UK minister expects substantial changes to NICE following review
UK life sciences minister George Freeman has said nothing is ruled out in terms of reforming NICE, promising an institute fit for the 21st century, but stopping short of endorsing the industry-favoured model of different approaches to assess different types or uses of medicines.
In a wide-ranging interview with APM, he noted that the
accelerated access review (AAR) of UK medicines was due for publication within
months and would help guide policies designed to maximise the benefits of drugs
to patients, target spend on the most effective medicines and make the UK as
attractive as possible as a base for pharma research.
Following the radical transformation of drug development
over the recent years, two "profound questions" are being asked and
NICE was central to answering them, he said in an interview at the Parliament's
Portcullis House in London last week.
He said he wanted to know how personalised medicines,
genomic profiling and information will change the way drugs are likely to be
According to Freeman, the challenge is how NICE and the
Medicines and Healthcare Products Regulatory Agency "assess innovation and
how best to harness the UK's significant unique global strengths of single
payer universal health system and our science base."
NICE TO CHANGE BUT INDEPENDENCE AND REPUTATION SECURE
Freeman said he wants NICE to keep its independence and
global reputation, but wants changes need to be made throughout the institute.
"I'm delighted that (CEO) Sir Andrew Dillon and the
team at NICE embraced my review (AAR) wholeheartedly and are working closely
with the AAR team on a range of ideas to give NICE new flexibilities, pathways
for accelerated access for drugs and devices diagnostics and digital
"But the life science sector has gone through a
transformation since the mid-nineties and we do need to look at making sure
that NICE has the appropriate mechanism for the innovation of today and even
more so for those (drugs) in the pipeline for tomorrow."
He would not be drawn on what NICE might look like post
reform, but indicated he expected radical changes rather than a tinkering with
the existing system.
ACCURATE 'PAYMENT BY RESULTS' FOR DRUGS
The new systems would use more sophisticated tools to
provide "much more accurate payment by results," Freeman continued.
Pharmas would be rewarded for: "Genuine innovation on
the basis of real-time data from real patients with real disease (by) a more
intelligent real-time model for measuring cost of disease, cost of treatment
and cost benefits in a more accurate way."
UK pharma has called for NICE to end its reliance on the
quality-adjusted life year (QALY), utilising this model only when it was most
effective for capturing the value of medicines and using other devices when
they may better show the true value of new treatments.
The minister neither dismissed nor endorsed this line of
thinking, but acknowledged in some cases that the QALY potentially failed to
show the true value of treatments.
"The truth is it (the effectiveness of the QALY as a
measure) varies between different products, classes and within different drugs
"We need to give NICE the flexibilities to develop more
bespoke assessments. Some of the new classes of drugs coming down the pipeline
will ... fundamentally challenge the traditional model of reimbursement."
DRUG SPEND FINITE BUT ISSUE NEEDS SOCIETAL, PARLIAMENTARY
Freeman indicated he saw the issue of the UK's cap on total
drug spend as a separate issue to capturing the value of drugs for
reimbursement, although "working out what is the best use of inevitably
finite health resources is an obligation we owe every bit as much to patients
and taxpayers as to industry."
Pharma had come out well from the spending plans of his
Conservative party, he argued, with an increase in drugs spend as part of an
overall rise in health service spend.
"There are some important policy questions around where
competing claims on innovation budgets required a judgement about what impacts
society most, and these are judgements parliament should rightly take an
interest in," he concluded.