This study demonstrates that add-on omalizumab therapy is cost-effective in patients with severe persistent allergic asthma.
Given the apparent importance of triggers in attaining and maintaining asthma control, empirical research concerning optimal trigger management is needed. Results demonstrate that asthma triggers are similar across continents, suggesting a global checklist of triggers for use in research and clinical practice would be feasible.
BackgroundMedications for respiratory disorders including asthma and chronic obstructive pulmonary disease (COPD) are typically delivered to the lung by means of a handheld inhaler. Patient preference for and ability to use the inhaler may influence their adherence to maintenance therapy, and adherence may affect treatment outcomes. In this study, patient experience of using a dry powder inhaler (DPI), the ELLIPTA™ DPI, in clinical trials of a new maintenance therapy for asthma and COPD was investigated. The ELLIPTA DPI has been designed to contain two separate blister strips from which inhalation powder can be delivered, and to be simple to use with a large, easy-to-read dose counter.MethodsSemi-structured, in-depth, qualitative interviews were carried out 2–4 weeks after patients had completed one of six phase IIIa clinical trials using the ELLIPTA DPI. Interview participants were asked about their satisfaction with various attributes of the inhaler and their preference for the ELLIPTA DPI relative to currently-prescribed inhalers, and responses were explored using an inductive content analysis approach. Participants also rated the performance of the inhaler on several criteria, using a subjective 1–10 scale.ResultsParticipants with asthma (n = 33) and COPD (n = 42) reported high levels of satisfaction with the ELLIPTA DPI. It was frequently described as straightforward to operate and easy to use by interview participants. Ergonomic design, mouthpiece fit, and dose counter visibility and ease of interpretation emerged as frequently cited drivers of preference for the ELLIPTA DPI compared with their current prescribed inhaler. Of participants with asthma, 71% preferred the ELLIPTA DPI to DISKUS™ and 60% to metered dose inhalers. Of participants with COPD, 86% preferred the ELLIPTA DPI to DISKUS, 95% to HandiHaler™, and 85% to metered dose inhalers. Overall average performance scores were >9 (out of 10) in participants with asthma and COPD.ConclusionThe ELLIPTA DPI was associated with high patient satisfaction and was preferred to other inhalers by interview participants with asthma and COPD. The development of an inhaler that is regarded as easy and intuitive to use may have positive implications for adherence to therapy in asthma and COPD.Trial registrationAsthma: NCT01165138, NCT01431950. COPD: NCT01053988, NCT01054885, NCT01009463, NCT01017952.
Many studies have estimated utilities in ESRD patients, but only a few have estimated utilities based upon public preferences. Further empirical research is needed to produce more reliable utilities for economic modelling in the UK, especially in chronic kidney disease patients who do not require dialysis.
Objective:To identify the types, frequency and impact of asthma triggers and the relationship to asthma control among adults with asthma in Europe.Methods:Adults with self-reported physician-diagnosed asthma receiving maintenance asthma treatment and self-reported exposure to known asthma triggers completed an online questionnaire; a subset completed a diary over 3–4 weeks. Information on asthma control (Asthma Control Test™ [ACT]), asthma triggers, frequency of exposure and behaviours in response or to avoid asthma triggers and the perceived impact on daily life was captured. A post-hoc analysis evaluated the impact of high trigger burden on the frequency of severe asthma exacerbations, hospitalisations and days lost at work/study.Results:A total of 1202 adults participated and 177 completed the diary. Asthma was uncontrolled for the majority (76%) of participants and most (52%) reported exposure to 6–15 asthma triggers. As trigger burden increased, behavioural changes to manage trigger exposure had a significantly increased impact on daily life (p < 0.0001) and job choice (p = 0.002). Participants reporting a high trigger burden (>16) were more likely to report uncontrolled asthma than those with a low trigger burden (1–5). Participants with a high trigger burden had previously experienced on average two more severe asthma attacks during a lifetime (p < 0.001), two more hospitalisations (p < 0.001) and 3.5 more missed days at work or study in the last year due to their asthma (p < 0.001) than those with a low trigger burden.Conclusions:Adults with asthma reporting a high trigger burden (>16 different triggers) experience more severe asthma attacks than those reporting lower trigger burdens.
