Cost-effectiveness of umeclidinium/vilanterol combination therapy compared to tiotropium monotherapy among symptomatic patients with chronic obstructive pulmonary disease in the UK.

BACKGROUND: The cost-effectiveness of umeclidinium bromide-vilanterol (UMEC/VI) versus tiotropium monotherapy in the UK was assessed using a UMEC/VI treatment-specific economic model based on a chronic obstructive pulmonary disease (COPD) disease-progression model. METHODS: The model was implemented as a linked-equation model to estimate COPD progression and associated health service costs, and its impact on quality-adjusted life years (QALYs) and survival. Statistical risk equations for clinical endpoints and resource use were derived from the ECLIPSE and TORCH studies, respectively. For the selected timeframe (1-40 years) and probabilistic analysis, model outputs included disaggregated costs, total costs, exacerbations, life-years and QALYs gained, and incremental cost-effectiveness ratios (ICERs). RESULTS: Random-effects meta-analysis of tiotropium comparator trials estimated treatment effect of UMEC/VI as 92.17 mL (95 % confidence interval: 61.52, 122.82) in forced expiratory volume in 1 s. With this benefit, UMEC/VI resulted in an estimated annual exacerbation reduction of 0.04 exacerbations/patient and 0.36 life years gained compared to tiotropium over patient lifetime. With an additional 0.18 QALYs/patient and an additional lifetime cost of £372/patient at price parity, the incremental cost effectiveness ratio (ICER) of UMEC/VI compared to tiotropium was £2088/QALY. This ICER increased to £17,541/QALY when price of UMEC/VI was increased to that of indacaterol plus tiotropium in separate inhalers. The ICER improved when model duration was reduced from patient lifetime to 1 or 5 years, or when treatment effect was assumed to last for 12 months following treatment initiation. CONCLUSION: UMEC/VI can be considered a cost-effective alternative to tiotropium at a certain price.

Resource Use and Costs up to Two Years Post Diagnosis Among Newly Diagnosed COPD Patients in the UK Primary Care Setting: A Retrospective Cohort Study.

The objective of this study was to estimate the annual resource use and costs before and after COPD diagnosis and compare it across stages of airflow obstruction and levels of dyspnoea in the UK primary care setting. A retrospective cohort of newly diagnosed COPD patients (1/1/2008-31/12/2009) was identified in the UK Clinical Practice Research Datalink (CPRD). Resource use did not include medication costs and comprised of exacerbations, all cause GP interactions, and non-COPD hospitalisations, which were estimated for up to 12 months before and 24 months after COPD diagnosis. It was further stratified using baseline characteristics, Medical Research Council (MRC) dyspnoea score, and stages of airflow limitation. COPD costs were estimated using NHS reference costs. The analysis included 7881 newly diagnosed COPD patients (mean age, 67.2 years; 45% females). In the 2 years follow-up, the cohort experienced moderate and severe exacerbations, non-COPD hospitalisations, and GP surgery visits at an annual rate of 0.51, 0.13, 0.47, and 12.85, respectively. All resource components showed an upward trend with increase airflow limitation and dyspnoea. GP interactions accounted for 58.5% of annual per patient COPD management costs, estimated to be £ 2047 during the observation period. The annual costs doubled from patients with low levels of dyspnoea (MRC = 1; £ 1473) to those with high levels of dyspnoea (MRC = 5; £ 3243). COPD management costs in the primary care setting continued to remain high up to 2 years following initial diagnosis. The cost burden increased with high levels of dyspnoea and airflow obstruction, suggesting that both measures can identify patients requiring increased monitoring.

Cost effectiveness of golimumab for the treatment of active psoriatic arthritis.

BACKGROUND: Golimumab is a novel TNF-α inhibitor licensed to treat patients with active PsA. Although its clinical efficacy has been proven in clinical trials, its cost effectiveness is yet to be established. OBJECTIVES: To estimate the cost effectiveness of golimumab among patients with active PsA from the UK NHS perspective. METHODS: A decision analytic model was used to simulate progression of a hypothetical cohort of active PsA patients on golimumab and other TNF-α inhibitors as well as palliative care. The clinical evidence was derived from clinical trials of TNF-α inhibitors and compared using mixed treatment models. The primary outcome measure was quality-adjusted life years (QALYs) estimated based on change in Health Assessment Questionnaire (HAQ) and Psoriasis Area Severity Index (PASI) from baseline. The annual acquisition cost of golimumab was assumed to be identical to annual cost of other subcutaneous TNF-α inhibitors. The resource use costs and outcomes were discounted at 3.5% over a period of 40 years. The uncertainty surrounding important variables was further explored using probabilistic sensitivity analyses (PSA). RESULTS: TNF-α inhibitors were significantly superior to palliative care but comparable to each other on Psoriatic Arthritis Response Criteria (PsARC), HAQ and PASI response. The incremental cost effectiveness ratio (ICERs) for golimumab compared to palliative care was £16,811 for PsA patients and £16,245 for a subgroup of PsA patients with significant psoriasis. At an acceptability threshold of £30,000 per QALY, the probability of golimumab being cost effective is 89%. CONCLUSION: Once monthly, golimumab is a cost-effective treatment alternative for patients with active PsA. With its patient-focussed attributes, golimumab is likely to offer additional choice in PsA treatment.

