NICE: the end of an era

After 11 years as the villain, NICE will no longer be asked to make the ‘nasty decisions’

NICE is undergoing a momentus shift in its role which will see it leave behind the frequent clashes and controversy surrounding its appraisal system of drugs.

Observers of the NHS will be forgiven for having missed the full import of recent announcements about NICE, coming as they have amid a tidal wave of change for the whole health service.

The key message from health secretary Andrew Lansley is clear, however - NICE will no longer have to power to say yes or no to new medicines, to recommend or not recommend their use on the NHS.

This will strip NICE of its single greatest power, which will now pass into the hands of the soon-to-be-created NHS Board.

It seems likely that NICE will still undertake ‘technology appraisals’ but that these will simply inform the NHS Board’s decision, and will not be the final word on a new medicine’s use on the NHS.

Since it was first established in 1999, NICE has barely gone 12 months without one significant shift in its remit or another, but this is a very significant change - an end of an era for the organisation. No longer to be the body which commentators in the The Daily Mail attack for blocking access to cancer drugs, NICE will now focus on providing strategic guidance on standards of care in the NHS.

This move could be construed as a humbling of NICE, but this is probably the wrong conclusion to reach. While removing these powers is certainly a signal the government believes its health technology appraisal model has been a failure, it has simultaneously given a vote of confidence in NICE’s overall ability to help set the clinical agenda of the NHS.

It is now charged with setting the quality standards for GP-led commissioning, putting it at the heart of the new vision for the health service.

This is apparent in the plans to put NICE on a ‘firmer statutory footing’ by establishing it in primary legislation and by widening its scope to include social care standards.

A problem eliminated or simply relocated?

NICE is already shifting its emphasis away from Health Technology Assessment towards public health topics.

But just as NICE is ‘here to stay’ then finite health budgets, new technological innovation and the need for rationing decisions (implicit or otherwise) also remain.

The Conservative-Lib Dem coalition government plan to create an NHS Board by 2011, which will take on a number of duties from NICE. But the government hopes to avoid giving a blanket ‘no’ to some new medicines by introducing Value-Based Pricing (VBP). However one problem with this plan is that the goverment has promised not to fully introduce VBP until 2014. This leaves a long period in which the new NHS Board will not have the power to negotiate prices - leaving it to use NICE’s appraisal methodology, or adopt a more lenient approach.

The introduction of the Cancer Drugs Fund (the first version is a £50 million reserve available from October) is another new mechanism to help patients bypass NICE’s veto on new oncology treatments.

Industry response

The response from pharma industry body the ABPI has been as low key as the government’s announcements, with the body’s director-general Dr Richard Barker only remarking on the ‘widening’ of NICE’s remit in to social care, and not the removal of its power to recommend or not recommend, but the industry will be delighted at what looks like the removal of a very considerable obstacle.

Dr Barker said in July that the ABPI agreed with the government on the importance of set quality standards “for the new era of GP-led commissioning” and welcomed NICE’s involvement in the process.

Barker said: “The ABPI believes that this expansion of NICE’s remit to promote clinical best practice is a higher priority for the future of the NHS than the overly narrow cost effectiveness calculations on new medicines it currently conducts.”

But he was far more cautious when it came to the proposed pricing changes, noting only: “The new government also proposes to introduce a Cancer Drugs Fund and to review how better to reflect value in the pricing of NHS medicines. We look forward to working with the government to develop these proposals further whilst maintaining the stability of the current PPRS agreement.”

After 11 years of dealing with NICE’s barriers the pharma industry is all too wary of new obstacles being put up as part of a new system.

THE NEW NICE

Responsibility for ‘recommending’ or ‘not recommending’ medicines will be transferred to the new NHS Board.

NICE will instead develop quality standards, to be used by the NHS Commissioning Board. The standards will set out each part of the patient pathway, and indicators for each step.

NICE will rapidly expand its existing work programme to create a ‘comprehensive library of standards’ for all the main pathways of care. The first three on stroke, dementia and prevention of venous thromboembolism were published in June. NICE is expected to produce 150 standards in the next five years.

The NHS Commissioning Board will provide a framework to support GP consortia in commissioning services, including setting commissioning guidelines. This will be done on the basis of clinically approved quality standards developed with advice from NICE, in a way that promotes joint working across health, public health and social care.

Andrew McConaghie