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In its latest draft guidance, NICE has recommended trastuzumab (Herceptin, Roche Products) for certain patients with metastatic gastric cancer who have high levels of human epidermal growth factor receptor 2 (HER2).

HER2 is a protein found on the surface of some cancer cells. Gastric cancer cells have higher levels of the HER2 protein than normal cells. Trastuzumab attaches itself to the protein so that epidermal growth factor production is reduced in the cancer cells; this stops the cells from dividing and growing.

In draft guidance published today, NICE has recommended trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of people with HER2-positive, metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior treatment for their metastatic disease and whose tumours express high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive).

Andrew Dillon, Chief Executive of NICE said: “During consultation on the first draft guidance, Roche Products, the manufacturer of trastuzumab, submitted a new analysis on a subgroup of patients with the highest levels of HER2. The Committee discussed this new information and concluded that trastuzumab was cost-effective in this patient group The Committee also agreed that trastuzumab for this group of patients fitted the criteria for consideration for appraising a life-extending, end-of-life treatment.”

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

Notes to Editors

About the appraisal

1. The preliminary guidance is available at: http://guidance.nice.org.uk/TA/Wave19/63

2. Gastric cancer, which is also known as stomach cancer, affects approximately 8,200 people in the UK every year - of whom approximately 500 would be suitable for treatment with trastuzumab

3. Immunohistochemistry (IHC) is used to show whether or not the cancer cells have HER2 receptors and/or hormone receptors on their surface. If the cancer cells score 0 to 1+, it's HER2 negative. If it scores 2+, it may be HER2 positive, but requires confirmation via another test known as FISH (flourescence in situ hybridisation). If it scores 3+ then it is HER2 positive, with no FISH confirmation test required.

4. A 150-mg vial of trastuzumab costs £407.40. In the regulatory clinical trial people received on average 8 infusions of trastuzumab. The total drug cost of trastuzumab is approximately £10,185 per patient based on a patient weight of 62 kg.

5. The most plausible estimates of cost effectiveness for the IHC3 positive subgroup were between £45,000 and £50,000, whilst those for the full licensed population were between £63,100 and £71,500 per QALY gained.

6. For gastric cancer patients, the average life expectancy is less than 24 months, trastuzumab has been found to increase median overall survival by 5.6 months for the IHC3 subgroup.

7. Trastuzumab is administered at an initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals. Providing treatment is tolerated, it can be given until disease progression.

About NICE

8. The National Institute for Health and Clinical 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.

9. 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.

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