Thanks to favourable regulations from the Ministry of Health and Prevention (MoHaP) which include fast-track regulatory pathways, patients in the UAE are gaining access to innovative medicines in similar time frames to their counterparts in the US and Europe, in some cases even ahead. Against this backdrop, the representatives of global biopharma implanted in the country must decide how to prepare both the external landscape and their internal capabilities for cutting-edge product launches in the country.
Beyond Pricing
Pfizer has launched a significant number of new products in the region in recent years, with 47 products introduced in 2022 and 55 planned by the end of 2023, covering both long-awaited assets and those that have achieved rapid regulatory approvals. Patrick van der Loo, MERA regional president, feels, however, that there is more than cost to think about in this flurry of launches.
While launching new products is important, we recognize that access goes beyond pricing considerations
Patrick van der Loo, Pfizer
“While launching new products is important, we recognize that access goes beyond pricing considerations. It involves collaborating with governments on regulatory timelines, implementing patient programs, and establishing pathways for patients to ensure responsible and controlled access to drugs and vaccines. We are committed to innovation and access in all six of our therapeutic areas, including vaccines, which have traditionally been significant for the company.”
A Support Ecosystem
Following the spin-off of MSD’s women’s health business two years ago, the US-headquartered firm opened a new regional office for the GCC and managed to bring a significant number of innovative new medicines to patients in the region as well as expanding indications for existing therapies, especially in its key area of oncology. GCC Managing Director Ashraf Mallak highlights that the launch itself is just one part of a wider process that involves partnering across the entire ecosystem to support cancer patients.
We are only scratching the surface of public awareness around cancer and need to develop more ‘out of the box’ solutions to reach more people
Ashraf Mallak, MSD
“MSD is in the unique and privileged position of manufacturing leading medications to treat cancer and leading vaccines for cancer prevention. This comes with a responsibility to act as a partner to the overall ecosystem and find solutions for both the prevention and treatment of cancer. We work to help ensure that GCC countries such as the UAE and Saudi Arabia are among the first in the world to approve new indications, which comes with a lot of work in terms of file preparation but is paying off for patients.
“MSD has also partnered with various patient organizations to amplify the voices of cancer patients, as well as drive prevention and awareness of the importance of early detection.
“In my opinion, we are only scratching the surface of public awareness around cancer and need to develop more ‘out of the box’ solutions to reach more people. MSD recently partnered with a popular food delivery company who, using their digital platform, were able to deliver brochures to population groups within the segment for potential cancer cases.
“Finally, increased patient access through our indication approvals also comes with the responsibility of supporting the low-income population. Hence our dedication to launch a Patient Support Program (PSP) in the UAE. We launched the AWN program in 2021 with the aim of providing access to cancer medications to those who most need them but who otherwise would not have access.”
Tech Partnerships
The Gulf region is strategically significant for Novartis due to what Novartis Gulf Head Mohamed Ezz Eldin calls “a remarkable appetite to embrace innovation and maximize investment in healthcare services & infrastructure. A clear example is the UAE, which has positioned itself as an innovation hub on both regional and global levels, and subsequently a priority country for new launches of innovative medicines/ treatments.”
We have collaborated with the DoH Abu Dhabi to improve the overall patient experience and model of care in cardiovascular disease by enhancing Abu Dhabi’s digital healthcare ecosystem
Mohamed Ezz Eldin, Novartis
With the realisation that digitalisation is playing an increasing role in healthcare’s future, the Basel-based drugmaker is increasingly partnering with tech companies to support diagnosis and patient support beyond product launches alone.
“There’s a lot that we are doing in the UAE,” he says. “For example, we have collaborated with the DoH Abu Dhabi to improve the overall patient experience and model of care in cardiovascular disease by enhancing Abu Dhabi’s digital healthcare ecosystem.
“Another example is our partnership with Aster DM Healthcare on digital transformation and clinical research, which will provide Aster access to our advanced therapy platforms and data science to improve patient outcomes.
“Also, we have launched InNovaHeart in collaboration with EchoNous. It is the first AI-assisted handheld portable ultrasound device that helps reduce the time to diagnosis of heart failure.”
Medical Affairs is Key
CSL Behring hopes to launch at least 12 products in immunology and haematology globally over the next five years with the MEA’s leading markets – the UAE and Saudi Arabia – absorbing these therapies in line with global timeframes. The company’s MEA GM Hassan Herrou cautions that there is work to do on a human resource level to prepare his regional team for this upcoming wave of launches.
CSL Behring is both developing and looking for professionals with [a] market access mindset
Hassan Herrou, CSL Behring
“Our commercial operations are more than ready. However, we will need to bolster our medical affairs function within Saudi Arabia and the UAE to have the best impact. On top of that, we must have a strong focus on market access due to the premium price of plasma-derived treatments. Therefore, CSL Behring is both developing and looking for professionals with this market access mindset. This means we should be working on a launch at least three years before it happens. This proactive approach is even more important in areas such as recombinant therapies which have such fierce competition from other large biotech players looking to bring forward their innovations.”
Competing in Oncology
Astellas too is prioritising talent development in the region as it seeks to bolster internal capabilities ahead of a broadened footprint in oncology. Given the competitiveness of oncology as a therapeutic area and Astellas’ status as a relative newcomer that is primarily entering the space via acquisitions, MEA Area Lead Amr Seif outlines his approach thusly.
I have been impressed by the level of homegrown local medical talent and commercial sales teams in the region
Amr Seif, Astellas
“To be able to compete in oncology, we have been working on two dimensions since 2014 to acquire talent with the necessary skills and then further develop these capabilities. We did not launch all our products in one go, rather we started with extending our talent pool by acquiring experts in commercial areas. Furthermore, we began developing internal capabilities and bringing in foreign colleagues on international assignments to the UAE. However, there are still some areas, such as market access and government affairs, particularly in countries like Saudi Arabia where local expertise is essential for success. In such cases, the talent pool is small, and the competition is high, making it challenging to acquire talent. Nonetheless, I have been impressed by the level of homegrown local medical talent and commercial sales teams in the region.”
Early Engagement on Rare Diseases
Given the high-price/small-patient population dichotomy of rare disease therapies, early and meaningful pricing negotiations with the relevant authorities are critical for market access, says Ahmad Abu Dahab, VP for the Middle East, Turkey, and Northern Africa at Swedish-headquartered haematology, immunology and specialty care player SOBI.
Our strategy is to have early discussions with the relevant stakeholders even before the product’s launch
Ahmad Abu Dahab, SOBI
“Our strategy is to have early discussions with the relevant stakeholders even before the product’s launch. We create value not only for our patients and their families but also for governments when discussions are initiated to create awareness on the cost-benefit analysis and the value created to the overall nations’ health and wellbeing. We look at health authorities as our partners in attaining sustainable healthy well-being as we bring our lifesaving products to the patients and the country in a sustainable manner is essential, and they are very receptive to our approach.”
