The next big thing in HTA - Saudi Arabia

A market access professional in pharma faces the challenge of balancing complex pricing and reimbursement strategies, regulatory compliance, stakeholder engagement, and the effective communication of a product's value across diverse markets to ensure successful launch and patient access. To the astute Market Access professional, there is a market for pharmaceutical products today which promises the following at global launch:

• Pricing parity to the USA
• Open product access to their entire population
• An early win in the global launch sequence

This market? Saudi Arabia.

Saudi Arabia's Vision 2030 is an ambitious plan to diversify the national economy, promote social reform, and transform the country into a global investment hub.

Pharmaceutical development, assessment, and reimbursement is a centerpiece of the Vision 2030 plan; a Central Health Technology Assessment (HTA) is being established under the Ministry of Health to fulfill the promise. This new HTA framework will provide evidence-based recommendations to guide policy decisions on the pricing, reimbursement, and adoption of health technologies.

The implications for pharmaceutical development and commercial launch are huge.

Opportunities for Market Access in Saudi Arabia:

• Pricing: Saudi Arabia offers the potential for pricing similar to the United States, making it a lucrative market for launching new therapies. The alignment with global pricing standards enhances the attractiveness of entering this market.
• Open Access to a Large Market: With 36 million people and no copayments or restrictions, Saudi Arabia allows pharmaceutical companies broad patient access. This facilitates faster adoption and market penetration for new products.
• Early Launch Sequence: Saudi Arabia’s healthcare reforms support early market entry for new drugs, offering a chance for companies to establish a presence early in the product commercial life cycle -- ahead of competitors and securing a first-mover advantage.
• Focus on Generic Medicines and Local Manufacturing: The government's push for generics and local manufacturing reduces import dependency and enhances drug security, providing an opportunity for companies that align with these goals.
• Policy Recommendations and Health Innovation: Companies that align with Saudi health policies, particularly in oncology and pricing, will find favorable conditions for market access. The emphasis on innovation also supports the introduction of new health technologies.

Methodology of The Saudi Arabia HTA process:

The methodology incorporates elements from HTA processes in the UK (NICE), Sweden (TLV), and Canada (CADTH), including:

• United Kingdom (NICE): Systematic literature reviews and critical appraisal of clinical evidence. Economic evaluation, including cost-effectiveness and cost-utility analyses.
• Sweden (TLV): Establishment of a cost-effectiveness threshold based on the QALY. Consideration of disease severity, unmet medical need, and societal impact.
• Canada (CADTH): Stakeholder engagement, including healthcare professionals, patient groups, and industry representatives.

FIECON + Pharma BP collaborate to deliver HTA excellence in Saudi Arabia:

FIECON has partnered with Pharma BP , a leading life sciences?consultancy with specialty expertise in the Middle East and Africa (MEA) region and a?trailblazer in the evolving regional landscape.?

Together, our expertise bridges the gap between technical excellence and practical solutions in HEOR, market access, and HTA. With an impressive 96% success rate across more than 75 global HTA submissions and a perfect 100% success rate in rare disease HTA submissions, FIECON consistently delivers results that matter.

FIECON can offer comprehensive HTA support services, including:

• Pricing: Assistance with strategic pricing decisions.
• Economic Modelling: Development of economic models to assess cost-effectiveness.
• HTA Strategy: Formulation of strategies for successful HTA submissions.
• Submission Dossier: Preparation of detailed submission dossiers.
• Post-Submission Negotiations: Support during negotiations after the submission process.

Our deep understanding of Saudi Arabia's emerging HTA framework in the UAE, combined with on-the-ground expertise, positions us as leaders in this space. By partnering with local experts, we are uniquely equipped to deliver impactful, tailored solutions. This collaboration strengthens our approach and enables us to navigate the evolving healthcare landscape with confidence and precision.

Start your Saudi Arabia commercial journey with HTA by contacting us for a consultation:

FIECON: [email protected] | website: https://www.fiecon.com/landing/contact

PharmaBP: Lavni Varyani - [email protected] | phone: +971-55-946-5499