People with asthma who do not adhere to their maintenance medication may experience poorer asthma control and need more healthcare support than those who adhere. People (N = 1010) aged 18–55 years with self-reported asthma, taking one or more asthma maintenance medication(s), from five European countries, participated in a survey using validated scales (Medication Adherence Report Scale [MARS], Asthma Control Test™ [ACT], Beliefs about Medicine Questionnaire [BMQ] and the Asthma Treatment Intrusiveness Questionnaire [ATIQ]). We performed a post hoc evaluation of adherence to maintenance medication, asthma control, beliefs about medication, preferences for once-daily vs. twice-daily asthma maintenance medication and treatment intrusiveness, using structural equation modelling to investigate the relationships between these factors. Most participants reported potential problems with asthma control (ACT < 19: 76.8% [n = 776]), low adherence (median MARS = 3.40) and preferred once-daily medication (73.5% [n = 742/1010]). Non-adherence was associated with worse asthma control (r = 0.262 [P < 0.001]) and a expressed preference for once-daily medication over a "twice daily medication that works slightly better" (test statistic [T] = 2.970 [P = 0.003]). Participants reporting non-adherence/preferring once-daily medication had negative beliefs about their treatment (BMQ necessity-concerns differential: r = 0.437 [P < 0.001]/T = 6.886 [P < 0.001]) and found medication intrusive (ATIQ: r = −0.422 [P < 0.001]/T = 2.689[P = 0.007]). Structural equation modelling showed complex relationships between variables, including: (1) high concerns about treatment associated with increased perceived treatment intrusiveness and reduced adherence, which influenced asthma control; (2) high concerns about treatment and healthcare seeking behaviour, which were predictive of preferring twice-daily asthma medication. Concerns about medication and perceived treatment intrusiveness were predictive of poor adherence, and were associated with preference for once-daily asthma medication. Confirm the utility of the PAPA model and NCF in explaining nonadherence linked to poor asthma control.
Acceptable reproducibility of the percentage of RFD (ICC = 0.78) was only observed for the e-diary using the FEV(1) stability criterion. The ICCs for SFD and RFD were acceptable, 0.84 and 0.70, respectively, suggesting better reliability for the e-diary.
Aims: Nivolumab has been approved for advanced squamous and non-squamous non-small cell lung cancer (NSCLC) following platinum-based chemotherapy in both Canada and Sweden. We aimed to determine the value-for-money of nivolumab versus docetaxel in a Canadian and Swedish setting based on 5-year data. Methods: These cost effectiveness analyses used partitioned survival models with three mutually exclusive health states: progression-free, progressed disease, and death. All clinical parameters were derived from two registration phase 3 randomized trials, CheckMate 017 and CheckMate 057, with a minimum follow-up of 5 years. Treatment duration was based on time-on-treatment data from the clinical trials. Costs were derived from published sources. The primary outcomes of the analyses were quality-adjusted life-years (QALYs), life-years gained, and incremental cost-effectiveness ratios (ICERs). The model input parameters for each analysis were chosen in line with guidance from the respective HTA authorities. Results: From a Canadian payer perspective, the ICERs were CAN$140,753 per QALY in the squamous population, and CAN$173,804 per QALY in the non-squamous population, assuming a 10-year time horizon and a 5% discount rate for both costs and outcomes. Sensitivity analyses demonstrated that changes to the discount rates for outcomes had the highest impact on the ICERs. In the Swedish analysis, the ICERs were SEK568,895 per QALY in the squamous population and SEK662,991 per QALY in the non-squamous population, assuming a 15-year time horizon, a 3% discount rate, and a 2-year maximum treatment duration for nivolumab. Sensitivity analyses demonstrated that the ICERs were most sensitive to changes in the discount rate for outcomes. Conclusion: These updated analyses, based on more mature trial data with a minimum follow-up of 5 years, generate more favorable ICERs versus the previously submitted HTA assessments that resulted in approval of nivolumab for patients with previously treated NSCLC in Canada and Sweden.
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