In final guidance, NICE endorsed routine NHS funding for use of the drug in adults with untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC), who have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations.

But Keytruda (pembrolizumab) should be stopped after two years of uninterrupted treatment, or earlier in the event of disease progression, it said.

The decision follows data from MSD’s KEYNOTE-024 study, which showed that the drug extended overall survival by nearly 16 months more than chemotherapy (30.0 months versus 14.2 months, respectively).

Also, as Keytruda is the first drug to break the new budget impact threshold for new products costing more than £20 million a year, NHS England said it worked closely with MSD to reach a deal, "showing the new system works for patients, the taxpayer and industry".

The drug would have cost around £84,000 per patient at its full list price, but NHS England and MSD agreed a confidential arrangement for reimbursement which will enable NICE to recommend it be routinely available on the NHS.

"It is so exciting to see the first immuno-oncology treatment for lung cancer leaving the redesigned CDF for routine funding on the NHS. This is a landmark decision for lung cancer patients, who can now have complete confidence in ongoing access to pembrolizumab," said Gary Middleton, professor of Medical Oncology at the University of Birmingham.

"Lung cancer is such a tough disease but treatments like immunotherapies that harness the patient’s own immune system to fight their cancer have transformed the way we think about the disease and more importantly treat it. These drugs do not work for everyone but when they do they can truly make a difference to patients quality and quantity of life."

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