HPR45 Analysis of Alternative Access Routes and Time to Access for Paediatric Indication Expansions with Consideration of Regulatory, Pricing, and Access Incentives

Abstract

Many regulatory organisations provide incentives for the development of paediatric medicines. Data generation in paediatric indications, and even more so orphan paediatric indications, is challenging and as such pharmaceutical manufacturers face evidence and consequently price and access challenges when expanding into these indications. This study aims to evaluate routes of access and time to access for paediatric indication expansions in Germany, France, Italy, Spain, UK, Canada, Japan, and China.