The next stop in our around the world in HTAs adventure is Saudi Arabia. This blog breaks down how the Kingdom is reshaping access to new health technologies through regulatory reform, a formal HTA framework, and value-based care. It provides a comprehensive overview of the structural and regulatory reforms underway as part of Vision 2030, highlighting how these changes are reshaping the way new health technologies are evaluated, priced, and brought to market.
Saudi Arabia’s healthcare system is undergoing a significant transformation, driven by ambitious structural, regulatory and financial reforms outlined in Vision 2030. These changes are creating a dynamic environment for health technologies and their pathway to market. With the emergence of a formal HTA framework, the Kingdom is positioning itself as a regional leader in the adoption of value-based healthcare.
The health system in the country
The national healthcare system is divided into a public sector that primarily serves Saudi citizens and a private sector that provides care to economic migrants and some nationals. Historically, the Ministry of Health (MOH) has been the primary provider and payer, accounting for around 60% of healthcare expenditure. Under Vision 2030, the MOH is shifting from direct service provision to a role focused on policy and regulation, paving the way for a more privatised and efficient system.
Public healthcare services are delivered at primary, secondary and tertiary levels, through primary healthcare centres, hospitals and specialist centres. Saudi citizens receive full coverage across all levels of care, including medications. For non-Saudis, health insurance is mandatory and typically provided by employers, covering the employee and their dependents.
The private sector accounts for approximately 32% of hospitals and 25% of total bed capacity and also delivers care at all levels. A major restructuring is underway, with MOH centres being grouped into 20 health clusters managed by the state-owned Health Holding Company (HHC). The aim is to deliver more integrated and comprehensive care across the Kingdom. By 2027, the Council of National Health Insurance (CNHI) is expected to become the main budget holder for healthcare services, overseeing funding for health clusters and other public institutions. Funding will be based on a risk capitation model for general healthcare services.
A roadmap for new technologies
Introducing new health technologies in Saudi Arabia requires navigating several steps: market authorisation, pricing, HTA, and reimbursement or procurement. Market authorisation is granted nationally by the Saudi Food and Drug Authority (SFDA), with four distinct approval pathways:
- Standard route for non-innovative drugs (up to ~335 working days or 469 calendar days)
- Verification pathway for products approved by both the FDA and EMA (30 days)
- Abridged pathway for products approved by either the FDA or EMA (60 working days)
- Breakthrough medicine programme for products not registered with any stringent regulatory authority (up to 60 working days depending on data completeness)
Pricing is also managed by the SFDA and reassessed every five years. The system largely relies on reference pricing, comparing prices across 16 international markets. Value-based pricing is also supported, particularly for new therapies. From July 2025, the SFDA will require the inclusion of Economic Evaluation Studies (EES) for all therapies undergoing pricing procedures (including new product registration, price re-evaluation, or renewal). Accepted EES formats include Budget Impact Analysis, Cost-Minimisation Analysis, Cost-Utility Analysis, and Cost-Benefit Analysis. These studies will inform pricing decisions and the list price for new therapies.
HTA has recently been formalised in Saudi Arabia, influencing both access and pricing processes. The Centre of Health Technology Assessment (CHTA) is responsible for the economic evaluation of pharmaceutical products to support reimbursement decisions across public and private sectors. The HTA process follows a structured, multi-step format aimed at ensuring transparency and alignment with national priorities. It begins with an initial meeting to define the clinical and economic need, followed by the manufacturer submitting a dossier including clinical data, real-world evidence (if available), cost-effectiveness and budget impact analyses, and pricing information.
CHTA then conducts a dual-track clinical and economic review. The process is expected to take 60–90 days and may run in parallel with SFDA regulatory approval. Cost-effectiveness is a key factor, with an informal willingness-to-pay threshold of 50,000-75,000 SAR (~13,000-20,000 USD) per quality-adjusted life year (QALY), though flexibility is anticipated.
Access and reimbursement typically follow regulatory approval and HTA. Formulary inclusion is a key determinant of access. Institutional and hospital-level Pharmacy and Therapeutics (P&T) committees review new products, with decisions often influenced by key opinion leader (KOL) input and institutional preferences. Private hospitals may maintain independent formularies.
In the public sector, the National Unified Procurement Company (NUPCO) manages consolidated tenders and national procurement, forecasting drug volumes in coordination with hospitals. Early access may also be available through the Special Access Program (SAP) for individual patients with life-threatening conditions, based on intended use. Managed Entry Agreements (MEAs), both financial- and outcomes-based, are increasingly used to support market uptake strategies.
Current challenges
HTA in Saudi Arabia is in a phase of rapid development. While the formal process has been introduced, full implementation is expected over the coming years. The internal structure of CHTA is still evolving and may eventually resemble a national P&T committee model.
Although the value of Clinical Outcomes Assessments (COAs), such as patient-reported or performance-based measures, is acknowledged, there is currently no standardised requirement to include COAs for specific therapeutic areas. COAs are a measure that aims to reflect how a patient feels, functions, or survives. There are four types of COAs are: clinician-reported outcome, observer-reported outcome, patient-reported outcome, and performance outcome.
Instead, inclusion is determined by the context of the submission, such as disease area, intervention type, and expected clinical impact. COAs tend to be more relevant in submissions for chronic and rare diseases.
More broadly, the wider healthcare system is undergoing large-scale transformation. The shift to the HHC model and the anticipated transition of funding responsibility to CNHI by 2027 present both opportunities and challenges, especially during this period of change. Ensuring equitable access across different population groups particularly given the dual-tier system for nationals and immigrants may also present future challenges.
Next steps for Saudi Arabia’s HTA
Looking ahead, further progress is expected in the development of Saudi Arabia’s HTA framework. CHTA will likely focus on building internal capacity to assess and interpret COA data, and on refining submission requirements.
Clarifying the role of COAs in HTA submissions will be a key step. This may include defining where such measures should appear in the value dossier, how expert committees will evaluate them, and what criteria determine their acceptability. Local evidence, real-world data, and budget impact models will all remain central to HTA submissions. COA data from clinical trials is considered relevant when it demonstrates measurable impacts on symptoms or disease progression. While head-to-head trials are valued, they are not considered sufficient in isolation.
The integration of HTA with broader reforms to healthcare delivery and financing – including the evolving role of HHC and CNHI will be essential. The upcoming requirement for EES from July 2025 is also expected to significantly shape reimbursement decision-making.
As Saudi Arabia continues to strengthen its HTA infrastructure, it has the potential to become a leading voice in the region and contribute to the global dialogue on value-based healthcare.