NICE unable to recommend imatinib due to lack of clinical evidence
In its latest draft guidance NICE has not been able to recommend imatinib (Glivec) as an adjuvant treatment for people who have had a gastrointestinal stromal tumour (GIST) removed and who are at risk of the cancer recurring.
The Appraisal Committee concluded that there is evidence to show that giving imatinib after surgery (that is, as adjuvant therapy) can delay the recurrence of GIST. However, there is currently a lack of evidence about key aspects of the clinical effectiveness of imatinib, in particular whether adjuvant imatinib extends life expectancy, how long treatment should be continued and whether resistance to imatinib develops. If resistance develops as a result of treatment after surgery, that could reduce the benefits of imatinib if a patient needs it at a later stage after their cancer has recurred. More mature evidence is expected to be available in 2011 and the Appraisal Committee has therefore recommended that the appraisal be considered for review at an early stage.
Andrew Dillon, Chief Executive of NICE said: “NICE already recommends imatinib for patients with chronic myeloid leukaemia and for those with gastrointestinal stromal tumours that cannot be removed by surgery. There is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumours, but it is not clear that it increases survival or that it improves patients' quality of life.
“The Appraisal Committee did, however, recommend that an early review date should be set for this appraisal so that evidence on the impact of adjuvant imatinib treatment on overall survival can be considered as soon as results from ongoing trials become available.
“At about £19,500 per patient per year, this is a relatively expensive drug, and we need to be sure about how well it works and what its side- effects are before we can recommend it as cost-effective for use in the NHS.”
Draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the guidance
1. Further information on this appraisal is available on the NICE website at: http://guidance.nice.org.uk/TA/Wave20/79.
2. In its previous draft guidance, the Committee requested further data from the manufacturer of imatinib to address uncertainities presented in their original submission relating to the clinical effectiveness and cost-effectiveness of adjuvant imatinib treatment. This additional information was considered by the Committee at their second meeting.
3. Gastrointestinal stromal tumours (sometimes called gastrointestinal soft tissue sarcomas) are a rare kind of tumour which predominatly occur in the stomach or bowel. Many of these tumours are benign, and those usually cause few symptoms. If they become malignant and are confined to one area of the stomach or bowel, they can often be removed surgically.
The annual incidence of GISTs is estimated to be 14.5 per million population which equates to approximately 791 new cases per year in England and Wales (mid-2008 population). Approximately one-third would be considered unresectable.
4. In this case, adjuvant therapy is an additional treatment, given after surgery when all detectable GIST has been removed, but there remains a risk of tumour recurrence.
5. The National Institute for Health and Care 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.
6. 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.
This page was last updated: 24 June 2010