2 Information about tivozanib

2 Information about tivozanib

Marketing authorisation

Tivozanib (Fotivda, EUSA Pharma) is indicated for 'the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC'.

Dosage in the marketing authorisation

1,340 micrograms taken orally once daily for 21 days, followed by a 7‑day rest period to make up 1 complete treatment cycle of 4 weeks. The treatment schedule should be continued until disease progression or unacceptable toxicity.

Price

A 21‑pack of 1,340 microgram hard capsules (that is, the pack size needed for 1 treatment cycle) costs £2,052 excluding VAT.

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of tivozanib, 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.

  • National Institute for Health and Care Excellence (NICE)