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NICE decision on nivolumab with ipilimumab for renal cancer

NICE has published final draft guidance approving nivolumab with ipilimumab for use within the Cancer Drugs Fund (CDF) for adults with untreated intermediate- or poor-risk advanced renal cell carcinoma (RCC).

The decision is based on findings from the CheckMate 214 trial, which showed that the combination improved progression-free survival (PFS) compared to sunitinib (11 months vs 8.3 months; HR 0.76; 99.1% CI 0.60-0.95). However, at the cut-off point of August 2017, overall survival (OS) data were still immature. Median OS was not reached with nivolumab with ipilimumab (95% CI 28.2 to not evaluable) and was 26.0 months (95% CI 22.1 to not evaluable) for sunitinib (HR 0.63; 99.8% CI 0.44-0.89).

The final draft recommendation acknowledged that the combination has the potential to be a cost-effective treatment for this patient population, but added that more evidence is needed to address the clinical uncertainties.

Currently, nivolumab is available at a list price of £439 per 40 mg vial or £1097 per 100 mg vial (excluding VAT). Ipilimumab is available at a list price of £15,000 per 200 mg vial or £3750 per 50 mg vial (excluding VAT). However, a sizeable discount has been agreed which will allow the treatment to be available to eligible patients within the CDF, while further long-term data accrue.

The appeal period for this appraisal will close at 5pm, 23 April 2019. The final recommendation is due to be published in mid-May.


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