Receiving a cancer diagnosis is a very confusing and emotional time, unlike any other in a person’s life. With a few sobering words from a physician, they are unwillingly thrust into a new world where they must face their disease head-on. Through this illness, they will navigate a new part of the healthcare system, attend medical appointments, have difficult conversations with family and friends, and make important decisions about their treatment.

Patients are increasingly being involved in their care, and patient-centred care and participation has been shown to improve both outcomes and experience, so it’s important that they be informed and prepared for these discussions. 

With these patients in mind, Roche has relentlessly pursued the development of innovative oncology treatments for decades. Our research has played a pivotal role in the development and use of biologic treatments — medicines made from living organisms — which have been approved and used in Canada for several decades, and have had a marked impact on quality and quantity of life for many patients with cancer and other diseases. 

Developments in the treatment landscape, such as the recent introduction of biosimilars in Canada, are providing patients and healthcare professionals with more options to treat cancer. While biosimilars are similar in structure and function to reference (originator) biologic drugs, they are not identical because they come from different cell lines and manufacturing processes. While there are many opportunities that come along with the entry of biosimilars, they also bring with them a host of considerations. 

To help understand and address these considerations, the Canadian Breast Cancer Network (CBCN) recently released a Breast Cancer & Biosimilars White Paper, highlighting their recommendations on biosimilars use, implementation, and patient communications. “Interviews, surveys and focus groups have all demonstrated that the general breast cancer patient community doesn’t understand biosimilars — it’s not even a term that patients or families are familiar with,” says Jenn Gordon, the Director of Operations at CBCN. “Given that there are now biosimilars approved by Health Canada for the treatment of breast cancer, we expect there will be patients treated with these drugs in the near future. We wanted to understand the perspectives of both patients and physicians to ensure that we can communicate them to regulators, policy makers and health care providers.”

The report highlights patients’ perception of confidence or trust in biosimilars when used to treat potentially fatal diseases such as cancer. The type of data required to support a biosimilar approval from Health Canada is different from that of an originator biologic drug — biosimilar manufacturers  must demonstrate that the biosimilar is similar in structure and function to the reference biologic and that there are no clinically meaningful differences in safety and efficacy.  Clinical studies don’t need to be repeated for each indication in order to receive an approval. 

As Jenn Gordon explains, “A breast cancer diagnosis already brings with it a tremendous amount of anxiety, uncertainty and fear; having confidence that the treatments being prescribed are effective and safe is critical. As biosimilars become available for use in the oncology treatment space, patients want assurances that they are going to offer the same benefit and outcomes as the reference biologic.”

In light of these considerations, the report also speaks to the need to communicate and inform patients about biosimilars and the importance of their involvement in treatment decisions. In oncology, patients are treated with biologics for a shorter amount of time than in many of the chronic disease areas, and so patients felt that guiding principles specific to oncology were needed, to ensure that parameters such as type of cancer, stage, whether the cancer is recurrent, and the age of the patient are considered. Ultimately, patients trust the treatment recommendations of healthcare professionals, but they would like to be better informed.  

While there was generally a lack of patient knowledge and awareness, the report also found that there was a wide range of physician knowledge and perspectives about biosimilars. While some were familiar with their use and data from countries where biosimilars are already approved, others were unfamiliar with their status in Canada. For CBCN, this is an important observation arising from the discussion because “physicians will ultimately be responsible for presenting the various treatment options to their patients and being confident in the treatments they are using,” says Jenn Gordon. 

The physicians who participated in the report discussed their opposition to switching a patient mid-treatment, highlighted the need for ongoing monitoring for safety for all biologics, the importance of naming conventions to differentiate between reference biologics and biosimilars, the need to provide patient support programs for biosimilars, as well as the challenges surrounding patient communication. 

“Educational opportunities and a staggered approach to the integration of biosimilars in the oncology space will hopefully allow for increased knowledge and understanding of these therapies from the physicians that can then be translated to the patient,” says Jenn Gordon.

While Health Canada recommends that the decision to switch a patient currently on treatment should be made by the treating physician in consultation with the patient, and has indicated that both the brand name and International Nonproprietary Name should be used to support differentiating between these medicines, much remains to be seen in terms of how provincial health authorities will integrate biosimilars into their respective healthcare systems. 

CBCN continues to work with the pan-Canadian Oncology Biosimilars Initiative through the Education Working Group to ensure that patient needs and considerations are addressed as biosimilars are integrated into the oncology space. As biosimilars become available to patients, they are committed to continuing to work with provincial agencies to ensure the patient perspective is considered and informs the policies that are developed.

The shifting oncology treatment landscape offers new hope to patients with cancer and their families, and all types of treatments have an important role to play in our healthcare system. Innovative products may provide options for patients that currently have none, offer more personalized approaches to cancer treatment, and in some cases improve quality or length of life. Biosimilars provide more treatment options for patients and support healthcare system sustainability. With the integration of biosimilars into our Canadian healthcare system, it’s important that we keep patients at the centre of everything we do, and that they are ultimately involved in their treatment choices.

July 11, 2019

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