Cervarix Reimbursement Will Be Key Challenge For Adoption, GSK Says
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline plans to submit a BLA for the human papillomavirus vaccine by year-end.
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Government reimbursement will be a key challenge for adoption of GlaxoSmithKline's human papillomavirus vaccine Cervarix once it is approved, the firm said Feb. 8. "The overall reception has been very positive, the big question is [how governments will] figure out how to pay for it. People are trying to figure out how to deal with it within their budgets, how to time it within their budgets," Pharmaceutical Operations President David Stout said during GSK's fourth quarter earnings call. "Of course we are always full of ideas there on where they can find money elsewhere in their healthcare budgets," Stout offered. "There is a lot of work in progress here as the governments start to face the fact that we're going to have this product approved and at some point be ready to be launched," CEO J.P. Garnier said. GSK recently announced that it will file a BLA for Cervarix in the U.S. by the end of the year. The firm plans to file in Europe as soon as March. Garnier noted that although he had not witnessed resistance to reimbursement from continental European countries, these countries struggled with the problem of deciding who they should reimburse. "Their enigma is, 'Should I reimburse young women, should I reimburse women past 25 and beyond, and how do I justify not to reimburse them all?'" Garnier said. Especially in European countries with national health programs, "that's a big budget hit for a country that is a single payor." The Phase III 008 Cervarix trial is an event-driven trial, Stout said. Rather than setting a time period, "we need to get to a certain number of legions to get to what we think will be a statistical significance based on what we saw in the very positive Phase II trials." Merck's HPV vaccine Gardasil was granted priority review by FDA on Feb. 7 (1 (Also see "Gardasil Granted Priority Review" - Pink Sheet, 7 Feb, 2006.)). Although it is likely that Gardasil will reach the market before Cervarix, Stout predicted that "the adjuvant will be a key differentiator to a longer duration of protection." GSK obtained its adjuvant technology when it acquired the biotech company Corixa for $300 mil. last year (2 (Also see "GSK Acquisition Of Corixa Means End To Royalty Payments" - Pink Sheet, 29 Apr, 2005.)). Garnier added that "we have higher antibody levels than our competitors." GSK's announcement that it will file the vaccine in the U.S. by year-end suggests the company believes FDA will accept data based on surrogate endpoints; in July, the firm said that the timeline for submission - either 2006 or 2007 - would depend on FDA's acceptance of surrogate data. "We are in a normal situation where we had a good exchange of information [with FDA] and are going to file by year-end. We think we have a good file, but the FDA will have to speak," Garnier said. GSK has put a lot of emphasis on its vaccine pipeline, investing £1.1 bil. ($1.9 bil.) in its vaccines business in 2005. Vaccine revenues for the year rose 15% to £1.4 bil. ($2.5 bil.). "I predict that oncology and vaccines will be the fastest growing segments of our business in years to come," Garnier said. "We have five significant vaccines to be introduced in the next five years." In addition to Cervarix, GSK is developing vaccines for rotavirus ( Rotarix ), meningitis and pediatric streptococcal pneumonia ( Streptorix ), as well as an improved flu vaccine. Pharmaceutical revenue for the fourth quarter totaled £5.1 bil. ($8.9 bil.); for the year, revenue grew 8% to £18.7 bil. ($32.6 bil.). -Kathryn Phelps |