1Khalid A. Alnaqbi, 2Nasra Al Adhoubi, 3Sara Al Dallal, 4Samar Al Emadi,5Adeeba Al Herz, 6Amin M. El Shamy, 7Suad Hannawi, 8Mohammed A. Omair, 9Sahar A. Saad, 10Tore K. Kvien
1Tawam Hospital; College Of Medicine & Health Sciences, UAE University, 2Royal Hospital, 3Dubai Health Authority, 4Hamad Medical Corporation, 5Al-Amiri Hospital, 6Ministry of Health and Prevention, 7Emirates Health Services, 8King Saud University, 9King Hamad University Hospital, 10Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital
Objective(s):
The treatment of rheumatic diseases with biologic agents has significantly improved disease management and patient outcomes; however, innovator reference products are associated with high costs which may limit access. Biosimilars, which are highly similar to reference products in terms of quality, safety and efficacy can reduce the financial burden and underutilization of medication while still being effective and safe.
The objective was to utilize the outputs of a comprehensive systematic review to develop evidence-based consensus recommendations and overarching principles aimed at standardizing and driving alignment on best practices for the use of biosimilars in treating adult patients with rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, and ankylosing spondylitis in the Gulf region.
Method(s):
A scientific committee comprising expert rheumatologists, pharmacists, and healthcare economists reviewed the outputs of a systematic literature review conducted to address PICO questions related to key topics and challenges regarding the use of biosimilars for the treatment of rheumatic diseases among patients in the Gulf region. They developed and critically reviewed recommendations and overarching principles based on the evidence using a GRADE-style approach to assess the quality of evidence and strength of recommendations.
Voting on the level of agreement on the overarching principles and consensus statements was conducted anonymously through an online voting system. This was performed using a 5-point Likert scale with a level of agreement of 70% or more required to reach a consensus.
External review and validation was conducted with a group of external stakeholders comprising rheumatologists, nurses, pharmacists, payers, regulators, and patients.
Result(s):
Consensus was reached for all overarching principles and recommendations by the scientific committee and external stakeholders. The recommendations are largely congruent with previously published guidelines, with adaptation for regional clinical practice and consideration of the nuances of the healthcare systems within the Gulf region.
Summary of principles and recommendations
The overarching principles emphasize the importance of increasing awareness, understanding, and perception of biosimilars among rheumatologists, patients, and other stakeholders in order to consider biosimilars in rheumatic disease treatment strategies. Collaborative efforts are required to standardize protocols for collecting real-world regional data and 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 switching/transitioning from reference products to approved biosimilars or between approved biosimilars, given the comparable efficacy, long-term safety, and immunogenicity profiles. 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 to develop standardized pharmacovigilance initiatives for generating data on the use of biosimilars, as well as national health policies governing the adoption and prescription of biosimilars in clinical practice across the Gulf region.
Conclusion(s):
The findings of this study represent the first regional consensus recommendations for the Gulf region based on a systematic literature review and PRISMA guidelines, integrating clinical evidence with clinical expertise to optimize decision-making for the use of biosimilars in adult patients with rheumatic diseases.