Gilead, Steele says, recognized the potential need for tenofovir beyond the U.S. because its dosing, safety and low-maintenance qualities were likely to be attractive to providers in limited resource settings. Wishing to avoid delay, they decided to launch a proactive access plan in anticipation of the need.
Initially, the Gilead program will address Africa, the less-developed countries (LDC), Latin America, Russia and Eastern Europe. The program was designed by Axios International, a technical assistance consultant specializing in healthcare issues for the developing world that had set up similar programs for Abbott and Boehringer Engelheim. But Gilead sought to design a program that could skirt some of the problems that have limited the impact of earlier programs.
The price for Viread through the program is $39 per bottle, roughly 10 percent of the U.S. wholesale price of $360 per bottle. The price does not include shipping, since purchasers may require flexibility in how they receive the drugs.
Recognizing that the standard commercial model of drug distribution would not apply, particularly in Africa, Gilead decided to forego traditional methods by not seeking product registration in the countries they want to serve. Instead they will sell the drug directly to NGOs, clinics and individual physicians to avoid the high mark ups taken by pharmaceutical distributors. Gilead will follow a model of named-patient sales to entities that have been vetted by Axios or a panel of regional experts that Axios has assembled. When it has been determined that a clinic is legitimate and has sufficient funding to offer a sustainable treatment program, they will be sold the drug.
The named-patient route avoids the need to gain full registration for Viread in every country where it could be useful. Clinic doctors need only to obtain an import license for their program's use. This could be as simple as demonstrating that the drug they wish to import has an approved package insert from the U.S. FDA.
After a program or clinic has been approved, and funds or a letter of credit has been received, the drug will be shipped from Gilead in San Dimas, California via DHL or a similar carrier. Reorders can be placed though the Internet.
After discussions with the FDA, Gilead decided to produce a white tablet version of Viread intended for the special program to distinguish it from the blue tablet approved in the U.S. It's hoped that this will offer some protection against diversion or re-importation of the discounted product to countries where Viread is marketed conventionally. It will be illegal to sell the white tablet in the U.S.
Back to the GMHC Treatment Issues May 2003 contents page.