More data or better pricing needed to approve Keytruda & Xospata in England

Keytruda and Xospata have not been recommended for NHS use with NICE seeking additional data on the cancer drugs’ benefits or for makers Roche and Astellas to offer a new price.

For Keytruda (pembrolizumab), NICE have requested extra information from Roche to help them interpret clinical trial data, before making a follow-up decision.

Pembrolizumab is an immunotherapy that aims to boost the immune system’s ability to recognise and kill cancer cells. It works by blocking a molecule often found on cancer cells – PD-L1 – from talking to immune cells.

Currently, treatment for head and neck cancer in the NHS in England will depend on where the cancer started growing. But pembrolizumab could provide a new treatment option for adults whose cancer has spread to other parts of the body and have not received any treatment, or whose cancer has returned and cannot be removed surgically.

“Clinicians told NICE pembrolizumab could cause less severe side effects for many head and neck cancer patients than current treatments, and clinical trial evidence suggests it could help some patients live longer,” says Rose Gray, policy manager at Cancer Research UK

But NICE flagged some uncertainties with the clinical trial data.

Pembrolizumab was only compared to a combination of cetuximab and chemotherapy, regardless of where the tumour started growing. But this doesn’t reflect how patients are currently treated in the NHS.

This has made it difficult to determine if the drug would be cost effective on the NHS, so NICE has requested more evidence on the drug’s benefits before the committee make a recommendation on its value for money.

A second drug also received an initial ‘no’ from NICE recently. Gilteritinib is a targeted cancer drug, which works to block chemical signals that would otherwise help a cancer grow.

It would have been a new treatment option for adults with acute myeloid leukaemia (AML), if their cancer tests positive for a particular DNA error in the FLT3 gene, where the disease has returned or is not responding to treatment. This DNA error is linked to aggressive leukaemia that’s more likely to return after treatment.

Currently, the majority of adults with this type of leukaemia are treated with chemotherapy once all other options have been exhausted.

In a clinical trial involving 371 patients, Xospata (gilterinib) was found to increase survival. People taking gilteritinib lived for 9.3 months on average, compared with 5.6 months for those taking chemotherapy.

And patients told NICE that gilteritinib could improve people’s quality of life, as the drug can be taken at home.

But uncertainties over the long-term benefits of the treatment – in particular whether it helps patients who are able to receive a stem cell transplant after initial treatment to live longer – meant NICE couldn’t be confident it would offer the NHS value for money.

NICE will review both decisions later this year.

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