Patient, Provider Views About Biosimilars for Breast Cancer in Canadian Healthcare

An advocacy group for patients with breast cancer in Canada recently published a series of recommendations after convening roundtable discussions with both patients and providers about their knowledge of biosimilars.

The white paper, Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications, discussed the results of 2 national virtual meetings, 1 with 7 patients and 1 with 6 medical oncologists.

In Canada, biosimilars have been available since 2009. Mvasi, a bevacizumab biosimilar for reference bevacizumab (Avastin), was approved for different types of cancer last year. The advocacy group, the Canadian Breast Cancer Network (CBCN) called the meeting knowing that trastuzumab biosimilars are on the way.

The CBCN noted the 2 groups had varying degrees of knowledge about biosimilars, and had somewhat similar concerns. For instance, both groups had questions about the implications of the name “biosimilars,” thinking it might imply they are inferior to reference biologics.

Patients also had concerns about the following:

Efficacy and side effects. Patients may need extra reassurance about biosimilars, the report noted. Patients thought that diseases that are potentially fatal, as opposed to chronic diseases, should have a more stringent review process. They also had questions about side effects that would arise from switching from an innovator biologic, or about the extrapolation of data used to gain approval for a biosimilar.

Communication. The thought of being switched to a biosimilar raised patient anxiety levels considerably, but the group also said that they trust their oncologists and would follow their advice.

Need for guidance on the use of biosimilars in oncology treatment. Patients felt that breast cancer treatment with biosimilars needed parameters that are probably not used for other conditions, such as type of breast cancer, stage, whether the cancer is recurrent, and the age of the patient. Patients also were opposed to the idea of interchangeability.

Cost savings. Patients were pleased with the idea of biosimilars saving healthcare costs, but preferred that the benefits of savings go back into breast cancer research or providing access to existing treatments.

The report listed 4 takeaways from the conversations with oncologists:

Experience and comfort in use. Providers had different levels of awareness about biosimilars and their use, including about their future place in breast cancer treatment. Some doctors were not comfortable with extrapolating data from the metastatic setting to the curative one. The report also said there is a need to ensure awareness across the medical community that Health Canada does not currently recommend interchangeability for biosimilars.

Implementation. Doctors felt strongly about a number of issues, including: opposition to switching a patient off a biologic; using monitoring or post-marketing surveillance of biosimilars to build industry confidence, including the monitoring of outcomes, toxicity, and side effects; the importance of naming conventions and computer coding; and having similar patient support programs as reference biologics.

Communication with patients. The providers had what the report called “considerable debate around how much and what to tell patients about prescribing a biosimilar.” All agreed that the name “biosimilar” could be confusing and might cause patient anxiety; physicians should tell patients that Canada’s health regulators are strict about what is approved for use. However, until biosimilars become commonplace, their use should be communicated to the patient, the group agreed.

Cost implications. The physician group was more focused on long-term savings than short-term ones, and also noted that savings should not be used to guide treatment decisions. Although the patients wanted savings funneled back into research and patient access, the physicians felt that this would be difficult due to the healthcare system’s structure.

Given what the 2 groups discussed, the CBCN said they had 5 recommendations:

• Patients need educational materials about biosimilars.
• Healthcare professionals need information about the role of biosimilars in breast cancer treatment, including providing research and data from other countries.
• Once more than 1 biosimilar is available to treat breast cancer, the Canadian government will need to provide guidance about issues like naming conventions, computer coding and identification of the ideal stage and type of breast cancer.
• Whether to use a biologic or a biosimilar should be left up to the patient and provider, the CBCN says, and provinces should not mandate interchangeability between biologics and biosimilars. CBCN does not recommend that any patients who are being successfully treated with a reference biologic be switched off their treatment.
• Health Canada should regulate the provinces, institutions, and biosimilar manufacturers to fund and conduct post-marketing surveillance and share data on treatment outcomes.