Creating win-win-win situations with managed entry agreements? Prioritizing gene and cell therapies within the window of opportunity

Drug Discov Today. 2024 Jul;29(7):104048. doi: 10.1016/j.drudis.2024.104048. Epub 2024 Jun 1.

Abstract

Outcome-based reimbursement models are gaining attention for managing the clinical uncertainties and financial impact of gene and cell therapies. Little guidance exists on how such models can create win-win-win situations, benefiting health-care payers, health-technology developers and patients. Our innovative approach prospectively prioritizes therapies for which a 'window of opportunity' might occur through the analysis of health-technology assessments and product characteristics. Within this window, one size does not fit all, and depending on the extent of clinical uncertainty and potential added benefit levels, different win-win-win situations exist in the United States, the United Kingdom and the Netherlands. Dutch Horizon scanning data prioritized etranacogene dezaparvovec (Hemgenix) and mozafancogene autotemcel for their potential to benefit from outcome-based reimbursement models. These insights extend beyond gene and cell therapies, and could help to provide sustainable health care and patient access to innovative therapies.

Keywords: ATMPs; Delayed payments; Gene and cell therapies; Horizon scanning; Managed entry agreements; Outcome-based reimbursement.

MeSH terms

  • Cell- and Tissue-Based Therapy* / methods
  • Genetic Therapy* / methods
  • Humans
  • Netherlands
  • Reimbursement Mechanisms
  • Technology Assessment, Biomedical
  • United Kingdom
  • United States