Tuesday, July 14, 2009

Stuck at NICE? Flash your Innovation Pass

Well, you will be able to soon, anyway. The Innovation Pass was a top action item within the UK government’s new Life Sciences Blueprint, unveiled at Imperial College Business Center in London today.

The Blueprint’s lofty goals include turning the UK into a more attractive location for life sciences companies (not least through tax incentives and measures to facilitate clinical trials), improving the country’s currently dire financing situation for small companies, encouraging industry-academia collaboration and—here it is—improving access to innovative new medicines. (Read the whole thing here.)

Enter the Innovation Pass, administered by the National Institute of Clinical Excellence, which, from next year, will make “selected innovative medicines” available on the National Health Service for three years. The idea is that highly novel drugs treating very small patient populations, where a lack of clinical data would make a regular NICE assessment unfeasible, thereby reach patients, and allow real-life data to be collected to inform the standard NICE process later on. (These days, typically, any novel drug that hasn’t been through NICE is more or less ignored.)

Who chooses which drugs will be selected? NICE will, noted deputy CEO Gillian Leng during the Blueprint launch. “We will decide on the criteria for granting an innovation Pass”, she said, following consultation with stakeholders at the end of this year. With a budget of just £25 million for the 2010/2011 pilot year for the initiative, we’re not talking hundreds of drugs here. More like ten.

Which helps explain why a Genzyme executive thoughtfully thrust his proposal for the “kind of drug that we think might be included in the scheme” under this blogger’s nose during coffee. It’s ataluren (there, I’ve done the favor)—an oral compound, previously known as PTC124, which targets a nonsense genetic mutation believed to cause Duchenne and Becker muscular dystrophy in boys. The compound’s in a 165-patient Phase IIb trial in collaboration with PTC Therapeutics, its originator.

Drugs like this for rare diseases might well benefit from an Innovation Pass, but Lord Drayson, Minister for Science & Innovation, in the Q&A session following the announcement chose as his example of qualifying drugs treatment for late-stage cancers—raising at least in this blogger’s mind the question of how this new process will sit alongside another recent NICE loophole (if we may call it that): the end of life medicines guidance issued late last year. (This, if you’ve forgotten, was a relaxing of the normal NICE cost-effectiveness criteria specifically for treatments used to extend life for terminal patients; several drugs, including Celgene’s Revlimid, have had a green light from NICE as a result.)

The Innovation Pass will sit on top of all this, according to Lord Drayson (a co-founder in 1993 of PowderJect, sold to Chiron—now Novartis—ten years later for £542 million). “It’s time-limited, budget-limited, and highly complementary to the normal NICE process,” he said. Indeed, once sufficient data is collected on a drug with an Innovation Pass, that treatment will go through the regular NICE appraisal system—and may be rejected, Drayson confirmed. (Sparks will fly among patient groups and the public if so, but NICE is used to that.)

Still, it’s reforms to the normal, broader NICE process that larger companies--those like Pfizer less likely to churn out Innovation Pass winners--are more interested in. Those ongoing reforms include increased dialog between industry and NICE’s assessment teams--in particular, the opportunity for companies to attend NICE appraisal committee meetings and respond to questions “on matters of factual accuracy”--and manufacturer debriefing meetings with NICE at the end of a drug appraisal.

On the red-hot question of how NICE assesses value, and whether its methodologies take into account a sufficiently wide range of factors to keep the industry happy, we must wait a little longer for the publication, on July 22, of Sir Ian Kennedy’s report. (Read this for background, and watch this space next week.)

image by flikrer Chris Fleming used under a creative commons license

No comments: