National Agreement Reached between Pan-Canadian Pharmaceutical Alliance and Bristol-Myers Squibb for Immuno-Oncology Treatment OPDIVO® (nivolumab)
Decisions on public reimbursement now in hands of provincial and territorial jurisdictions
Bristol-Myers Squibb Canada Co. today announced that the company has reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for the immuno-oncology treatment OPDIVO®, bringing patients with advanced, difficult-to-treat cancers closer to accessing a new treatment option. This critical agreement for Canadian patients living with metastatic melanoma[i], locally advanced or metastatic pre-treated non-small cell lung cancer (NSCLC)[ii] and advanced or metastatic pre-treated renal cell carcinoma (RCC)[iii] follows a positive recommendation by the Pan-Canadian Oncology Drug Review (pCODR), a health technology assessment agency which assesses the value of new medicines for public coverage.
The national pCPA agreement is aligned with the pCODR recommendation for the three tumours and will help ensure consistent patient access across the country. Starting today, BMS Canada will work with each provincial, federal and territorial jurisdiction to implement this agreement into their own publicly funded system in order to make OPDIVO® accessible to eligible patients – a significant milestone for patient access to this innovative therapy.
“Cancer is the leading cause of death among Canadians. Establishing access to new medicines for Canadian cancer patients is critical to advance the standard of cancer care and improve the survival rates of this devastating disease,” said Dr. Rosalyn Juergens, Associate Professor of Oncology, McMaster University, and medical oncologist, Juravinski Cancer Centre. “Immuno-oncology treatments, like OPDIVO®, have been shown in clinical trials to improve survival in several types of cancer with generally fewer and less severe side effects. The goal is gaining more quality time for people fighting cancer allowing them to spend more time enjoying life with friends and family and being active members within our communities.”
The OPDIVO® Health Canada submissions for the metastatic melanoma, NSCLC and RCC indications received priority reviews after meeting the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. In addition, the phase 3 studies for the three tumour types were also stopped early by an independent data monitoring committee for demonstrating superior overall survival in patients receiving OPDIVO® versus standard of care.[iv],[v],[vi]
“At Bristol-Myers Squibb, we are proud to be part of an innovation that has the potential to change survival expectations for patients across multiple tumour types,” says Dr. Nawal Peacock, president and general manager, Bristol-Myers Squibb Canada Co. “Starting today, we will work with provincial and territorial jurisdictions to ensure that people who can benefit from OPDIVO® will have public coverage in their home provinces quickly.” In an effort to help people living with advanced cancer benefit from OPDIVO®, Bristol-Myers Squibb Canada provided more than 3,000 Canadian patients with the treatment free-of-charge through different access programs.
About the pCPA
The pCPA conducts joint provincial/territorial negotiations for brand name drugs in Canada to achieve greater value for publicly funded drug programs and patients. All brand name drugs coming forward for funding through the national review processes Common Drug Review (CDR) or Pan-Canadian Oncology Drug Review (pCODR) are considered for negotiation through the pCPA.[vii]
OPDIVO®is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, OPDIVO® has become an important treatment option across multiple cancers.
OPDIVO®’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the OPDIVO® clinical development program has enrolled more than 25,000 patients. The OPDIVO® trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from OPDIVO® across the continuum of PD-L1 expression.
In July 2014, OPDIVO® was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. OPDIVO® is currently approved in more than 60 countries, including Canada, the United States, the European Union and Japan. In October 2015, the company’s OPDIVO® + YERVOY® combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 11 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb global operations, visit www.bms.com. Bristol-Myers Squibb Canada Co. has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada Co. employs over 300 people across the country. For more information, please visit www.bmscanada.ca.
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[i] Health Canada approved OPDIVO® is the first anti PD-1 (programmed death-1) approved to treat previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma in adults. http://www.bmscanada.ca/en/news/release/bristol-myers-squibb-s-immunotherapy-opdivo-nivolumab-approved-by-health-canada-for-the-treatment-of
[ii] Health Canada approved OPDIVO® (nivolumab) injection, the first and only immuno-oncology therapy (anti PD-1 agent) approved in Canada for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. http://www.bmscanada.ca/en/news/release/health-canada-approves-opdivo-nivolumab-for-the-treatment-of-advanced-or-metastatic-non-small-cell-l
[iii] Health Canada approved OPDIVO® (nivolumab) injection, for intravenous use, for the treatment of adult patients with a form of kidney cancer, renal cell carcinoma (RCC), who have received prior anti-angiogenic therapy in the advanced or metastatic setting. http://www.bmscanada.ca/en/news/release/health-canada-approves-opdivo-nivolumab-for-the-treatment-of-advanced-or-metastatic-renal-cell-carci
[iv] CheckMate-066 (Melanoma): Robert C, Long GV, Brady B et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Eng J Med 2015;372(4):320-330.
[v] CheckMate-017: Brahmer J, Reckamp KL, and Baas P, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer. N Engl J Med 2015; 373:123-135 and CheckMate-057: Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous-Cell Non–Small-Cell Lung Cancer. N Engl J Med 2015; 373:1627-1639
[vi] CheckMate-025: Motzer RJ, Escudier B, McDermott DF et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Eng J Med 2015; 373:1803-1813
[vii] The Council of the Federation of Canadian Premiers. The pan-Canadian Pharmaceutical Alliance. Accessed at http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance. October 2016.