The National Institute for Health and Care Excellence (NICE) has declined nivolumab to treat advanced kidney cancer, with consultation documents now available.

Citing an increase in cost per quality adjust life years (QALY) in excess of £60,000 , "the committee concluded that, compared with any comparator, the ICER for nivolumab was substantially above the range that could be considered a cost-effective use of NHS resources."

In the UK, kidney cancer cases have risen dramatically over the last 30 years, with latest data showing around 11,900 people were diagnosed in 2013 and an average of 11 people died every day in 2012 from this disease.

Today’s decision focuses on patients with advanced kidney cancer, whose cancer has spread and is incurable.

Almost one in three kidney cancers (27%) are diagnosed at this advanced stage.

For these patients, prognosis is poor and the goal of treatment is largely to extend survival.

Approximately one in 10 patients diagnosed at an advanced stage will survive five years or more.

Despite this, there remain limited treatment options available on the NHS that can extend survival once kidney cancer has spread

Nivolumab, a PD-1 immune checkpoint inhibitor, is currently approved in the UK for skin cancer and lung cancer as a single agent, and is also effective in combination to treat melanoma.

In America, it has already received approval for treating Hodgkins lymphoma and metastatic renal cell carcinoma.

Even with results as recent as ASCO this June indicating improved survival for kidney cancer patients, the increased cost compared to current everolimus or alternative atixinib treatments is a major hurdle for NICE approval. 

In considering alternative sources or supplementary funding, the NICE committee concluded that it would be " willing to consider a proposal for nivolumab to be funded through the Cancer Drugs Fund, but only if:

• the company was able to show plausible potential for cost-effectiveness using the committee’s preferred assumptions in the economic model, and
• the company provided detailed evidence of how CheckMate 025 will address the uncertainty around long-term survival within a limited time period."

A second appraisal meeting is set for the 4^th of August.

Source: NICE