EMA seeks more payer, patient involvement in adaptive pathway

In a report released Wednesday, EMA said deeper involvement of payers and patients would likely improve its adaptive licensing pathway. Launched via a pilot program in 2014, the pathway is designed to bring drugs to market through iterative phases of evidence gathering and licensing, with further approvals or adjustments based on postmarket trials and real-world data (see BioCentury, June 23, 2014).

The agency said early input from payers in EU member states would be important for companies as they explore adaptive pricing strategies linked to data collection. Payers were not involved in discussions under the pilot. EMA may explore "possible synergies" among regulatory bodies, health technology assessment (HTA) bodies and payers to ensure timely, affordable access to drugs, the report said. ...