SFDA New Economic Evaluation Guide:

The SFDA – هيئة الغذاء والدواء, Saudi Food & Drug Authority (“SFDA“) issued new guidance document, entitled Economic Evaluation Studies Guidelines, Version 1 of July 2024 (“EES Guidance“). It aims to help manufacturers, marketing authorization holders, and agents by describing a standard method for performing, submitting, or publishing an Economic Evaluation Study (“EES“).

This guidance will have a phased implementation as follows:

• July-December 2024, voluntary for General Requirements and For Economic Evaluation Requirements;
• January – June 2025, mandatory for General Requirements and voluntary for Economic Evaluation Requirements; and
• July 2025, mandatory for both General and Economic Evaluation Requirements.

SFDA uses EES’ to determine the added value deserved over the current standard of practice utilized in Saudi Arabia’s healthcare system. During SFDA’s pricing of pharmaceutical products, SFDA may consider economic studies; innovative and biological product pricing should take into account “clinical comparative studies and pharmacoeconomics studies with registered therapeutic alternatives” (Article 3 of the Pharmaceutical Pricing Rules).

This new EES Guidance applies to all human pharmaceutical products undergoing pricing procedures including, registration, price re-evaluation, and renewal in SFDA.

GENERAL REQUIREMENTS

General requirements include:

1. Epidemiological Data: Information on the disease, its prevalence, incidence, targeted population, no. of patients both globally and in Saudi Arabia;
2. Market Share: The proportion of the pharmaceutical product sales in volume and value compared to the total number of alternatives used in treating the same condition. Information on the current market share of the product in Saudi Arabia are required to be documented in the submission file to the SFDA. In case of a new product, the estimates of the market share for the upcoming five years are required to be documented;
3. Drug Marketing Plan: Drug marketing plan refers to the targeted segment of healthcare in Saudi Arabia that the product is mainly distributed in. Information on the targeted segment should be presented in the submission file to the SFDA; and
4. Access Agreements: Access agreements are defined as arrangements with companies at time of submission to address points supporting the access of medicine, such as: 1. Entry agreements; 2. Localization; 3. Incentives granted; 4. Breakthrough designation; 5. Patient Support Program (PSP); or 6. any other initiatives to support the access of medicine.

In addition, a summary conclusion from the following Health Technology Assessment (HTA) agencies are required to be presented, such as: The National Institute for Health and Care Excellence (NICE); Institute for Clinical and Economic Review (ICER); Canadian Agency for Drugs and Technologies in Health (CADTH); Haute Autorité de santé (HAS); Pharmaceutical Benefits Advisory Committee (PBAC) …etc.

EES REQUIREMENTS

The SFDA EES Guidance provides information on the most suitable EES based on the product type (such as new chemical, biologic, general chemical, biosimilar), including full economic evaluation (such as cost effectiveness analysis, cost minimization analysis, and cost utility analysis) and partial economic evaluation (such as budget impact analysis).

For generic chemical products, it’s optional to submit an EES.

The relevant forms are attached in the EES Guidance’s appendix, which should be submitted to the SFDA as part of the eCTD section 1.8.2 (Other documents related). The applicant must provide justifications for not submitting any required data.