National Institute for Health and Clinical Excellence (NICE)
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NICE updated guidance recommends imatinib for digestive system cancers

NICE has issued final guidance to the NHS recommending 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.

Commenting on the guidance, Professor Carole Longson, health technology evaluation centre director at NICE, said: “Since the publication of the original guidance, clear evidence has emerged showing that giving imatinib after surgery can delay the recurrence of GISTs and in some cases increase survival. This updated guidance means that the NHS will provide imatinib for these patients.”

This appraisal reviewed previous guidance (NICE technology appraisal guidance 196) issued to the NHS in 2010. At that time, NICE did not recommend imatinib because of uncertainty about its clinical effectiveness but further clinical trial evidence has become available since then. This is why the new final guidance now recommends imatinib after surgery, as adjuvant therapy, for up to 3 years for adults who are at high risk of the cancer recurring.

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 guidance

  1. The guidance will be available at /guidance.nice.org.uk/ta326 from 26 November 2014.
  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

  1. 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.
  2. 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.
  3. 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. 

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.

 

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