As we've discussed here repeatedly over the past two and a half years or so, it is increasingly apparent that pharma product development teams were (and to some extent, remain) "out of sych" with the long-emerging trend among payers -- Medicare, Medicaid and private insurers here in the US (and the central government healthcare agencies in the EU like the UK's NICE) -- in that the latter group will expect proof of real additional outcomes benefit, and cost effectiveness, before a new drug will be added to the top-tier of the various formularies. We've discussed legacy Schering-Plough's Saphris® (asenapine, Salmon's speciality), and Bridion® (sugammadex, imaged at right) specifically, in the past.
To echo -- and amplify -- those links, here is some of what Roger Longman, one of the founders of Windhover, and CEO of Real Endpoints LLC, a new company focused on "helping payers and drug and device companies create greater value from new and existing products in an outcomes-focused health-care economy", had to say in InVivo this morning -- do go read it all:
. . . .And yet the further a start-up goes down the development path, the more it’s making reimbursement choices -- even if it doesn’t recognize it’s doing so. Because just as Big Pharma is learning: the data gathered in clinical trials is not necessarily the data payers want.
Ask Lilly after their huge Phase III Effient trial. Or Merck (or perhaps more appropriately, Schering-Plough) for both Saphris and Bridion. Or Bristol-Myers Squibb and AstraZeneca for Onglyza. All of those drugs passed muster with regulators (in Bridion’s case, European regulators) but payers have simply turned up their noses.The inattention to payer-focused endpoints is not just a pharmaceutical problem. My bet is that discovery-intensive diagnostic companies like Genomic Health, CardioDx, and XDx would have seen success far earlier had they accelerated their efforts to jibe clinical and reimbursement endpoints. . . .
Indeed. Do go read it all -- but Bridion is a particularly apt example of his thesis. Ex-CEO Fred Hassan must have devoted 250 separate breathy adjectives to describing how "revolutionary" it would be -- from late-2007 to late-2009 -- and yet it remains unapproved in the US, and barely noticed in the EU. But "Fast" Fred is already off to sell his next "big thing" -- privately held, and Warburg Pinccus-backed ($4.5 billion worth) -- Bausch + Lomb.
No comments:
Post a Comment