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The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Received: 26 January 2021     Accepted: 13 February 2021     Published: 27 February 2021
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Abstract

Background: Special access programs provide physicians in Canada access to new drugs before they are publicly funded, but little is known about how they impact prescribing practices. For men with metastatic castration-resistant prostate cancer post-docetaxel chemotherapy, a special access program for enzalutamide was open from June-December 2013. To better understand how this impacted prescribing practices, we surveyed medical oncologists at our institution. Methods: All four genitourinary medical oncologists at the Princess Margaret Cancer Centre completed an anonymous paper or electronic survey for each patient enrolled. The survey consisted of seven multiple-choice questions (with free text option) asking about disease characteristics, prior treatments, and reasons for prescribing enzalutamide. Results: Surveys were completed on all 155 patients; 92% (142/155) had metastatic disease, with 20% (28/142) having visceral disease; 8% (13/155) had non-metastatic disease; and the majority (92%) had progressive disease. All patients were on androgen deprivation therapy, 60% had prior prednisone, 30% had prior abiraterone, and 34% had prior docetaxel. Most (50%) used enzalutamide because it was supported by available data; 35% reported free drug was the motivating factor; 10% indicated their patients were unfit for chemotherapy; and in 5%, all other options were exhausted. Over half reported feeling enzalutamide was the appropriate treatment option for their patient at that time. Conclusions: During the special access program, most patients received enzalutamide in settings supported by available evidence. A minority did, however, received enzalutamide outside of the formally studied setting, suggesting that funding and accessibility can impact prescribing practices.

Published in International Journal of Clinical Oncology and Cancer Research (Volume 6, Issue 1)
DOI 10.11648/j.ijcocr.20210601.15
Page(s) 33-37
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Prostatic Neoplasms, Medical Oncology, Special Access Programs, Enzalutamide

References
[1] Government of Canada. Canada Health Act (R. S. C., 1985, c. C-6). http://laws-lois.justice.gc.ca/eng/acts/C-6/FullText.html. Accessed June 15, 2017.
[2] Government of Canada. Food and Drug Act (R. S. C., 1985, c. F-27). http://laws-lois.justice.gc.ca/eng/acts/F-27/. Accessed June 15, 2017.
[3] Pan-Canadian Oncology Drug Review. https://www.cadth.ca/pcodr. Accessed June 15, 2017.
[4] D. A. Ezeife, T. H. Truong, D. Y. C. Heng, et al, “Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration,” Cancer, vol. 121, pp. 1688-93, 2015.
[5] J. J. Darrow, A. Sarpatwari, J. Avorn, et al, “Practical, legal, and ethical issues in expanded access to investigational drugs,” N Engl J Med, vol. 372, pp. 279-86, 2015.
[6] D. Han, M. Trinkaus, S. Hogeveen, et al, “Overcoming obstacles in accessing unfunded oral chemotherapy; physician experience and challenges,” J Oncol Pract, vol. 9, pp. 188-93, 2013.
[7] H. I. Scher, K. Fizazi, F. Saad, et al, “Increased survival with enzalutamide in prostate cancer after chemotherapy,” N Engl J Med, vol. 367, pp. 1187-97, 2012.
[8] Astellas News Release October 22, 2013. https://www.astellas.com/en/corporate/news/detail/post.html. Accessed June 16, 2017.
[9] T. M. Beer, A. J. Armstrong, D. E. Rathkopf, et al, “Enzalutamide in metastatic prostate cancer before chemotherapy,” N Engl J Med, vol. 371, pp. 424-33, 2014.
[10] I. D. Davis, A. J. Martin, M. R. Stockler, et al, “Enzalutamide with standard first-line therapy in metastatic prostate cancer,” N Engl J Med, vol. 381, pp. 121-31, 2019.
[11] A. J. Armstrong, R. Z. Szmulewitz, D. P. Petrylak, et al, “ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer,” J Clin Oncol, vol. 37, pp. 2974-86, 2019.
[12] J. Martinalbo, D. Bowen, J. Camarero, et al, “Early market access of cancer drugs in the EU,” Ann Oncol, vol. 27, pp. 96-105, 2015.
[13] D. Hogg, J. G. Monzon, S. Ernst, et al, “Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma,” Curr Oncol, vol. 27, pp. 204-14, 2020.
[14] T. C. Gangadhar, W. J. Hwu, M. A. Postow, et al, “Efficacy and safety of pembrolizumab in patients enrolled in KEYNOTE-030 in the United States: an expanded access program,” J Immunother, vol. 40, pp. 334-40, 2017.
[15] J. Tie, P. Gibbs, “Treatment with unfunded drugs in oncology: the impact of access programmes and clinical trials,” Intern Med J, vol. 43, pp. 23-31, 2013.
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    Nimira Alimohamed, Raya Leibowitz-Amit, Arnoud Templeton, Jo-An Seah, Francisco Emilio Vera-Badillo, et al. (2021). The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC). International Journal of Clinical Oncology and Cancer Research, 6(1), 33-37. https://doi.org/10.11648/j.ijcocr.20210601.15

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    ACS Style

    Nimira Alimohamed; Raya Leibowitz-Amit; Arnoud Templeton; Jo-An Seah; Francisco Emilio Vera-Badillo, et al. The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC). Int. J. Clin. Oncol. Cancer Res. 2021, 6(1), 33-37. doi: 10.11648/j.ijcocr.20210601.15

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    AMA Style

    Nimira Alimohamed, Raya Leibowitz-Amit, Arnoud Templeton, Jo-An Seah, Francisco Emilio Vera-Badillo, et al. The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC). Int J Clin Oncol Cancer Res. 2021;6(1):33-37. doi: 10.11648/j.ijcocr.20210601.15

