Physicians, not policies, should determine appropriate patient care
For several years, government and private payers around the world have implemented policies to ensure the integration of biosimilars alongside existing reference biologics. Biologics are original products that have been in use in therapeutic areas, including rheumatology, gastroenterology, oncology, and ophthalmology. As patents expire on biologics, there has been a trend towards transitioning to biosimilars, which are manufactured to be clinically similar to the originator (biologic) medicine. Various policies have been developed globally on how to ensure biosimilars are integrated into the reimbursement programs currently in place for the biologics for ease of transition.
Europe has significant experience in the implementation of biosimilars, with the largest biosimilar market in the world. Market share ranges from 43% for newer products, approved after 2013, to more than 90% for older products. Successful uptake of biosimilars in Europe is widely credited because physician choice is preserved and forced switching to biosimilars rejected. In nearly every advanced European country, physicians are permitted to choose between reimbursed products, including the originator biologic and biosimilars, though many countries encourage prescribing biosimilars for new patients.
Biosimilars were introduced to Canada in 2009 with the first ophthalmic biosimilar announced in late 2022. In contrast with Europe, provinces in Canada have implemented forced switching policies, meaning that tens of thousands of Canadians with arthritis, psoriasis, and diabetes have been moved from their originator biologic medicines to the government’s choice of biosimilar product. Ontario announced the biosimilar policy in December 2022 and the implementation plan was unveiled March 2023, which outlines forced switching.
Physicians, patients, medical societies, and patient organizations alike have formally and informally registered their concern that forced switching will negatively affect patient care and, in the case of ophthalmology, may result in vision changes. In 2020, a report published by Quebec’s Institut National d’Excellence en Santé et Services Sociaux (INESSS) concluded that the available scientific data were insufficient to support the safe switching between the originator biologic and biosimilar, and “forced switching is generally not accepted by learned societies and the consulted clinicians” due to the potential destabilization of the health and wellbeing of complex patients.
Ontario has implemented a policy that does not respect the qualified opinion of the physician in consultation with their patient to determine safe, effective, and appropriate treatments. This is not about economics as Europe has demonstrated that forced switching is not necessary for market penetration.
The recent introduction of the first ophthalmic biosimilar into the Canadian marketplace places this policy and the vision health of Canadians front and center. Medical societies, including the Canadian Ophthalmology Society, the Canadian Retina Society, the American Academy of Ophthalmology, alongside patient and advocacy organizations such as International Federation on Ageing (IFA) have issued statements opposing forced switching policies due to the potential risk of retinal damage or blindness. “We’ve seen the impact of policies that favour cost savings over patient care, it has a cascading effect detrimental to the person and their overall health and wellbeing. Loss of vision has been linked to loneliness, social isolation, and feelings of worry, anxiety, and fear” says Dr. Jane Barratt, Secretary General, IFA.
In survey of 41 Canadian ophthalmologists conducted by Alliance for Safe Biologic Medicines (ASBM) in collaboration with the IFA, most indicate that having sole authority, with their patient, to decide which medicine is most suitable is very important or critical. Where a payer requires a switch (as in Ontario’s policy), 91% of ophthalmologists say the ability to prevent a forced switch by writing “Dispense as Written” is very important or critical. In the main they agree with the European-style access scenario in which multiple products, including the originator and biosimilars are reimbursed. Physicians are encouraged to prescribe biosimilars for new patients and forced switching is not permitted. Only 15% of ophthalmologists preferred the Ontario policy in which all patients must be prescribed (or switched to) a preferred, government-chosen product.
Canadian findings are consistent with those of physicians surveyed worldwide across many specialties. European and U.S. physicians also consider it very important or critical that the physician and patient determine treatment decisions, including the decision to switch to a biosimilar, alongside the ability to remain on the originator medicine.
With implementation of the Canadian biosimilar policy, the vision heath of Canadians with retinal diseases may well be at stake. Policies that demand forced switching from an originator biologic to a biosimilar in the field of ophthalmology are largely opposed by health care professionals and advocacy groups due to the absence of necessary studies that address the impact on the stability of a patient’s condition.
Ontario has a window of opportunity to shape biosimilar policies in favor of the proven path of creating a robust and sustainable biosimilar market that achieves savings through competition and increasing, rather than restricting, the treatment choices available to its physicians and patients.
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 Reilly MS, Schneider PJ. Policy recommendations for a sustainable biosimilars market: lessons from Europe. GaBI Journal. 2020;9(2):76-83.
 Reilly MS, Spiegel A. 1633PD. Biosimilar Substitution: European Prescriber Perspectives. Poster presentation at: Annual Congress of the European Society of Medical Oncology; Barcelona, Spain. September 27 – October 1, 2019.