National Institute for Health and Clinical Excellence (NICE)
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NICE announces measures on end of life medicines

The National Institute for Health and Clinical Excellence (NICE) has today announced proposals that will enable it to provide its independent advisory bodies with additional advice when they are asked to make recommendations on the use of medicines for treating certain rarer conditions which extend life at the end of life.

The proposed changes to its technology appraisal process, which are the subject of a five-week public consultation, will mean that NICE is to supplement the advice it currently gives to its Appraisal Committees. This supplementary advice will enable access to medicines licensed for terminal illnesses affecting small numbers of patients which, although offering demonstrable and substantial survival benefits over current NHS practice, are deemed not to represent a good use of NHS resources. To be considered under this supplementary advice, a medicine would need to:

• Be licensed for treating a patient population not normally exceeding 7000 new patients each year

• Be indicated for the treatment of patients with a diagnosis of a terminal illness and who are not, on average, expected to live for more than 24 months

• Have sufficient evidence to indicate that it offers a substantial average extension to life compared to current treatment.

• Have been assessed by NICE as having an incremental cost effectiveness ratio in excess of the upper end of the range (£30,000) normally considered by NICE’s Appraisal Committees to represent a cost effective use of NHS resources.

In addition, no alternative treatment with comparable benefits should be available through the NHS
Commenting on today’s announcement Andrew Dillon, NICE Chief Executive, said: “The Institute is aware that patients, and the public, place considerable value on treatments which offer the possibility of extending life when we are close to death. We believe that we should reflect that view when we are asked to make recommendations on the use of medicines that are designed to extend life, at the end of life. The new advice we are giving to our Appraisal Committees will help them to take account of this and will better enable them to decide when to recommend the use of life extending treatments.

He continued: “Our thinking about how best to approach decisions on life extending medicines has evolved over recent months. When Professor Mike Richards was preparing his report, we decided to make our contribution to finding a solution to the issue of co-payments. What we have announced today are proposals for an amendment to the advice we give to our Appraisal Committees in the difficult task of advising the NHS and patients on the use of new medicines. Following public consultation on the detail, we intend to apply the supplementary advice at our next scheduled Appraisal Committee meetings in January 2009.”
In addition, and subject to agreement with the Department of Health, medicines recommended for use on the basis of the criteria set out in these proposals would be subject to an appropriately designed programme of evidence development to ensure that the anticipated survival gains are evident when used in routine practice.

Notes to Editors

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

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