Opinions of decision-makers on the clinical development and assessment of antineoplastic agents

Abstract

A poster presentation regarding the opinions of decision-makers on the clinical development and assessment of antineoplastic agents. Introduction: Regulatory early access routes in the European Union (EU) have increased flexibility in the authorisation of promising treatments. Health Technology Assessment (HTA) bodies tend to request mature clinical data sets for economic and relative efficacy assessments. Industry stakeholders have indicated that oncology products are associated with divergences between regulatory and HTA clinical assessments potentially hindering access to novel medicines. Aims: To explore and compare regulatory and HTA expert opinions on the following aspects related to antineoplastic agents: •The quality of clinical evidence generated, •The alignment of clinical evidence needs between regulatory and HTA decision-makers •The impact of improving the regulatory-HTA interface.