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NICE backs advanced melanoma drug in draft guidance

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The National Institute for Health and Care Excellence has recommended nivolumab (Opdivo) as monotherapy for treating advanced skin cancer in final draft guidance.

Nivolumab, manufactured by Bristol Myers Squibb, should be made available on the NHS for advanced – unresectable or metastatic – melanoma in adults, said NICE in its final appraisal determination.

“It’s vital that we get novel and exciting cancer treatments to patients as quickly as possible”

Paul Workman

The draft guidance, published today, is now with consultees, who have the opportunity to appeal against it. Final guidance is expected to be published in February.

Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. I am sure this will be welcome news to patients and healthcare professionals alike.”

She added: “In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined.”

Cancer cells in tumours can exploit immune checkpoint pathways, allowing them to hide from the immune system and be shielded from immune attack.

Nivolumab is a PD-1 (programmed death-1) immune checkpoint inhibitor that works by harnessing the ability of the immune system to find and fight cancer.

It costs £439 per 4ml (40mg) vial and £1,097 per 10ml (100mg) vial (excluding VAT).

The Scottish Medicine’s Consortium is also due to publish advice on nivolumab for the treatment of patients with advanced unresectable or metastatic melanoma in March.

“I am sure this will be welcome news to patients and healthcare professionals alike”

Carole Longson

It is the latest in a series of similar drugs approved since 2012 by NICE for treating advanced melanoma, including vemurafenib, dabrafenib, ipilimumab and pembrolizumab.

Professor Paul Workman, chief executive of the Institute of Cancer Research, London, said: “It’s great to see NICE approve nivolumab, which is an effective and innovative new immunotherapy for melanoma, for use on the NHS.

“Patients with advanced melanoma currently have few treatment options, so it’s positive that NICE has approved this at the first time of asking,” he said.

“It’s vital that we get novel and exciting cancer treatments to patients as quickly as possible, and avoid the tortuous back and forths we have seen with other recent appraisals,” he added.

Gill Nuttall, founder of the charity Melanoma UK, said: “Melanoma can progress very quickly and many patients simply can’t afford to wait for treatment. We are, therefore, really pleased that NICE has now committed to making this medicine available to NHS patients.

“Immunotherapies are changing survival expectations in cancer and we need to do more to bring patient access to these potentially life-extending cancer medicines as quickly as possible,” she said.

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