2 The technology

2 The technology

Description of the technology

Nivolumab (Opdivo, Bristol–Myers Squibb) is a monoclonal antibody that targets a receptor on the surface of lymphocytes known as the programmed cell death protein‑1 (PD‑1) receptor. This receptor is part of the immune checkpoint pathway, and blocking its activity may promote an anti-tumour immune response.

Marketing authorisation

Nivolumab has a marketing authorisation for treating 'locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults'. Before the marketing authorisation was granted, nivolumab was available in the NHS through the early access to medicines scheme.

Adverse reactions

The most common adverse reactions with nivolumab are immune-related adverse reactions, including pneumonitis, colitis, hepatitis, nephritis and kidney dysfunction, endocrinopathies and rash. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Nivolumab is given intravenously, at a dose of 3 mg/kg body weight every 2 weeks.

Price

Nivolumab is available at a list price of £439 per 40‑mg vial (excluding VAT; 'British national formulary' [BNF], accessed online April 2017). This equates to £2,634 per dose, and £5,268 per month, for a person weighing 73 kg.

The pricing arrangement considered during guidance development was that the company had agreed a patient access scheme with the Department of Health. This scheme would provide a simple discount to the list price of nivolumab with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS. The managed access agreement agreed between the company and NHS England will replace this patient access scheme.

  • National Institute for Health and Care Excellence (NICE)