- Date 02 April 2014
- Documents : 5
- Economic analysis
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XOFIGO (radium dichloride), radioisotope
Reason for request
Minor improvement in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases.
XOFIGO has Marketing Authorisation in the treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases.
Its efficacy was demonstrated versus placebo on overall survival (difference of +2.8 months) and time to occurrence of the first symptomatic skeletal event (difference of +5.1 months).
In the absence of comparative data, its role in the therapeutic strategy compared with ZYTIGA (abiraterone acetate) in mildly symptomatic patients presenting only bone metastases is unclear.
Clinical Benefit
| Substantial |
The actual benefit of XOFIGO in the indication of treatment of castration-resistant prostate cancer, with symptomatic bone metastases and no known visceral metastases is substantial. |
Clinical Added Value
| minor |
XOFIGO provides a minor improvement in actual benefit (IAB IV) compared with a placebo in the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. |
Therapeutic use
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