Analysis of Leadtimes and Factors Impacting Leadtimes in Reimbursement Processes in the Netherlands to Estimate and Optimize Time Till Patient Access

OBJECTIVES: The objective is getting insights in factors associated with reimbursement process leadtimes, so that authorities and other stakeholders can better estimate the leadtime till patient access and may contribute to an optimal flow of the reimbursement process.

METHODS: Leadtimes are divided in phases, based on the CIBG Dashboard:

• submission: EMA approval - Zorginstituut (ZIN) declaration of dossier ‘completeness’
• assessment: declaration - publication ZIN advice
• negotiation: advice - inclusion in insured package

We investigated possible association between factors and leadtimes for a selection of HTA assessed products (finalisation phase 2 in April ’23 - April ’24 and finalisation phase 3 before June ’24). We specifically included recent cases to minimize the impact of changing policies.

RESULTS: Total leadtimes vary considerably (160-2.064 days), with most variation in phase 1 (97-1.554 days). Factors contributing to variation in phase 1 are mostly not publicly available, e.g. a companies’ strategic considerations or the informal processes prior to declaration of dossier completeness. Also factors impacting phase 3 (64-331 days) are mostly confidential. In relation to the total leadtimes, phase 2 leadtimes seem rather limited (23-304 days). Factors that can be identified based on publicly available information in phase 2, may also impact the other phases. Potential factors include reimbursement route, level of innovation, implementation of new policies, budget impact, ICER, etcetera. The number (n = 17) and heterogeneity of cases clearly does not allow statistical significance on association between identified factors and leadtimes.

CONCLUSIONS: Determination of quantitative impact of factors on leadtime appears not feasible, since changing policies limit the analysis period and hence the number of assessments. However, further qualitative research may give more information on factors impacting leadtime and their causality. The formal assessment phase is least determining in time till patient access, but excludes the informal pre-dossier-completeness process.