Novel Health Technology Assessment (HTA) Guidelines in Abu Dhabi
Novel Health Technology Assessment (HTA) Guidelines in Abu Dhabi
Article written by Ari Levin and Amy Morgan, Windrose Consulting Group
Situation Assessment:
Innovative pharmaceutical products are constantly seeking access to developed and emerging markets across the globe, but gaps in clinical evidence and limited real-world data often leave uncertainty around their true value and impact on health and societal benefits. Health Technology Assessments (HTA) present a systematic and multidisciplinary framework for evidence-based evaluations of new therapies (i.e., pharmaceuticals and medical devices); typically conducted by governmental bodies, HTA aims to predict the expected clinical, economic, and societal value, and provide guidance on how these therapies may fit into health guidelines [1]. In June 2025, the Abu Dhabi Department of Health (DoH) established new HTA guidelines to provide a structured and standardized framework for evaluating new health technologies, and to support informed decisions on adoption, utilization, and management of new technologies in the Emirate of Abu Dhabi. Importantly, this development aligns with a broader Gulf region trend, as countries such as Saudi Arabia, Qatar, and Bahrain are also advancing HTA frameworks to evaluate both comparative efficacy against current standard of care and the economic feasibility of new product introduction. Despite this initiative, the UAE as a whole still lacks a unified HTA system. Regional initiatives are emerging in other Emirates such as Dubai, signaling a potential shift to a national HTA system in the future. For now, Abu Dhabi will lead in formalizing its own HTA system while assisting in broader implementation by focusing on coordination between territories, capacity building, and stakeholder engagement.
Step 1 – Clinical Evaluation
The new HTA guidelines are not intended to reassess previously reimbursed technologies, but future revisions, which are updated every two years, will expand to include them. For now, the DoH requires appraisal of innovative health technologies (both pharmaceuticals and medical equipment) launching in a first or new indication, targeting new patient populations, or offered in a new dosage form or formulation. Priority will be placed on biologics and Advanced Medical Treatment Products, such as gene therapies, specialized biologics, and CAR-T cells, with the process ultimately extending to all new innovative branded pharmaceuticals. High-cost products are also in scope, defined as those exceeding AED 10 million annually or AED 100,000 per patient per year. Generics remain excluded, though future revisions may consider provisional reviews.
As a first step, the DoH will conduct clinical evaluations to determine the relative safety and clinical effectiveness compared to existing standards of care (SoC). This is to be led by the Health Life Sciences Sector, a scientific evaluation body within the DoH, and will involve a detailed review of the target indication, therapeutic area, and intended patient population, including defining relevant unmet needs, gaps in effective treatment, or limitations of existing therapies. Evaluators will also consider the broader disease burden and whether the new technology could address disparities in access or outcomes for vulnerable groups.
Applicants must provide evidence from high-quality clinical trials, ideally randomized controlled trials or systematic meta-analyses, supplemented by real-world evidence where relevant. The clinical evaluation will examine mortality, morbidity, quality of life, functional outcomes, and patient satisfaction, while also establishing the benefit-risk considerations for the new therapy. If local epidemiological data is unavailable, international data may be considered, though preference is given to UAE or regional sources to ensure applicability. Early engagement with Pharmacy and Therapeutics Committees within healthcare facilities is also built into the process, allowing for alignment on efficacy assessments in relation to the final therapeutic positioning to be applied across Abu Dhabi. Ultimately, the clinical assessment serves as the foundation for all subsequent appraisal steps, defining how a therapy compares to existing options and where it fits in the Emirate treatment landscape. A determination of meaningful added benefit over the SoC strengthens the case for a positive HTA outcome and can influence both the economic evaluation and final reimbursement decision. Without this demonstration of comparative value, even promising therapies may face significant hurdles in securing market access in Abu Dhabi.
Step 2 – Economic Analyses
Historically, reimbursement decision-making in Abu Dhabi has centered on budget impact, measuring the affordability of new therapies within the health system over a short-term horizon (often 1-3 years). Under the new DoH HTA guidelines, this approach will evolve. The Healthcare Payer Sector, an economic evaluation body within the DoH, will now require both a cost-effectiveness analysis (CEA) and a budget impact analysis (BIA) as part of the second step in the HTA process. This shift aligns Abu Dhabi with global HTA standards by assessing not only the financial feasibility of adopting a new therapy but also its long-term value for money. Both the BIA and CEA analyses must be conducted from the perspective of publicly funded healthcare payers (e.g., programs such as Thiqa*), which place emphasis on drug acquisition costs, administration, hospitalizations, etc., and use authorized, covered standards of care as comparators. Local cost and resource utilization data take precedence, while international clinical data may be accepted if justified for relevance to the Abu Dhabi setting. The DoH has also introduced an incremental cost-effectiveness ratio (ICER) threshold set at 0.75 times GDP per capita, which can be increased through multipliers for disease severity, health gain, and rarity. For high-cost therapies, managed entry agreements (i.e., price-volume agreements) or risk-sharing arrangements (i.e., outcome-based payments) may be incorporated to address payer uncertainty. Together, these measures signal a more rigorous, value-based framework that will influence both market access decisions and pricing strategies for new pharmaceutical products in Abu Dhabi.
Windrose’s Take
The launch of formal HTA guidelines in Abu Dhabi represents a step-change in how evidence is evaluated, moving from ad-hoc affordability considerations toward a structured, transparent process that balances clinical and economic value. The incorporation of cost-effectiveness thresholds and structured economic modelling marks a clear alignment with global practices. Saudi Arabia is also advancing its own HTA framework, signaling that payers across the Middle East will increasingly require robust clinical and economic justification for market entry. For pharmaceutical companies, this means traditional strategies of regulatory approval and price negotiation will no longer suffice. Instead, success will hinge on demonstrating incremental value over existing standards of care, supported by locally relevant cost-effectiveness and budget impact analyses. In our view, these shifts represent both a challenge and an opportunity; companies that adapt early, build the right evidence packages, and anticipate payer expectations will be best positioned to secure sustainable access and capture value in these rapidly evolving healthcare markets.
Ari Levin and Amy Morgan, Windrose Consulting Group
Additional Information:
* The Thiqa is a comprehensive healthcare program offered by the government of Abu Dhabi to UAE Nationals and those of similar status in the Emirate. The Thiqa provides access to the most comprehensive care and broadest network (including hospitals, health centers, clinics and pharmacies) in the Emirate of Abu Dhabi. [3]
Sources:
1. https://www.who.int/health-topics/health-technology-assessment#tab=tab_1
2. Public United Arab Emirates (UAE) HTA Guidelines (Available through: https://www.doh.gov.ae/-/media/1A2C713CA4A942D09AC18A11C5E37AE2.ashx)