DuPont Pharmaceutical's new drug efavirenz (Sustiva) has enjoyed a favored position among treatment activists, offering both high levels of antiviral activity and a simplified dosing regimen. The company has worked to build a harmonious relationship with the community by being responsive to community concerns and agreeing to a generous expanded access program. Just days before the drug's expected approval by the FDA, however, that honeymoon quickly soured and a contentious battle over pricing began. The company launched the product at a price far exceeding the others in its NNRTI class (nevirapine and delavirdine), a price that approached the cost of protease inhibitors (at least $5,000 per year retail).
The first hint of these changing attitudes came when the DuPont PR machine cranked into high gear in the weeks preceding the World AIDS Conference in Geneva. A week prior to the conference, treatment activists were invited to the company's headquarters in Wilmington, Delaware, for a sneak preview of the "exciting" 24-week Study 006 data. This trial compared efavirenz/AZT/3TC, indinavir/AZT/3TC and efavirenz/indinavir. The preliminary data from the efavirenz/AZT/3TC arm seemed impressive in this nearly treatment-naïve population, equal to, or slightly better than, the other two arms using indinavir. Such results prompted the company to herald a new era of "protease-sparing" treatment regimens. But questions of durability of response and whether this protease-sparing regimen will be effective in treatment-experienced populations remain unanswered (see article, "An Even Dozen: Another Expensive Drug for Your Cocktail"). DuPont also avoided comparing efavirenz directly to others in its own class, obscuring its relative worth.
Nonetheless, "protease-sparing regimens" and "once-daily dosing" became media buzzwords in Geneva, fueled by a slick promotional campaign, press releases, dazzling exhibits, and wining and dining U.S. attendees at five-star restaurants. The timing was propitious: conference presentations on increased protease inhibitor failures, due to noncompliance and drug-resistant HIV, and on such side effects as fat redistribution ("buffalo humps" and "protease paunch") raised serious doubts about the wisdom of protease inhibitor therapy.
Back on the home front, a marketing research firm had begun testing the waters of higher pricing, surveying people with HIV and posing such pointed questions as, "If you could take a once-a-day dosing regimen, without a protease inhibitor, would you be willing to pay $3,770 per year?" Inquiries were also made to state AIDS Drug Assistance Programs (ADAPs) and Medicaid programs to assess how high a price the market would be willing to bear.
No matter how desirable the drug looks based on interim data, activists were adamant that such results cannot justify another increase in the total cost of therapy. Although the overall cost when using the drug in the proposed "protease-sparing" regimen promoted by the company may approximate the price of similar protease-containing regimens, this proposed use likely represents a minority of the drug's sales. For people with prior therapy, efavirenz most likely will be used in conjunction with, rather than as a replacement for, a protease inhibitor. Many researchers believe such a combination would be better even in drug-naïve patients. Thus, the high premium DuPont is charging for efavirenz as compared to other drugs in its class will represent a major increase in the total cost of therapy.
The exceptionally high price sets a new standard for HIV drug pricing if left unchallenged. It signals to other companies that they may charge more for new and existing HIV drugs. This sort of inflationary pressure would put an enormous strain on ADAP, Medicaid programs and private insurance plans. Privately insured individuals also would face increased financial pressure since they would have to spend more to meet copayment requirements and may risk maxing out on their insurance drug coverage.
When rumors began circulating of an impending high price, a community working group issued a "Fair Price Consensus Statement" that has now been endorsed by over 100 organizations worldwide. The statement demands that both efavirenz as well as the new nucleoside analog expected shortly from Glaxo, abacavir (also known as Ziagen) be priced no higher than similar drugs in their respective classes. On September 10, activists met with DuPont officials in Wilmington, but both the consensus statement and their impassioned speeches fell on deaf ears. Even though it was obvious that activists had come to Wilmington primarily to discuss price, and not just trial data, not one person from DuPont with authority over pricing was in attendance. The meeting ended with a demand to meet with Nicholas Teti, DuPont Pharmaceuticals' president, but arrangements for the encounter broke down as DuPont rapidly moved toward launching its new product.
Community action on pricing is, if anything, long overdue. Despite sporadic protests from individual groups, the community has not taken coordinated action against unfair pricing for several years. The effort around efavirenz should provide the impetus for people with HIV, activists and AIDS service organizations to confront the exceptionally high cost of antiviral therapy. The prices established in the U.S. have an enormous worldwide impact. HIV treatment is almost completely out of reach for the vast majority of infected people in developing countries -- who make up 90% of the global total. Unaffordable drugs are essentially ineffective, no matter how good they look in clinical trials.