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  • @article{10.11648/j.ijcocr.20210601.15,
      author = {Nimira Alimohamed and Raya Leibowitz-Amit and Arnoud Templeton and Jo-An Seah and Francisco Emilio Vera-Badillo and Anthony Michael Joshua and Sarah Elizabeth Wong and Jennifer Jane Knox and Ian Frederick Tannock and Srikala Sujata Sridhar},
      title = {The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC)},
      journal = {International Journal of Clinical Oncology and Cancer Research},
      volume = {6},
      number = {1},
      pages = {33-37},
      doi = {10.11648/j.ijcocr.20210601.15},
      url = {https://doi.org/10.11648/j.ijcocr.20210601.15},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcocr.20210601.15},
      abstract = {Background: Special access programs provide physicians in Canada access to new drugs before they are publicly funded, but little is known about how they impact prescribing practices. For men with metastatic castration-resistant prostate cancer post-docetaxel chemotherapy, a special access program for enzalutamide was open from June-December 2013. To better understand how this impacted prescribing practices, we surveyed medical oncologists at our institution. Methods: All four genitourinary medical oncologists at the Princess Margaret Cancer Centre completed an anonymous paper or electronic survey for each patient enrolled. The survey consisted of seven multiple-choice questions (with free text option) asking about disease characteristics, prior treatments, and reasons for prescribing enzalutamide. Results: Surveys were completed on all 155 patients; 92% (142/155) had metastatic disease, with 20% (28/142) having visceral disease; 8% (13/155) had non-metastatic disease; and the majority (92%) had progressive disease. All patients were on androgen deprivation therapy, 60% had prior prednisone, 30% had prior abiraterone, and 34% had prior docetaxel. Most (50%) used enzalutamide because it was supported by available data; 35% reported free drug was the motivating factor; 10% indicated their patients were unfit for chemotherapy; and in 5%, all other options were exhausted. Over half reported feeling enzalutamide was the appropriate treatment option for their patient at that time. Conclusions: During the special access program, most patients received enzalutamide in settings supported by available evidence. A minority did, however, received enzalutamide outside of the formally studied setting, suggesting that funding and accessibility can impact prescribing practices.},
     year = {2021}
    }
    

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  • TY  - JOUR
    T1  - The Impact of Special Access Programs (SAP) on Prescribing Patterns in Metastatic Castration Resistant Prostate Cancer (mCRPC)
    AU  - Nimira Alimohamed
    AU  - Raya Leibowitz-Amit
    AU  - Arnoud Templeton
    AU  - Jo-An Seah
    AU  - Francisco Emilio Vera-Badillo
    AU  - Anthony Michael Joshua
    AU  - Sarah Elizabeth Wong
    AU  - Jennifer Jane Knox
    AU  - Ian Frederick Tannock
    AU  - Srikala Sujata Sridhar
    Y1  - 2021/02/27
    PY  - 2021
    N1  - https://doi.org/10.11648/j.ijcocr.20210601.15
    DO  - 10.11648/j.ijcocr.20210601.15
    T2  - International Journal of Clinical Oncology and Cancer Research
    JF  - International Journal of Clinical Oncology and Cancer Research
    JO  - International Journal of Clinical Oncology and Cancer Research
    SP  - 33
    EP  - 37
    PB  - Science Publishing Group
    SN  - 2578-9511
    UR  - https://doi.org/10.11648/j.ijcocr.20210601.15
    AB  - Background: Special access programs provide physicians in Canada access to new drugs before they are publicly funded, but little is known about how they impact prescribing practices. For men with metastatic castration-resistant prostate cancer post-docetaxel chemotherapy, a special access program for enzalutamide was open from June-December 2013. To better understand how this impacted prescribing practices, we surveyed medical oncologists at our institution. Methods: All four genitourinary medical oncologists at the Princess Margaret Cancer Centre completed an anonymous paper or electronic survey for each patient enrolled. The survey consisted of seven multiple-choice questions (with free text option) asking about disease characteristics, prior treatments, and reasons for prescribing enzalutamide. Results: Surveys were completed on all 155 patients; 92% (142/155) had metastatic disease, with 20% (28/142) having visceral disease; 8% (13/155) had non-metastatic disease; and the majority (92%) had progressive disease. All patients were on androgen deprivation therapy, 60% had prior prednisone, 30% had prior abiraterone, and 34% had prior docetaxel. Most (50%) used enzalutamide because it was supported by available data; 35% reported free drug was the motivating factor; 10% indicated their patients were unfit for chemotherapy; and in 5%, all other options were exhausted. Over half reported feeling enzalutamide was the appropriate treatment option for their patient at that time. Conclusions: During the special access program, most patients received enzalutamide in settings supported by available evidence. A minority did, however, received enzalutamide outside of the formally studied setting, suggesting that funding and accessibility can impact prescribing practices.
    VL  - 6
    IS  - 1
    ER  - 

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Author Information
  • Department of Medicine, Tom Baker Cancer Centre, Calgary, Canada

  • Department of Medicine, Sheba Medical Center, Tel-Hashomer, Israel

  • Department of Oncology, Claraspital, Basel, Switzerland

  • St Vincent’s Hospital, Melbourne, Australia

  • Department of Oncology, Queen’s University, Kingston, Canada

  • Department of Medical Oncology, St Vincent’s Private Hospital, Sydney, Australia

  • Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada

  • Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada

  • Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada

  • Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada

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