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Sovaldi sales suggest payer "tolerance" for drug [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) THE BIG STORY of Gilead's second quarter was supposed to be Sovaldi's astronomical sales figures. But its progress on pro- tease inhibitor GS-9857-which could serve as stiff competition for the asset Merck acquired in its recent $4-billion acquisition of HCV firm Idenix-may have quietly stolen the show. The Gilead protease inhibitor could span all genotypes and is "Phase 2 ready," wrote ISI ana- lyst Mark Schoenebaum in a July investor note. He admitted that its "precise timing is unclear," but that "this is important as a counter to Merck's triplet 4 week data coming later this year." While Congress and payors have been quick to criticize Gil- ead on the price of Sovaldi, the Foster City, CA, drugmaker's earnings report suggests those lectures have done little to keep the drug off formularies or slow down its sales. Total US product sales were slightly over $4.8 billion-Soval- di total sales reached $3.4 billion, with $3 billion in the US alone- meaning nearly three-quarters of the drugmaker's domestic revenue comes from that one $1,000 pill. Gilead estimates that 9,000 Sovaldi patients have been cured of hepatitis C-a total they believe will grow rapidly as the drug gains traction. Physician penetration, too, proved strong. Seventy percent of targeted doctors have written a script for Sovaldi, according to the drugmaker. As a comparison, Biogen's MS pill Tecfidera saw 62% penetration after launch. Despite American Health Insurance Plans calling for the drugmaker to lower the price and Kaiser Permanente calling the cost "outrageous," only three states are currently not cover- ing Sovaldi. Of those remain- ing 47 states half require prior authorization and half require a certain level of fibrosis (i.e. liver damage). However, of the patients treated so far, 60% had "low fibrosis scores," Schoenebaum wrote. This could signal that the hard-to-treat patient is still a pressing unmet need. Also of note was how, and to whom, the drug has been pre- scribed. Sixty percent of patients treated had genotype 1 (the most common subset of the disease) and 70% of usage was for inter- feron-free regimens, including combination with J&J's Olysio. Physician confidence in pre- scribing both drugs had Jefferies analyst Thomas Wei predicting that this may mean more relaxed formularies going forward. "[This] indicates payer toler- ance for expensive combination therapies and raises interesting questions on pricing flexibility for the combination pill," Wei wrote. Gilead also said that it believes physicians are ware- housing patients in anticipa- tion of its ledipasvir/sofosbuvir combo therapy, which received a Breakthrough Therapy designa- tion this past April. Its PDUFA date is slated for October 10. -Kevin McCaffrey Gilead's Sovaldi has racked up over $3.4 billion in total sales (c) 2014 Haymarket Media, Inc. |