacy endpoint in clinical studies of hepatitis C, and represents the eradication of HCV from the body. The aim of the current review was to examine the long-term clinical, economic and quality of life benefits associated with achieving SVR. Methods: A systematic literature review was performed using the PubMed, EMBASE and Cochrane library databases to identify articles examining the clinical, economic and quality of life benefits associated with SVR, published in English language from 2002-2013. For inclusion studies were required to enroll ≥100 patients and to report clinical endpoints including hepatocellular carcinoma, overall- or liver-related mortality, or progression of disease/complications (e.g. portal hypertension, esophageal varices). Review of economic studies on cost/cost-effectiveness of achieving SVR were focused on studies assessing boceprevir/telaprevir plus pegIFN and ribavirin as this represents the current standard of care in several jurisdictions worldwide. Quality of life evidence was required to use validated quality of life instruments and provide a quantitative analysis of the impact of SVR versus no treatment or treatment failure. Results: SVR is durable with late relapse rates over 4-5 year periods being in the range of 1-2%. Patients who achieve SVR frequently demonstrate some regression of fibrosis/cirrhosis and have a substantially reduced risk for hepatocellular carcinoma (relative risk [RR] 0.1-0.25), liver-related mortality (RR 0.03-0.2) and overall mortality (RR 0.1-0.3) in comparison with no treatment or treatment failure. In the 5 years post-treatment, medical costs for patients achieving SVR are 13-fold lower than patients not achieving SVR. Patients who achieve SVR also have health state utility values that are 0.05 to 0.31 higher than non-responders to treatment. Conclusions: SVR represents the fundamental goal of antiviral treatment for patients infected with chronic HCV, so as to reduce risk of liver disease progression. Achievement of SVR has implications beyond those of clearing viral infection; it is associated with improved long-term clinical outcomes, economic benefits and improved health-related quality of life. © Smith-Palmer et al.

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