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

Abstract

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.

Can a Joint Assessment Provide Relevant Information for National/Local Relative Effectiveness Assessments? An In-Depth Comparison of Pazopanib Assessments

“…It is increasingly recognized that there is considerable scope for better, coordinated interactions between regulators and payers [29,31]. Although the end conclusion may differ, the examples above confirm the relevance of regulator-payer interaction because it is very likely that they face similar evidence dilemmas for the same compound.…”

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

“…This should also help reduce duplication between the requirements of the different government groups as well as build trust between the various groups. This is already happening in Australia and Europe (128,139), building on initiatives to try and harmonise information requirements between payers and HTA bodies across continents (67).…”

La articulación en los sistemas de priorización

“…al., 2011) (Fondsal et. al., 2012, el asesoramiento conjunto entre las ARM e IETS (Wonder et. al., 2013), y el diseño y conducción de los ensayos clínicos comparativos (Eichler et.…”

“…Estos mecanismos generan un debate sobre la conveniencia de que estas medidas se lleven a cabo sin que medien procesos de priorización basados en las necesidades, en especial, cuando se trata de nuevas tecnologías (Vines, 2009 En el nivel operativo de la articulación existen diversas oportunidades. Como lo veremos más adelante, los casos de bevacizumab y drotecogina ayudan a ilustrar la articulación que debería ocurrir en las instituciones con relación a la cancelación de una indicación o el retiro de un medicamento del mercado.…”