Patient perspective elicitation on benefits and risks of medicinal products, from development through the entire life cycle, to inform the decision-making process by regulators and Health Technology Assessment bodie

To establish recommendations with the view of supporting the development of guidance for industry, regulators and health technology assessment (HTA) bodies on how and when in the product life-cycle to consider patient perspectives on benefits and risks of medicinal products to inform the decision-making process by regulators and HTA bodies.

While there is an emerging consensus among stakeholders that patients’ values and perspectives are important to inform decision-making processes during the development of medicines as well as during the approval and post-approval phases, it is not clear when patient perspective elicitation on benefits and risks of medicinal products is most valuable, and how this can best be performed.

Consensus between patients, physicians, regulators, HTA bodies, academia and industry stakeholders on an approach, including a set of methodologies suitable for patient involvement, acceptable to regulators and HTA bodies for inclusion of patient preferences to inform benefit-risk decision-making throughout the product life-cycle: