NICE approve treatment for untreated metastatic colorectal cancer

May 14, 2021

A potentially life-extending treatment for some people with untreated metastatic colorectal cancer, who have specific mutations in their cancer cells, has been approved for routine commissioning by NICE in draft guidance published today (14 May 2021).

The draft guidance recommends pembrolizumab (also called Keytruda and made by Merck Sharp & Dohme) for untreated metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency.

High MSI or MMR deficiency occurs in around 4 per cent of metastatic colorectal cancer patients. Around 450 people will be eligible for this treatment in England. Colorectal cancer with high MSI or MMR deficiency is associated with a poorer prognosis and a greater risk of death than colorectal cancer that is microsatellite stable. There are currently no specific treatments for this type of colorectal cancer.

Clinical trial evidence shows that pembrolizumab increases the time before the cancer gets worse compared with current treatments such as chemotherapy and may also be more effective at extending life. However, the independent appraisal committee found the long-term evidence is limited so it is uncertain how much overall survival benefit it offers.

“There are currently no specific treatments for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.”

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE

The clinical trial stopped treatment with pembrolizumab after 2 years. There is no evidence that additional benefit would be gained from treatment beyond 2 years so the draft guidance recommends that treatment with pembrolizumab is stopped at 2 years if there is no evidence that a person’s disease has got worse.  

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “There are currently no specific treatments for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.

“Pembrolizumab has shown the potential to extend the lives of hundreds of people with this form of colorectal cancer. It also works in a different way to current standard care with chemotherapy and the committee heard that people appreciated its faster and less frequent administration, and preferable adverse effects compared with chemotherapy. We are pleased, therefore, to be able to recommend pembrolizumab for routine use in the NHS.”

Pembrolizumab is given intravenously every 3 weeks. The average cost of a single administration is £5,260 at its list price but it will be available to the NHS at a discounted price through a confidential arrangement.

NICE expects to publish final guidance on pembrolizumab in June 2021.

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