Astellas Announces Reimbursement for XTANDI® (enzalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

XTANDI is the only treatment approved for three clinical disease states across four indications, and the improved access for mCSPC patients will support earlier treatment

MARKHAM, ON, June 23, 2022 /CNW/ - Astellas Pharma Canada, Inc., announces that XTANDI^® (enzalutamide), an oral once-daily therapy,¹ is now reimbursed across most of Canada for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).² Reimbursement for this indication is available in the following: British Columbia,³ Alberta,⁴ Saskatchewan,⁵ Manitoba,⁶ Ontario,⁷ Quebec,⁸ New Brunswick,⁹ Newfoundland and Labrador,¹⁰ Nova Scotia,¹¹ and the Non-Insured Health Benefits (NIHB) program.¹² 

Prostate cancer is the most common cancer affecting Canadian men (excluding non-melanoma skin cancers) and is the third most common cause of cancer deaths.¹³ When diagnosed early, prostate cancer can often be successfully treated, leading to better outcomes.¹⁴ However, advanced and recurrent prostate cancer is hard to treat¹⁵ while metastatic prostate cancer remains incurable.¹⁶ mCSPC is a disease in which men have prostate cancer that has spread beyond the prostate, and who have never received, or still respond to androgen deprivation therapy (ADT).^17,18 While ADT is initially effective in most patients, progression is inevitable, demonstrating the need for treatment options in addition to ADT.¹⁹

"This reimbursement is wonderful news since mCSPC often has a very poor prognosis, and XTANDI has established its efficacy and tolerability through a decade of use and real-world evidence," says Dr. Fred Saad, MD, FRCSC, Professor and Chief of Urology and Director of G-U Oncology at the University of Montreal Hospital Centre. "Providing access to men with mCSPC allows them to start on this therapy as early as possible to experience significant prolonged radiographic progression-free survival and overall survival, as well as help them maintain a good quality of life."

XTANDI has the potential to improve treatment outcomes and slow disease progression for patients by inhibiting the binding of androgen receptors to DNA thereby inducing cell death of prostate cancer cells and decreasing tumour size.²⁰ XTANDI is the only second-generation androgen receptor-axis-targeted therapy (ARAT) approved by Health Canada for all three of the following prostate cancer indications: mCSPC, metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).^{21, 22, 23, 24} 

Astellas first received Health Canada approval for XTANDI in 2013 for the treatment of mCRPC. This was followed by approvals for the treatment of nmCRPC in 2019 and mCSPC in 2020. Since its launch, more than 10,000 patients have been treated with XTANDI in Canada, combined across all three indications. Globally, more than 700,000 patients have been prescribed XTANDI.²⁵

"Since XTANDI was first approved for use in Canada, we've maintained a strong focus and commitment to deliver value and expand treatment options for individuals diagnosed with prostate cancer," says Frank Stramaglia, General Manager, Astellas Pharma Canada, Inc. "It's important that we are able to help more eligible Canadians access this targeted therapy with this reimbursement in first line mCSPC."

Astellas continues to work with governments, payers, advocacy groups, healthcare providers and patients to support access for any adult with mCSPC, nmCRPC and mCRPC, who may benefit from XTANDI.

About XTANDI (enzalutamide)

Enzalutamide is an androgen receptor inhibitor that acts on several steps in the androgen receptor signaling pathway. Enzalutamide competitively inhibits binding of androgens to androgen receptors and, as a result, inhibits translocation of androgen receptors and association of androgen receptors with DNA. By inhibiting the binding of androgens to androgen receptors, enzalutamide treatment decreases the proliferation and induces cell death of prostate cancer cells and decreases tumour volume.

About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical company conducting business in more than 70 countries around the world. Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people in Canada and around the world. For more information on Astellas in Canada, please visit: astellas.com/ca.

References
^1 XTANDI Product Monograph; June 1, 2020. p.17.
^2 XTANDI Product Monograph; June 1, 2020. p.3.
^3 BC Cancer Protocol Summary for Treatment for Metastatic Castration Sensitive Prostate Cancer using Enzalutamide. December 1, 2021. Available at: http://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Genitourinary/UGUPENZ_Protocol.pdf (accessed May 13, 2022).
^4 Alberta Health Services Outpatient Cancer Drug Benefit Program. March 25, 2022. Available at: https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf (accessed May 13, 2022).
^5 Saskatchewan Cancer Agency Drug Formulary. March 1, 2022. Available at: http://www.saskcancer.ca/images/pdfs/health_professionals/drug_formulary/drug_formulary/SCA_Drug_Formulary_-_2022-03-01.pdf (accessed May 13, 2022).
^6 Manitoba Drug Benefits and Interchangeability Formulary Amendments. April 16, 2014. Available at: https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin77.pdf (accessed May 13, 2022).
^7 Ontario Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs. January 1, 2022. Available at: https://www.health.gov.on.ca/en/pro/programs/drugs/docs/frequently_requested_drugs.pdf (accessed May 13, 2022).
^8 Régie de l'assurance maladie du Québec. List of Medications (RAMQ: Official Mark of the Régie de l'assurance maladie du Québec.) March 2, 2022. Available at: https://ramqinter.prod.acquia-sites.com/sites/default/files/documents/liste_med_2022-03-02_en.pdf (accessed May 13, 2022).
^9New Brunswick Drug Plans Formulary. April 2022. Available at: https://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf  (accessed May 13, 2022).
^10Newfoundland and Labrador Prescription Drug Program. October 2021. Available at: https://www.health.gov.nl.ca/health/prescription/criteria/Enzalutamide_Xtandi.pdf (accessed May 13, 2022).
^11Nova Scotia Formulary. May 2022. Available at: https://novascotia.ca/dhw/pharmacare/documents/formulary.pdf  (accessed May 13, 2022).
^12Government of Canada. Non-Insured Health Benefits program updates. Available at: https://www.sac-isc.gc.ca/eng/1572892470997/1572892515134 (accessed May 13, 2022)
^13Canadian Cancer Society. Prostate Cancer Statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=on. (accessed May 13, 2022)
^14Canadian Cancer Society. Survival Statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/prognosis-and-survival/survival-statistics/?region=on (accessed May 13, 2022)
^15Canadian Cancer Society. Survival Statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/prognosis-and-survival/survival-statistics/?region=on (accessed May 13, 2022)
^16So, A.I., et al. Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer. Canadian Urological Association Journal. 14, 2 (Dec. 2019), 17-23. DOI:https://doi.org/10.5489/cuaj.6384.
^17 Uro Today. Treatment Advances in Metastatic Hormone-Sensitive Prostate Cancer. Available at: https://www.urotoday.com/library-resources/mhspc/111513-treatment-advances-in-metastatic-hormone-sensitive-prostate-cancer-mhspc.html. (accessed May 13, 2022)
^18American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2021). Available at: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. (accessed May 13, 2022)
^19 So, A.I., et al. Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer. Available at: https://www.cua.org/themes/web/assets/files/6384_revised.pdf (accessed May 13, 2022)
^20 XTANDI Product Monograph; June 1, 2020. p.18.
^21 XTANDI Product Monograph; June 1, 2020. p.17.
^22 National Comprehensive Cancer Network. Prostate Cancer. Version 3.2020. November 17, 2020.
^23 Erleada™ Product Monograph, Janssen Inc., July 2, 2021.
^24 Nubeqa® Product Monograph, Bayer Inc., July 14, 2021.
^25 Astellas data on file.

SOURCE Astellas Pharma Canada, Inc.

Amanda Mills Sirois, Senior Communications Manager, Astellas Pharma Canada, Inc., 905-940-5752, [email protected].