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PharmacoEconomics

, Volume 35, Issue 6, pp 661–663 | Cite as

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”

  • Odette Reifsnider
  • Fiona Hall
  • Sonja Sorensen
  • Irina Proskorovsky
  • Isabelle Girod
  • Jennifer Lee
Letter to the Editor

Ramaekers et al. [1] describe a review of the single technology appraisal [2] 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...

Notes

Compliance with Ethical Standards

Funding

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.

References

  1. 1.
    Ramaekers BL, Riemsma R, Tomini F, et al. Abiraterone acetate for the treatment of chemotherapy-naive metastatic castration-resistant prostate cancer: an evidence review group perspective of an NICE single technology appraisal. Pharmacoeconomics. 2017;35(2):191–202. doi: 10.1007/s40273-016-0445-5.CrossRefPubMedGoogle Scholar
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    National Institute for Health and Care Excellence. Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: technology appraisal guidance [TA387]. Published date: 27 Apr 2016. Last updated: 27 July 2016. https://www.nice.org.uk/guidance/ta387. Accessed 6 Dec 2016.
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    Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015;16(2):152–60. doi: 10.1016/S1470-2045(14)71205-7.CrossRefPubMedGoogle Scholar
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    Sorensen S, Hall F, Reifsnider O, et al. Modeling treatments and outcomes in metastatic castration-resistant prostate cancer: a case study of discrete event simulation and the challenges for a UK NICE evaluation. Presented at the ISPOR 19th Annual European Congress; 29 Oct–2 Nov 2016; Vienna. http://www.valueinhealthjournal.com/article/S1098-3015(16)33577-X/abstract. Accessed 15 Mar 2017. [Value Health. 2016;19(7):A733, abstract PCN137].
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Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • Odette Reifsnider
    • 1
  • Fiona Hall
    • 2
  • Sonja Sorensen
    • 1
  • Irina Proskorovsky
    • 3
  • Isabelle Girod
    • 2
  • Jennifer Lee
    • 2
  1. 1.EvideraBethesdaUSA
  2. 2.Janssen-Cilag LimitedBuckinghamshireUK
  3. 3.EvideraMontrealCanada

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