Monday, October 04, 2010

Euro-NICE? Not Likely

European regulatory experts gathered in London this morning to discuss the possibility of closer collaboration on two fronts: among Europe's various health technology assessment agencies, and between regulators and HTAs across the continent.

Good news, right? After all, it's not uncommon for pharmaceutical companies to have to foot the bill for additional trials, often large trials, to satisfy the particular requirements of maybe just one or two HTAs. And thanks to the growth in regional-level decision-making, Europe now boasts over 30 different HTA agencies and processes--more than the number of member states. A single set of requirements across the board would save time and money.

Don't get too excited. Sure, there's movement towards harmonization of HTA methodologies across Europe--via the well-intentioned EUNetHTA network of European HTA organizations--but it's slow. And anyway, as Jerome Boehm, Policy officer, Health Systems at the European Commission pointed out, the idea of this network "is not to produce a Euro-NICE". (Do I hear sighs of relief?)

Harmonizing Clinical Issues, Not Cost

He clearly distinguished clinical issues--which, the thinking goes, can be harmonized--from cost issues--politically impossible for member states to relinquish control of. The focus of EUNetHTA is on "testing a core [European] HTA methodology", promoting information exchange between national HTAs, and accessing new methodologies for measuring drugs' value. In other words, it's about aggregation and exchange of ideas among national HTAs, and about allowing those states without well-established HTA agencies to tap into official European consensus data (rather than simply downloading translations of appraisal documents from the UK's NICE or Germany's IQWiG, as some currently do).

And what of closer collaboration between HTAs and regulators? Another thorny area. But there too, success depends on segregating clinical and cost issues. On the one hand, regulatory approval can't be contaminated by cost-influenced HTA methods, as Hans-Georg Eichler, EMA's Senior Medical Officer, pointed out this morning. "In our lifetime, these [two processes] will remain separate," he promised.

But on the other hand Eichler and others within the regulatory community are adamant that standards of clinical value must be brought in line. "There's an urgent need for rapprochement" between regulators and HTAs, he said. "There's currently a huge cultural divide" between them in terms of evidence standards: what level of uncertainty is acceptable, the merits of absolute versus relative efficacy, perceptions of what's clinically relevant, and methodological issues.

Thus regulators, for instance, may okay the 6-minute walk test among patients with pulmonary arterial hypertension, but at least one senior HTA official, Eichler reports, describes this test as 'useless'. Conversely, certain HTAs value the EQ-5D index as a measure of quality-of-life, yet some regulators apparently think it's drivel.

These differences translate into huge additional trial burdens for companies, and tough decisions as to which trials to fund, with which comparators, endpoints or assessment measures, for which HTAs. "We end up doing multiple studies," spells out Alan Barge, AstraZeneca's VP and Head of Oncology and Infection, "and it can take more than a year between regulatory approval and actual reimbursement," he continues.

So how close is Europe to clinical cohesion? Well, stuff's happening on the scientific advice front: EMA's Eichler claims that this month will see the first 'tripartite' scientific advice meeting gathering together EMA, the company and several members of the HTA community. There's similar action at member-state level: Sweden has been running a pilot scheme to issue joint regulator/HTA advice for some time, and the UK regulator announced a similar program with NICE in April 2010.

Even if these meetings facilitate individual product submissions, that's still a long way off agreed common standards and measures of clinical effectiveness between regulators and HTAs. Indeed, some drug company executives--for all their hoping that such a goal is possible--remain skeptical. Their point: HTAs are unlikely to agree to be restricted to using a certain set of clinical measures since this may give them less wiggle room when deciding what data to feed into their cost-effectiveness calculations. "The cost-per-QALY [quality-adjusted life year, NICE's preferred measure of cost-effectiveness] can increase up to five-fold depending on which quality-of-life measure one plugs into the equation," illustrates Clare McGrath, Senior Director HTA Policy for Europe and RoW at Pfizer.

Separating out clinical and cost issues may look possible in theory. The practice will be trickier.

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