2 Information about regorafenib

Marketing authorisation indication

2.1 Regorafenib (Stivarga, Bayer) is indicated as 'monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib'.

Dosage in the marketing authorisation

2.2 160 mg (4×40 mg tablets) orally once daily for 3 weeks followed by 1 week off therapy. A 4‑week period is considered a treatment cycle.


2.3 The list price per treatment cycle for 160 mg of regorafenib is £3,744.00 (excluding VAT; British national formulary online [accessed October 2018]). The company has a commercial arrangement. This makes regorafenib 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)