An Economic and Regulatory Analysis of Breast Cancer Drugs Approved by the US Food and Drug Administration

Author

Abdullah Althomali, Chapman UniversityFollow

Date of Award

Spring 5-2023

Document Type

Thesis

Degree Name

Master of Science (MS)

Department

Pharmaceutical Sciences

First Advisor

Enrique Seoane-Vazquez

Second Advisor

Rosa Rodríguez Monguio

Third Advisor

Lawrence M. Brown

Fourth Advisor

Marc L. Fleming

Abstract

Introduction

Breast cancer is the most common cancer among women and the leading cause of cancer death among women worldwide. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. This study assessed trends in FDA approvals and prices at the market entry of new drugs indicated for breast cancer in the period 1980-2022. The study also evaluated the factors associated with the price of the new breast cancer drugs at market entry.

Material and Methods

Regulatory data were collected from the FDA website, and the wholesale acquisition cost (WAC) at market entry from the IBM Micromedex Redbook. We estimated the cost per year or per treatment as defined on the FDA-approved drug label. The WAC was adjusted to 2022 dollars using the consumer price index. Descriptive statistics and generalized linear model regression analysis were conducted.

Results

As of December 31, 2022, the FDA approved 30 drugs including 23 new molecular entities and 7 new biologics, with 60 indications for different stages of breast cancer and 71 indications for other diseases. The FDA approved 22 (75.9%) drugs using a priority review designation and 5 (17.2%) were granted orphan designation. The median of the inflation-adjusted WAC treatment cost at market entry was higher for drugs approved for advanced and metastatic stages of breast cancer (n=42, median=$88,019, interquartile range (IQR)=$148,969) than those approved for early stages of breast cancer (n=18, median=$51,150, IQR=$141,203).

The price of breast cancer drugs at market entry was positively associated with the stage of cancer (specifically, stage 4), approval date, priority review designation, and HER2-positive or TNBC breast cancer subtypes.

Conclusions

The FDA approved a large number of drugs indicated for the treatment of different types of breast cancer in the period 1980-2022. The CPI-adjusted WAC treatment cost at market entry significantly increased in the period of analysis. Drugs for advanced cancer states, priority review designation, and for specific cancer subtypes were associated with higher treatment costs.

Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

Recommended Citation

Althomali, A. An Economic and Regulatory Analysis of Breast Cancer Drugs Approved by the US Food and Drug Administration. [master’s thesis]. Irvine, CA: Chapman University; 2023. https://doi.org/10.36837/chapman.000444