AIDSWEEKLY Plus; Monday, October 5, 1998
Daniel J. DeNoon, Senior Editor
Excitement over U.S. Food and Drug Administration (FDA) approval of Dupont Pharma's anti-HIV drug Sustiva (efavirenz) has been muted by the firm's announcement that the drug's wholesale price will be $4000 per year. Pharmacies are charging $4800 per year.
"Dupont Pharma has engaged in opportunistic pricing and dramatically increased the cost threshold for drugs of this type," said Martin Delaney of the patient-advocate group Project Inform. Delaney is one of the organizers of a coalition of more than 100 AIDS groups - including several care-provider groups - formed to monitor the pricing of new AIDS drugs.
Efavirenz was the word on everyone's tongue at last summer's World AIDS Conference. The novel DuPont antiretroviral - a potent non- nucleoside reverse-transcriptase analog (NNRTI) - proved much more powerful than anyone expected for a drug of this class.
Excitement over the drug comes from clinical trial results showing that the drug works at least as well as any of the highly proclaimed protease inhibitors as part of combination therapy with zidovudine (AZT) and lamivudine (3TC). If these results hold up over the long term, efavirenz combinations could well become the first-line treatment of choice for many physicians.
Despite the drug's success in so-called protease-sparing regimens, it may frequently be used in maximally suppressive regimens including a protease inhibitor.
The drug's pricing makes it more expensive than any other drug of its class (the NNRTIs), but less costly than protease inhibitors. "Sustiva is priced in the mid-range of the antiretroviral class at $3,942 per year ($10.95 per day)," Dupont announced in a recent press release. "When used in triple-combination therapy, as it was studied, Sustiva will be less expensive than the current standard of care including protease inhibitors."
Such triple combination obviously does not include a protease inhibitor.
"This [the Dupont pricing rationale] is highly misleading since only a small percentage of HIV infected people will ever use the drug in this fashion," said Linda Grinberg, another member of the pricing coalition. "The price is simply unconscionable."
Other patient advocates have added their voices to the protest. One is David Gilden, editor of the highly respected Treatment Issues newsletter.
"For the vast majority of people who will use this drug, the cost announced by Dupont will represent a major escalation in the price of therapy, adding an extra thousand dollars a year or more to the cost of staying alive," Gilden said. "There seems to be no end to the greed of the pharmaceutical industry these days."
Such language must come hard to Dupont. The firm's public relations with the AIDS community have been unusually successful. A very generous pre-approval access program for efavirenz drew loud applause and was hailed as a new industry standard. And the firm's pledge to supply the drug to clinical-trial subjects was warmly received.
How well the firm weathers this downturn in patient popularity will soon be apparent, as efavirenz data is presented at major medical conferences, including the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the upcoming Retrovirus conference.
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