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18 September 2014

NICE calls for a new approach to managing the entry of drugs into the NHS

In its response to comments on proposals for changes to its current methodology for evaluating new drugs, the National Institute for Health and Care Excellence is positioning itself for a wider role in the way drugs are developed, evaluated and taken up in the NHS.

Following a consultation, the institute 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 argues that any changes to NICE’s methods need to be made as part of a wider review of the innovation, evaluation and adoption of new treatments (including those for cancers) involving patients, people working in or with the NHS, the life sciences industries and health researchers.

Alongside any changes to its methods, NICE proposes:

  • 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 (NHS England’s “commissioning through evaluation” process could be used to for this).

The institute’s proposals follow a detailed examination of its role in determining which new technologies the NHS should pay for. In 2013, the Department of Health asked the institute to consider additional “terms of reference” in the appraisal of new health technologies. The aim was to supplement the existing NICE methodologies.

Earlier this year, NICE published its proposals on “value-based assessment” for consultation. They were intended to give more direction to the independent committees which appraise new technologies on behalf of the institute.

NICE’s Board of Directors, which has met at a public meeting in Kendal, has considered the results of the 3 month consultation of stakeholders – including patient groups, the Department of Health, companies, learned societies, charities and researchers.

The Board found no agreement in responses on the proposed changes. The chief executive of NICE, Sir Andrew Dillon, explained:

“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’ arrangements for supporting innovation and evaluating and adopting new treatments. And it’s essential that industry also recognises its role in making innovative treatments available to people at a fair price.”


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Notes to Editors

  1. In March 2014, the consultation set out proposals to amend NICE’s Guide to the Methods of Technology Appraisal 2013. The Guide is used by the independent committees of experts who appraise medicines and other technologies on behalf of NICE, for use in the NHS.
  2. To evaluate the clinical and cost effectiveness of a technology, NICE measures its merit using a unit known as a quality adjusted life year or QALY. This is a useful way of comparing the costs and benefits of sometimes very different technologies in different conditions by looking at the gains to quality of life and life expectancy.  This way of comparing technologies allows our independent advisory committees to understand the impact that introducing a new treatment will have on the ability of the NHS to maintain the services it already provides.
  3. In its current appraisal processes, NICE advises its appraisal committees to support the use of a new drug within a range of £20,000 to £30,000 per QALY. In exceptional circumstances more expensive treatments (up to about £50,000 per QALY) can be recommended. There are very specific circumstances for new drugs that are designed to extend life at the end of life. That has been applied frequently, particularly to new cancer treatments.
  4. The advisory committees are able to use their discretion to support the use of a treatment at a higher cost per QALY. The proposals on value based assessment were to regularise the decision-making process more explicitly in the methodology.
  5. In July 2013, the Department of Health asked NICE to take into account additional terms of reference in the appraisal of new health technologies. They were intended to supplement but not replace NICE’s current approach to assess the clinical and cost effectiveness of new treatments.
  6. The terms of reference asked NICE to include a simple system of weighting for burden of illness that appropriately reflected the differential value of treatments for the most serious conditions, encompass the differential valuation of treatments designed to extend life at the end of life used in the current approach within a new system of burden of illness weights and include a proportionate system for taking account of wider societal benefits.
  7. The value based assessment proposals, published in March 2014, included proposals to take into account more systematically and explicitly the severity of a disease, as well as the effect that diseases and conditions have on our capacity to engage in society. The aim was to add further clarity to NICE’s recommendations and enable the independent advisory committees to explore more fully the potential treatments have to improve outcomes for patients.
  8. The consultation drew more than 900 comments from 121 organisations and individuals. The life science industry and patient groups each made up approximately a third of the responding organisations. The majority of the rest were from academics and clinical/professional organisations, with the remaining response from a small number of health technology assessment agencies, NHS organisations (including NHS England) and the English Department of Health.

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Following an extensive consultation, it’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments.

Sir Andrew Dillon, Chief Executive of NICE