The National Institute for Health and Clinical Excellence has published final guidance recommending Roche’s Herceptin as a treatment for gastric cancer on the National Health Service in the England and Wales.

The final guidance endorses Herceptin (trastuzumab) in combination with cisplatin and either capecitabine or 5-fluorouracil as an option for certain patients with metastatic adenocarcinoma of the stomach and gastro-oesophageal junction.

However, the Institute has stipulated that treatment should be restricted to patients who have high levels of human epidermal growth factor receptor 2, as defined by a positive immunohistochemistry score of 3 (IHC3), and have not received prior treatment for metastatic disease.

Results from a Phase III clinical trial have shown that the drug, when given alongside chemotherapy, can significantly increase the lives of patients with HER2-positive gastric tumours, from 11.8 months to 16 months compared to those receiving chemotherapy alone, forming the basis of its regulatory approval earlier this year.

But this data – which relates to all patients with HER2-expressing tumours - was not enough to persuade the cost regulator of Herceptin’s value to the NHS, and it initially rejected the drug in this setting. It was only after Roche submitted a new analysis of the Herceptin’s benefit to patients with high levels of HER2 during the consultation period that NICE changed its mind.

The Institute’s cost-modelling - based on the new data from Roche - calculated that the most plausible estimates of cost effectiveness for the IHC3 positive subgroup were between £45,000 and £50,000, while those for an unrestricted population fell between £63,100 and £71,500 per QALY gained - and so well above what would normally be considered a cost-effective use on NHS resources.

Gastric cancer is a particularly aggressive form of the disease and is associated with a poor prognosis and low survival rates. There are currently few treatment options for patients with gastric cancer, and so the approval of a new therapy with the potential to significantly extend life will be welcomed those who fit the treatment criteria.