The Price of Speed: Estimating the Impact of List Prices on Time to Availability of New Medicines in 18 European Countries

OBJECTIVES: To examine whether higher national list prices for new medicines are associated with faster patient access across 18 European countries. METHODS: Data were drawn from the 2023 European Federation of Pharmaceutical Industries & Associations (EFPIA) Patients Waiting to Access Innovative Therapies (WAIT) Indicator Survey and the Swedish TLV's 2023 international price index. Time to availability was defined as the number of days between marketing authorisation and national reimbursement access. A multivariable linear regression model was applied, controlling for gross domestic product (GDP) per capita, population size, health technology assessment (HTA) duration, and the use of Managed Entry Agreements (MEAs). To address endogeneity, a two-stage least squares (2SLS) regression was conducted using a composite headquarters (HQ) Index as an instrumental variable for national list prices. RESULTS: In the multivariable model, each one-point increase in the list price index (European average = 100) was associated with a 7.9-day reduction in time to availability (p = 0.091). A slow HTA/reimbursement process was significantly associated with longer delays (p = 0.022). Managed entry agreement intensity was positively associated with longer delays but did not reach statistical significance (p = 0.103). In the 2SLS model, a one-point increase in the instrumented list price was associated with a 14.1-day reduction in access delays in the preferred parsimonious specification (p = 0.011). Sensitivity analyses showed that the negative association was generally preserved across alternative instrumental variable specifications and after exclusion of Poland, although effect sizes and first-stage strength varied. CONCLUSIONS: Higher national list prices may be associated with faster patient access to new medicines in European markets. Although the findings are consistent with a possible causal effect, they should be interpreted with caution given the sensitivity of the estimates to specification and sample composition, as well as concerns about instrument validity and strength. The results highlight a potential policy trade-off between affordability and timely availability in pharmaceutical pricing and access frameworks.