Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel

Cabazitaxel (Jevtana, Sanofi) is an antineoplastic drug in a class of drugs known as taxanes, which includes paclitaxel and docetaxel. Taxanes disrupt the microtubular network essential for mitotic and interphase cellular functions, therefore inhibiting cell division and causing cell death. Cabazitaxel has a UK marketing authorisation for use 'in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel‑containing regimen'. It is administered by intravenous infusion.

The summary of product characteristics lists the following adverse reactions for cabazitaxel as being very common (that is, occurring in 1 in 10 or more people): anaemia, leukopenia, neutropenia, thrombocytopenia, anorexia, dysgeusia, dyspnoea, cough, diarrhoea, nausea, vomiting, constipation, abdominal pain, alopecia, back pain, arthralgia, haematuria, fatigue, asthenia and pyrexia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

The list price of cabazitaxel is £3,696 per 60‑mg vial (excluding VAT; BNF edition 70). The company originally agreed a patient access scheme with the Department of Health and a commercial access arrangement with NHS England. Under the terms of this agreement, Sanofi facilitated the supply of cabazitaxel in pre-prepared (compounded) intravenous infusion bags containing the number of milligrams needed for each individual patient or in vials, at a reduced price with a discount reflecting the average cost of waste per patient from part-used vials (this discount in addition to the patient access scheme). Sections 3.36, 4.19, 4.21 and 4.32 in the committee discussion of this guidance reflect original committee discussions around commercial ways to mitigate concerns about wastage.

In October 2020 the company agreed an updated commercial arrangement with NHS England and NHS Improvement which replaces the original commercial access arrangement. This makes cabazitaxel 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.

NICE published technology appraisal guidance on cabazitaxel in 2012; it did not recommend cabazitaxel for hormone‑refractory metastatic prostate cancer previously treated with a docetaxel‑containing regimen. Since then, additional evidence has been published and the company has agreed a new patient access scheme. Accordingly, NICE decided to update its guidance on cabazitaxel.