Astellas Pharma Canada announced that XTANDI (enzalutamide) is now funded by the Ontario Drug Benefit Program under the Exceptional Access Program for treating patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of metastasis. This milestone makes XTANDI the first and only androgen receptor pathway inhibitor indicated and reimbursed in Ontario for this specific patient population.
The reimbursement decision follows Health Canada's market authorization for XTANDI in nmCSPC granted in January 2024. The approval was expedited through XTANDI's inclusion in Project Orbis, an initiative of regulatory bodies including Health Canada designed to provide patients faster access to promising cancer treatments globally.
Clinical Significance for High-Risk Patients
The expanded coverage addresses a critical unmet need for patients with high-risk biochemical recurrence. According to the source materials, of men who have undergone definitive prostate cancer treatment including radical prostatectomy or radiotherapy, an estimated 20-40 percent will experience biochemical recurrence within 10 years. Particularly concerning, about 9 out of 10 men with high-risk biochemical recurrence will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer.
"The public reimbursement of XTANDI in Ontario is important because it expands access to a vital treatment for prostate cancer patients who are at high risk of metastasis," said Tony Finelli, MD, FRCSC, Professor of Surgery and Chair of Urology at the University of Toronto and Urologic Oncologist at University Health Network. "Reducing the barriers to accessing XTANDI allows us as physicians to offer even more comprehensive care to those navigating the challenges of living with prostate cancer."
Disease Burden and Treatment Landscape
Prostate cancer represents a significant health burden in Canada, accounting for an average of 76 new diagnoses every day among Canadian men. It is estimated that about 1 in 8 Canadian men will develop prostate cancer during their lifetime and 1 in 30 will die from it. Approximately 98 percent of cases occur in men above the age of 50.
nmCSPC describes the early stage of prostate cancer where the disease remains localized and still responds to medical or surgical treatment to lower testosterone levels. XTANDI functions as an androgen receptor inhibitor that overcomes resistance to conventional antiandrogens by inhibiting androgen receptor signaling at multiple steps in the pathway.
Comprehensive Coverage Achievement
With this latest reimbursement decision, XTANDI is now publicly covered in Ontario for all of its approved prostate cancer indications, which span four disease states across five specific indications:
- Treatment of patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk of metastasis
- Treatment of patients with metastatic castration-sensitive prostate cancer
- Treatment of patients with non-metastatic castration-resistant prostate cancer
- Treatment of metastatic castration-resistant prostate cancer in both chemotherapy-naïve and post-docetaxel patients
"We applaud Ontario's decision to publicly reimburse XTANDI for the treatment of nmCSPC patients with high-risk BCR," said Sandra Heller, General Manager of Astellas Pharma Canada. "At Astellas, we remain dedicated to ensuring that patients have access to the therapies they require for better health outcomes, and we are honoured to support men facing this difficult journey."
Global Regulatory Status
XTANDI has established itself as a standard of care, having received regulatory approvals in more than 90 countries, including the United States, the European Union, and Japan. The drug is supported by Astellas through the XTANDI Patient Assistance Program, which offers coverage navigation, financial assistance, patient and caregiver education, and specialty pharmacy dispensing for patients with valid prescriptions.
