OBJECTIVES: The increased focus on healthcare budgets driven by newer high-cost innovative drugs and the COVID-19 pandemic led EU5 countries (Germany, Spain, France, Italy, and UK) to implement pricing policy reforms. This research analysed the commonalities and impact of the recent EU5 pricing reforms on the pharmaceutical industry.

METHODS: Analysis of healthcare pricing policies (laws, decrees, memorandums, guidelines) promulgated by EU5 Ministries of Health (MoH) or Health Technology Assessments (HTA) bodies since 2019.

RESULTS: We have identified eleven policies, impacting three areas:

• Pricing negotiations:
  • Germany’s GKV-FinStG act (2022) introduced price-volume agreements and reduced orphan drugs revenue threshold.
  • NICE updated review methodology (2022) to allow higher ICERs.
  • AIFA merged committees (2024) to speed-up pricing negotiations and JCA implementation.
• Healthcare spending:
  • Germany increased “mandatory discounts”, reduced free pricing to 6-months, and introduced a combination drug markdown.
  • The UK merged CCGs into ICSs (2022) and adjusted VPAS rebates.
  • In France, the CEPS-LEEM agreement (2021) clarified originators and biosimilars discounts based on market share.
  • In Spain, the Reference Pricing Order (2022) introduced new reference groups for discounted rates.
• Access and manufacturing:
  • The MHRA plan (2023) expedited post-Brexit approvals.
  • IMF (2022) funded innovative medicines.
  • France incentivised innovative medicines production and introduced Direct Access Scheme (2023).
  • An Italian decree (2020) permitted price increases and renegotiation incentivising manufacturing.

CONCLUSIONS: Most identified policies (n=7) aimed to contain costs by increasing payer negotiation and pricing powers, while four policies focused on optimising access to innovative treatments. With further pricing reforms planned in Germany and Spain, and budgetary constraints weighing on healthcare spending across Europe, this observed trend of pricing policies ensuring cost containment will continue. Understanding the value drivers of successful pricing negotiation outcomes will be pivotal for an optimal market access strategy for pharmaceutical companies in Europe.