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PharmacoEconomics

, Volume 35, Issue 6, pp 665–667 | Cite as

Response to Letter to the Editor Regarding “Abiraterone Acetate for the Treatment of Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal”

  • Bram L. T. RamaekersEmail author
  • Rob Riemsma
  • Florian Tomini
  • Thea van Asselt
  • Sohan Deshpande
  • Steven Duffy
  • Nigel Armstrong
  • Johan L. Severens
  • Jos Kleijnen
  • Manuela A. Joore
Letter to the Editor

Dear Editors,

We very much appreciate the interest Reifsnider et al. [1] have taken in our perspective on the single technology appraisal (STA) of abiraterone acetate (tradename Zytiga®) plus prednisolone (AAP) acetate for the treatment of chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) prepared for the UK National Institute for Health and Care Excellence (NICE) [2, 3]. Here, we respond to the aspects highlighted by Reifsnider et al. [1] and correct factual inaccuracies in their reasoning. The main issues are printed in italics [1]. These points relate to (1) the statistical significance of the COU-AA-302 survival results and (2) the justification of the discrete-event simulation (DES) approach utilised by the company. Reifsnider et al. [1] also highlight aspects that are unrelated to these main points, and we discuss these separately.

Statistical Significance of the COU-AA-302 Survival Results

  1. 1.

    The ERG [evidence review group] alleged that “it is unlikely...

Notes

Compliance with Ethical Standards

Funding

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. See the HTA programme website for further project information (http://www.hta.ac.uk). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of NICE or the Department of Health.

Conflicts of interest

Bram Ramaekers, Rob Riemsma, Florian Tomini, Thea van Asselt, Sohan Deshpande, Steven Duffy, Nigel Armstrong, Johan Severens, Jos Kleijnen and Manuela A. Joore have no conflicts of interest.

References

  1. 1.
    Reifsnider O, Hall F, Sorensen S, Proskorovsky I, Girod I, Lee J. 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”. Letter to the Editor. Pharmacoeconomics. 2017. doi: 10.1007/s40273-017-0502-8.
  2. 2.
    Ramaekers BL, Riemsma R, Tomini F, van Asselt T, Deshpande S, Duffy S, et al. Abiraterone acetate for the treatment of chemotherapy-naïve 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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    Riemsma R, Ramaekers BLT, Tomini F, Wolff R, van Asselt ADI, Joore MA, et al. Abiraterone for the treatment of chemotherapy naïve metastatic castration-resistant prostate cancer: a Single Technology Appraisal. York: Kleijnen Systematic Reviews Ltd.; 2014. https://www.nice.org.uk/guidance/ta387/documents/prostate-cancer-metastatic-hormone-relapsed-not-treated-with-chemotherapy-abiraterone-acetate-with-prednisolone-id503-evaluation-report. Accessed 21 March 2016.
  4. 4.
    Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, 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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    National Institute for Health and Care Excellence (NICE). Abiraterone for treating metastatic hormone-relapsed prostate cancer not previously treated with chemotherapy. NICE final appraisal determination. London: NICE; 2014. https://www.nice.org.uk/guidance/indevelopment/ta387/documents. Accessed 21 March 2016.
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    Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010;303(12):1180–7. doi: 10.1001/jama.2010.310.CrossRefPubMedGoogle Scholar
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    National Institute for Health and Care Excellence (NICE). Abiraterone for treating metastatic hormone-relapsed prostate cancer not previously treated with chemotherapy. NICE final appraisal determination 2. London: NICE; 2016. https://www.nice.org.uk/guidance/indevelopment/ta387/documents. Accessed 21 March 2016.
  8. 8.
    Janssen. Abiraterone acetate for the treatment of metastatic hormone relapsed prostate cancer not previously treated with chemotherapy [ID503]. Response to NICE request for additional information on 22 October 2015: Janssen; 2015. https://www.nice.org.uk/guidance/GID-TAG434/documents/appraisal-consultation-document-2. Accessed 21 March 2016.
  9. 9.
    National Institute for Health and Care Excellence (NICE). Abiraterone acetate for the treatment of metastatic hormone relapsed prostate cancer not previously treated with chemotherapy [ID503]. Clarification letter. Manchester: NICE; 2014. https://www.nice.org.uk/guidance/ta387/documents/prostate-cancer-metastatic-hormone-relapsed-not-treated-with-chemotherapy-abiraterone-acetate-with-prednisolone-id503-evaluation-report. Accessed 21 March 2016.

Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • Bram L. T. Ramaekers
    • 1
    Email author
  • Rob Riemsma
    • 2
  • Florian Tomini
    • 1
  • Thea van Asselt
    • 1
    • 3
    • 4
  • Sohan Deshpande
    • 2
  • Steven Duffy
    • 2
  • Nigel Armstrong
    • 2
  • Johan L. Severens
    • 5
  • Jos Kleijnen
    • 2
    • 6
  • Manuela A. Joore
    • 1
  1. 1.Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA)Maastricht University Medical CenterMaastrichtThe Netherlands
  2. 2.Kleijnen Systematic Reviews LtdYorkUK
  3. 3.Department of Epidemiology, University Medical Center GroningenUniversity of GroningenGroningenThe Netherlands
  4. 4.Department of PharmacyUniversity of GroningenGroningenThe Netherlands
  5. 5.Institute of Health Policy and Management, iMTA-Institute for Medical Technology AssessmentErasmus University RotterdamRotterdamThe Netherlands
  6. 6.School for Public Health and Primary Care (CAPHRI)Maastricht UniversityMaastrichtThe Netherlands

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