2 Information about cemiplimab

2 Information about cemiplimab

Marketing authorisation

Cemiplimab (Libtayo, Sanofi) as monotherapy is indicated for 'the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation'.

Dosage in the marketing authorisation

The recommended dose of cemiplimab is 350 mg every 3 weeks. Treatment may be continued until symptomatic disease progression or unacceptable toxicity. Administration is by intravenous infusion.

Price

£4,650 per 350-mg vial (1 treatment cycle). The cost for 1 year of treatment with cemiplimab based on the list price is £80,877 (all prices excluding VAT, company submission).

The company has a commercial arrangement. This makes cemiplimab 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.

  • National Institute for Health and Care Excellence (NICE)