Can Generalized Cost-Effectiveness Analysis Leverage Meaningful Use of Novel Value Elements in Pharmacoeconomics to Inform Medicare Drug Price Negotiation?

Autor: Padula WV; Department of Pharmaceutical and Health Economics, Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, USA; Leonard D. Schaeffer Center for Health Policy and Economics, Los Angeles, CA, USA; Stage Analytics, Baltimore, MD, USA. Electronic address: padula@usc.edu., Kolchinsky P; RA Capital Management, Boston, MA, USA; No Patient Left Behind, Westland, MI, USA.
Jazyk: angličtina
Zdroj: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2024 Aug; Vol. 27 (8), pp. 1100-1107. Date of Electronic Publication: 2024 Apr 26.
DOI: 10.1016/j.jval.2024.04.013
Abstrakt: Objectives: Decision makers considering using cost-effectiveness analysis (CEA) to inform health-technology assessment must contend with documented and controversial shortfalls of CEA, including its assumption of disease severity independence and static pricing. ISPOR has recently introduced novel value elements besides direct healthcare cost and effectiveness for the patient, and these should be captured in CEA. Although novel value elements advance our understanding of "what" should be measured (value of hope, severity of disease, health equity, etc), there is limited direction on "how" to measure them in conventional CEA. Furthermore, with Medicare empowered to set drug prices under the Inflation Reduction Act, it is not clear what role CEA might have on where prices are set, given objections to the quality-adjusted life year in conventional approaches.
Methods: We critically reviewed the evidence for expanding conventional CEA methods to a more generalized approach of generalized CEA (GCEA).
Results: GCEA accounts for methods that address objections to the quality-adjusted life year and incorporate novel value elements. Although GCEA offers advantages, it also requires further research to develop "off-the-shelf" resources to help inform, for example, maximum fair price in the context of Medicare drug price negotiation.
Conclusions: Should a shift toward GCEA reveal that the societal value of novel medicines exceeds their market-based costs, which will raise the key question of what market failure Medicare negotiation is meant to solve, if any, and therefore what the appropriate role of such negotiation might be to maximize the value society might garner from the development of novel medicines.
Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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