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Are Medical Devices Cost-Effective?

James D Chambers1, Madison C Silver2, Flora C Berklein2

  • 1Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, 35 Kneeland St., Boston, MA, 02111, USA. jchambers@tuftsmedicalcenter.org.

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This summary is machine-generated.

This study analyzed the cost-effectiveness of medical devices approved by the FDA. Most analyzed device categories demonstrated good value, offering significant health benefits relative to their costs.

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Area of Science:

  • Health economics
  • Medical device evaluation
  • Health technology assessment

Background:

  • Medical devices offer therapeutic advances but require cost-benefit analysis.
  • Assessing the economic value of new medical technologies is crucial for healthcare systems.
  • Pre-market approval (PMA) devices by the FDA represent significant innovations.

Purpose of the Study:

  • To evaluate the cost-effectiveness of FDA-approved pre-market medical devices.
  • To determine the health benefits and associated costs of PMA devices across different categories.
  • To compare the cost-effectiveness of medical devices against established benchmarks.

Main Methods:

  • Searched PubMed for cost-utility and comparative-effectiveness studies of PMA devices (1999-2015).
  • Calculated incremental cost-effectiveness ratios (ICERs) using quality-adjusted life-years (QALYs) and costs.
  • Conducted sensitivity analysis excluding industry-funded studies.

Main Results:

  • Cost-effectiveness data was available for 15.9% of non-cosmetic PMA devices and 26.2% of generic categories.
  • Median incremental cost was $1701 and median health gain was 0.13 QALYs per category.
  • 68% and 81% of device categories had ICERs below $50,000 and $150,000 per QALY, respectively.

Conclusions:

  • Published cost-effectiveness evidence exists for approximately one-quarter of major PMA device categories.
  • Available evidence indicates that most analyzed medical devices offer good value for money.
  • Findings support the favorable cost-effectiveness of many medical devices based on established benchmarks.