Marshal your PROs for market access
This article was originally published in Scrip
Patient reported outcomes (PROs), with their ability to reflect patients' experience of a drug's impact on symptoms or overall quality of life (QoL), are increasingly valued by the regulators and health technology assessment (HTA) bodies. However, manufacturers need to ensure the PROs they capture satisfy the regulators' and HTAs' standards and requirements in order to have an impact.
You may also be interested in...
Including the impact on hospitalizations in the label for Novartis's heart failure drug Entresto was critical to enable execution of outcome-based agreements. Such deals present an opportunity for pharma and payers to work together, but many challenges remain.
Despite the challenges with the implementation of managed entry agreements, the debate involving these complex market access routes is not abating. Speakers at the International Society for Pharmacoeconomics and Outcomes Research Europe meeting in Milan on 7–11 November 2015 discussed current experiences with such agreements across Europe, as they are about to make a bigger showing across the Atlantic.
Four years after its introduction, Germany's early benefit assessment process continues to make waves in the industry.