NICE calls for review into way drugs are developed, evaluated and adopted in the NHS

The call for the review was made after NICE stepped back from making changes to the current way it determines which drugs to recommend for use in the NHS under its value-based assessment model. The model involves the assessment of potential new treatments in accordance with a number of different factors to ultimately determine whether the cost of those drugs is worth bearing by the NHS.

NICE said there was a lack of consensus in the responses it obtained to a consultation it held on proposed changes to its methods for value-based assessment.

NICE chief executive Sir Andrew Dillon said: "We’ve been looking in detail at how to change the way we appraise medicines and other technologies on behalf of the NHS. Following an extensive consultation, it’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments."

"We also need to look at other processes, including the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and in the arrangements for commissioning expensive new treatments," he said.

Dillon said it is "essential that industry also recognises its role in making innovative treatments available to people at a fair price".

If changes are made to the way it assesses, NICE said it also recommends that a new "office for innovation" be setup within its structures. The new office would "provide companies with a 'flight path' through the stages of the development, evaluation and adoption of their products into the NHS".

NICE also said that there needs to an agreement between it, NHS England and the Department of Health on how willing the NHS is to pay for new drugs. The collective view on the subject should also "take account of any special cases, such as ultra-orphan conditions and cancer", it said.

NICE also suggested more flexibility in drugs pricing within the NHS and appeared to suggest that prices fluctuate depending on the accumulation of knowledge about their effects. This would represent a "more productive sharing of risk between companies and the NHS", it said.

"The aim would be to progressively reflect the value of new treatments as our knowledge of what they can offer to patients increases," NICE said.

Christian Hill, director of market access and government affairs at med-tech and bio-pharma consultancy group MAP BioPharma and MAP MedTech, generally welcomed the proposals by NICE and said changes to the way potential NHS treatments are assessed could help "orphan drugs" for rare illnesses. However, he warned that there is a risk of "analysis paralysis" in NICE's effort to "do the right thing".

"These efforts, while being well founded and well intended, may lead to no changes at all for more than another year," Hill said. "As we know, value based assessment evolved from value based pricing and is now delayed significantly despite suggesting that the incremental cost-effectiveness ratios (ICERs) threshold should be variable between £20,000 and £50,000 per quality-adjusted life year (QALY) based on several criteria, not just end of life. We should be mindful of the risks of delay throughout this evolution of UK health technology assessment."

'QALY' is the measure of someone's health with reference to their length of life adjusted by their quality of life. According to guidance on the NICE website, "one QALY is equal to one year of life in perfect health".

"QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality of life score (on a zero to 1 scale)," the guidance said. "It is often measured in terms of the person's ability to perform the activities of daily life, freedom from pain and mental disturbance."

Life sciences expert Paul Ranson of Pinsent Masons, the law firm behind Out-Law.com, said: "These developments have to be considered in the light of the recent debate on alleged high medicines pricing in the European Parliament and the forthcoming informal EU Health Council meeting on 22-23 September where the issue will be considered in more depth."