The National Institute for Health and Clinical Excellence has rejected the use of Roche’s targeted cancer therapy Herceptin as a treatment for patients with gastric cancer, over uncertainty over the magnitude of its effect.

The cost regulator has now published draft guidance that does not recommended Herceptin (trastuzumab), in combination with cisplatin and capecitabine or 5 fluorouracil, as an option for treating patients with HER2-positive forms of metastatic gastric cancer.

Gastric cancer is a particularly aggressive form of the disease that is associated with a poor prognosis and low survival rates, particularly as there are few treatment options available. And while there are around 8,200 new cases of gastric cancer diagnosed in the UK each year, only 500 of these would be eligible for treatment with Herceptin.

In February this year regulators issued a green light for Herceptin to treat patients with HER2-positive gastric cancer alongside chemotherapy, but only in those who have not received any previous therapy for their metastatic disease.

The decision came after Phase III clinical trail data showed 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.

But explaining the Institute’s reluctance to approve the drug, its chief executive Andrew Dillon said “although clinical trials suggest [Herceptin] can extend life for patients with HER2-positive metastatic gastric cancer, there is considerable uncertainty about the data on how long this extension would be”.

And this uncertainty, coupled with the cost of the therapy - estimated to be around £10,185 per patient based on a weight of 62kg - meant that NICE was unable to recommend the drug at this time. However, Roche and other consultees “now have an opportunity to help the independent Appraisal Committee resolve this uncertainty, to the extent that they can,” Dillon stressed.

The Institute has recommended the use of Herceptin in patients with HER2-positive early stage breast cancer on the NHS, on the basis that, despite a price tag of about £20,000 per patient per year, the drug is able to extend progression-free life for a number of years.