The Centers for Medicare & Medicaid Services (CMS) has issued an information collection request (ICR) addressing the collection of data elements CMS must use to determine its offer amount when negotiating a selected drug’s maximum fair price.
CMS seeks comment on the collection of this information, which includes certain manufacturer-specific data a manufacturer must submit about a selected drug and evidence CMS must consider about therapeutic alternatives for a selected drug.
Manufacturer-Specific Data for the Selected Drug
- R&D costs and the extent of recoupment
- Current unit costs of production and distribution
- U.S. market, revenue, and sales volume data
- Prior federal financial support for novel therapeutic discovery and development
- Data on pending and approved patent applications and exclusivities
Evidence About Therapeutic Alternatives for the Selected Drug
- The extent of therapeutic advancement and costs compared to existing therapeutic alternatives
- Extent of addressing unmet medical needs
- Comparative effectiveness, including the effects on specific populations
- Prescribing information approved by the FDA for the drug and therapeutic alternatives
By September 1, 2023—the date CMS must announce the first 10 Part D selected drugs—CMS intends to develop an automated tool on the Health Plan Management System for manufacturers to submit manufacturer-specific data and manufacturers and the public to submit evidence for therapeutic alternatives before the October 2, 2023, data submission deadline.
CMS estimates the total cost of this information collection for the 2026 price applicability year to be $51,588.50 for each manufacturer of a selected drug.
As highlighted in CMS’s initial guidance addressing the negotiations program, since CMS may not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as lower value, CMS intends to substantially limit consideration of research that uses quality-adjusted life-years (QALYs).
Next Steps for Stakeholders
- Submit comments to CMS’s initial guidance on the negotiations program—which addresses the data in more detail—by April 14, 2023, to IRARebateandNegotiation@cms.hhs.gov.
- Submit comments to this ICR by May 22, 2023, on http://www.regulations.gov or via regular mail.
Date of Issuance: March 21, 2023