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Meeting highlights:
- Dr Almudaiheem oversees drug policy and regulation at the Saudi Ministry of Health, ensuring adherence to therapeutic guidelines across 300 hospitals and 1,200 primary healthcare centers
- Saudi Arabia's successful Drug Information Center with a 24/7 hotline (937) to provide public support on medication-related queries.
- Vision 2030 aims to increase life expectancy to over 80 years, focusing on improving access to care and quality of life.
- Saudi Arabia’s flagship cluster system to ensure consistency in patient care across healthcare facilities
- Saudi Arabia developed a Multi-Criteria Decision Analysis (MCDA) report to prioritize diseases and embrace value-based healthcare, managing over 20 value-based programs or agreements, including pay-for-performance and outcome-based models.
- Efforts are underway to establish a Rare Diseases Center of Excellence and improve clinical trial infrastructure.
- The Saudi Food and Drug Authority (SFDA) introduced a Breakthrough Medication Designation process to increase access to innovation.
- Public-private partnerships are being leveraged to increase awareness about various health conditions and treatments.
- Saudi Arabia implemented the first national spinal muscular atrophy (SMA) program globally, integrating comprehensive patient care and genetic counselling
- The Ministry is expanding pharmacy education programs to meet evolving healthcare demands, including vaccine administration certification and health technology assessment training.
EF: Could you elaborate on the role you are in, your background, and your current priorities?
HA: I am a clinical pharmacist by background. I oversee the drug policy and regulation department at the Ministry of Health under the leadership of Therapeutic Affairs. My role focuses on ensuring adherence to therapeutic guidelines across all MOH hospitals. The Ministry of Health is the largest healthcare provider in bed capacity, hospitals, medical cities, and primary healthcare facilities. We monitor approximately 300 hospitals and 1,200 primary healthcare centers to ensure compliance with therapeutic guidelines. A major part of our work involves formulary management, which provides the availability of medications for both primary healthcare and hospital use.
We established a Drug Information Center with a national call center under the Drug Policy and Regulation Department. This call center operates under the Ministry of Health and is accessible via the 937 hotlines. It provides 24/7 public support, answering medication-related queries and addressing hospital poisoning cases. The center has been operational for over seven years. I was privileged to set up more than 16 Drug Information Centers across the Kingdom and train pharmacists to manage calls effectively under the 937 supervision. Although the 937 center now operates as a separate entity with its regulations and department, I continue to support them by providing training, referencing resources, and helping pharmacists develop their expertise in drug information.
EF: How are your efforts supporting the Vision 2030 objectives and the targets set to modernize Saudi Arabia's healthcare sector?
HA: One of the main objectives of Vision 2030 is to increase the life expectancy of citizens to over 80 years. Achieving this goal presents challenges related to medication access, quality of care, and overall quality of life. We operate based on several KPIs and pillars, with two main focuses: access to care and quality of life. All our projects are designed to align with these pillars, emphasizing access to medication and the unification of healthcare management. To create a more unified approach, the Ministry of Health has introduced a cluster system that ensures consistency in patient care across hospitals and other healthcare facilities. For instance, in Riyadh, there are three main clusters organized geographically. Each cluster is anchored by a central medical city, with several hospitals and primary healthcare facilities beneath them. This structure ensures that patients within a cluster receive the same level of care, services, and outcomes. It also standardizes therapeutic management pathways, ensuring a unified healthcare system.
EF: As the director of drug policy and regulation, what opportunities do you identify for harmonizing drug policies with global standards to address local needs?
HA: Our healthcare system has significant potential for improvement through enhanced integration. By developing a centralized platform for disease burden data and prioritization tools, we can streamline our approach to therapeutic areas. This presents an exciting opportunity to harmonize our diverse Health Information Systems (HIS), fostering better coordination and efficiency in patient care and public health management. One of our first steps is improving how we manage formularies, which are crucial in patient care.
