LAUSR

Objectives: Health technology assessment (HTA) bodies and pharmaceutical companies have been forced to react to an unprecedented level of disruption due to COVID-19 This study aims to determine the impact of the COVID-19 pandemic on the processes of European HTA bodies (Transparency Committee (TC), France;G-BA, Germany;NICE, England;SMC, Scotland;AIFA, Italy;CIPM, Spain) and activities of pharmaceutical companies Methods: NICE, SMC, G-BA, AIFA, TC and CIPM guidelines were analysed to assess how COVID-19 has affected HTA decision-making in Europe Additionally, an online survey of pricing and market access (PMA) employees from a range of pharmaceutical and biotech companies, covering the following key topics was conducted: • Impact of COVID-19 on access to marketed products • The company and payer / HTA challenges for new products • Factors that would impact future PMA activities Results: Of the HTA agencies in scope, only the G-BA expected no delays in assessments AIFA, the TC and CIPM expected some impact on PMA decision making The SMC and NICE, anticipated severe disruptions to their activities All respondents acknowledged that COVID-19 is having some level of impact on their company: around 60% of respondents believed the impact on the company to be medium or significant HTA activities are particularly disrupted, as 100% of respondents with products undergoing assessment were impacted in some way For already marketed products, 60% of companies are observing an impact on uptake and/or market access, although only 10% experienced an impact on list or net price 80% of respondents have had their ability to initiate new PMA projects disrupted Conclusions: In the short term, main challenges are disruption of new product launch PMA activities with minimal impact on marketed products There is anxiety that continued disruption will lead to tighter healthcare budgets, tougher pricing negotiations, price cuts and unpredictable changes to the wider healthcare system