The Institute for Clinical and Economic Review (ICER) has updated its drug value assessment process for 2020 to include more real-world evidence (RWE), a one-year reevaluation and other new elements.
The update expands the categories of “potential other benefits” to include the level of health loss that would be experienced without the treatment and the mechanism of action’s similarity to other approved drugs, among other items.
The institute’s evaluations will also include a process for gauging if new evidence has become available that should be included in an updated report. The reevaluations will be conducted one year after a final evidence report is published.
In addition, ICER will launch a pilot program for updating original assessments after a medicine has been on the market for at least two years for drugs approved under the FDA’s accelerated approval pathway. “This pilot will explore how best to develop and assess new RWE as a cornerstone of the update process,” it said.