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P107: Perspectives of Canadian Ophthalmologists on Biosimilars

Poster Presenter

Ralph McKibbin

Chairman
Alliance For Safe Biologic Medicines
United States

Objectives

The objective of this survey was to document Canadian ophthalmologists' perspectives on biosimilar substitution and pharmacovigilance, including their attitudes toward prescribing and reimbursement practices, product identification, and the role of third parties in switching patients to biosimilars.

Method

In October/November 2022, ASBM and IFA conducted a web-based survey of 41 ophthalmology practitioners in Canada, all of whom prescribe biologic medicines. The questionnaire was developed collaboratively by the two patient advocacy organizations.

Results

The survey found that Canadian ophthalmologists have a high level of confidence in biosimilars, with 83% willing to prescribe them to a new patient, and 62% comfortable switching a stable patient to a biosimilar. However, the survey revealed that 81% of respondents were not comfortable with a third-party payer, such as a government, switching a patient’s medicine for non-medical reasons such as cost- as is the policy in some Canadian provinces. Ninety percent of respondents said that having sole authority, with the patient, to decide which biologic medicine to use is very important or critical. And 91% considered the ability to prevent a forced switch by a public or private payer very important or critical. Seventy-eight percent of respondents said their patients would be best served by a European-style access scenario where multiple products including innovator and biosimilars are reimbursed, with biosimilars encouraged for new patients but no automatic substitution. Only 15% preferred a system similar to that of a recently-announced Ontario policy where only government-chosen biosimilars are reimbursed, new patients must be prescribed these products, and current patients are forced to switch. While Canada does not currently require distinct non-proprietary names for biosimilars, the survey found that clear product identification is highly important to respondents. When reporting an adverse event 78% use a product's brand name to identify the exact medicine involved, but 20% use only an International Nonproprietary Name (INN) shared by the originator product and all biosimilars to that product. Only 2% use Canada's country-specific identifier, the Drug Identification Number (DIN.) 88% of respondents would support Health Canada harmonizing with an international distinct naming standard, such as the suffix-based system recommended by the WHO's INN Expert Group in 2015 to help avoid inadvertent or inappropriate substitution and promote more accurate pharmacovigilance.

Conclusion

The survey revealed a high level of confidence in biosimilars, especially for new or bio-naive patients. A majority were comfortable switching a stable patient to a biosimilar themselves, however a significant fraction were not. An overwhelming majority were uncomfortable with third-party substitutions made for non-medical (i.e. cost, coverage) reasons. Nearly all physicians considered it very important that they are able to prevent a forced switch. Similarly, an overwhelming majority of respondents preferred a European-style biosimilar access scenario to a system of forced-substitution, as is becoming increasingly common in Canadian provinces. In nearly every European country, physicians are free to choose among multiple reimbursed products including originators alongside biosimilars. Biosimilars encouraged for new patients, but automatic substitution is not permitted and no forced substitution is required for stable patients. These results suggest that the Canadian healthcare system should prioritize patient choice and access to a range of treatments and achieve cost savings as European countries have: through competition rather than forced switching. Furthermore, the survey revealed a strong preference for distinct biologic nomenclature and harmonization with proposed international standards. Implementing a suffix-based naming system, as recommended by the WHO's INN Expert Group, or harmonizing with the suffix-based system used by the neighboring United States, would facilitate more accurate pharmacovigilance and help prevent inadvertent or inappropriate substitution. The findings of this survey should inform policy decisions regarding the use and reimbursement of biosimilars in Canada, and provide guidance to other countries grappling with similar issues. Ultimately, the goal should be to ensure that patients have access to safe, effective, and affordable treatments, while also maintaining physician and patient choice in treatment decisions.