U.S. HIV/AIDS Treatment Pricing Controversies and the Emergence of "Rebate Advocacy".

When people living with HIV in the U.S. pick up a prescription at a pharmacy, they are confronted with a shocking price tag. The annual "list price" of an HIV regimen in the U.S. is approximately $25,000. However, though patients are confronted with this price tag when, few insurers, including federal payers such as Medicaid and the AIDS Drug Assistance Program pay this "list price". This paper addresses the social production of knowledge about pharmaceutical prices through historical case studies of three controversies over HIV/AIDS treatment costs in the U.S. I first provide a brief history of the U.S. Orphan Drug Act (ODA). While the ODA was intended to create incentives for the development of unprofitable drugs for the treatment of rare diseases such AIDSrelated pneumonia, today, almost 40% of all drugs approved by the FDA receive the orphan designation. Rare disease is big business. Second, I briefly describe the debates about the costs of AIDS that led up to the passage of the Ryan White Care Act in 1990. I track the ways that financialization of biomedicine has reshaped U.S. HIV/AIDS treatment prices and payment. In the wake of the U.S. FDA approval of Highly-Active Antiretroviral Treatment (HAART), HIV treatment advocates took a different approach to controversies about costs. Their "rebate advocacy" leveraged industry-standard practices to decrease the payment price of HAART and extend access for a narrow group of HIV positive people. Finally, I address Turing Pharmaceuticals 2016 decision to increase the list price of a treatment for an AIDSdefining infection by 5000% and subsequent pricing transparency interventions, including California's Proposition 61. I argue that rebated advocacy and confidentially-negotiated rebates as pragmatic strategies to control pharmaceutical costs has eschewed fundamental questions about profit, cost and value in biomedical markets. [ABSTRACT FROM AUTHOR]