Abstract
Background: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to address the HTA requirements early during development to improve reimbursement outcomes. Currently, there is a lack of research to assess the impact of HTA on development and jurisdictional outcome from companies’ perspectives. This study aimed to assess companies’ HTA strategy and characterise HTA practice in seven jurisdictions. Methods: A multi-year, annual study collected information for individual products, focusing on development activities regarding inclusion of HTA requirements and selection of global comparators. The generation of local contextual information, submission strategies and predictability of HTA outcomes was examined jurisdictionally in Australia, Canada, England, France, Germany, Italy and Spain. The study questionnaire was built into a secure online data collection platform and data were provided annually by participating companies. Results: Data for 169 compounds were provided by nine international companies between 2014 and 2018. HTA requirements were implemented in evidence generation plan for 63% of products during development. Global comparators were accepted by HTA bodies for more than half of studied products; Spain showed the highest acceptance rate (85%). Companies took advantages of parallel process in Australia and Canada to shorten product rollout time. Australia demonstrated general consistency in HTA review time, and England had the longest variation (interquartile range, 216 days). Requirements for additional information after submission occurred at all HTA bodies. Germany and Italy showed the highest percentage of products being reimbursed as per regulatory label (80 and 68%, respectively). Canada was the most predictable jurisdiction, with the highest proportion of review outcome (90%) that met companies’ expectations. Conclusion: Companies are addressing HTA requirements during development for many products; however, they are challenged by varying requirements and practices and product success ultimately depends on how HTA organisations and payers assess added value in the context of the national healthcare systems. This ongoing study created a baseline to help capture fact-based changes for company HTA strategies and HTA body practices.
Highlights
Drug development is a long, costly and complex process (DiMasi et al, 2016) and in response to competitive pressure, pharmaceutical companies continue to improve research and development productivity to bring innovative medicines to market (Cohen, 2005; Smietana et al, 2015)
One study showed that only a proportion of regulatory approvals received an initial positive heath technology assessment (HTA) recommendation (Wang et al, 2019), which could result in price constraints, reimbursement restrictions by the payer and time delay to patient access, as new products might become available in different jurisdictions at different times
This study aimed to characterise the practices of international pharmaceutical companies that address HTA requirements by collecting specific metrics and activities for new products from development to rollout at the jurisdictional level
Summary
Drug development is a long, costly and complex process (DiMasi et al, 2016) and in response to competitive pressure, pharmaceutical companies continue to improve research and development productivity to bring innovative medicines to market (Cohen, 2005; Smietana et al, 2015). HTA has increased in importance in supporting payer decision making by assessing the relative and cost-effectiveness of new medicines in comparison to existing technologies based on local context (Goodman and Ahn, 1999). One study showed that only a proportion of regulatory approvals received an initial positive HTA recommendation (Wang et al, 2019), which could result in price constraints, reimbursement restrictions by the payer and time delay to patient access, as new products might become available in different jurisdictions at different times. Pharmaceutical companies need to address the expected HTA requirements during drug development in order to improve the HTA outcome and to maximise patient access and commercial success. Pharmaceutical companies need to address the HTA requirements early during development to improve reimbursement outcomes. This study aimed to assess companies’ HTA strategy and characterise HTA practice in seven jurisdictions
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