Tuesday, September 29, 2009

What's the Hardest Job in the Biopharma World?

Maybe it's yours. Maybe it's Jeff Kindler's (keep Pfizer small? Yeah right.) Maybe it's Elan CEO Kelly Martin's(all those shenanigans with Biogen over the J&J Alzheimer deal, ouch).

Most likely, though, it's Andrew Dillon's--he, in case you forgot, is the CEO of UK cost-effectiveness watchdog, NICE. That's what David Mott, ex-CEO of MedImmune and now a General Partner with VC firm New Enterprise Associates, thinks (and this blogger agrees). "Andrew has the hardest job of anyone up here," Mott remarked from the stage during a panel at last week's Pharmaceutical Strategic Alliances conference in New York.

Harder, then, than that of drug developers like co-panelist Peter Wirth, EVP Legal & Corp. Dev at Genzyme, which (besides dealing with manufacturing snafus extraordinaire) is having to "quite deliberately gather the information [around our development programs] that people like NICE will use in their decisions"--(not that we think all of NICE's analysis is right, he added later on). Harder than Mott's, faced as he is with the "triple whammy" of reimbursement hurdles, the elimination of the IPO market and "fundamental changes in Big Pharma's pipelines," all of which have "raised the innovation bar significantly," leaving him (and one presumes any other VCs that have money) with fewer promising investment opportunities. Harder than Ian Spatz's--no longer VP, Global Health Policy at Merck, instead running his own policy advisory firm (and due to start a policy advisory service with Elsevier Business Intelligence, too--plug plug).

Yup, Dillon's job takes the biscuit: He is responsible for 'rationing' health care in the UK--a word so hated in the US that we were pleasantly surprised that no audience-launched projectiles made it up onto the stage. To him (and his teams) to decide "what level of reward is given for the benefit being offered, much of a fixed resource to make available [for a particular drug] given the opportunity cost, if that cost was allocated somewhere else, for another patient group perhaps."

We felt Dillon calmly defended NICE's approach, acknowledged its weaknesses, and tried to correct misconceptions. "I know we have a reputation for only caring about cost, but that simply isn't the case," he argued. "We begin our exploration of the product with the evidence of its clinical effectiveness and try to measure the impact [of that] on patients," he said. "By and large our decision-makers are physicians in the NHS," he added, who know their decisions affect patient wellbeing. (Not that this necessarily means they don't think about cost, mind you.)

In response to accusations that NICE stifles innovation, Dillon elaborated on how the agency attempts to unpick sponsors' 'innovation' claims and translate them into concrete clinical benefits. It's not easy, and he knows NICE needs to be more transparent in explaining how and at what point in the assessment process this is done. "We need to be much more explicit about the particular innovative features that [we believe] will bring benefits to patients. We probably didn't [used to] spend enough time talking about that [with sponsors] right at the start" of the assessment process, he told the PSA audience.

While conceding on transparency, though, Dillon put up a robust defense of the QALY, the controversial utility metric used by NICE, and its 'acceptability range' of around £30,000-per-QALY. (Refresher: Quality-Adjusted-Life-Year is the estimated cost of one additional year of life per person when comparing a new drug with the current standard.) "The QALY is the best approach despite its flaws," he said. And as to why the QALY threshold hasn't increased over the years, with inflation, "well there isn't really a fixed threshold. Advisory Committees aren't told not to go beyond £30,000-per-QALY," he said. (Hear that? Indeed there's already ample evidence of slippage....)

Dillon left the stage at PSA composed and unscathed, we'd say. Which is a very good thing (thank you, audience, for not throwing things) since he--and others with similar jobs, and there will be a growing number thereof, including, yes, in the US--will be invited back to similarly important industry events. Reimbursability is the new proof-of-concept, after all.

image by flickrer Brooks Elliott used under a creative commons license

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