Trad Alkhelaiwi, country director for Amgen in Saudi Arabia, discusses the intricacies of the Saudi healthcare transformation including the push for a value-based healthcare system that adopts best practices from other healthcare systems, Amgen’s upcoming launch in lung cancer, its plan to invest over USD 80 million in Saudi in the next five years, and how the company is preparing for upcoming cost containment measures.

 

Can you begin by introducing your career and what made you choose the pharma industry?

I have been involved with the pharmaceutical industry for over 20 years, all of it in Saudi Arabia with different companies and in different functions. I am fortunate to have worked in regulatory, marketing, sales, public affairs, pricing, reimbursement, and policy, because it provided me with the opportunity to familiarize myself with most aspects of the business. I have been with Amgen for three years, two of them as country director and one working with the GCC’s Value, Access &Policy team helping Amgen anticipate, prepare for and shape the payer and reimbursement environment.

I am fortunate to work with great talent and a capable team that brings a breadth of international experience to benefit the Saudi healthcare system, especially in the fields where Amgen is present, including dyslipidemia, nephrology, oncology, osteoporosis, and more recently into Biosimilars.

As to why I chose to work in the pharmaceutical industry, it had to do with the value of bringing health to patients and positively impacting their lives.

 

How does Amgen deal with the fact that it is a relative newcomer to the Saudi pharma market, having established the affiliate in 2020, and what place can it earn within the Saudi ecosystem?

Yes indeed, we are quite new compared to many of our peers. However, Amgen has been in the Saudi market for almost a decade through different models and business operations, Amgen transitioned from operating through a distributor to establishing a standalone affiliate in 2020 with an aim to increase its footprint and investment. We are expecting to invest not less than 300 million Saudi Riyals (USD 80 million) in the next five years. The affiliate might be new, but we have taken great leaps on many fronts.

Our breakthrough medicines have generated value for the Saudi healthcare system, and today, we are proud to offer a comprehensive Biosimilar portfolio that considerably reduced costs and introduced efficiencies.

When it comes to value-based care, Saudi Arabia is still at an early phase, but we are on the right track. We expect the local healthcare system to adopt a more advanced methodology for assessing value. The value chain of pharmaceuticals makes it possible to bring value on all fronts – clinical, prevention, and treatment – and presents an opportunity to elevate the tools that support good clinical outcomes.

When we defined our five-year strategy, we knew that we were operating in a country that is in the midst of a transformation and whose healthcare system dynamics are moving in a positive direction. The Saudi Healthcare system is moving towards a value-based approach which is an accommodating environment for Amgen given the Kingdom’s focus on outcomes. Today, the solution must be innovative whilst also addressing the system’s most pressing issues.

Amgen is well positioned for this value-based environment because our approach translates directly to patient benefits and in turn, saves lives and boosts productivity.

The way we approach our work presents a great opportunity for us in Saudi Arabia, foreseeing greater collaboration with various stakeholders including the Ministry of Health, Saudi FDA, Saudi Health Council, as well as other tertiary care organizations in the public and private sectors.

It is important to note that in the past 25 years, Saudi Arabia has excelled at tertiary care, but it came at a very high cost as patients were not at the right place. A big part of the transformation of the public sector is strengthening the primary care setting, making it suitable for patients and their families. This is very compatible with Amgen’s solutions for cholesterol management and osteoporosis, all of which are best served in a primary care setting. Just as important is prevention and predictive measures, and we are looking forward to offering machine learning tools that have potential applications in early diagnosis and risk management.

 

Can we foresee Saudi Arabia following a more European approach to healthcare, where the focus is on cost management executed by governments and strong primary care networks, or an American model where private insurance remains the driver of the system with high tertiary care intervention?

I believe that the Saudi healthcare system will adopt the best of both models; we want great tertiary care centres that can provide specialized treatments whilst also offering the best of the primary care settings we see in Western European with patients being diagnosed earlier. I am confident that Saudi Arabia will achieve this.

As with any healthcare sector, as the system evolves with higher patient coverage, cost containment measures become evident. The industry understands that more cost containment measures may be implemented in the future, but we also expect that as more patients are treated, we can establish a balanced model.

In terms of the implementation of value-based healthcare, Amgen goes beyond being a provider of medicine. We offer sustainable and innovative solutions that contribute to the development of a robust healthcare system.

 

How do you assess the general level of digitalization of the Saudi system considering the objective of introducing early diagnosis?

