Budget Impact Analysis of Mepolizumab for Eligible Patients in the Setting of a Severe Asthma Clinic Within Dubai Health Authority (DHA).

Purpose: To estimate 5-years budgetary impact of introducing mepolizumab to eligible patients with uncontrolled severe eosinophilic asthma treated at a tertiary care hospital within Dubai Health Authority (DHA). Patients and Methods: A budget impact analysis (BIA) model was adapted to the setting of Rashid Hospital, DHA to estimate the budgetary implications of introducing first-in-class anti-IL5 (mepolizumab) as add-on therapy for eligible patients with severe eosinophilic asthma. The eligible patient population (n=60) was estimated from aggregate data provided by the clinic. Patients were eligible to treatment with mepolizumab if they had ≥2 exacerbation in the previous year and eosinophil count ≥150 cell/µL. The analysis compared the cost of treating patients in two alternative scenarios; a scenario where patients are treated with optimized usual care or with available biologic as add-on therapy, and a second scenario where mepolizumab is fully accessible to eligible patients. Results: Administration of mepolizumab to eligible patients at Rashid Hospital is predicted to result in overall savings estimated at £270,545 over a 5-year time horizon. Exacerbation rates could not be indirectly compared for mepolizumab and omalizumab, since treatment continuation rules were defined differently. Therefore, these parameters were directly taken from the clinical trials for mepolizumab and omalizumab. The savings were estimated due to drug acquisition costs (£269,900) and estimated reduction in exacerbation (n=15). One-way sensitivity analysis showed that the model results was most sensitive to changing the method of calculating omalizumab dose and varying the drug acquisition cost of omalizumab by ±20%. Conclusion: The BIA showed that full accessibility of mepolizumab to eligible severe asthma patients is predicted to be budget saving in the Dubai Health Authority. This evaluation is relevant to healthcare decision making as it demonstrates that mepolizumab is budget saving for eligible patients, while reducing burden by improving their control and symptoms.

Asthma control factors in the Gulf Cooperation Council (GCC) countries and the effectiveness of ICS/LABA fixed dose combinations: a dual rapid literature review.

BACKGROUND: Asthma control is influenced by multiple factors. These factors must be considered when appraising asthma interventions and their effectiveness in the Gulf Cooperation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates [UAE]). Based on published studies, the most prevalent asthma treatment in these countries are fixed dose combinations (FDC) of inhaled corticosteroid and long-acting beta-agonist (ICS/LABA). This study is a rapid review of the literature on: (a) factors associated with asthma control in the GCC countries and (b) generalisability of ICS/LABA FDC effectiveness studies. METHODS: To review local factors associated with asthma control and, generalisability of published ICS/LABA FDC studies, two rapid reviews were conducted. Review 1 targeted literature pertaining to asthma control factors in GCC countries. Eligible studies were appraised, and clustering methodology used to summarise factors. Review 2 assessed ICS/LABA FDC studies in conditions close to actual clinical practice (i.e. effectiveness studies). Eligibility was determined by reviewing study characteristics. Evaluation of studies focused on randomised controlled trials (RCTs). In both reviews, initial (January 2018) and updated (November 2019) searches were conducted in EMBASE and PubMed databases. Eligible studies were appraised using the Critical Appraisal Skills Program (CASP) checklists. RESULTS: We identified 51 publications reporting factors associated with asthma control. These publications reported studies conducted in Saudi Arabia (35), Qatar (5), Kuwait (5), UAE (3), Oman (1) and multiple countries (2). The most common factors associated with asthma control were: asthma-related education (13 articles), demographics (11articles), comorbidities (11 articles) and environmental exposures (11 articles). Review 2 identified 61 articles reporting ICS/LABA FDC effectiveness studies from countries outside of the GCC. Of these, six RCTs were critically appraised. The adequacy of RCTs in informing clinical practice varied when appraised against previously published criteria. CONCLUSIONS: Asthma-related education was the most recurring factor associated with asthma control in the GCC countries. Moreover, the generalisability of ICS/LABA FDC studies to this region is variable. Hence, asthma patients in the region, particularly those on ICS/LABA FDC, will continue to require physician review and oversight. While our findings provide evidence for local treatment guidelines, further research is required in GCC countries to establish the causal pathways through which asthma-related education influence asthma control for patients on ICS/LABA FDC therapy.

Therapeutics discovery: From bench to first in-human trials.

The 'Therapeutics discovery: From bench to first in-human trials' conference, held at the King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard Health Affairs (MNGHA), Kingdom of Saudi Arabia (KSA) from October 10-12, 2017, provided a unique opportunity for experts worldwide to discuss advances in drug discovery and development, focusing on phase I clinical trials. It was the first event of its kind to be hosted at the new research center, which was constructed to boost drug discovery and development in the KSA in collaboration with institutions, such as the Academic Drug Discovery Consortium in the United States of America (USA), Structural Genomics Consortium of the University of Oxford in the United Kingdom (UK), and Institute of Materia Medica of the Chinese Academy of Medical Sciences in China. The program was divided into two parts. A pre-symposium day took place on October 10, during which courses were conducted on clinical trials, preclinical drug discovery, molecular biology and nanofiber research. The attendees had the opportunity for one-to-one meetings with international experts to exchange information and foster collaborations. In the second part of the conference, which took place on October 11 and 12, the clinical trials pipeline, design and recruitment of volunteers, and economic impact of clinical trials were discussed. The Saudi Food and Drug Administration presented the regulations governing clinical trials in the KSA. The process of preclinical drug discovery from small molecules, cellular and immunologic therapies, and approaches to identifying new targets were also presented. The recommendation of the conference was that researchers in the KSA must invest more fund, talents and infrastructure to lead the region in phase I clinical trials and preclinical drug discovery. Diseases affecting the local population, such as Middle East Respiratory Syndrome and resistant bacterial infections, represent the optimal starting point.