Pharmaceutical pricing and managed entry agreements: An exploratory study on future perspectives in Europe

Objectives: This paper illustrates the results of a research aimed at investigating the opinions collected from selected European payers (HTA organisations, authorities/committees assessing, appraising and negotiating drug prices) and experts (researchers/consultants identified through LinkedIn groups) on drug price regulation, managed entry agreements, transparency and HTA advice. Methods: Expert and payer opinions were gathered through a structured questionnaire, validated by three potential respondents and self-administered online between July and November 2021. Results: Respondents totalled 39 (response rate 29%). The response rate was higher among the experts than the payers. Respondents mostly agreed that price regulation should award drug value through a multiple criteria approach (21 respondents) or cost-effectiveness evidence (14). For most respondents the added therapeutic value and the comparative safety profile should be the main drivers of a premium price. A quite high proportion of respondents supported the use of cost-effectiveness, and suggest relying on the perspective of the health care system. Most respondents expect larger diffusion of outcome-based and financial-based managed entry agreements in the future. Finally, respondents advocated for higher transparency of the negotiation process rather than net price transparency, and expressed the belief that HTA advice could be useful in reaching consensus on the level of unmet need, the comparators to consider, and the dimension of the target population. Conclusions: Despite the limited number of respondents, the paper provides very interesting exploratory insights into much-debated topics related to drug price regulation. The opinions of European payers and experts are very useful for future regulation of drug pricing in Europe. Public interest summary: Our research aimed at gathering the opinions of payers and experts on drug price regulation. The main findings are that pricing should reflect the value of medicines, that a premium price should be awarded only to those drugs that provide for an added therapeutic value and/o a better safety profile, even if other value dimensions (patient preferences and organisational impact) should be not disregarded. Experts and payers expect a larger role of managed entry agreements in the future, despite they may impose an important administrative burden. Finally, transparency of price negotiation is prioritized compared to net price transparency.