Saudi sits on a very strong digital base as the Kingdom has a high penetration of mobile devices. The Saudi government has excelled at engaging with its digitally savvy populace, with the Ministry of Health having recently supported the establishment of virtual clinics. The Covid-19 pandemic has illuminated the value that digital solutions bring to the healthcare sector, including being used for diagnosis, logistics, distribution, doctor interactions and referrals across all levels of care.

 

Do you perceive the establishment of the National Unified Procurement Company (NUPCO) as Saudi’s unified hospital procurement body to be a positive development for the healthcare system and the industry?

The enhanced role of NUPCO is another positive step towards the transformation of healthcare services in Saudi Arabia. The body is focused on procurement and will venture into logistics, warehousing and distribution. On the procurement front, NUPCO’s evolution has greatly benefited the public sector by making the procurement process more transparent and streamlining access to medicines across the country.

The most interesting development is the new marketplace that centralizes the medication ordering process. Hospitals can now access a catalog of medicines and place orders on the platform itself. In addition to streamlining the procurement process, NUPCO has partnered with private pharmacies to launch the ‘Wasfati’ program, making medicine more accessible to the community as patients are able to receive and refill their prescriptions minutes from their homes.

These advancements are a testament to the healthcare sector’s evolution and a clear indication that more and more patients will have access to healthcare and to early diagnosis. The government is already doing a lot to propel the healthcare sector forward, and we are pleased to be contributing to this growth.

 

You briefly discussed your biosimilars portfolio, a product category that presents a good solution but lacks a homogeneous regulatory framework in many countries. What is the status of biosimilars regulation in Saudi?

Europe has the most experience with biosimilars, both on the legislative side and in the marketplace. Saudi is relatively new to biosimilars, but the regulatory system is clear and strong. Biosimilar products entering the Saudi market are usually US FDA or EMA approved so there is a high-quality threshold that companies must clear.

The question remains on how will biosimilars be used in the marketplace, the level of adoption and the potential of treating more patients with biologics due to the introduction of Biosimilars.

The recent NUPCO procurement announcement is a clear signal that creating a sustainable market for Biosimilars is a goal that the country desires to achieve.

Saudi is moving in a positive direction, and we project that more biosimilars will continue to enter the market and more patients will benefit from them.

 

One big part of Amgen’s upcoming portfolio is oncology. What product launches are you looking forward to and what role will clinical trials play in your success?

Amgen is very active in the oncology and haematology disease space, having launched six molecules to date. We have a robust pipeline of molecules with plans to bring a first-in-class treatment for a mutation in lung cancer that has been un-druggable for 40 years. Some of the greatest advances in science are unfolding now inside Amgen, and this is one of them. The treatment has already been approved by the US FDA and we look forward to working with the Saudi FDA to secure local approval. We are complementing our Saudi FDA application with a clinical trial as part of an expanded early access program, and we are eager to bring this asset to patients with limited alternatives in this mutation.

We believe that Saudi Arabia offers an accommodating environment for advancing the healthcare sector, including a higher number of clinical trials and innovative access at an early stage. There are three prerequisites to excelling in clinical trials: clarity of regulations and speed of approvals, availability of patients for recruitment as well as an intellectual property (IP) system that protects knowledge-based investments.

 

As a Saudi national, how do you perceive the impact of Vision 2030 and how do you articulate it in your work leading the Amgen organization?

As a company, we established Amgen Saudi Limited in 2020, which is a testament to our commitment to the Kingdom and our willingness to bring valuable solutions and significant investment. We believe that the healthcare transformation plan is paving the way for a more sustainable healthcare sector. Having set base in Saudi Arabia, we can recruit and develop more Saudi nationals that will in turn support our stakeholder engagement and help bring our innovative solutions to life. Beyond a pharmaceutical company, Amgen is a partner and champion of the Kingdom’s Vision 2030.

 

After leading Amgen in Saudi for two years, what would you like to achieve for the organization?

My answer goes back to the basis of what we do every day. We are here to bring innovative solutions to healthcare and to contribute to developing the sector in Saudi Arabia.

We have already delivered on our promise to bring value to the Kingdom. We recently launched the Capture the Fracture program, working with the International Osteoporosis Federation to support osteoporosis patients. We also spearheaded the development of the dyslipidemia program, having partnered with various stakeholders to reduce the burden of cardiovascular diseases in Saudi. With every single disease area, we come with innovative solutions that address either the patient journey or a healthcare issue in the marketplace.

We have a sustainable and insight-driven strategy in place to ensure that our approach is focused on supporting patients and aligning with Vision 2030. We are here to invest in the country’s transformation and will continue to pave the way for a more sustainable healthcare sector in Saudi Arabia.