HTA in MENA: A Practical Guide for 2025

Health Technology Assessment in MENA is no longer optional. With Saudi Arabia's NCBE expanding its scope, Egypt rolling out its UHC framework, and the UAE tightening reimbursement criteria, companies that treated HTA as a formality are now facing delisting and price renegotiations.

The shifting landscape

Five years ago, a strong clinical trial package was sufficient for most GCC registrations. Today, health authorities are asking harder questions: What is the cost per QALY in our population? What is the budget impact over three years? What comparators are relevant to our formulary?

Key frameworks to understand

Saudi Arabia (NCBE): The most structured HTA process in the region, now requiring full economic submissions for high-cost medicines and vaccines. The NCBE uses ICER thresholds calibrated to Saudi GDP per capita.

UAE (DOH / DHA): A tiered approach — routine submissions for established classes, enhanced review for novel mechanisms and orphan drugs. Budget impact is weighted heavily.

Egypt (HIOC): With universal health coverage expanding, Egypt is building HTA capacity rapidly. Early engagement with HIOC is strongly advised.

Building a submission that works

The most effective submissions we see share three characteristics: they use local utility data (or transparently justify using European proxies), they model the comparator landscape accurately, and they engage the payer narrative — not just the clinical story.

Practical next steps

If you have a product entering MENA markets in 2025–2026, now is the time to commission a gap analysis of your existing dossier against regional HTA requirements. Biowave can conduct this analysis and develop a submission strategy aligned to your specific markets and timeline.