Rochelle Walensky, MD, MPH: Antivirals and Cost Considerations

Rochelle Walensky, MD, MPH, Division of Infectious Diseases, Massachusetts General Hospital, Harvard Medical School: So first line antiretrovirals in the US as recommendation by the DHHS guidelines and the IAS-USA guidelines are generally in the range of $35,000 to $44,000 per patient per year. And those drug prices have gone up somewhere in the range of 10—20% in the last 2 years. So I would argue that we are on a skyrocketing course of antiretroviral drug costs and that something needs to be done about it. What we looked at this morning, is the issue of generic antiretrovirals. One of the challenges associated with generic antiretrovirals and generic drugs in general , s that by the time they come off patent, drug manufacturing and drug development has happened so quickly that there's always something new or better that has come along that has replaced what is potentially coming off patent with a newer, better drug. And so the hope of having a generic has actually never really been realized. So some of the drugs that have been proposed for generics, or that are coming off patent are a faverins, FTC and tenofovir, TDF, tenofovir disoproxil fumarate. And so some of the things that I talked about in those 3 examples and how they may impact drug pricing in the US.

So it's a complex web of how we finance antiretroviral therapy in the US. For the most part most people get treatment, whether it is through drug discounts, through co-payments, through accessibility with manufacturers, through 340b programs, or AIDS drug assistance programs, fraud and by Ryan White. There is a safety net, however somebody is paying these prices and how they get reimbursed and sort of the perverse nature of how some of these things happen and the ability of these drug prices to go up, is you know a real challenge in the US.

You know I think that when antiretrovirals were FDA-approved in the US, they were around $15,000 per year and I think there has been so much research and development associated with them, that the drug companies have continued to increase the prices. They are always getting better, they always have improved toxicity profiles, they have improved pill burdens, and so I think that they feel like they are merited to increase in price. The other thing that's interesting about it, is that through the President's Emergency Plan for AIDS Relief we are able to supply an antiretroviral therapy in resource-limited settings. And by doing that, the drug companies have lost their patents at least for use in resource-limited settings and they're now co-formulated with generics there. In their ability to be able to do that for resource-limited settings, they need to make money in resource-rich settings and I think that that's part of the issue.