Presentation (CTI)

OBJECTIVES: Spending caps on pharmaceuticals (PSC) may improve short-term cost control but favors silos budgeting approach (being the impact of pharmaceuticals on other costs disregarded). Furthermore, they may undermine market launch in Europe, should the possible associated paybacks be included in the MFN cross-reference pricing system. This paper provides a comparative analysis of PSC in France, Germany, Greece, Italy, Spain, Portugal and UK, updating and integrating a paper published in 2020.
METHODS: A literature review was carried out on five prioritized domains: how the spending cap is calculated; if stakeholders are involved; pay-back/claw-back systems; which medicines are exempt from the payback; duration/renewal. Both scientific and grey literature were considered in the review.
RESULTS: All countries have introduced PSC with an associated payback, except for Germany. Caps are, in most cases, annually determined by the Parliament/Government based on the expected market growth and the macroeconomic constraints (e.g. GDP growth). Only in Italy the two PSCs (retail medicines/drugs procured by hospitals) are set as fixed proportion of healthcare funds. In Portugal, Spain and UK the cap is negotiated with the relevant industry association. Non-reimbursed drugs are excluded from capping. France, Italy, and UK provided for some other exemptions (orphan medicines/drugs with an important therapeutic added value/drugs more recently launched into the market). Greece and Spain introduced partial exemptions for companies investing in the relevant country. Payback is allocated based on overall turnover (France, Spain, Portugal), market share (Italy, UK) and a mixed method (Greece).
CONCLUSIONS: This comparative analysis is the starting point of a second phase of the research, aimed at integrating it with the grey evidence on the perceived/actual impact of PSC on firms’ market launch and investment strategies. Semi-structured interviews will be administered to national experts to gather this information.