Insufficient new evidence available on increased doses of imatinib for treating GIST
In draft guidance, published today, NICE has been unable to recommend imatinib (Glivec) at doses of 600 or 800 mg/day for people with unresectable and/or metastatic gastrointestinal stromal tumours (GIST) whose disease has progressed after treatment with 400 mg/day imatinib.
NICE has previously issued guidance on the use of imatinib to treat GIST, and has recommended imatinib at a dose of 400 mg/day (NICE technology appraisal guidance 86). This review looks specifically at increased doses of imatinib after treatment with 400 mg/day has stopped working. The higher doses being considered are 600 mg/day and 800 mg/day.
Andrew Dillon, Chief Executive of NICE said: “NICE already recommends imatinib at a dose of 400 mg/day for patients with gastrointestinal stromal tumours that cannot be removed by surgery. However, since the appraisal was published in October 2004, there has been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800 mg/day. On this basis, we cannot recommend these higher doses of imatinib for use on the NHS.
“NICE has already recommended sunitinib (Sutent) as a treatment option for patients with unresectable or metastatic malignant gastrointestinal stromal tumours for whom treatment with 400 mg/day imatinib treatment has not worked or was not suitable.”
Draft guidance has been issued for public consultation and the manufacturer and other consultees now have an opportunity to consider and respond to comments made by the independent Appraisal Committee.
Notes to Editors
About the guidance
1. For further information view the appraisal.
2. 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). Of these two thirds are considered to be resectable (from the manufacturer's submission).
3. If a daily dose of 400mg/day were given for a year, the drug cost would be approximately £19,500 per patient, per year; for 600mg/day approximately £29,300 and £39,067 for 800 mg/day.
4. The limited available data was used to try and establish the cost effectiveness of increased doses of imatinib, and the results have lead the Committee to conclude that increased doses of imatinib are not appropriate use of NHS resources
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: 29 June 2010