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NICE slowed by budget cut

The decision making process at NICE is likely to increase after budget cuts sees the loss of appraisal committee

A glut of crucial new pharmaceutical products awaiting review by the National Institute of Health and Clinical Excellence (NICE) will be delayed in reaching patients in England and Wales after a funding chop led to the loss of a key appraisal committee.

Some £3.5m was reportedly wiped off the budget when NICE merged with the Health Development Agency in April this year, forcing the body subsequently to lose one of its three product appraisal committees and narrowing the bottleneck for new products to gain funding and filter through into patient use.

The government decided to cut NICE's budget in favour of deploying the resources to the front line in the health system - a move that NICE understands and has accepted, it said. However, the delay for many patients awaiting valuable new cancer drugs that are now dribbling through the slow-moving review process - the backlog is understood to comprise more than 60 new products and is expected to grow - may prove to be too long.

It is understood that of the appraisals currently requiring attention, nearly one quarter could be delayed by up to an extra four months, meaning that some patients in England and Wales may have to wait until late 2007 to receive drugs that are already available elsewhere. The queue includes new treatments for colon and pancreatic cancer that represent significant advances.

ìNICE recognises how important it is for the NHS and for patients to have timely advice on the use of new medicines, particularly for life threatening conditions such as cancer,î a spokesperson told Pharmaceutical Marketing. ìThe Institute knows that sometimes its guidance is published after drugs are licensed [and] wants to minimise the time gap between licensing and publication - so is working hard in this direction.î

It is possible for doctors and hospitals to prescribe or administer new drugs that have not yet been officially recommended by NICE, though this happens in the minority of cases and is not a frequent occurrence when it comes to new cancer drugs, which are notoriously expensive. Yet, NICE is adamant that patients should not necessarily go untreated pending a positive review outcome for a medicine.

ìIt's important to note that there is no ban or restriction on the prescribing of drugs in England and Wales within their licensed indications whilst NICE is carrying out an appraisal. The Department of Health has made it clear that funding for licensed treatments should not be withheld because guidance from NICE is unavailable. In these circumstances, the Department of Health expects Primary Care Trusts to take full account of the available evidence when reaching their funding decisions.î

However, CEO Andrew Dillon told the Daily Telegraph in an interview that NICE was considering introducing a fast-track appraisal process that would halve the current time for simpler, more clear-cut cases.

"The wider the neck of the funnel, the more rapidly the appraisals are going to go through. But periodically you get to the point where you say we are going to have to improve quality and volume by being better at what we do; we have to see whether there are circumstances in which we can run a more rapid appraisal than the standard 14-month one."

NICE added: ìThings will improve over the longer term as NICE is working to ensure that topics are referred to it earlier in the licensing process, so it can issue guidance quickly after a drug has been licensed.î

30th September 2008

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