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.

Highlights

  • In Canada, novel therapeutics are regulated by Health Canada (HC) through the Food and Drug Act [1, 2]

  • Possible reasons included: 1) enzalutamide is only available to patients at no cost for the few weeks/months, 2) the use of enzalutamide is supported by the data, 3) the patient is not fit for chemotherapy, 4) the patient has exhausted all other treatment options

  • During the special access programs (SAP), most patients received enzalutamide in settings supported by available evidence

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Summary

Introduction

In Canada, novel therapeutics are regulated by Health Canada (HC) through the Food and Drug Act [1, 2]. During the long interval from HC approval to drug access, physicians may be able to access new drugs through clinical trials, private insurance plans, or special access programs (SAP). 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. 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. Conclusions: During the special access program, most patients received enzalutamide in settings supported by available evidence. A minority did, received enzalutamide outside of the formally studied setting, suggesting that funding and accessibility can impact prescribing practices

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