Gilead's Viread International Access Program

Last December Gilead Sciences announced a plan to make their nucleotide reverse transcriptase inhibitor Viread (tenofovir) available to clinics and treatment programs in the developing world at an affordable price. Joe Steele, the architect of Gilead's plan, recently answered questions about the logistics and motivation for the program.

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.

The cost of the drug has been set as the cost of goods plus the cost of administering the program. The mandate was to sell the drug for as low a price as possible with no expectation of making money. At this price, Gilead expects to lose money until 2006 or 2007, depending on how quickly volume sales develop, when prices will likely drop. With new money coming in from the Global Fund, the Bush initiative, and the Gates Foundation, a more rapid uptake of the program may lower prices sooner.

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.

Who Is This For?

This drug, while cheap, is not affordable to every program that would like to offer treatment. Until the large funding streams come online, the number of people receiving Viread is likely to be relatively small. Gilead has projected the need for Viread by taking an estimate of how many people in Africa need treatment currently, then estimating the rate at which people currently being treated will need a second-line or salvage regimen. Because of the cost, Viread will not be a first-line choice for many programs. Yet because the treatment situation in the next three years is so uncertain, Gilead plans to remain flexible with its plans while maintaining the overall goal of making their drug available to meet the need.