Innovation Incentives and Biomarkers

Ariel Dora Stern; Brian M. Alexander; Amitabh  Chandra

Article | Clinical Pharmacology & Therapeutics | January 2018

Innovation Incentives and Biomarkers

by Ariel Dora Stern, Brian M. Alexander and Amitabh Chandra

Abstract

Previously, we have discussed the importance of economic incentives in shaping markets for precision medicines. Here we consider incentives for biomarker development, including discovery and establishment. Biomarkers can reveal valuable information regarding diagnosis and prognosis, predict treatment efficacy or toxicity, serve as markers of disease progression, and serve as auxiliary endpoints for clinical trials. Some have multiple uses, while others have a specialized role, resulting in diverse incentives across players in the healthcare system.

Keywords: Health Care and Treatment; Innovation and Invention; Research and Development; Markets;

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Stern, Ariel Dora, Brian M. Alexander, and Amitabh Chandra. "Innovation Incentives and Biomarkers." Clinical Pharmacology & Therapeutics 103, no. 1 (January 2018): 34–36.

Chapter | Innovation Policy and the Economy, Volume 19 | 2018

The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, Ariel Dora Stern, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern

On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else being equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set of natural monopoly-like markets in which firms face little competition, even after the end of formal periods of patent protection and market exclusivity. Additionally, the evolving technologies of drug development—in particular, the increasingly common use of auxiliary endpoints in clinical trials and the use of biomarkers for patient selection for treatment—now allow manufacturers to target smaller populations. Taken together, these changes raise doubts about whether the ODA encourages the development of products that otherwise would not have been brought to market—or whether, instead, it simply rewards the producers of inframarginal products. After presenting empirical support for our claims of an evolving marketplace, we discuss the tradeoffs associated with reshaping the ODA for the 21st century.

Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly;

Citation:

Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018. View Details

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Innovation Incentives and Biomarkers

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