Consensus-Based Recommendations for the Implementation of Health Technology Assessment in the United Arab Emirates.

OBJECTIVES: Healthcare research and development have accelerated at an unprecedented rate creating a challenge even for high-income countries to finance all new technologies. Health technology assessment (HTA) aims to maximize health gains out of available resources. Our study aimed to provide tailor-made recommendations for HTA implementation in the United Arab Emirates (UAE). METHODS: We conducted a policy survey to explore the gap between the current and preferred future environment of HTA implementation in the UAE. The survey was distributed in 2 workshops discussing the importance of HTA implementation, and results were further aggregated to yield a list of draft recommendations. Recommendations were then assessed for their feasibility in a round table discussion with experts in the field to generate actions for HTA implementation. RESULTS: Survey results and round table discussion indicated the need to leverage HTA for value-based decision making. Experts confirmed the unmet need for broader coverage of graduate and postgraduate HTA training with the aim of specific PhD programs in the UAE. Public funding for HTA appraisals and expanding the scope of HTA to nonpharmaceuticals was recommended. Furthermore, experts recommended that several HTA bodies should be coordinated centrally and highlighted the importance of having an explicit soft cost-effectiveness threshold for common technologies and a higher threshold for orphan drugs. CONCLUSIONS: Although HTA in the UAE is still in its early stages, strong initiatives are being taken for its implementation. Our survey results served as a step in developing a detailed action plan for HTA implementation that will enhance the sustainability of the healthcare system.

Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region.

BACKGROUND: Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication. OBJECTIVE: The objective of this initiative was to develop an evidence-based consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region. METHODS: A task force of practicing rheumatologists, a clinical pharmacist, a health economist, patients, regulators, and payors from across the Gulf region developed recommendations and overarching principles based on the outputs of a systematic literature review conducted to address Patient-Intervention-Comparison-Outcome (PICO) questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region. As the data before 2017 have been previously reviewed in another publication, the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002). Consensus on each statement required a level of agreement of 70% or greater. RESULTS: Consensus was reached for five overarching principles and nine recommendations by the task force. The principles emphasize the importance of improving the awareness, understanding, and perception of biosimilars, as well as the need for regulated regional real-world data generation and protocols to make biosimilars a viable and affordable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering biosimilars. They further recommend that confirmation of a biosimilar's efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, there is a need for pharmacovigilance and national health policies governing the adoption and prescription of biosimilars in clinical practice across the region. CONCLUSIONS: These are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world.

Overview of Procurement and Reimbursement of Pharmaceuticals in Saudi Arabia, United Arab Emirates, Qatar, and Egypt: Challenges and Opportunities.

Introduction: There is an increased interest in cost consciousness concerning healthcare spending worldwide. In the Arab world, a major transformation is underway in the healthcare sectors to achieve national and government visions to attain better outcomes with optimal value. This article contains expert recommendations on how decision-makers can implement pharmacoeconomic principles at a national level in the Arab world. Methods: A multidisciplinary panel of experts was formed of policymakers, clinical pharmacists, health economists, and chronic disease control and public health experts from different countries and healthcare sectors. The panel developed consensus recommendations for different stakeholders using a framework analysis method. Results: The experts discussed the limitations and opportunities of implementing the pharmacoeconomics concept in evaluating new technologies in their respective countries. Common limitations recognized in the included countries were a lack of infrastructure to support the adoption of the concept in practice, challenges in obtaining data to support the decision-making process, and the lack of human resources to raise awareness among decision-makers and the public to use health economics in making informed decisions in reimbursing new technologies. Conclusion: The expert panel recommendations will guide relevant stakeholders at a national level per country. Adapting these recommendations to each setting is essential to accommodate the situation and needs of each country.