P&R brief Saudi Arabia: Navigating P&MA implications of the new SFDA economic guidelines

Aligned with Vision 2030 and the Saudi Ministry of Health’s national health transformation program, focused on creating a value-based healthcare system, the Saudi Food and Drug Authority (SFDA) has issued guidelines for the evaluation of economic studies. Its overall objective is to integrate pharmacoeconomic evaluation methods into the decision-making processes for pricing and reimbursement of novel drugs.

The recent Saudi Food and Drug Authority (SFDA) guidelines propose a gradual implementation of general requirements and economic studies as part of a new dossier submission. 

General requirements will include local epidemiological data, market share, the drug’s marketing plan (including its targeted healthcare setting and distribution channel) as well as the planned access agreements (e.g., Patient Support Programs, entry agreements).

Economic evaluation pertains to the submission of the most appropriate economic evaluation study based on…