Cost-effectiveness of infliximab for the treatment of active and progressive psoriatic arthritis.

BACKGROUND: Despite its proven efficacy, infliximab is often considered to be an expensive treatment for patients with psoriatic arthritis. OBJECTIVES: To estimate the cost-effectiveness of infliximab among patients with active and progressive psoriatic arthritis. METHODS: A decision analytic model was constructed to simulate disease progression in hypothetical cohorts of patients with psoriatic arthritis receiving infliximab maintenance treatment. The primary response measure was change in Health Assessment Questionnaire score from a baseline estimated from mixed treatment models drawn from published clinical trials. Palliative care, comprising nonbiologic disease-modifying antirheumatic drugs, was used as a comparator. The primary outcome was quality-adjusted life years. The dose of infliximab was estimated for a range of 60 to 80 kg per patient body weight. The costs and outcomes were discounted at 3.5% for a period of 40 years. Uncertainty around the results was explored with probabilistic sensitivity analysis. RESULTS: The mixed treatment comparison showed a significant reduction in Health Assessment Questionnaire score across all patients. The tumor necrosis factor α inhibitors were significantly superior to palliative care but comparable with one another. The incremental cost-effectiveness ratios for etanercept, adalimumab, and infliximab relative to palliative care were £17,327; £19,246; and £16,942 to £23,022, respectively, across all patients with psoriatic arthritis and £16,613; £18,170; and £15,788 to £21,736, respectively, in the subgroup with significant psoriasis. CONCLUSION: Infliximab represents a cost-effective treatment option well within the National Institute for Health and Clinical Excellence threshold relative to palliative care. In light of equivalent outcomes with other tumor necrosis factor α inhibitors, its position in the treatment pathway is likely to be governed by treatment costs.

Cost-effectiveness of scheduled maintenance treatment with infliximab for pediatric Crohn's disease.

BACKGROUND: Infliximab recently became the only biologic approved for use in pediatric patients with severe active Crohn's disease (CD). OBJECTIVES: To estimate the cost-effectiveness of scheduled maintenance treatment with infliximab compared with standard care in children suffering from severe active CD over 5 years from the UK National Health Service perspective. METHODS: A Markov model was constructed to simulate the progression of a hypothetical cohort of CD children through predefined health states on scheduled maintenance treatment with infliximab (5 mg/kg). The data to populate the model came from infliximab trials from Targan et al., ACCENT I, and REACH. The health states included in the model were remission, responding active disease, nonresponding active disease, surgery, postsurgery remission, postsurgery complications, and death. Standard care, comprising immunomodulators, and/or corticosteroids were used as a comparator. The primary outcome was quality-adjusted life-years (QALY) estimated using the EuroQol (EQ-5D) from a European CD population. To account for the weight-based dosing of infliximab, a baseline patient weight of 40 kg that increased by 5 kg/year up to 60 kg was used. The costs and outcomes were discounted at 3.5% over a period of 5 years. Probabilistic sensitivity analyses were performed by varying the infliximab efficacy estimates, costs, and utilities. RESULTS: The incremental cost-effectiveness ratio (ICER) for infliximab treatment was pound14,607 compared with standard care. The sensitivity analyses revealed the treatment effect of infliximab to be the most influential parameter with ICERs ranging from pound10,480 to pound37,017. Assuming a willingness to pay of pound30,000 per QALY, the probability of infliximab being cost-effective is 78.6%. CONCLUSION: Scheduled maintenance treatment with infliximab (5 mg/kg) is likely to be a cost-effective treatment in children suffering from severe active CD under an 8-week maintenance program.

Cost-effectiveness of infliximab for the treatment of acute exacerbations of ulcerative colitis.

BACKGROUND: Infliximab has been shown to be efficacious in acute exacerbations of ulcerative colitis (UC). AIM: To evaluate the cost-effectiveness of infliximab treatment in patients hospitalised with acute exacerbations of UC. METHODS: A decision analysis model was constructed to simulate the progression of acute UC patients treated with infliximab induction regimen over 1 year. Infliximab treatment was compared with standard care, ciclosporin and surgery using transitions derived from infliximab and ciclosporin randomised trials. Costs and outcomes were discounted at 3.5%. Intermediate outcomes of colectomy and post-surgery complications were translated into the primary effectiveness measurement, which was quality-adjusted life years (QALYs) estimated using EQ-5D. One-way and probabilistic sensitivity analyses were performed to estimate the uncertainty around the results. RESULTS: The incremental cost effectiveness ratio (ICER) for infliximab was pound19,545 per QALY compared to ciclosporin, which in turn dominated standard care. Sensitivity analysis indicated patient body weight, utility estimates and treatment effect of alternative treatment strategies to be the most important factors affecting cost-effectiveness. CONCLUSION: Infliximab induction regimen appears to be a cost-effective treatment option for UC patients hospitalised with an acute exacerbation.