NICE UK Issues New Guidance for Cabazitaxel

Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel

The National Institute for Health and Care Excellence (NICE) UK published on 25 May 2016 the evidence-based recommendations on cabazitaxel (Jevtana) for patients with prostate cancer that has relapsed after the treatment with docetaxel. The guidance TA391 replaces NICE technology appraisal guidance on cabazitaxel for hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen (TA255). It does not cover the use of cabazitaxel for patients who have had docetaxel and then abiraterone, enzalutamide or radium 223 dichloride.

Recommendations

Cabazitaxel in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone‑relapsed prostate cancer in patients whose disease has progressed during or after docetaxel chemotherapy, only if:

  • the person has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • the person has had 225 mg/m2 or more of docetaxel
  • treatment with cabazitaxel is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first)
  • NHS trusts purchase cabazitaxel in pre‑prepared intravenous‑infusion bags, not in vials, and
  • the company provides cabazitaxel with the discount agreed in the patient access scheme.

When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.

This guidance is not intended to affect the position of patients whose treatment with cabazitaxel was started within the NHS before this guidance was published and whose treatment with cabazitaxel is not recommended in this NICE guidance. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

The appraisal committee considered evidence submitted by Sanofi and a review of this submission by the evidence review group. Evidence about the clinical and cost effectiveness of cabazitaxel can be read here.