UK's NICE recommends Merck KGaA's Erbitux cetuximab for the first-line treatment of metastatic colorectal cancer

The UK's National Institute for Health and Clinical Excellence (NICE), on August 26, published final guidance on the use of German drugmajor Merck KGaA's Erbitux (cetuximab) for the first-line treatment of metastatic colorectal cancer under the National Health Service in England and Wales. The guidance recommends:

' Cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and oxaliplatin (FOLFOX), within its licensed indication, for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met:
a. The primary colorectal tumor has been resected or is potentially operable.
b. The metastatic disease is confined to the liver and is unresectable.
c. The patient is fit enough to undergo surgery to resect the primary colorectal tumor and to undergo liver surgery if the metastases become resectable after treatment with cetuximab.
d. The manufacturer rebates 16% of the amount of cetuximab used on a per patient basis.

' Cetuximab in combination with 5-FU, folinic acid and irinotecan (FOLFIRI), within its licensed indication, for the first-line treatment of metastatic colorectal cancer when criteria a, b and c are met and the patient is unable to tolerate or has contraindications to oxaliplatin.

' Patients who meet the above criteria should receive treatment with cetuximab for no more than 16 weeks. At 16 weeks, treatment with cetuximab should stop and the patient should be assessed for resection of liver metastases.
' People with metastatic colorectal cancer 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.

Peter Littlejohns, Clinical and Public Health Director said: 'Metastatic colorectal cancer describes when the primary cancer has spread from the colon or rectum to other parts of the body, such as the liver. 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.'