2 Information about nivolumab with ipilimumab

Marketing authorisation indication

2.1 On 21 May 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of indication for nivolumab with ipilimumab (Opdivo and Yervoy, Bristol–Myers Squibb). The CHMP adopted a new indication as follows: adults with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.

2.2 The exact wording of this indication will be available in the summary of product characteristics when nivolumab and ipilimumab receives its marketing authorisation.

Dosage in the marketing authorisation

2.3 The dosage schedule is available in the summary of product characteristics.

Price

2.4 The list price of nivolumab is £2,633 per 240 mg per 24‑ml vial (excluding VAT; BNF online, assessed March 2021). The company has a commercial arrangement. This makes nivolumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

2.5 The list price of ipilimumab is £15,000 per 200‑mg vial (excluding VAT; BNF online, assessed March 2021). The company has a commercial arrangement. This makes ipilimumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.