trastuzumab (Herceptin)

Advice

following a re-submission:

trastuzumab (Herceptin) is not recommended for use within NHS Scotland.

Indication under review: in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herceptin is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.

The addition of trastuzumab to doublet chemotherapy has shown benefits in overall and progression-free survival and tumour response.

The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient and the economic case was not sufficiently robust to gain acceptance by SMC.