ABSTRACT
Introduction: Real-world evidence (RWE) is increasingly being used in coverage, reimbursement and formulary decisions for medicines globally.
Areas covered: The Middle East (ME) region is significantly behind in generating and using RWE in health policy decisions due to several factors that shaped the health sector over the past few decades. The trend, however, is changing due to several factors that are shaping the future of the healthcare industry in the region. Among other factors, rising healthcare cost, changing population and disease demographics, increased focus on the quality of healthcare, digitization of medical data, increased demand for local clinical and economic data, and overall greater influence of global trends in the healthcare industry. For the region to realize the benefit of RWE in healthcare decisions, it needs to overcome several challenges including embracing the value that RWE brings to healthcare decisions, building trust between stakeholders, establishing reliability and validity of databases used to generate RWE, enhancing technical capabilities, investing in local data generation, and conducting high-quality RWE studies while maintaining patients’ confidentiality.
Expert commentary: We believe that the next decade will witness significant increase in RWE generation in the region, and will play a key role in driving efficiency in healthcare delivery.
Acknowledgments
We wish to thank Mrs. Marina Al-Bada, MSc. for her assistance in the preparation of this manuscript. M Al-Bada is affiliated with Novartis Pharma AG.
Declaration of interest
KS Akhras was employed by Novartis Pharma at the time of writing this manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.