Conditional recommendation issued for Erbitux in mCRC

NICE has issued final guidance recommending Erbitux (cetuximab) as a first line treatment for metastatic colorectal cancer (mCRC).

The guidance recommends cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and oxaliplatin (FOLFOX) within its licensed indication, but only when the primary colorectal tumour has been resected or is potentially operable, the metastatic disease is confined to the liver and is unresectable, and the patient is fit enough to undergo surgery if necessary.

Another condition of the recommendation is that the manufacturer, Merck Serono, will rebate 16% of the cost of cetuximab used on a per patient basis.

The drug is also recommended for use in a similar indication where the oxaliplatin is replaced with irinotecan (FOLFIRI) for patients who are unable to tolerate the former.

For those patients who meet the above criteria, NICE suggests that they should receive treatment with cetuximab for no more than 16 weeks, when the patient should be assessed for resection of liver metastases.

The guidance also specifies that patients with metastatic disease confined to the liver who receive cetuximab should have their treatment managed only by multidisciplinary teams that involve highly specialised liver surgical services.

Professor Peter Littlejohns, Clinical and Public Health Director, said: “Before making these recommendations the Appraisal Committee considered the manufacturer’s cost-effectiveness estimates and the proposed 16% rebate scheme, as well as the evidence on cetuximab successfully shrinking liver metastases enough so that they can be removed via surgery.

“The Committee concluded that under the specific circumstances outlined in the guidance the cost of cetuximab in relation to how well it works is an effective use of NHS resources. This guidance means that those patients who meet these criteria will have a further treatment option.”