NICE has published final draft guidance approving nivolumab with ipilimumab for use within the Cancer Drugs Fund (CDF) for adults with untreated intermediate- or poor-risk advanced renal cell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