Objectives: The rising prices of specialty drugs have prompted a debate about how medications are priced. With the average price of cancer drugs doubling in the last decade, the unsustainability of drug prices is especially concerning in oncology and hematology. The objective of this study was to compare the prices of monoclonal antibodies (mAbs) approved in the last 20 years by the FDA across disease states.
Study design: We identified all indications approved by the FDA for mAbs from 1997 to 2016 and calculated the annual price of 1-year treatment for each mAb-indication combination as the product of the US average wholesale price per milligram and the recommended dose.
Methods: We compared the annual price of treatment with each mAb across disease states using generalized linear models with gamma distribution and log link, controlling for route of administration, chemical structure, source, and time since FDA approval.
Results: The average annual price of a mAb was $96,731, exceeding $100,000 for 34 mAb-indication combinations. Oncology and hematology mAbs represented 40% of the mAb-indication combinations approved, yet they accounted for more than 85% of those priced $100,000 or higher. After adjusting for factors that can affect production costs, the annual price of oncology or hematology mAbs was $149,622 higher than those used in cardiovascular or metabolic disorders; $98,981 higher than in immunology; $128,856 higher than in infectious diseases or allergy; and $106,830 higher than in ophthalmology (all P <.001).
Conclusions: The annual price of mAb therapies is about $100,000 higher in oncology and hematology than in other disease states.