2 The technology
2.1 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.
2.2 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.
2.3 The list price of cabazitaxel is £3,696 per 60‑mg vial (excluding VAT; British national formulary [BNF] edition 70). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of cabazitaxel 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. In addition, the company has agreed a commercial access agreement with NHS England. Under the terms of this agreement, Sanofi facilitates the supply of cabazitaxel in 2 ways:
In a pre‑prepared (compounded) intravenous infusion bag containing the number of milligrams needed for each individual patient (see sections 3.20 and 5.4). This aspect of the arrangement was agreed before the guidance was published.
In vials, at a reduced price with a discount reflecting the average cost of waste per patient from part-used vials (this discount is in addition to the patient access scheme). The company will provide a rebate to NHS England equivalent to the cost of compounding per patient. The arrangement for supplying cabazitaxel in vials was agreed in August 2016, after guidance publication.
The average cost of each cycle is commercial in confidence. The summary of product characteristics does not limit the number of cycles; the median number of cycles was 6 in the key clinical trial, which capped cycles at 10.
2.4 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.