Friday, April 3, 2015

Maybe Just "A Tempest In A Teapot," But I'll Note It -- Zostavax® Edition (Per Cowen & Co.)

First, the good news: Kenilworth has eclipsed the $750 million per year mark in sales of Zostvax®. That's quite respectable, indeed. And to be fair, the Cowen analysis probably doesn't play out in full until 2018 or later. But for its part, Cowen is pointing out that a GSK shingles vaccine candidate (called HZ/su) is preliminarily seeming to show better efficacy in people over the age of 60 -- at preventing this condition (which disproportionately strikes the elderly). So, longer term, that might give GSK's HZ/su candidate an important sales edge, in this, the most affected demographic. But that is quite a way from here -- and a 16,000 person study needs to be completed by GSK. As a refresher, back in 2010, I detailed the challenges facing the Zostavax franchise, thus:

. . .On and off since 2009, there have been supply issues, due to difficulties in manufacturing these sorts of delicate biologics, at Merck. Next, and partially related to the first issue -- until 30 minutes prior to administration, Zostavax must be kept hard-frozen (circa 16┬║ -- thus, there is no easy way to hold mass "point of common access" vaccine campaigns -- at senior centers, for example -- without heavy, high-end refrigeration equipment). In addition, insurers and Medicare require that separate forms be filled out for reimbursement -- and that the patient pay out of pocket for it, before seeking later reimbursement through this arcane form submission process. On top of all that, though -- the killer! -- these shingles vaccines cost nearly ten times as much as the typical seasonal flu vaccine.

As the ACA of 2010 has become fully ensconced in the reimbursement world, though, the price compared to a flu vaccine has become less important. Most seniors (the target market in the US) now qualify for expanded reimbursement, under Obamacare. Which, in no small part, explains the $765 million a year in sales, in 2014.

But, just to complete the record -- here is FierceVaccines, quoting Cowen, for your edification:

. . . .The incidence of shingles increases with age, but Zostavax's ability to decrease risk of shingles declines in older people, the [Cowen & Co.] analysts wrote in a note. If Glaxo's double-blind trial--involving 16,000 people in 18 countries--shows a more "robust" response in the elderly, it would be a key differentiator to Zostavax. . . .
We shall -- as ever -- see about that. In the meantime, we are shutting down early today, and planning to. . . overeat on Sunday. Smile. . . .

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