Cabazitaxel (1) – Jevtana®

a) Patients with hormone-refractory metastatic prostate cancer who have progressed during or after chemotherapy containing docetaxel and for whom further treatment with docetaxel is no longer an option

• For patients whose disease has progressed during or after chemotherapy containing docetaxel and for whom further treatment with docetaxel is no longer an option, there is an indication of a minor additional benefit compared with the appropriate comparator therapy.
• The certainty of the evidence (probability of additional benefit) is classified as ‘indication’.
• In its overall assessment of these findings, the G-BA concludes that, for the ‘Best Supportive Care’ patient group, there is an indication of a minor additional benefit of cabazitaxel compared with ‘Best Supportive Care’.
• Mortality – Overall survival
  • With regard to the endpoint “overall survival”, the G-BA assesses the extent of the additional benefit of cabazitaxel compared with the appropriate comparator therapy “Best Supportive Care” for the endpoint ‘overall survival’ as considerable, based on the criteria set out in Section 5(7) of the AM-NutzenV.
  • Compared with the appropriate comparator therapy ‘Best Supportive Care’, there is, in accordance with Section 5(7) in conjunction with Section 2(3) of the AM-NutzenV, a significant improvement in treatment-related benefit that has not previously been achieved, as a moderate prolongation of survival is achieved.
• Side effects
  • However, the additional benefit of cabazitaxel is offset by pronounced side effects.
  • In the TROPIC study, serious adverse events, adverse events leading to discontinuation of the study, and fatal adverse events occurred at a statistically significantly higher rate in the cabazitaxel arm than in the mitoxantrone arm.
  • Of particular significance is neutropenia, which occurred with a CTCAE (Common Terminology Criteria for Adverse Events) severity grade of 3 or higher (based on laboratory values) in 81.7% of patients in the cabazitaxel arm.
  • The G-BA is of the view that, in order to assess the extent of the additional benefit, the positive benefits must be weighed against this pronounced potential for harm associated with cabazitaxel.
• Health-related quality of life
  • No usable data were presented regarding quality of life.
  • In palliative care, great importance is attached to quality of life.
• Overall assessment
  • In its overall assessment of these facts, the G-BA concludes that, for the ‘Best Supportive Care’ patient group, there is an indication of a minor additional benefit of cabazitaxel compared with ‘Best Supportive Care’.

b) Patients with hormone-refractory metastatic prostate cancer who have progressed following docetaxel-containing chemotherapy but who are, in principle, still eligible for further docetaxel-containing chemotherapy

• For patients whose disease has progressed following docetaxel-based chemotherapy and who are eligible for further treatment with docetaxel, additional benefit is deemed not proven, as the necessary proof was not submitted in full by the pharmaceutical manufacturer at the relevant time (Section 35a(1), fifth sentence, of Book V of the Social Code).
• The pharmaceutical manufacturer regards the ‘best supportive care’ patient group as the actual target population for cabazitaxel and does not claim any additional benefit for the ‘docetaxel retreatment’ patient group (see verbatim transcript of the oral hearing on cabazitaxel on 21 February 2012).

Courtesy translation only, please refer to the German original.