2 The technology

Regorafenib (Stivarga, Bayer)

Marketing authorisation

Regorafenib is indicated 'for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib'.

Recommended dose and schedule

The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy. This 4‑week period is considered a treatment cycle.

Price

£3,744.00 for 84 tablets of 40 mg (excluding VAT; British national formulary [BNF] edition 72).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of regorafenib, 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 does not constitute an excessive administrative burden on the NHS.