TRENDS
FROM THE FIELD
Pricing of Monoclonal Antibody Therapies: Higher If Used for Cancer?
Shivani Sampathkumar, BS; and William H. Shrank, MD, MSHS
he unsustainable rising prices of specialty drugs have prompted a debate about how medications are priced. Manufacturers contend that high prices are essential
ABSTRACT
to recoup research and development costs; however, a growing societal chorus believes that manufacturers are maximizing profits at the expense of patients and the healthcare system. Concerns about drug pricing policies are amplified in oncology and hematology, 1- where vulnerable patients and their families often have unrealistic expectations about the value of treatment. Of note, the mean price of a cancer drug has doubled in the last decade, and targeted therapies represent an important driver of this increase.. In this study, we compared the annual price of monoclonal antibody (mAb) therapies approved in the last 20 years by the FDA across disease states. Specifically, we evaluated whether the prices were higher for mAbs used in cancer than for those used in other disease states. We limited our analysis to mAbs to minimize the potential impact of varying production costs among different types of molecules.
OBJECTIVES: The rising prices of specialty drugs have prompted a debate about how medications are priced. With
(mAbs) approved in the last 20 years by the FDA across disease states.
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.
exceeding $100,000 for 34 mAb-indication combinations. Oncology and hematology mAbs represented 40% of the
METHODS
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).
Study Design We identified all indications approved by the FDA for mAbs from 1997 to 2016 using the FDA website? After excluding radioactive mAb-indication combinations (n = 1), antidotes (n = 1), andthose approved for diagnostic purposes (n =3), withdrawn from the market by 2016 (n = 2), or not available to the public for other reasons (n =2), oursampleincluded 107 unique mAb-indication combinations (eAppendix Table 1[eAppendices available at ajmc.com]). From the FDA-approved label of each mAb, we extracted the recommended dose for each indication, chemical structure (whole mAb, antigen- binding fragment antibody, or other), source (human, humanized, chimeric, or murine), and route of administration (subcutaneous, intravenous, intramuscular, or intraocular). We categorized indica- tions into 5 disease states: oncology or hematology, cardiology
CONCLUSIONS: The annual price of mAb therapies is about $100,000 higher in oncology and hematology than in other disease states.