OBJECTIVES:

In advanced, previously-treated renal cell carcinoma (RCC), nivolumab monotherapy was the first treatment to demonstrate a significant overall survival (OS) benefit in a Phase III trial setting (CheckMate 025). The superior OS benefit observed versus everolimus [hazard ratio: 0.73 (98.5% confidence interval: 0.57, 0.93); p=0.0018] is expected to translate into long-term OS benefits for a substantial proportion of patients treated with nivolumab. This expectation is based on the immunogenic nature of RCC, the immunomodulatory action of nivolumab and supportive Phase I/II data with up to 5 years follow-up.

This study aimed to assess the cost effectiveness of nivolumab versus everolimus or axitinib as monotherapies for the treatment of advanced, previously-treated RCC from a Scottish National Health Service (NHS) perspective.

METHODS:

A previously reviewed de novo state-transition model was adapted to the NHS Scotland perspective. The model is based on the key clinical outcomes of disease progression and death, and is informed by CheckMate 025 data and published literature, with modelling assumptions clinically and economically validated for the NHS Scotland setting. The base case assumes efficacy and utility equivalence between everolimus (mTORi class) and axitinib (VEGFR-TKI class), and considers nivolumab’s expected immunomodulatory effect on OS.

RESULTS:

Nivolumab was associated with incremental cost-effectiveness ratios (ICERs) of £36,685 and £46,140 versus axitinib and everolimus, respectively (all list prices, Dec 2016). Robust sensitivity analyses suggest that nivolumab is a cost-effective alternative to the primary comparator of axitinib; ICERs were below £50,000 for all scenarios tested.

CONCLUSIONS:

The results show nivolumab to be a highly effective and cost-effective end-of-life treatment option for patients with advanced, previously-treated RCC in Scotland. As the first immunotherapy in RCC, nivolumab represents a notable advancement in current treatment options and is considered a step-change in the management of this life-limiting condition.