NICE has issued final draft guidance proposing to recommend imatinib, also known as Glivec and made by Novartis, for up to 3 years for people who have had a gastro-intestinal stromal tumour (GIST) removed and who are at high risk of the cancer recurring.

GISTs are found in the digestive system, most commonly in the stomach and small bowel. Some are benign and cause few symptoms. If they become cancerous and are confined to one area, they can often be removed surgically.

This appraisal reviews previous guidance (NICE technology appraisal guidance 196) issued to the NHS in 2010. At that time, NICE did not recommend imatinib but further clinical trial evidence has become available since then, which addresses several uncertainties. This is why the current final draft guidance now recommends imatinib after surgery, as adjuvant therapy, for up to 3 years for adults who are at high risk of relapse.

Commenting on the draft guidance, Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “When the original guidance was published, the committee felt there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, the results from ongoing trials have now been published. There is clear evidence that giving imatinib after surgery can delay the recurrence of GIST and in some cases increase survival.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

1. The draft guidance will be available at http://guidance.nice.org.uk/TAG/359 from 17 October 2014. Embargoed copies 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).

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. One clinical trial showed that 1-year adjuvant imatinib increased recurrence-free survival compared with placebo but it was unclear if this resulted in longer overall survival. Another clinical trial showed that adjuvant treatment with imatinib for 3 years was more clinically effective than giving it for 1 year, as shown by statistically significantly longer recurrence-free survival and overall survival during clinical trial follow-up.
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.