Thursday, October 20, 2011

European Regulator-HTA Rapprochement Not Quite There

Oh wouldn't it be nice if regulators and cost-effectiveness bodies could align their demands a little more helpfully? What a boon such hand-holding would be for controlling the costs of drug development, while still supporting innovation and recognizing value.

Still, there remains little substance as to how such a partnership could be effectively achieved, as was clear from this year's meeting of The Organisation for Professionals in Regulatory Affairs in Rome, Italy, on Oct. 13-14.

Despite the logic of closer HTA/regulatory harmonization -- the timelines are so close anyway, and patient access is impossible unless both sets of demands are met – regulators and price-sensitive HTAs remain uneasy bedfellows.

Indeed, back in Sept. 2009, EMA's then-director Thomas Lönngren expressed an almost ethical concern that the two sides were getting too close, as if one risked undermining the other. Since then, there's a more widespread agreement that things need to change, but certain executives, such as Aginus Kallis, head of the Dutch medicines agency, are still skeptical as to whether a closer relationship could ever work.

The fact that HTAs are now requiring even earlier-stage data further increases the value of (and need for) a coordinated regulatory/HTA approach. But according to Mats Mårfält, Senior Director, European Regulatory Affairs at AstraZeneca, progress in a Swedish pilot study designed to promote such coordination has been disappointing.

The idea was for Sweden's medicines agency (Läkemedelsverket) and its HTA body (TLV) to progress step-wise from single, to parallel and finally to joint scientific advice. Mårfält’s assessment was that the result was cacophony, as each stakeholder – including the manufacturer – sought only to blow its own horn. The regulator and HTA were reluctant to disagree and even discuss in from of the applicant; there was no attempt to align views at all. Far from building relationships, this looked more like playground squabbles.

And sadly, Anders Blanck, current head of the Swedish pharmaceutical industry association, later confirmed that there had been no further advance since this embarrassing, early stage.

If the relatively progressive Swedes can't do it, what hope for regulatory-HTA rapprochement across the rest of Europe's nations, let alone the whole region? Not much, it seems.

But maybe that doesn't matter, suggested Andrea Rappagliosi, Vice President European Government Affairs, GSK. Sure, HTA is a hurdle (albeit one that we know won't go away), and the lack of coordination with regulators is a pain. But it's Europe's patchwork of pricing and reimbursement systems – some tied up inextricably with HTA and even approval, others not – that are the real problem for market access.

So let HTA and authorization bodies continue to remain apart, provided they enjoy "robust two-way communication" in order to avoid overlap and duplication (which, judging from the Swedish experience, may be a stretch). Just speed up pricing and reimbursement – something that's being attempted, via proposed amendments to the European Transparency Directive. And here progress is being made, according to Rappagliosi, but as always the wheels of the EU legislative process move slowly -- Faraz Kermani

image by flickrer wolfsoul used under creative commons

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