Health economics is set to undergo significant changes in Saudi Arabia as the Saudi Food and Drug Authority (SFDA) has announced new guidelines for full or partial economic evaluations. These guidelines will become mandatory in 2025, marking a pivotal shift in how health economic evaluations are conducted for new chemical entities and biologics in the country. Companies seeking to introduce new medications will now have to provide comprehensive economic evaluations, including budget impact analysis, cost-effectiveness analysis, or cost-utility analysis.
The SFDA’s new requirements stipulate that submissions must include detailed information about the disease targeted by the medication, its prevalence and incidence, the targeted population, and the number of patients both globally and within Saudi Arabia. Additionally, companies will need to document their drugs’ current market share if they are already available in the market or provide estimates for the next five years if the drugs have not yet been launched. This comprehensive approach ensures that the SFDA has a clear understanding of the potential impact and reach of new medications.
Health Economics: New Guidelines Emphasize Detailed Access Agreements for Medication Submissions in Saudi Arabia
Moreover, the submission dossier must encompass details of any existing access agreements, such as entry agreements, localization initiatives, incentives granted, breakthrough designations, patient support programs, and other initiatives aimed at supporting access. This information is crucial as it highlights the strategies in place to make the medication accessible and affordable to the target population.
The SFDA also emphasizes the importance of understanding how other leading health technology assessment (HTA) agencies have evaluated similar medicines. Consequently, companies will be required to submit details of published economic evaluations, including specifics on the disease area, time horizon, method of analysis, model used, comparators, cost measures, outcome measures, results, and conclusions.
Additionally, summaries of conclusions from evaluations conducted by agencies such as NICE, ICER, Canada’s Drug Agency, Haute Autorité de Santé, and the Pharmaceutical Benefits Advisory Committee must be included. This comparative analysis ensures that the SFDA can benchmark new treatments against international standards and best practices.
For full economic evaluations, which include cost-effectiveness analyses (CEAs), cost-utility analyses (CUAs), cost-minimization analyses (CMAs), and cost-benefit analyses (CBAs), clinical data should be derived from randomized controlled trials, real-world evidence, and/or network meta-analysis. Comparators must reflect the current standard of care, including the least expensive and most effective treatments, and the inclusion of emerging technologies is encouraged.
Health Economics: Saudi Arabia Sets Stringent Cost-Effectiveness Thresholds in New Guidelines
The current estimated cost-effectiveness threshold in Saudi Arabia is SAR 50,000-75,000 ($13,331-19,996) per QALY, although exceptions may be made for certain products. The annual discount rate of 3-5% must be included for cost calculations. This threshold is significantly below the Saudi GDP per capita figure of $28,895 in 2023, as reported by the World Bank, highlighting the stringent economic evaluation standards set by the SFDA.
For partial economic evaluations, such as budget impact analyses, the perspective should be that of the healthcare payer. Cost data must be derived from the Saudi healthcare system and should include direct healthcare costs. The required time horizon for these analyses is 2-5 years. Comparators should reflect the current standard of care, including the least expensive and most effective treatments, and the inclusion of emerging technologies is encouraged. This approach ensures that the economic evaluations are grounded in the realities of the Saudi healthcare system and provide a realistic assessment of the financial implications of new treatments.
Although adherence to the new guidelines is currently voluntary, it will become mandatory for general requirements starting in January 2025 and for economic evaluation requirements from July 2025. This phased approach allows companies time to adjust to the new requirements and ensure their submissions meet the necessary standards.
In conclusion, the new health economic guidelines introduced by the SFDA represent a significant advancement in the evaluation of new chemical entities and biologics in Saudi Arabia. By requiring comprehensive economic evaluations and benchmarking against international standards, the SFDA aims to ensure that new treatments are not only effective but also economically viable.
This move is expected to enhance the overall quality of healthcare in Saudi Arabia and ensure that patients have access to the best possible treatments. The implementation of these guidelines will undoubtedly present challenges for pharmaceutical companies, but it also offers an opportunity to demonstrate the value and impact of their innovations in a rigorous and transparent manner.
This new was inspired by Neil Grubert.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
