Globally, while there is broad stakeholder alignment on topics like clinical trials and innovation, there is real divergence in approaches to pharmacoeconomics and health technology assessment (HTA). This is perhaps in part due to the differences between systems like those in Europe where these functions are state mandates and those, such as the US, which are more fragmented and rely on input from private groups. In other markets – such as those within MEA – HTA approaches vary even more dramatically. Many of the emerging economies in EMA lack the infrastructure and expertise to create domestic bodies with oversight for HTA, while its leading countries are keen to blaze their own trails, distinct from those in other parts of the world, in striking an access/affordability balance.
Small Steps Forward
HTA – described by the WHO as a bridge that connects the worlds of research and policy making, leading to more evidence-based drug pricing assessments – is becoming more widely adopted in the MEA region, influenced by the cutting-edge and expensive new medicines now coming to market. “The new wave of specialised precision medicines like gene therapies is driving a revolution of pricing systems across the GCC,” says Ashraf Mallak, managing director for the GCC cluster at MSD. “This is leading to wider adoption of HTA practices, especially in the UAE and Saudi Arabia.”
“There is a consensus among healthcare authorities in MEA countries about the importance of the HTA process when making informed decisions on reimbursement of new medications and technologies,” notes Amr Seif, MEA area lead at Astellas. “HTA has been evolving in many MEA countries, with Saudi Arabia and Egypt progressing quickly.”
There is a consensus among healthcare authorities in MEA countries about the importance of the HTA process when making informed decisions on reimbursement of new medications and technologies
Amr Seif, Astellas
Myriam Hakim of Kyowa Kirin, a Japanese firm active in the orphan drug space, adds that, “Behind the pricing structure, there exists a rationale that justifies the value we seek for our products. However, the final decision rests with the authority, which underscores the significance of HTA in pricing discussions within the GCC and the UAE. HTA has emerged as a pivotal trend in this context, and we believe it is incumbent upon us, as companies, to focus on this aspect, including through engaging in constructive dialogue and collaboration with the relevant authorities and healthcare stakeholders.”
This dialogue and consciousness-raising is similarly important in the point-of-care (POC) diagnostics field, says Marwa Soliman, MEA general manager of blood gas testing pioneer Radiometer. “Awareness is still growing, and health economics has not yet been optimally introduced in the field of POC diagnostics,” she notes. “Education and partnerships with policymakers are critical. This does not mean we are far away from progress, as policymakers in UAE and Qatar are highly interested in assessing the value of not only in terms of price but also in the cost of avoided health expenditure if the right test is used at the right time.”
These are, however, still early days in terms of regional HTA adoption, as Pfizer MERA Regional President Patrick van der Loo points out. “While HTAs are not as prevalent in the MERA region as they are in Europe, governments are exploring innovative ways to ensure access to medicines without compromising their budgets. The specific approach may vary depending on the country and the healthcare system in place. In private systems, pharmaceutical companies may have more flexibility, while in public systems, requests for access support may arise.”
Data: The Name of the Game
A more impactful HTA ecosystem in MEA is largely contingent on being able to generate and crunch local patient data. As Mallak opines, “When it comes to HTA, the name of the game is local data generation, which helps establish a treatment’s relevance for people in that country.”
He continues, “MSD has established the collection of this data as a core effort as it has become a key tool in our pricing negotiations, helping more clearly determine how a therapy brings value. Value-based pricing – another crucial trend – will also depend on this local data.”
I anticipate that the region will increasingly demand their own metrics and measures for HTA evaluations. Numerous initiatives are already underway to address this need
Myriam Hakim, Kyowa Kirin
Hakim is aligned on the need for industry to contribute to this data generation push, adding that “there is a growing awareness of the need to substantiate how a pharmaceutical product can bring additional value and cost savings to a healthcare system. It is therefore essential for us to proactively contribute more input and data to support HTA processes for reimbursement purposes.”
She continues, “I anticipate that the region will increasingly demand their own metrics and measures for HTA evaluations. Numerous initiatives are already underway to address this need. As we navigate these developments, it is imperative for us to be prepared to collaborate closely with local authorities, providing comprehensive and region-specific data to facilitate well-informed decisions on reimbursement. By actively engaging in this process and advocating for a more unified approach, we can strive to enhance the access and affordability of our product for patients across the region, ultimately contributing to improved healthcare outcomes and increased value for the healthcare system.”
Hallak does caution that “there is no need to reinvent the wheel,” particularly in the GCC, when it comes to HTA. “We should learn from Europe, where HTA is well-established,” he says. “In Germany, for example, companies begin collecting data two years ahead of registration in preparation for future value-based pricing negotiations. In the GCC, we currently do not begin until post-registration, but I foresee a more proactive approach in the future.”
The UAE: Going its Own Way
Founded in July 2020, the Emirates Health Economics Society – led by Dr Sara Al Dallal – aims to create a space for the discussion of health economics, including approaches to HTA, within the UAE. While Dr Al Dallal is positive about the evolution of this topic in her country, she cautions that any future policy and strategy should not be a carbon copy of what already exists in Europe, but instead take the UAE’s specificities into account.
Looking at the experiences of countries like the UK, Germany, and Italy with HTA, it is clear that if we put in place such a model it must be unique for the UAE
Sara Al Dallal, Emirates Health Economics Society
“We do need to put models in place to regulate decision making in areas such as reimbursement and financing of therapies,” she notes. “However, looking at the experiences of countries like the UK, Germany, and Italy with HTA, it is clear that if we put in place such a model it must be unique for the UAE.”
Dr Al Dallal continues, “Recommendations for regulatory decisions should be made based on the principles of health economic modelling and should look at the entire health system level, not just one area. If we are bringing in innovative therapies, we need to balance things out and have the ability to support and adopt the innovation completely.”
She concludes, “the UAE is keen to adopt new innovations and health technologies, providing early access while maintaining and achieving health equity and desirable health outcomes for all.”
