Despite significant scientific advances in the development of precision health technologies and interventions (PHTI), many fail to advance to clinical and other applications due to deficiencies in (a) rigorous and efficient evidence development at the pre-clinical and clinical research phases; (b) capacity to navigate regulatory approval processes; (c) understanding of market-access pathways, including reimbursement/payer and/or adoption decision-making; and (d) understanding of the practical and cultural challenges posed by the implementation of potentially disruptive precision medicine in real-world contexts. Those Precision Medicines that have been translated to marketed products have created substantial financial, operational, and/or cultural challenges for regulators, payers, and health systems
On June 27th to 29th, 2017, the Precision Medicine Policy Network and Paceomics will bring together international experts from Canada, the United Kingdom, Australia, Japan and the United States. These experts – representing regulatory agencies, reimbursement agencies, the insurance industry, health system data analytics, the biotechnology sector, investors, clinicians, and patient organizations – will explore and identify promising strategies that can support the timely, risk managed, and sustainable adoption of PHTIs.
The workshop will address key challenges for health care payers and developers in evaluating and funding precision medicines. Sessions will focus on:
(1) Price based solutions to the challenges faced by health care payers in managing market access for precision medicines, such as price discounts or volume price agreements;
(2) Research based solutions to the challenges faced by health care payers in managing market access for precision medicines, such as only-in-research and only-with-research schemes; and
(3) The use of routine data infrastructure to address the challenges faced by health care payers in using real-world evidence to manage reimbursement of precision medicines, such as post-market surveillance infrastructure.
Stay tuned! Outputs will include a summary of workshop discussion & conclusions, and a manuscript will be prepared for publication.