OP132 What Future For Drugs After An Early Dialogue Procedure?

Abstract

IntroductionThe French health technology assessment (HTA) body, Haute Autorité de la Santé (HAS), started to provide early advice on evidence generation plans to pharmaceutical manufacturers in 2010. It became an official mission in 2016. Requests are eligible when the product has a new mechanism of action, if there is an unmet or partially met medical need in the claimed indication and when the pivotal study has not yet started. This analysis aims to provide a first overview of clinical developments for which pharmaceutical companies sought an early dialogue with HAS.MethodsFor each product that went through an early dialogue procedure with HAS, information regarding the clinical development was collected on pharmaceuticals companies’ pipelines, clinicaltrials.gov, the website of the European Medicine Agency (EMA) and HAS's internal database.ResultsBy the end of 2018, HAS has performed 84 early dialogues of which 53 were conducted in collaboration with the EMA and/or others European HTA bodies. They were mainly focused on phase III trials. Following early dialogue, the clinical study for which the company sought advice was not yet implemented in 25 cases. When the clinical trial was effectively launched, results were negative in 10 cases, positive in 11 cases and the study was still ongoing for 29 products. In nine cases, the clinical development was officially withdrawn or suspended before the initiation of the trial. Overall, only eight medicinal products were appraised by HAS, they all obtained a clinical added value score.ConclusionsThe success rate of clinical development for products that underwent an early dialogue procedure tends to be higher than data from literature, although it is likely to decrease in follow-up analysis. This could be partially explained by HAS's eligibility criteria that restrict early dialogues to promising products and by the scientific recommendations provided to pharmaceuticals companies.