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NICE reform put on hold – for now

Published on 17/09/14 at 03:24pm
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The reforming of NICE has been put on hold as the watchdog believes more changes must be wrought to deal with concerns over market access in the UK.

NICE has made the announcement following a key board meeting today which looked at new proposals that could change its current methodology for evaluating new drugs.

Following a three-month consultation triggered by the Department of Health, the Institute says it has decided to ‘undertake further work’ before making changes to the way it appraises new medicines and other technologies for use by the NHS. It has not given a timeline for when this should be completed.

The delay is because NICE and its board could not agree on the many changes needed to overcome major issues around market access, but also how to ascertain the best way forward for ensuring the cost-effectiveness of new drugs whilst getting more new treatments to patients.

NICE says that any changes needs to be made as part of a ‘wider review of the innovation’ as well as the evaluation and adoption of new treatments (including those for cancers).

This it insists, must involve patients; people working in or with the NHS; the life sciences industries and health researchers.

The Institute has come under fire in recent years over its rejection of new medicines, notably cancer drugs, and the fact that a siloed £280 million Cancer Drugs Fund is needed to pay for new oncology medicines not recommended by NICE.

But NICE has hit back too, saying that many of the issues surrounding market access are to do with the high prices set by pharma, who also refuse to show how it comes under with the price tag for its medicines.

Alongside any changes to its methods, NICE proposes three main topics for further discussion:

  • an office for innovation inside NICE to provide companies with a ‘flight path’ through the stages of the development, evaluation and adoption of their products into the NHS
  • agreement between NICE, NHS England and the Department of Health, on the NHS's willingness to pay for new treatments, which would take account of any special cases, such as ultra-orphan conditions and cancer
  • more productive sharing of risk between companies and the NHS. The aim would be to progressively reflect the value of new treatments as our knowledge of what they can offer to patients increases (it says NHS England’s ‘commissioning through evaluation’ process could be used to for this).

But all of this still needs to be discussed and will not be fully implemented given that the NICE board ‘found no agreement’ in responses on the proposed changes.

Value-based assessment

Earlier this year NICE published its proposals on ‘value-based assessment’ (VBA) for consultation.

These new VBA weightings have tentatively added ‘wider societal impact’ and the ‘burden of illness’ into NICE’s cost-effectiveness formula QALY (quality-adjusted life years) in an attempt to potentially allow more medicines through the system.

In terms of the wider societal benefit weighting, this will mean extracting the QALY expected from those with a certain condition compared to those without. Essentially, this means NICE could look at just how much does having a disease stop someone from being able to contribute to society.

With the second weighting, NICE says it will try to assess what it is to carry a burden of an illness throughout someone’s life, rather than not having it, and apply that to its QALY.

NICE has since March asked its committees to consider these weightings when looking at new drugs, but is yet to become a fully integrated part of its QALY process. NICE and its board will need to agree on this before it can go further.

Market access concerns prevail

The chief executive of NICE, Sir Andrew Dillon, explains: “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.

“There have been exciting changes in research and development of new medicines and other health technologies which is increasingly challenging all those involved in bringing new treatments to patients. This requires a wider review of the NHS’s arrangements for supporting innovation and evaluating and adopting new treatments.”

Sir Andrew made a parting shot at pharma and the increasingly public debate over drug prices, adding that “it’s essential that industry also recognises its role in making innovative treatments available to people at a fair price”, suggesting that he doesn’t feel it currently is.

The consultation drew more than 900 comments from 121 organisations and individuals, with the life science industry and patient groups making up around one-third of the responding organisations.

The UK pharma group the ABPI, which has also responded to the consultation, has told Pharmafile that it wants a root and branch political reform of NICE, rather than these types of internal changes, in order to fully deal with the issues around market access.

The ABPI wants to see wholesale reform of the QALY process, but this is not on the cards for NICE.

For more on the issues surrounding market access, see the free online version of our special 'Battle for Market Access' supplement.

Ben Adams 

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