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UK minister expects substantial changes to NICE following review

21/01/2016

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 developed.

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 innovations.

"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 within classes.

"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 DEBATE

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.

Source: www.apmhealtheurope.com


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