The United Kingdom's National Institute for Health and Clinical Excellence, or NICE, has come under fire from a government
committee that claims its evaluation process is too slow. It was also blasted for failing to include the wider benefits of
treatments to society, such as the impact on caregivers, in its assessments.
NICE was established in 1999, and its assessments and guidelines have been copied around the world. Yet this has been accompanied
by criticism from industry and patient groups alike that its decisions are not always fair or transparent and that it slows
down the availability of new medicines to patients.
The House of Commons Health Committee last looked at NICE back in 2002, and many—but not all—of the recommendations it made
have been implemented. At the top of the committee's list of recommendations this time was that drugs should be assessed at
the time of licensing, as all too often doctors and Primary Care Trusts (PCTs, the local organizations responsible for budgets)
await a NICE decision before they prescribe a newly approved treatment.
However, the committee acknowledged that NICE does not always have all the information it needs to make an assessment and
said that it should have access to all data submitted to the regulatory authorities. NICE should also work more closely with
pharma to ensure it can get the information it needs.
The committee also says that there is insufficient emphasis on disinvestment, with old treatments continuing to be used regardless
of the availability of newer, more effective alternatives that might also be cheaper in the long run. And it reiterates a
recommendation made in its 2002 report that has not been implemented: that the wider benefits to society of treatments should
be taken into account. If a treatment keeps a patient healthier for longer, then he will be able to earn money and pay taxes
for longer—and relatives who otherwise might have to give up their jobs to care for the patient would too.
The Association of the British Pharmaceutical Industry (ABPI) does not believe the committee's recommendations would benefit
patients. Claiming that the report contains the first formal admission that medicines are rationed in the United Kingdom,
ABPI believes that its recommendations would have no impact on patients' access to modern medicines. "British patients already
have worse access to new medicines than others in Europe," says ABPI director general Richard Barker. "Faster, 'quick and
dirty' assessments of medicines against tougher cost-effectiveness hurdles will make this problem worse. What we need most
is an innovative National Health Service, not one more determined to ration care before we even know how patients will benefit
In response to the suggestion that NICE should look at all drugs, chief executive Andrew Dillon says that it currently looks
at 30 to 40 percent of all the new treatments launched in the United Kingdom. However, he is not convinced of the value of
appraising everything. "We look at the most challenging, interesting, innovative, controversial, expensive things that come
in," he says. "Many of the new drugs that are introduced are license extensions, and...NHS can pretty much make its own judgment
on many of them. That said, if NHS particularly wanted us to do something, we'd be happy to—and we'd probably find that the
rate of appeals would reduce, as we'd be doing fairly uncontroversial things."
The committee's chairman, Kevin Barron, said the government should not interfere with NICE's work. "It is essential that NICE
is left to do its job without ministerial interference," he said. "At the same time, it must have the support of ministers
when it makes a difficult decision."
NICE will never be able to make everyone happy. Patient organizations and pharma companies both think that NICE's cost-effectiveness
thresholds are often set too low, whereas PCTs frequently struggle to implement its recommendations, citing a lack of resources,
and think the thresholds should be made lower still. The report concludes that implementation of NICE guidance should be improved
and, if necessary, some elements of the clinical guidelines made compulsory. "The fact that some PCTs apparently find NICE
recommendations unaffordable is more a reflection of poor forward planning for innovations in the NHS than it is of the value
they deliver," concludes ABPI's Barker.
Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at firstname.lastname@example.org