Insufficient new evidence available on increased doses of imatinib for treating GIST after the standard dose fails
In its latest draft guidance NICE has not recommended imatinib (Glivec) at doses of 600 or 800 mg/day for people with unresectable and/or metastatic gastrointestinal stromal tumours (GIST)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.
Draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance.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.
Andrew Dillon, Chief Executive of NICE said: "NICE has previously recommended imatinib at a dose of 400 mg/day to treat GISTs that cannot be removed by surgery and also recommends sunitinib (Sutent) for patients for whom treatment with 400 mg/day of imatinib has not worked or is not suitable. This review looks specifically at increased doses of imatinib after treatment with 400 mg/day imatinib has stopped working. The higher doses of imatinib being considered are 600 mg/day and 800 mg/day.
"The independent Appraisal Committee found that since the original guidance was published in October 2004, there have been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800 mg/day imatinib given after disease progression on a dose of 400 mg/day*. On this basis, we cannot recommend these higher doses of imatinib for use on the NHS."
GISTs are rare tumours which occur predominantly in the stomach or bowel. Many of these tumours can be removed by surgery but some cannot (unresectable tumours). Without treatment unresectable GISTs progress and will eventually metastasise.
Notes to Editors
About the guidance
1. View the final appraisal determination on Gastro-intestinal stromal tumours (unresectable/metastatic) - imatinib for further information.
2. 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 imatinib was 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 given after disease progression on 400 mg/day imatinib, and the results have led the Committee to conclude that increased doses of imatinib are not an appropriate use of NHS resources for people with unresectable and/or metastatic GIST whose disease has progressed after taking 400 mg/day imatinib.
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: 15 September 2010