Comment on: “Abiraterone Acetate for the Treatment of Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Evidence Review Group Perspective of an NICE Single Technology Appraisal”
Ramaekers et al.  describe a review of the single technology appraisal  of Janssen-Cilag’s abiraterone acetate (tradename Zytiga®) plus prednisolone (AAP) in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) from the perspective of the Evidence Review Group (ERG) commissioned by the UK’s National Institute for Health and Care Excellence (NICE). The company used a discrete-event simulation (DES) approach, based on prediction equations, to model the experiences of individual patients who had different treatment sequences. During the submission process, the company provided robust evidence that the model accurately replicated results of the AAP pivotal phase III trial (COU-AA-302). Nonetheless, the ERG criticized the methodological approach, the model assumptions, and both the transparency and validity of the model. Several aspects of the published review require further clarification or correction for factual accuracy.
Firstly, the ERG alleged that “it is...
Compliance with Ethical Standards
This analysis was sponsored and funded by Janssen-Cilag Limited.
Conflict of interest
Fiona Hall, Isabelle Girod, and Jennifer Lee are employees of Janssen-Cilag Limited. Sonja Sorensen, Odette Reifsnider, and Irina Proskorovsky are salaried employees of Evidera, a biopharmaceutical research and consulting firm. They are not allowed to accept remuneration of any sort from Evidera clients. Evidera received funding from Janssen-Cilag Limited.
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