2 The technology

2 The technology

Description of the technology

Sorafenib (Nexavar, Bayer) is a multikinase inhibitor that inhibits tumour blood vessel development and tumour cell proliferation. It does this by inhibiting the Raf cascade, vascular endothelial growth factor and platelet-derived growth factor receptors of tumour cells, vascular endothelial cells and pericytes.

Marketing authorisation

Sorafenib has a marketing authorisation in the UK for treating hepatocellular carcinoma.

Adverse reactions

The summary of product characteristics includes the following conditions that may be associated with sorafenib treatment: dermatological toxicities, hypertension, haemorrhage, cardiac ischaemia and/or infarction, gastrointestinal perforation, hepatic impairment and wound healing complications. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Sorafenib is administered orally as 200-mg film-coated tablets. The recommended dosage is 400 mg twice daily (a total daily dose of 800 mg). The dosage may be adjusted to 2×200-mg tablets once daily if adverse drug reactions are suspected. The summary of product characteristics recommends that treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.

Price

The price for a pack of 200-mg tablets (112 tablets per pack) is £3,575.56.

The company agreed a nationally available price reduction for sorafenib with the Commercial Medicines Unit. The pricing agreement considered during guidance development was that the company (Bayer) had agreed a commercial access agreement with NHS England inclusive of the reduction for sorafenib agreed with the Commercial Medicines Unit. The commercial access agreement replaces the Commercial Medicines Unit price used during the Cancer Drugs Fund reconsideration of technology appraisal guidance 189. The details of this commercial access agreement are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)