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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Integrating Price Benchmarks and Comparative Clinical Effectiveness to Inform the Medicare Drug Price Negotiation

Sean D Sullivan1, Olivier J Wouters2, Emma M Cousin3

  • 1The CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA; Department of Health Policy, London School of Economics and Political Science, London, England, UK.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|August 18, 2024
PubMed
Summary

The Centers for Medicare and Medicaid Services (CMS) will soon report negotiated drug prices. This study estimates initial offers using net prices, ceilings, and comparative effectiveness data for 10 selected drugs.

Keywords:
CMSMaximum Fair PriceMedicare Price Negotiation

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Area of Science:

  • Health Economics
  • Pharmaceutical Policy
  • Drug Pricing

Background:

  • The Centers for Medicare and Medicaid Services (CMS) is set to publicly report Maximum Fair Prices for 10 selected drugs by September 2024.
  • This initiative marks a significant shift in pharmaceutical pricing regulation and transparency.

Purpose of the Study:

  • To estimate plausible initial price offers for the first 10 drugs selected for negotiation by CMS.
  • To identify key price benchmarks and clinical evidence factors influencing these initial offers.

Main Methods:

  • Utilized net prices, statutory ceiling prices, and comparative effectiveness data for the 10 drugs and their therapeutic alternatives.
  • Analyzed CMS guidance and regulatory intent to outline a range of potential initial price offers.

Main Results:

  • Statutory ceiling prices are likely to determine initial offers for ibrutinib and ustekinumab.
  • Net pricing and clinical evidence will inform offers for apixaban, empagliflozin, etanercept, and insulin aspart.
  • Discounts may apply to rivaroxaban and sacubitril/valsartan due to generic alternatives; additional factors are needed for dapagliflozin and sitagliptin.

Conclusions:

  • The analysis highlights critical price benchmarks and clinical evidence for determining initial drug price negotiation offers.
  • Provides a systematic approach to generating initial offers aligned with CMS guidance, despite not simulating the full negotiation process.