NICE rejects MSD/Pfizer's combination in untreated kidney cancer

NICE said “no” to NHS funding for a combination of MSD’s Keytruda (pembrolizumab) immunotherapy and Pfizer’s Inlyta (axitinib) in untreated kidney cancer, citing uncertainties about its long-term benefits in first draft guidance.

In the guidance, NICE said the combination does not meet the organisation’s end of life criteria, which allow greater flexibility on cost.

The combination therapy is indicated for first-line treatment of advanced renal cell carcinoma in adults.

In its appraisal NICE noted that patients with untreated renal cell carcinoma would welcome a new treatment, given the side effects of the drugs that are already available.

Patient experts confirmed that people with the disease felt that the side effects of approved and funding treatments could substantially affect quality of life.

However in its appraisal document NICE noted its independent committee was also concerned about the impact that this treatment could have on the care pathway.

First line options are typically tyrosine kinase inhibitors, most likely Novartis’ Votrient (pazopanib) – and that prescribing Keytruda in first line would mean patients would not be eligible for Bristol-Myers Squibb’s rival immunotherapy Opdivo (nivolumab) later in the treatment pathway.

Subsequent treatment options would be likely to be from a combination of current first-line and second-line options.

NICE also thought that MSD’s estimates for long-term survival were optimistic, and that there was “considerable uncertainty” in survival estimates because of immaturity of the data from the open-label, randomised, phase 3 KEYNOTE-426 trial used for approval with regulators.

At full price a single administration of Keytruda costs £5,260, representing around three weeks of treatment, although MSD has agreed a confidential discount with the NHS.

Inlyta is also available at a commercially confidential discount from its list price of £3,517 for 56 5m tablets – around 28 days of treatment.

Keytruda is given intravenously every three weeks, while Inlyta is taken orally twice a day.

The European Commission approved the combination in September based on findings of the phase 3 KEYNOTE-426 trial, which showed the combination reduced risk of death by 46% compared with Pfizer’s commonly used Sutent (sutinib).

As this is first draft guidance, there is room for the companies to drop their prices further or submit further evidence ahead of final guidance due later this year.