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1 Recommendations

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2 Information about nivolumab

Anticipated marketing authorisation indication

2.1 On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product nivolumab. The CHMP adopted a new indication as follows: Nivolumab (Opdivo, Bristol-Myers Squibb) as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum-based combination chemotherapy.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics.

Price

2.3 Nivolumab is available in 3 different sizes as a concentrate for solution for infusion vials. The cost varies according to vial size: £439 (40 mg per 4 ml), £1,097 (100 mg per 10 ml) and £2,633 (240 mg per 24 ml) (excluding VAT; BNF online, accessed October 2020). The cost for 1 dose of treatment is £2,633 (240 mg per 24 ml).

The company has a commercial arrangement. This makes nivolumab available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. 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.