Early Scientific Advice Obtained Simultaneously from Regulators and Payers: Findings from a Pilot Study in Australia

The sessions proved highly informative and permitted better alignment of the possible positioning of new medicines with the clinical evidence that regulators and HTA agencies might subsequently require for favorable assessment. The process provided early and clear signals to inform major development investments and the probability of successful market access. A number of challenges need to be addressed before tripartite scientific advice can be provided on continual basis.