Transurethral water vapor therapy for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a cost-minimization and budget impact analysis from an Italian healthcare perspective.

BACKGROUND: The aim of this study was to compare the costs and budget impact of adopting water vapor thermal therapy with the Rezum™ System, for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) to transurethral resection of the prostate (TURP), from an Italian hospital healthcare perspective. METHODS: A Markov model (4-year time horizon, 3-month cycle length), developed to support a submission to the National Institute of Health and Care Excellence (NICE) in England, was adapted to an Italian payer perspective. A cost minimization analysis was conducted, assuming equal efficacy between both therapies. Net difference in costs per patient was reported, considering procedure, adverse events and retreatment costs. Probabilistic and deterministic sensitivity analyses considered the uncertainty of the results. Population data and market share distribution assumptions were applied to a cohort of Italian patients treated in one year to report the budget and capacity impact of increased use of Rezum. RESULTS: Over 4 years, the costs per patient with Rezum were €2072 compared to €2836 with TURP, resulting in net savings of €764. Sensitivity analyses showed that this conclusion was robust. Replacing 10% of TURP procedures with Rezum generates cost-savings of € 7,139,549 over 4 years and saves 4671 theatre hours and 26,856 bed days in one year. Replacing 30% of BPH surgical procedures with Rezum generates cost-savings to € 21,418,647 over 4 years, saves 14,012 theatre hours and 80,567 bed-days in one year. CONCLUSIONS: This analysis demonstrates that Rezum is highly likely to be cost-saving compared to TURP from an Italian hospital healthcare perspective.

FreeStyle Libre Flash Glucose Monitoring system for people with type 1 diabetes in the UK: a budget impact analysis.

INTRODUCTION: This study aims to estimate the budget impact of increased uptake of the FreeStyle Libre Flash Glucose Monitoring system in people with type 1 diabetes mellitus (T1DM) in the UK. RESEARCH DESIGN AND METHODS: A budget impact model was developed, applying real-world data collected in the Association of British Clinical Diabetologists (ABCD) FreeStyle Libre Nationwide Audit. Costs of diabetes glucose monitoring in a T1DM population (n=1790) using self-monitoring of blood glucose (SMBG) or the FreeStyle Libre system were compared with a scenario with increased use of the FreeStyle Libre system. RESULTS: The ABCD audit demonstrates FreeStyle Libre system use reduces diabetes-related resource utilization. The cost analysis found that higher acquisition costs are offset by healthcare costs avoided (difference £168 per patient per year (PPPY)). Total costs were £1116 PPPY with FreeStyle Libre system compared with £948 PPPY with SMBG. In an average-sized UK local health economy, increasing FreeStyle Libre system uptake from 30% to 50% increased costs by 3.4% (£1 787 345-£1 847 618) and when increased to 70% increased by a further 3.3%. CONCLUSION: Increased uptake of the FreeStyle Libre system in the T1DM population marginally increases the cost to UK health economies and offers many system benefits.

Cost-effectiveness of andexanet alfa versus four-factor prothrombin complex concentrate for the treatment of oral factor Xa inhibitor-related intracranial hemorrhage in the US.

AIM: To conduct a cost-effectiveness analysis (CEA) on the use of andexanet alfa for the treatment of factor Xa inhibitor-related intracranial hemorrhage (ICH) from the US third-party payer and societal perspectives. METHODS: CEA compared andexanet alfa to prothrombin complex concentrate for the treatment of patients receiving factor Xa inhibitors admitted to hospital inpatient care with an ICH. The model comprised two linked phases. Phase 1 utilized a decision tree to model the acute treatment phase (admission of a patient with ICH into intensive care for the first 30 days). Phase 2 modeled long-term costs and outcomes using three linked Markov models comprising the six health states defined by the modified Rankin score. RESULTS: The analysis showed that the strategy of using andexanet alfa for the treatment of factor Xa inhibitor-related ICH is cost-effective, with incremental cost-effectiveness per quality-adjusted life-year gained of $35,872 from a third-party payer perspective and $40,997 from a societal perspective over 20 years. LIMITATIONS: (1) Absence of head-to-head trials comparing therapies included in the economic model, (2) lack of comparative long-term data on treatment efficacy, and (3) bias resulting from the study designs of published literature. CONCLUSION: Given these results, the use of andexanet alfa for the reversal of anticoagulation in patients with factor Xa inhibitor-related ICH may improve quality of life and is likely to be cost-effective in a US context.

The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe.

Nonalcoholic fatty liver disease (NAFLD) is a major cause of chronic liver disease. There is uncertainty around the economic burden of NAFLD. We constructed a steady-state prevalence model to quantify this burden in the United States and Europe. Five models were constructed to estimate the burden of NAFLD in the United States and four European countries. Models were built using a series of interlinked Markov chains, each representing age increments of the NAFLD and the general populations. Incidence and remission rates were calculated by calibrating against real-world prevalence rates. The data were validated using a computerized disease model called DisMod II. NAFLD patients transitioned between nine health states (nonalcoholic fatty liver, nonalcoholic steatohepatitis [NASH], NASH-fibrosis, NASH-compensated cirrhosis, NASH-decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, post-liver transplant, and death). Transition probabilities were sourced from the literature and calibrated against real-world data. Utilities were obtained from NAFLD patients using the Short Form-6D. Costs were sourced from the literature and local fee schedules. In the United States, over 64 million people are projected to have NAFLD, with annual direct medical costs of about $103 billion ($1,613 per patient). In the Europe-4 countries (Germany, France, Italy, and United Kingdom), there are ∼52 million people with NAFLD with an annual cost of about €35 billion (from €354 to €1,163 per patient). Costs are highest in patients aged 45-65. The burden is significantly higher when societal costs are included. CONCLUSION: The analysis quantifies the enormity of the clinical and economic burdens of NAFLD, which will likely increase as the incidence of NAFLD continues to rise. (Hepatology 2016;64:1577-1586).