Friday, September 11, 2009

Regulators and Cost Watchdogs Getting Too Close, says EMEA's Lonngren

The European regulatory agency, EMEA, and Europe's various cost-effectiveness watchdogs are brushing up a little too close for comfort, according to Thomas Lonngren, EMEA's executive director. "The decision points for approval [of a medicine] and its health technology assessment [in individual European countries] are getting very close," he observed during a media workshop in London yesterday.

That in itself isn't the problem--it's simply a reflection of governments' and payers' increasing rigor in testing new drugs' cost-effectiveness before they dish out too much money for them. The problem, Lonngren continued, is that some health technology assessment agencies (HTAs) give scientific advice, "and so do we. And we'll have a big problem in drug development if there's too much different scientific advice going around," particularly as it's increasingly given at about the same time in a drug's development path.

The UK's NICE and Sweden's HTA both provide advice to companies on what kind of clinical data they need to provide in order for a green light. At least for NICE, it's a relatively recent additional activity, providing some welcome on-the-side income. Speaking to The IN VIVO Blog back in December 2007, NICE CEO Andrew Dillon argued: “Regulators charge extra for early consultations with companies,” he says, “so why not us? It’s what everyone wants.”

Now sure, companies want to know what kind of data they need to secure both an approval in the first place, and reimbursement. One's no good without the other. But "we need some agreement [with HTAs] so that industry doesn't find itself doing one development program for EMEA, and another 27 for the various member-state HTAs," Lonngren told The IN VIVO Blog.

He's gunning for harmonization of both sides' requirements, with the goal of an integrated drug development process that meets the needs of both regulators and payors.

This isn't pie-in-the-sky, at least according to EMEA. "We could possibly get consensus on the assessment of relative efficacy [of a drug] in the scientific and clinical setting," argues Hans-Georg Eichler, EMEA's senior medical officer. His point is that the cost element can be added later onto an agreed assessment of a drug's medical value, which may include impact on quality of life, for instance. (No one, Eichler included, sees standardization of HTA methodologies across Europe as likely to happen soon, though the hurdles are more political than scientific, according to EMEA execs.)

Some kind of harmonization between EMEA and HTA agencies' clinical guideline standards seems logical, though, given that HTA bodies are already banging on EMEA's door for more detailed information about its decision-making processes as a result of converging timelines. "They [the HTAs] need information [sooner], and they get that from our decision. But they're saying they need more insights [into our processes] in order to make their judgments about value," says Lonngren.

The HTA agencies (or at least some of them; they're not a coherent unit across Europe, although they have created an informal network) want more color on the various steps in EMEA's decision-making process, such as the first list of questions sent by the CHMP (the actual EMEA committee which assess drug applications) to the sponsor, the sponsor's reply, the assessment of those replies, and the weighting/significance attributed by the regulators to the various elements of a product's benefit/risk profile.

Fortunately, those demands tie in with EMEA's own drive to increase transparency--something that others including the media could benefit from too. And the work's on track, according to Patrick Le Courtois, EMEA's head of pre-authorization evaluations for human medicines. "We'll be liaising with various HTA agencies," he says, and are working to improve our EPAR (the European Public Assessment Report published for every drug that's approved, which sets out the scientific grounds for the approval, plus an SPC and labeling and packaging requirements for the product).

Whether HTA agencies will play ball remains to be seen (we'll be asking NICE's Andrew Dillon at our forthcoming Pharmaceutical Strategic Alliances conference--to which you may register here). Without their cooperation, Lonngren's concern over duplicate or conflicting advice increasing the cost and time for drug development will remain. But where EMEA is a politically neutral, executive beast, HTA agencies are, whether they admit it or not, steeped in national politics. That always puts a break on consensus-reaching.

image by flickrer athousandwordsormore used under a creative commons license

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