Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia

Value drivers for pharmaceutical products in health technology assessment (HTA) in Saudi Arabia: Results from a capacity Building, Multi-Stakeholder workshop

“…A high level of acceptability for the inclusion of RWE in future HTA submissions was also demonstrated by the participants in this workshop. However, participants also highlighted the potential challenges of local data availability in Saudi Arabia; local registries and databases are often not accessible, available and/or lack complete, high-quality data ( Al-Omar et al, 2020a , Al-Omar et al, 2020b , Fasseeh et al, 2020 ). With increasing concern over the generalizability of clinical evidence from RCTs between different countries, local RWE has been increasingly included in HTA submissions ( Berger et al, 2017 ).…”

“…Policies for RWE use in submissions are not consistent across HTA agencies, and some have argued for improved alignment of policies in order to encourage the consideration of RWE analyses in future HTA decision-making processes ( Makady et al, 2017 ). A recent drive to conduct more clinical trials in Saudi Arabia, coupled with investment in disease registries, may improve the availability and reliability of local Saudi data that can be used in future HTA decision-making processes ( Al-Omar et al, 2020a , Al-Omar et al, 2020b ).…”

“…Evidence from previous workshops has shown that both local Saudi experts and pharmaceutical representatives value the transparency provided by cost-effectiveness analyses, but that it is important to utilize Saudi-specific data and utility measures ( Al-Omar et al, 2020a , Al-Omar et al, 2020b ). In addition, these experts expressed concern over the applicability of a single WTP threshold (based on cost/QALY) for all of Saudi Arabia, as existing standards of care can vary across healthcare and regional settings ( Al-Omar et al, 2020a , Al-Omar et al, 2020b ). Participants in a multi-stakeholder conference on HTA implementation in the MENA region indicated a preference for an explicit soft threshold (51.0%) as compared with implicit (15.7%) or explicit hard thresholds (27.5%) ( Fasseeh et al, 2020 ).…”

“…Once established, these perspectives can provide input on the challenges and hurdles that industry may encounter due to changing HTA methodologies and processes ( Joint Healthcare Industry Paper, 2011 ). Results from a previous workshop attended by representatives from pharmaceutical companies suggested that the majority of industry participants understood the benefit of HTA processes for the Saudi healthcare system, and expressed a willingness to adapt to meet future HTA submission requirements ( Al-Omar et al, 2020a ). Incorporating an industry perspective may add value to HTA processes by providing information on specific health care sectors/products, sharing knowledge gained from HTA processes in different countries, and highlighting important factors to consider under ‘innovation’ ( Joint Healthcare Industry Paper, 2011 ).…”

“…Although there are some similarities in HTA processes and methods between countries, it is often the case that each country has a unique set of circumstances to consider in their implementation of HTA ( Akehurst et al, 2017 ). Although pharmaceutical companies are committed to delivering the high development standards required for an HTA submission, variation in the data required by each HTA entity to demonstrate a drug’s clinical effectiveness, safety, quality, and cost-effectiveness can lead to problematic disparities in data interpretation and valuation between different decision bodies ( Akehurst et al, 2017 , Al-Omar et al, 2020a , Joint Healthcare Industry Paper, 2011 ). Therefore, it is important for both pharmaceutical companies and other stakeholders to understand the overall HTA decision-making process and the specific drivers of decision-making that guide each HTA entity with regards to the reimbursement of pharmaceutical products.…”