Assessing the Added Therapeutic Benefit of Ultra-Expensive Drugs

Michael J. DiStefano, So Yeon Kang, Farah Yehia, Christian Morales, Gerard F. Anderson

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Objectives: While the United States does not have a method for assessing the added therapeutic benefit of drugs, France, Canada, and Germany do. We examined the added therapeutic benefit of the most expensive drugs prescribed to Medicare Part D beneficiaries in the United States. Methods: We identified ultra-expensive drugs with annual Medicare spending that exceeded $62 794 (United States GDP per capita in 2018) using Medicare Part D Prescription Drug Spending and Utilization Data. We used added therapeutic benefit ratings assessed by health technology assessment agencies in France, Canada, and Germany. Results: We identified 122 ultra-expensive drugs in 2018. Sixty-five percent of these drugs (n = 79) were assessed by at least one of the countries. Based on these assessments, approximately 75% received a low added therapeutic benefit rating. Conclusions: Most ultra-expensive drugs prescribed in the United States and assessed by France, Canada, and Germany provide low added therapeutic benefit. Policy reforms in the United States could use added therapeutic benefit to inform coverage and pricing decisions for ultra-expensive drugs. Similar to Germany, one approach would be to allow the company to set a market price for a limited period of time before requiring a price reduction if the added therapeutic benefit is below a certain threshold. Another approach would be to identify when drug prices are substantially more expensive in the United States and conduct an added therapeutic benefit assessment and price review on these drugs.

Original languageEnglish (US)
Pages (from-to)397-403
Number of pages7
JournalValue in Health
Issue number3
StatePublished - Mar 2021


  • Medicare
  • comparative effectiveness
  • drug prices
  • health technology assessment
  • value

ASJC Scopus subject areas

  • Health Policy
  • Public Health, Environmental and Occupational Health


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