OBJECTIVES: While international reference pricing (IRP) has traditionally been used to inform launch sequencing, European efforts to standardize the determination of clinical value for new products through joint clinical assessments (JCAs) are expected to impact launch preparedness. This research aims to analyze launch sequences of drugs to evaluate if launch preparedness is still heavily driven by IRP policies or is incorporating components to account for the future effects of JCAs.

METHODS: We selected 13 countries with established HTA entities that have IRP policies or act as IRP referenced countries and 10 multiple sclerosis (MS) drugs as the crowded MS spaced allowed for a robust drug sample despite the challenges of a mature market. We defined the launch sequences based on HTA submission dates, considering the average HTA process duration and excluding submissions preceding 2019. Finally, we analyzed launch sequences and IRPs to determine whether the latter may have informed the launch preparedness.

RESULTS: Overall, 5/10 drugs had six or more HTA submission dates that informed the launch sequence. The first-launch country was UK (n=3/5), Australia, or Norway (n=1/5 each). UK was most frequently followed by Norway (n=2/3), followed by Australia (n=1/3). Sweden was most often positioned as the fourth and Germany as the fifth/sixth country. France positioning ranged from second to seventh (n=1 each). Romania, Denmark, Poland, and Brazil were positioned after their IRP referencing countries. Launch sequences were consistent with IRP policies for 4/5 drugs, where companies launched first in non-IRP-guided countries (Australia) or countries negotiating confidential discounts (UK).

CONCLUSIONS: Manufacturers are still relying on IRP policies to inform their launch sequences. As JCAs policies start to be implemented, the influence of IRP on pricing decision-making is expected to decrease. Global pricing research and early engagement with JCAs stakeholders will likely become critical to inform new launch preparedness plans in the upcoming years.