Assessing the Real-World Clinical and Economic Outcomes of Emerging Innovative Technologies in Oncology: The Cases of Biosimilars and CAR T-cells

Lead Investigator(s): Kelvin Chan, Scott Gavura, Wanrudee Isaranuwatchai

Lead Institution: Sunnybrook Research Institute

Co-Investigators: Jaclyn Beca, Wei Fang Dai, Jessica Arias, Lisa Milgram, Elaine Meertens, Arthur Manzon, Sherrie Hertz, Sean Hopkins, Tom Kouroukis, Chris Bredeson, William Wai Lun Wong, Petros Pechlivanoglou, Pierre Villeneuve, Sumit Gupta, Alexandra Chambers, Christine Chen, Lee Mozessohn, Danielle Rodin, David Hodgson, Sang Mi Lee

ARCC Program Area(s): Health Technology Assessment

Main Funder/Other Partners: Ontario Institute for Cancer Research, BioCanRx

ARCC Contribution:   In-Kind (research support)

Funding Term: 2019-2021

See a project summary at  https://biocanrx.com/csei-chan

New cancer therapies on the horizon provide great promise to cancer patients, however, these new technologies are often very expensive and resource intensive in a health system already strained. Two examples of these new therapies include biosimilars and Chimeric Antigen Receptor T-cell (CAR T-cell) therapy. Biosimilars are biologic medical products that are equivalent, though not identical, to original biologics that are manufactured by different companies when original biologic patents expire. Biologics are often very expensive, with biosimilars promising substantial cost-savings once available. Bevacizumab (trade name Avastin), is a biologic used to treat several types of cancer including advanced colorectal cancer, and biosimilar bevacizumab was approved by Health Canada in mid-2018 with availability expected in early 2019. CAR T-cell therapy is a personalized therapy where a person’s own T-cells are harvested, modified to specifically target cancer cells, and readministered to the person where they bind to and kill cancer cells. While extremely promising for both pediatric leukemia and adult lymphoma populations in terms of efficacy, CAR T-cell therapy is very costly, and has significant toxicity and related resource needs associated with it.

CAR T-cell therapy has been approved by Health Canada in both populations, and a funding recommendation from CADTH is expected in early 2019. Understanding the real-world uptake, budget impact, effectiveness, safety, and cost-effectiveness of these new technologies is critical for system planning, resource allocation, and especially, ensuring the best patient care possible. We will conduct real-world evaluations of biosimilar bevacizumab and CAR T-cell therapy, evaluating uptake, health outcomes, and economic impacts in the Ontario landscape. The evidence generated by these valuations can then be used to make informed decisions regarding the real-world impact of these new technologies, and to help develop proper policies and guidelines to ensure the best evidence-based care for people with cancer.