Friday, December 3, 2010

InVivo, On Why Reimbursment Strategies Will Increasingly Drive Pharma Clinical Trials

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: