Impact of COVID-19 on HTA/PRMA of Medicinal Products in Europe: A Payer Perspective

ABSTRACT

Objectives: Assess payer perceptions of COVID-19 pandemic’s impact on health systems, focusing on HTA, pricing, reimbursement and market access (PRMA) of new, branded medicines in the EU4 and UK. Methods: In June 2021, MME Advisors conducted a virtual, national payer / advisor board with representatives from France (2), Germany (2), Italy (1), Spain (1), and the UK (2) - to discuss key topics within the pandemic’s context, such as • Disruption to healthcare systems • HTA impact backlog, re-prioritization, framework • PRMA impact net price pressure, conditional pricing/RWE and time to market • Differences and similarities within oncology, rare diseases, ATMPs and general medicines Results: Unlike the significant disruptions seen during the height of the pandemic in 2020, payers saw impact ranging from moderate (Italy) to high (Spain) as of June 2021. Disruption by disease state varied oncology was highly disrupted everywhere but Germany. Most payers did not anticipate shifts in long term priorities or budget cuts to healthcare post pandemic. HTA impact was minimal, with no need to re-prioritize by therapy area or alter plans to adjust frameworks. Likelihood of stricter HTA criteria varied with payers in Italy anticipating more scrutiny for oncology and in Germany for rare diseases/ATMPs. While time to market was expected to remain mostly stable, delays anticipated in Spain. Majority of payers anticipated increasing pressure on drugs’ net prices;however, they were divided on increases in conditional pricing/RWE. Conclusions: Perceived COVID-19 impact varied by country based on infrastructure and adaptability. Germany less impacted, whereas in other markets (e.g., Spain) COVID-19 seemed to have accelerated changes, rather than drive PRMA policy. Given the importance of healthcare, overall budget cuts were not anticipated, although the need to deploy funds to diverse areas (e.g., healthcare worker salaries, hospital capacity) could complicate future scenarios, especially for high-cost therapies. Therefore, continued monitoring is warranted.