NICE has issued new draft guidance proposing to recommend imatinib, also known as Glivec and made by Novartis, after surgery for some people with gastro-intestinal stromal tumours (GISTs). This appraisal reviews previous guidance issued to the NHS in 2010 which did not recommend imatinib.

GISTs are found in the digestive system, most commonly in the stomach. Many of these tumours are benign and cause few symptoms. If they become cancerous and are confined to one area of the stomach or bowel, they can often be removed surgically. This new draft guidance recommends imatinib after surgery, as adjuvant therapy, for up to 3 years for adults who are at high risk of relapse.

Commenting on the draft guidance, Professor Carole Longson, health technology evaluation centre director at NICE, said: “When the original guidance was published, the committee felt there wasn’t enough evidence about key aspects of the clinical effectiveness of imatinib. However, as the results from ongoing trials have been published and there is now clear evidence that giving imatinib after surgery can delay the recurrence of GIST and in some cases increase survival, we are pleased to be able to propose recommending the drug.”

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be considered by the Committee and following this meeting the next draft guidance will be issued. 

Ends

Notes to Editors

About the draft guidance

1. The draft guidance will be available from 27 June 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.
2. Imatinib is recommended as an option as adjuvant treatment for up to 3 years for adults who are at high risk of relapse after surgery for KIT (CD117)-positive gastrointestinal stromal tumours, as defined by the Miettinen 2006* criteria (based on tumour size, location and mitotic rate – a measure of how fast cancer cells are dividing and growing).

Imatinib has a UK marketing authorisation for the ‘adjuvant treatment of adult patients who are at significant risk of relapse following resection of KIT (CD117) positive gastrointestinal stromal tumours (GISTs). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment’.

* Miettinen M, Lasota J (2006) Gastrointestinal stromal tumours: review on morphology, molecular pathology, prognosis, and differential diagnosis. Archives of Pathology & Laboratory Medicine 130: 1466–78

3. The clinical trial showed that 1-year adjuvant imatinib increased recurrence-free survival compared with placebo but that it was unclear if this resulted in longer overall survival. Adjuvant treatment with imatinib for 3 years was more clinically effective than giving it for 1 year during clinical trial follow-up, as shown by statistically significantly longer recurrence-free survival and overall survival.
4. The Committee concluded that the cost per QALY (Quality Adjusted Life Year) was between £3,610 and £12,100 for 1-year adjuvant imatinib compared with no adjuvant treatment, and between £16,700 and £30,000 for 3-year adjuvant imatinib compared with 1-year adjuvant imatinib.
5. Imatinib is available in doses of 100 mg (60-tab pack) and 400 mg (30-tab pack) at net prices per pack of £862.19 and £1724.39 respectively. At a dose of 400 mg per day, drug costs for a course of treatment would be approximately £20,700 for 1 year and £62,100 for 3 years. The net price of imatinib has risen since the original appraisal of imatinib for the adjuvant treatment of gastrointestinal stromal tumours (NICE technology appraisal guidance 196). At that time, drug costs for a 1-year course of treatment (400 mg per day) would have been approximately £19,500.