Introduction
The Saudi Food & Drug Authority (SFDA) published their Economic Evaluation Studies Guidelines on the 10th July 2024. The guidelines are designed to assist manufacturers, marketing authorisation holders, or agents in conducting and submitting Economic Evaluation Studies (EES). These studies will be evaluated by the SFDA to determine their value over the existing healthcare practices in Saudi Arabia.
EES are critical tools used to analyse the cost and consequences of alternative courses of action in healthcare. The SFDA categorises EES into two main types:
- Partial Economic Studies: focus on either cost or consequence independently, such as Budget Impact Analysis (BIA)
- Full Economic Studies or Pharmacoeconomics Evaluation Studies (PES): Compare different interventions in terms of both cost and added value, including Cost Effectiveness Analysis (CEA), Cost Minimisation Analysis (CMA), Cost Utility Analysis (CUA), and Cost Benefit Analysis (CBA)
The Economic Evaluation Studies Guidelines specify general requirements, which will become mandatory in January 2025, and EES requirements, which will become mandatory in July 2025.
General requirements
Epidemiological data: submissions must include comprehensive data on the disease, its prevalence, incidence, and the targeted population globally and in Saudi Arabia.
Market share: information on the product’s market share in Saudi Arabia is required. For new products, market share estimates for the next five years must be provided.
Drug marketing plan: details about the drug marketing plan, including the targeted healthcare segment in Saudi Arabia, must be presented. This includes specifying whether the product will be distributed in hospitals, retail pharmacies, or the whole market, and its prescription type (e.g., OTC, controlled).
Access agreements: applicants must detail any access agreements anticipated for Saudi Arabia, such as entry agreements, incentives, and patient support programmes.
List of published EES and Health Technology Assessment decisions: submissions should include information on published EES and summaries of Health Technology Assessment (HTA) decisions from recognised agencies like NICE, ICER, CADTH, HAS, and PBAC.
EES requirements
The SFDA mandates at least one type of EES based on the product type. See Table 1.
Full economic evaluation and partial economic evaluation key criteria
Full economic evaluation | Partial economic evaluation (for Budget Impact Analysis (BIA) | |
Study objectives | The study objective(s) should be clearly stated including research questions for each goal | The study objective(s) should be clearly stated including research questions for each goal |
Targeted population | Detailed specifications, including sub-group analyses | Detailed specifications, including sub-group analyses |
Perspective of analysis | Indicating healthcare payer and/or societal perspectives | Healthcare payer perspective |
Time horizon | Including the natural disease history or encapsulating all cost and outcome differences | Typically 2-5 years |
Comparator | The comparator should be included from the current standard of practice. This include the least expensive and the most effective treatments available at least. Inclusion of emerging technologies are encouraged. | The comparator should be included from the current standard of practice. This include the least expensive and the most effective treatments available at least. Inclusion of emerging technologies are encouraged. |
Cost calculations | All relevant costs from the perspective chosen. The direct healthcare costs are required to be included at least. | |
Outcomes measurement | The outcome effectiveness measurement should be stated clearly in the evaluation. Quality Adjusted Life Years (QALYs) are acceptable for CUA. | |
Sensitivity analysis | Addressing uncertainties in the base-case scenario with probabilistic and deterministic analyses | Scenario analysis |
Conclusion
Saudi Arabia has long been considered an emerging market, much like many other countries in the MENA region. However, recent developments suggest these markets are no longer just “emerging”; they are becoming major players in the biopharma industry with tremendous growth potential.
Notably, the SFDA’s Economic Evaluation Studies Guidelines seem to be based on a combination of methodologies, incorporating practices from British and European HTA bodies. This integration underscores Saudi Arabia’s commitment to advancing its healthcare sector and enhancing its global standing in the biopharma industry.
What is the impact?
The SFDA’s guidelines for Economic Evaluation Studies represent both a challenge and an opportunity. The requirement for comprehensive economic evaluations allows manufacturers to clearly demonstrate the added value of their drugs over existing treatments. If a drug can be shown to provide significant health benefits relative to its costs, it can justify a higher price. By promptly and effectively developing localised strategies that align with the latest requirements, manufacturers can position themselves for success in the rapidly evolving Saudi market.
Source:
https://sfda.gov.sa/sites/default/files/2024-07/EconomicEvaluationStudies.pdf.Accessed 17/07/2024