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Merck criticises NICE ‘no’ to personalised bowel cancer drugs

Published on 19/11/15 at 09:26am

NICE has issued preliminary not recommending two specific personalised treatments used in combination with chemotherapy for previously untreated metastatic colorectal cancer, in a move criticised by Merck Serono, the producer of one of the drugs.

The UK regulator rejected Merck’s Erbitux (cetuximab) and Amgen’s Vectibix (panitumumab), which are the only two personalised options currently available for the disease: the fourth most common form of cancer in the UK.

Personalised medicines take into account a patient’s genetic information to predict whether they may or may not respond to a particular treatment better.

Merck reacted strongly to the negative decision, saying NICE funding would provide “a more long-term solution to making these treatments available on the NHS compared to temporary funding arrangements currently available in the UK such as the Cancer Drugs Fund (CDF) in England.”

Elisabeth Prchla, general manager, Merck in the UK and Ireland, says: “We are disappointed with the preliminary NICE recommendation which in our opinion brings into question the methodology used to assess personalised medicines in patients with metastatic cancer.”

Colorectal cancer or bowel cancer is the fourth most common cancer in the UK.  Advanced or metastatic colorectal cancer occurs when this cancer spreads to other parts of the body, and approximately 25% of people with colorectal cancer have metastatic disease when first diagnosed.

Charity Beating Bowel Cancer also reacted with dismay to the announcement, saying the decision “throws into doubt the future funding of these drugs for the treatment of advanced bowel cancer.”

It also noted that both rejected drugs are now only available through the Cancer Drugs Fund, which is due to come to an end in March 2016, leaving patients facing a future where the treatments will no longer be available in England.

Mark Flannagan, Chief Executive of Beating Bowel Cancer, comments: “Today’s news that NICE will not recommend the use of Cetuximab and Panitumumab on the NHS is devastating.  This decision will compromise doctor’s ability to provide the best international standards of care for advanced bowel cancer patients in England.

"The ability of NICE to give a positive assessment would have been seen as a test case for how a new, more flexible NICE methodology could work for cancer drugs, in particular flexibility around the assessment of end of life drugs and their affordability to the NHS.   

"So this negative recommendation means that treatment for advanced bowel cancer in this country will be going backwards, with patients diagnosed in 2016 facing worse care than patients diagnosed in 2015. We need NICE to reconsider its decision not to approve these drugs before the UK slips behind the rest of Europe and the world.

"With the uncertainty around the Cancer Drugs Fund, we need to find a longer-term funding solution now before bowel cancer patients start having their lives cut short.”

There are a number of steps in the NICE evaluation process and following this preliminary guidance, there will be a period of consultation to gather feedback until December 8 2015.

Final NICE guidance issued through the final appraisal determination (FAD) is due in Spring 2016.

Yasmita Kumar

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