Clinical and economic consequences of switching from omalizumab to mepolizumab in uncontrolled severe eosinophilic asthma.

Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS), which worsen patients' health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics, but not optimally controlled by omalizumab. We retrospectively enrolled uncontrolled severe asthmatic patients who switched from OMA to MEP during the last two years. Information included blood eosinophil count, asthma control test (ACT), spirometry, serum IgE, fractional exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and diagnostic exams. Within the perspective of Italian National Health System, a pre- and post-MEP 12-month standardized total cost per patient was calculated. 33 patients were enrolled: five males, mean age 57 years, disease onset 24 years. At OMA discontinuation, 88% were OCS-dependent with annual mean rate of 4.0 clinically significant exacerbations, 0.30 exacerbations needing emergency room visits or hospitalization; absenteeism due to disease was 10.4 days per patient. Switch to MEP improved all clinical outcomes, reducing total exacerbation rate (RR = 0.06, 95% CI 0.03-0.14), OCS-dependent patients (OR = 0.02, 95% CI 0.005-0.08), and number of lost working days (Δ = - 7.9, 95% CI - 11.2 to - 4.6). Pulmonary function improved, serum IgE, FeNO and eosinophils decreased. Mean annual costs were €12,239 for OMA and €12,639 for MEP (Δ = €400, 95% CI - 1588-2389); the increment due to drug therapy (+ €1,581) was almost offset by savings regarding all other cost items (- €1,181). Patients with severe eosinophilic asthma, not controlled by OMA, experienced comprehensive benefits by switching to MEP with only slight increases in economic costs.

A cost-effectiveness analysis of reslizumab in the treatment of poorly controlled eosinophilic asthma.

Introduction: Poorly controlled severe eosinophilic asthma is difficult and costly to manage. Reslizumab, an add-on treatment for adults with severe eosinophilic asthma, reduces the number of exacerbations and improves the quality of life (QoL). The objective of this study was to evaluate the cost-effectiveness of reslizumab. Methods: A Markov model was used to compare the cost-effectiveness of add-on reslizumab with the standard-of-care (SOC) from the US societal perspective over a five-year time horizon. Efficacy and safety inputs for the model were based on data from two clinical trials (NCT01287039 and NCT01285323). Other model inputs, including mortality rates, costs, and utility, were estimated from literature, the Centers for Disease Control and Prevention (CDC), the US Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). One-way, threshold, and probabilistic sensitivity analyses (PSA) were performed. Adherence, treatment response, and the placebo effect were evaluated in separate scenario analyses. Results: The base case incremental cost-effectiveness ratio (ICER) was $697 403 (2017 USD) per quality-adjusted life-years (QALYs). In the PSA, reslizumab becomes cost-effective in 50% of the iterations at a willingness-to-pay (WTP) threshold of $689 000. The model is most sensitive to the QoL improvement with reslizumab treatment in the one-way and threshold analyses. The response and adherence models had lower ICERs than the base model but still above $500 000. The ICER of the placebo effect model was $29 820. Conclusions: The improvement in QoL and exacerbation rates with reslizumab are associated with high costs, making reslizumab unlikely to be cost-effective at the $200 000 WTP threshold.

Healthcare resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population.

BACKGROUND: Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and associated costs. AIMS: We sought to determine the prevalence of SUEA and compare asthma-related healthcare resource use (HCRU) and associated costs with overall means for a general asthma population. METHODS: This cohort study evaluated anonymised medical record data (December 1989 through June 2015) from the Clinical Practice Research Datalink and the Optimum Patient Care Research Database to study UK patients with active asthma (diagnostic code and one or more drug prescriptions in the baseline year), aged 5 years and older, without concomitant COPD, and with recorded eosinophil count. SUEA was defined as two or more asthma attacks during 1 baseline year preceding a high blood eosinophil count (≥0.3×109/L) for patients prescribed long-acting ß2-agonist (LABA) and high-dosage inhaled corticosteroids (ICS) during baseline plus 1 follow-up year. We compared asthma-related HCRU and associated direct costs (2015 pounds sterling, £) during the follow-up year for SUEA versus the general asthma population. RESULTS: Of 363 558 patients with active asthma and recorded eosinophil count, 64% were women, mean (SD) age was 49 (21) years; 43% had high eosinophil counts, 7% had two or more attacks in the baseline year and 10% were prescribed high-dosage ICS/LABA for 2 study years. Overall, 2940 (0.81%; 95% CI 0.78% to 0.84%) patients had SUEA. Total mean per-patient HCRU and associated costs were four times greater for SUEA versus all patients (HCRU and cost ratios 3.9; 95% CI 3.7 to 4.1). CONCLUSIONS: Less than 1% of patients in a general asthma population had SUEA. These patients accounted for substantially greater asthma-related HCRU and costs than average patients with asthma.