Healthcare Economist May 10, 2024
What data do drug manufacturers need to submit to CMS as part of the IRA price negotiation? What data elements can they electively submit? The recent CMS guidance released May 3, 2024 outlines these elements.
What mandatory data are manufacturers required to submit?
On the mandatory side, drug manufacturers are required to provide CMS with the following types of data:
- Research and development (R&D) costs of the Primary Manufacturer for the selected drug and the extent to which the Primary Manufacturer has recouped those costs;
- Current unit costs of production and distribution of the selected drug, averaged across the Primary Manufacturer and any Secondary Manufacturer(s);
- Prior Federal financial support for novel therapeutic discovery and development with respect to the...
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