MISSISSAUGA, ON, 11.02.2020
Roche Canada response to recommendation by the pan-Canadian Oncology Drug Review for TECENTRIQ (atezolizumab) for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
MISSISSAUGA, ON, February 11, 2020 - On January 30, 2020, Hoffmann-La Roche Limited (Roche Canada) received an updated final negative reimbursement recommendation from the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) for TECENTRIQ (atezolizumab) in extensive stage small cell lung cancer (ES-SCLC).
Roche Canada fundamentally disagrees with the recommendation issued by pERC, and its associated impact to ES-SCLC patients in Canada, and will continue to pursue reimbursement of this treatment for patients.
The Canadian Agency for Drugs and Technologies in Health (CADTH) conducts evaluations of clinical, economic, and patient evidence on cancer drugs through the pCODR process. This evaluation provides reimbursement recommendations to provincial and territorial public drug plans (with the exception of Québec) and provincial cancer agencies. TECENTRIQ was granted priority review by Health Canada and was authorized for sale on August 8, 2019, for use in combination with carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). This authorization was based on the Phase III IMpower133 study, which is the first Phase III study with an immunotherapy-based combination to show improvement in overall survival and progression-free survival in first-line treatment of ES-SCLC.
Roche Canada disagrees with the pERC decision based on the following:
Pivotal trial IMpower133 is the first Phase III study with an immunotherapy-based combination to demonstrate clinically meaningful improvement in overall survival and progression-free survival in the first-line treatment of ES-SCLC
· The trial is a head-to-head, randomized, double-blinded, placebo-controlled phase III study, which represents the highest standard of evidence in which to evaluate the clinical benefit against the Canadian standard of care
· The pCODR Clinical Guidance Panel, which provides a clinical guidance report for pERC to review, concluded that there is a net clinical benefit for TECENTRIQ in ES-SCLC
· Overall survival (OS) data maturity has been demonstrated through appropriate long-term follow up
Stakeholder submissions into the pCODR review supported a positive funding recommendation
· Clinician and patient submissions into the pCODR review supported a positive decision, noting the unmet need in small cell lung cancer and the meaningful improvement in clinical outcomes demonstrated by the IMpower133 regimen
Regulatory and provincial authorities have validated the clinical value
· Priority review, which recognizes products which address an unmet need or therapeutic advancement, was granted by both Health Canada and the FDA
· Québec’s institute national d’excellence en santé et services sociaux (INESSS) determined that the survival benefit was deemed clinically significant and the therapeutic value was recognized
Supportive clinical practice guidelines
· The National Comprehensive Cancer Network (NCCN) practice guidelines have also adopted and recognized the IMpower133 regimen as the preferred therapy for ES-SCLC patients
A negative pERC recommendation poses a significant challenge to securing reimbursement for Canadians. However, Roche will explore any and all opportunities with provincial and territorial public drug plans and provincial cancer agencies to try to secure access for patients across the country.
About the Unmet Need for Treatments for SCLC
Lung cancer is the most commonly diagnosed cancer in Canada, with an average of 78 Canadians diagnosed every day. It is also the leading cause of death from cancer. SCLC is the most aggressive form of lung cancer, characterized by fast growing tumours and early metastasis, and accounts for approximately 15% of all lung cancer cases in Canada – the equivalent of 4,300 new patients each year. Of all new SCLC cases, two-thirds are diagnosed as extensive-stage. The prognosis for patients with ES-SCLC has historically been extremely bleak, with an estimated five-year survival rate of 3%.
"Extensive stage small cell lung carcinoma is difficult to treat, and although response to chemotherapy can be high, most patients succumb to their disease within one year," says Dr. Barbara Melosky, Professor of Medicine at the University of British Columbia. "The treatment regimen for this disease has not changed in the last thirty years and multiple trials with novel agents have failed. However, this year a benefit was seen when this immunotherapy/checkpoint inhibitor was added to the chemotherapy regimen. This is the first positive trial seen in this highly aggressive tumour."
About TECENTRIQ® (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells. This blocks the interactions of PD-L1 with other cell-surface receptors. By blocking PD-L1, TECENTRIQ may reactivate the anti-tumour immune response. Currently, Roche has twelve Phase III lung cancer studies evaluating TECENTRIQ as monotherapy or in combination with other medicines.
About Roche in Lung Cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with the disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. In Canada, we currently have four approved medicines to treat certain kinds of lung cancer and a range of additional medicines under development to target the most common genetic drivers of lung cancer or to boost the immune system’s ability to combat the disease.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.
Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.
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