Gilead: Launching Truvada in Europe

Gilead Sciences launched Truvada, a combination pill incorporating Gilead’s individual antiviral drugs, Viread and Emtriva, in the U.S. in 2004. This involved gaining FDA approval, setting a national price, and negotiating reimbursement levels with private and public insurers. While these activities had been resource intensive, their completion meant that Gilead was able to sell Truvada, a combination HIV/AIDS therapy, across the entire United States, approximately 50 percent of the worldwide market. The remaining 50% of Truvada’s potential commercial success, however, would be pursued in Europe. Europe presented a more complex environment for reimbursement than the U.S. for three reasons. First, the reimbursement process differed in each European country as to required submissions and approaches to pricing. Second, the average time between the beginning and end of reimbursement negotiations was highly variable across European countries. Third, the local office for Gilead in each European country had its own estimate as to the likely length of negotiations and level of reimbursed price for Truvada, making it challenging to devise and communicate a consolidated strategy across the organization. Gilead needed to determine the order by which it would pursue reimbursement approval for Truvada in Germany, France and Spain. Germany’s regulatory authority used a “free pricing” approach. In France and Spain, the government health ministers often (though not always) referenced neighboring markets’ prices for a given product in order to determine the product’s domestic reimbursable amount. The approach Gilead decided upon would not only determine the future for Truvada in Europe but also would have a significant impact on the company’s future financial health.