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

Nimira Alimohamed; Raya Leibowitz-Amit; Arnoud Templeton; Jo-An Seah; Francisco Emilio Vera-Badillo; Anthony Michael Joshua; Sarah Elizabeth Wong; Jennifer Jane Knox; Ian Frederick Tannock; Srikala Sujata Sridhar

doi:doi:10.11648/j.ijcocr.20210601.15

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

Nimira Alimohamed, Raya Leibowitz-Amit, Arnoud Templeton, Jo-An Seah, Francisco Emilio Vera-Badillo, Anthony Michael Joshua, Sarah Elizabeth Wong, Jennifer Jane Knox, Ian Frederick Tannock, Srikala Sujata Sridhar

Published in International Journal of Clinical Oncology and Cancer Research (Volume 6, Issue 1)

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

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[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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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

Nimira Alimohamed

Department of Medicine, Tom Baker Cancer Centre, Calgary, Canada
Raya Leibowitz-Amit

Department of Medicine, Sheba Medical Center, Tel-Hashomer, Israel
Arnoud Templeton

Department of Oncology, Claraspital, Basel, Switzerland
Jo-An Seah

St Vincent’s Hospital, Melbourne, Australia
Francisco Emilio Vera-Badillo

Department of Oncology, Queen’s University, Kingston, Canada
Anthony Michael Joshua

Department of Medical Oncology, St Vincent’s Private Hospital, Sydney, Australia
Sarah Elizabeth Wong

Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada
Jennifer Jane Knox

Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada
Ian Frederick Tannock

Department of Medicine, Princess Margaret Cancer Center, Toronto, Canada
Srikala Sujata Sridhar

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

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Plain Text BibTeX RIS

APA Style

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}
}

Copy | Download

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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