For now, it appears to be all about the data. Building relationships and establishing communities is all well and good. (And I’m of course fully behind our own efforts in this regard.)
But when it comes to payers agreeing to pay for pharma’s drugs, data – outcomes data specifically—is the only accepted currency.
Look no further than the flurry of dismissive added-benefit assessments of new drugs by Germany’s HTA, IQWiG. Merck’s Hep C hopeful Victrelis stumbled because its studies weren’t long enough to show outcomes and there was insufficient data on null responders. The benefits of InterMune’s IPF orphan Esbriet were deemed unquantifiable for a lack of real-world data. Most recently, Novartis’ Gilenya, the pioneering oral MS pill whose peak sales have been forecast at close to $1.5 billion, was deemed by IQWiG to show a small added benefit only in patients with the most extreme forms of the disease. A “lack of usable data” in two further patient groups condemned the drug to the no-better category. (On Friday January 20 came more bad news: European and U.S. regulators announced a review after reports of 11 deaths among patients who took the drug.)
These deals are just the star, however. They’re simply dots on the landscape. WellPoint’s claims data, for instance, stem from only the 40 million or so U.S. patients it covers. There’s no question that’s a sizable dot, but it’s still just a dot. IMS, meanwhile, has only certain data-sets from certain countries and certain parts of the health care provision chain to use in its analysis. Indeed, to paint a true picture of how well drugs really work and how much they really cost—and save — society, these dots need to be joined together.
That’s why AZ and HealthCore (WellPoint’s health outcomes division) are talking about a consortium that will include additional stakeholders such as hospitals and other payers. And it’s why Jon Resnick, IMS’s VP of Real-World Evidence Solutions, describes its first-in-kind tie-up with AZ “not just as an AZ/IMS collaboration, but as the start of a dialog with the health care system” about appropriate measures of value and roles of interventions in the market place.
So it’s about data AND relationships.
It’s no good if IMS and AZ piece together their own data sets to create what they feel is valuable outcomes data for, say, Brilinta (the clot-buster currently going through Germany’s assessment process), since AZ’s notion of value may not match-up with that of the HTA. “For this to be credible, we will have to attract multiple stakeholders, look at broad-based solutions, and build consensus and trust” around what is value, says Resnick. (And, apart from anything else, it will prove untenable for pharma to submit different data-sets and analyses to all the different HTAs.)
Building a multi-stakeholder consensus is an ambitious goal for the three-year AZ/IMS tie-up. But as Resnick points out, some of the hurdles are falling: the inherent limitations of trial data – and indeed real-world data — are better understood. Encryption techniques are allowing privacy rules to be upheld. Technological methods for linking data sets and bridging data codes are also advancing. Indeed, the highest hurdle remains the relationship bit – reaching agreements with multiple parties, each with their own different objectives around what data to collect and how to present it.
Still, there are strong signs that most of the players are on board, or at least thinking about getting there. Quite apart from the clear drive by U.S. insurers to both collect, and share (with selected, paying partners) outcomes data from their client base, the U.K. NHS has recently released both prescribing and clinical outcomes data from across England’s state-funded doctors’ practices; also coming soon is a tool to link the two data-sets together. Resnick doesn’t feel this tramples IMS’ turf, since, he argues, it’s interpreting and analyzing data — not data per se — that is what matters long-term. Meanwhile, IQWiG itself has made an appeal, via a recent BMJ article, for more, and better, trial data to be made available to assessors like itself.
And even though Europe’s insurers, including for example the German sick funds, have yet to announce specific pharma tie-ups, they don’t seem to be shutting their doors to all this dealmaking. “We have found people to be generally receptive” to the idea of teaming up to create information. “Conceptually, people are interested,” asserts IMS’s Resnick.
Image courtesy of flickrer The Infatuated.