We have also an opportunity to optimize our financial resources and enhance our pharmaceutical procurement strategy. While we currently operate on an annual budget, we can explore innovative funding models and partnerships to keep pace with rising medication prices and cutting-edge innovations. By proactively addressing this challenge, we can create a more flexible and responsive system that better accommodates breakthrough medications, new interventions, and emerging drug pipelines. To address this, we first established a baseline to understand the cost-effectiveness threshold for the Kingdom of Saudi Arabia, particularly within the Ministry of Health. This allows us to determine which medications or classes are financially viable within our budget. Last year, we also published a groundbreaking study, the first in the region, on the utilities of Saudi Arabia. This provides a foundation for us to evaluate if the interventions are cost-effective. They reflect our commitment to improving financial sustainability while maintaining high-quality patient care.
The second challenge we face is the rising diagnosis of disease areas like rare diseases, especially with the new pharmaceutical breakthroughs emerging. Having a comprehensive screening program for rare diseases in Saudi Arabia would require us to identify patients and provide treatment, but most rare diseases currently have limited or no proven therapeutic interventions. Moreover, many medications for rare diseases are prohibitively expensive and fall outside the published cost-effectiveness thresholds for chronic disease treatments. We developed a Multi-Criteria Decision Analysis (MCDA) report focusing on three key areas to address this. First, it helps us prioritize diseases from potential health challenges. Second, it guides us in embracing value-based healthcare, enabling negotiations beyond just price. Price negotiations are managed nationally across all governmental sectors, but value-based agreements allow us to work directly with pharmaceutical companies on performance and outcomes. We establish agreements based on specific outcomes for medications with uncertain effectiveness or limited data in our population as high-cost treatments. These agreements often involve setting measurable timelines and tracking patient progress. Treatment continuation is decided based on these outcomes, ensuring financial resources are preserved for new patients or emerging interventions.
We manage over 20 value-based programs or agreements, including pay-for-performance and outcome-based models. We have developed multiple electronic registries linked to patient diagnoses, therapy monitoring, and other management activities. This registry provides annual reports for the Ministry of Health, and the pharmaceutical industry is also used to facilitate rebates. We aim to improve access to breakthrough medications while leveraging these strategies to ensure cost-effectiveness and sustainable healthcare management.
We are working on establishing a Rare Diseases Center of Excellence under the Ministry of Health. This initiative aims to unify the management of rare diseases across various healthcare sectors in Saudi Arabia. Rare disease management requires a national-level approach to ensure equity and equality in access to care. To achieve this, standardized guidelines and eligibility criteria are being developed to allow patients from different sectors access to hospitals and treatments that may not be available in their primary healthcare facilities. The Ministry of Health is working to identify rare diseases, capture data within an electronic platform, and study each disease using specific parameters. One of the pressing challenges currently being addressed is the limited capacity for clinical trials within the Ministry of Health. As the largest healthcare payer and having access to a vast pool of patients and physicians across multiple specialties, our clinical trial infrastructure has the potential to be one of the most robust ones.
Clinical trials have multiple benefits. These benefits include gaining valuable expertise, providing medications free of charge during trials, and exposing physicians to international standards through collaboration with global committees. The Ministry of Health focuses on establishing Clinical Trial Units (CTUs) and improving infrastructure to increase participation in clinical trials, particularly in therapeutic areas like rare diseases. These efforts align and emphasize the expansion of clinical trials that were set forth through a strategic vision by His Highness Prince Mohammed. A critical player in this effort is the Saudi Food and Drug Authority (SFDA), which oversees medication registration in Saudi Arabia. Under the new vision, the SFDA has introduced the Breakthrough Medication Designation process. The Breakthrough Medication Designation allows first-in-class medications not yet registered elsewhere to be approved in Saudi Arabia without being tied to lengthy price negotiations. Healthcare sectors can directly engage with pharmaceutical companies to secure patient access to these groundbreaking treatments. To address drug policy and regulation challenges, particularly for rare diseases and clinical trials, the Ministry of Health is taking bold steps by improving infrastructure, leveraging partnerships with SFDA, and adopting innovative approaches.
EF: What initiatives are taking place in Saudi Arabia to increase awareness?
HA: Raising awareness is a key focus area, and the Ministry of Health in Saudi Arabia is investing heavily in public-private partnerships to achieve this goal. These partnerships involve the government, scientific societies within Saudi Arabia, and the pharmaceutical industry, all working collaboratively to address awareness at both the patient and healthcare professional levels. This collaborative model is also utilized when drafting national guidelines to ensure they are comprehensive and inclusive of all key stakeholders. Recent examples of such collaborations include partnerships with Takeda, the Saudi Society of Clinical Pharmacy, the Saudi Gastroenterology Society, and the Ministry of Health. Similarly, other partnerships have focused on areas like dermatology through the Saudi Society of Dermatology and obesity, a pressing health concern in Saudi Arabia, with initiatives targeting surgical and pharmacological interventions. Collaborations have also extended to fields like neuroscience, addressing conditions like multiple sclerosis and rare diseases like spinal muscular atrophy (SMA) through the Saudi Pediatric Neurology Society.
The mindset regarding partnerships with the pharmaceutical industry has shifted significantly over the last decade. The current approach emphasizes the mutual benefits of these partnerships. The pharma industry is now a valuable partner in fostering international collaboration with hospitals, universities, and healthcare projects. These collaborations have allowed us to understand better why certain initiatives succeed internationally but face challenges locally. Thereby paving the way for knowledge exchange and growth.
Additionally, Saudi Arabia is leveraging these partnerships to enhance its presence in scientific publications and international benchmarking. The country is exchanging knowledge and building bridges between local and international scientific communities by collaborating on research and publications. This has opened dialogues with global scientists and institutions, promoting the exchange of expertise and fostering progress in healthcare beyond national boundaries. These efforts underscore Saudi Arabia's commitment to aligning its healthcare strategies with global best practices while addressing local health challenges effectively.
EF: In the future, when you look back at these times, what would you want to be most proud of?
HA: Saudi Arabia has achieved a groundbreaking milestone with its national spinal muscular atrophy (SMA) program, the first of its kind globally. The Kingdom has also led the way in HIV treatment, being the first to implement three types of interventions: interfacial, oral, and gene therapy. These treatments are entirely funded by the Ministry of Health, ensuring coverage for the entire nation, and have produced outstanding patient outcomes. To support these initiatives, the country has increased the number of certified centers for treatment and follow-up. The SMA program, running successfully for over six years, integrates a comprehensive, multidisciplinary approach to patient care. In addition to providing medications, the program includes allied services such as respiratory care, nutrition counseling, and physiotherapy. These services are critical for enhancing adherence to treatment and physiotherapy regimens. A network of clinics has been established to monitor patients effectively, emphasizing patient-reported outcomes to improve the program continuously.
This initiative has also significantly focused on genetic counseling to raise awareness about SMA and other genetic diseases like sickle cell disease. The Kingdom’s progress in shaping policies and raising awareness has resulted in approximately 60-70% adherence to new guidelines, which aims to lessen the impact of these diseases. Saudi Arabia's commitment to holistic patient care and innovative treatments demonstrates a pioneering effort to address genetic and chronic diseases nationally.
EF: Do you have any final words?
HA: The success of these initiatives in Saudi Arabia can only be attributed to the visionary leadership and strong support from the Ministry of Health (MOH). The leadership's unwavering belief in healthcare teams and their ability to execute these groundbreaking programs plays a pivotal role in the success of these projects. With clear direction and backing, these initiatives are not only achievable but are making a profound impact on patient care. This combination of visionary leadership and empowered healthcare professionals is a driving force behind the country's advancements in healthcare and patient outcomes.
