Gilead will not add any more sales reps to Solvadi despite the unanticipated indication it grabbed for genotype-1 patients when the FDA approved the drug Dec. 6, Gilead’s director of public affairs, Michele Rest told MM&M. The company’s spokesperson also noted that, “We sized our sales force from the beginning to address not only the needs today but also as HCV treatment expands in the future.”
The drug was also approved for genotypes 2, 3 and 4. ISI Group’s Mark Schoenebaum noted in his analysis that Wall Street did not know that Gilead sent genotype 1 data to the FDA. The game plan, then, remains the one the company mentioned in its Q3 earnings call—spreading the word with 150 sales reps.
The FDA’s decision could offer significant upside to the Foster City, CA, drug maker as 70% of the U.S. HCV population is genotype 1. However, being able to treat such a large patient population may not lead to a major increase in prescriptions.
Among the problems that Schoenebaum notes: price. “Cost might be a problem at about $168,000 per patient,” he said in a research note note and added “payors could make life difficult for these patients and treating physicians.” WorldOne Interactive hit on this sentiment in a MedLIVE PULSE survey it did for MM&M before the FDA approved the drug, with 39 out of 48 polled doctors saying sticker shock could dampen enthusiasm.
Docs may also be wary of the treatment due to data concerns and other prospective medicines. “Doctors might not be comfortable recommending this regimen yet,” Schoenebaum added, “especially since they know Gilead will launch a potentially simpler, cheaper (likely around $100,000), safer and more effective regimen in about a year.”
US hepatologists also seem unlikely to go the interferon route (Solvadi was approved for use in treatment-naïve GT-1 patients along with interferon). Most US hepatologists—83% (40 out of 48)—told researchers they would still warehouse their GT-1 patients in anticipation of an all-oral formulation, rather than treat these patients with sofosbuvir and injected antivirals.