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Breakthrough therapy (BT) drugs offer greater health benefits and value for money compared to non-BTs, though cost-effectiveness varies by disease area and drug type. This analysis supports the FDA

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Area of Science:

  • Health Economics and Outcomes Research
  • Pharmacoeconomics
  • Drug Approval Pathways

Background:

  • An increasing number of drugs are approved via accelerated pathways, particularly the US Food and Drug Administration's breakthrough therapy (BT) designation.
  • BT designation signifies substantial potential for improved health outcomes, but their economic value remains incompletely understood, especially given higher costs compared to non-BTs (NBTs).

Purpose of the Study:

  • To evaluate the cost-effectiveness (CE) of BTs and identify factors influencing their reported economic value.
  • To compare the CE of BTs and NBTs within the United States market.

Main Methods:

  • Utilized the Tufts Medical Center Cost-Effectiveness Analysis Registry to summarize CE data (cost per quality-adjusted-life-year [QALY]).
  • Compared CE ratios for BTs and NBTs in the US.
  • Employed general estimating equation models to identify factors associated with BT CE across US willingness-to-pay (WTP) benchmarks ($50K-$150K/QALY).

Main Results:

  • Between 2013-2018, 32% of 279 FDA-approved drugs were BTs, with higher incremental costs and QALY gains than NBTs.
  • BTs demonstrated more favorable median CE ratios ($38,000/QALY) compared to NBTs ($50,000/QALY).
  • Hepatitis C treatments showed the most favorable CE, and new molecular entities (NMEs) had approximately 40% lower CE ratios than non-NME BTs.

Conclusions:

  • Published CE studies indicate BTs generally provide greater health benefits (QALYs) than NBTs.
  • The FDA's BT designation appears associated with increased value for money.
  • Cost-effectiveness is influenced by disease area, NME status, and comparator choice (active vs. standard of care).