NPC responds to CMS's Information Collection Request on the Negotiation Data Elements and Drug Price Negotiation Process for the Initial Price Applicability Year 2027
NPC offered the agency insights on the data collection requirements it has proposed to inform the second round of the the price-setting efforts in the Medicare Drug Price Negotiation Program.
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NPC submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the notice, “Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 (CMS-10849).” NPC provided insights that will help the agency assess the utility and burden of the data requested by the agency to inform the implementation of the Medicare Drug Price Negotiation Program under the IRA. NPC's comments address key areas, including:
- Administrative Burden and Transparency
- Reducing Administrative burden for patients and manufacturers
- Increasing Transparency and Revising Timelines between the Evidence Collection and Review
- Section I: Evidence about Alternative Treatments
- Data on Therapeutic Alternatives
- Patient-Specific Data Elements
- Treatment Costs and Offsets
- Unmet Medical Need
- Drug Price Negotiation Process ICR Form
- Opportunities for meaningful in-person CMS-manufacturer engagement