1 Recommendations

1.1

Nivolumab can be used as an option for neoadjuvant treatment with platinum-based chemotherapy, then alone as adjuvant treatment, for non-small-cell lung cancer (NSCLC) with a high risk of recurrence in adults whose tumours:

are resectable (4 cm or more or node positive) and
have no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Nivolumab can only be used if the company provides it according to the commercial arrangement.

1.2

Use the least expensive option of the suitable treatments (including nivolumab, pembrolizumab and durvalumab), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.

1.3

This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

Nivolumab with platinum-based chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Nivolumab must be funded in England within 30 days of final publication of this guidance.

There is enough evidence to show that nivolumab provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Why these recommendations were made

Usual treatment for resectable NSCLC in adults includes pembrolizumab or durvalumab with chemotherapy (neoadjuvant) then pembrolizumab or durvalumab alone after surgery (adjuvant). A resectable tumour is one that can be removed surgically. Nivolumab would be offered to the same population as pembrolizumab and works in a similar way.

Clinical trial evidence shows people who have neoadjuvant nivolumab with chemotherapy and then adjuvant nivolumab have longer before their cancer gets worse than people who have placebo with chemotherapy and then placebo alone. Nivolumab has not been directly compared in a clinical trial with pembrolizumab. Indirect comparisons suggest that people who have nivolumab and people who have pembrolizumab have about the same amount of time before their condition gets worse and live for a similar length of time. But these results are highly uncertain. Because of this uncertainty, these results alone do not show whether nivolumab is more, less or as effective as pembrolizumab. Clinical expert feedback suggests that they are clinically similar though, and because they work in the same way, it is likely that nivolumab is as effective as pembrolizumab.

A cost comparison suggests the costs for nivolumab are similar to or lower than pembrolizumab. To be recommended as a treatment option, nivolumab has to cost less or have similar costs to 1 relevant comparator recommended in a published NICE technology appraisal guidance (see NICE's cost comparison methods). So, nivolumab can be used.

For all evidence see the committee papers. For more information on NICE's evaluation of pembrolizumab, see the committee discussion section in NICE's technology appraisal guidance on pembrolizumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer.