The revamped NAFTA deal that Mexico struck with the U.S requires it to boost the ‘data-exclusivity’ period for so-called biologic drugs to 10 years. There are other ways to realize savings, including negotiating lower costs with manufacturers.
B.C. recently implemented a policy for multiple-sclerosis patients to switch to a less-expensive medication. Non-medical switching is changing medications not based on the best medical interest of the patient, but rather to cut costs. The medicine in question is a generic, albeit a complex one, and such substitutions are widely accepted because generics are considered to be identical to the originator product on which they’re based.
But the same isn’t true for a new class of medicines called biosimilars — less expensive but non-identical copies of the biologic medicines used to treat serious and chronic conditions like rheumatoid arthritis, Crohn’s disease and cancer. Biosimilars offer patients and physicians more treatment options and promise savings of 20-40 per cent. Well-established federal government processes allow for confidential negotiated lower prices of medications, making these sticker-price differences potentially neutral.
Shouldn’t this allow for policy to focus on the best medical interest of patients? Many Canadian prescribers have expressed strong concerns about when and how biosimilars may be substituted in place of their reference product, especially when those patients are stable and doing well on their current treatment.
As I wrote last year, two-thirds of Canadian physicians surveyed aren’t comfortable with a third party (such as a private insurer or government agency) switching a patient to a biosimilar for non-medical reasons such as lower cost. They cited the possibility of unwanted immune reactions, return of symptoms and even changes to the patient’s support system — such as the site of the clinic administering the product and related support services (which are provided by the drug manufacturer) needing to change.
More than 80 per cent said that before automatic substitution of a biosimilar can be permitted at the pharmacy, studies should be conducted that measure the effects of switching on patient safety and product efficacy. The controversial practice remains banned in many European countries and is permissible in the U.S. only after a biosimilar has shown switching can occur without loss of efficacy or additional risks.
Health Canada recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.
The College of Pharmacists of B.C. also recommends following Health Canada’s advice: “Pharmacists should not automatically substitute these products, but rather conduct an appropriate assessment in consultation with the prescriber before making changes. Consent for change should be clearly documented.”
Nevertheless, substitution policy is decided at the provincial level and rumours abound in the physician community that B.C.’s Ministry of Health may soon implement non-medical switching policy for patients stable on their current biologic, forcing them to switch to a biosimilar to maintain public reimbursement. This would be a mistake.
With biosimilars, prioritizing savings above health and safety isn’t only troubling to health-care professionals, it may also be ineffective at containing costs. Indeed, while only a handful of advanced countries permit automatic substitution of biosimilars, experience has shown that ignoring the concerns of physicians translates into low confidence, low uptake and, ultimately, low savings.
For example, in 2015, Australia’s Pharmaceutical Benefits Advisory Committee began permitting the automatic substitution of biosimilar infliximab over the objections of the Australian Rheumatology Association, which warned that “patient safety may be compromised by allowing (automatic) substitution.” The committee’s decision made substitution economic, rather than a medical decision. Three years later, after lingering in the single digits, uptake rates for the biosimilar hover around 10 per cent as cautious physicians continue to check “brand substitution not permitted” when prescribing. Without physician and patient confidence in safe substitution, the projected savings have failed to materialize.
Provincial governments eager to cut health costs, such as B.C.’s, shouldn’t view the legitimate concerns of health-care professionals and patients as obstacles to be overcome. The Australian experience shows this approach to be short-sighted and ultimately counterproductive. Concerns should instead be viewed as guidance on how to make the most-effective use of limited health-care resources without potentially sacrificing patient safety and good health outcomes.
Expanding a misguided switching policy to additional disease states isn’t the answer. There are other ways to realize savings, including negotiating lower costs with manufacturers. These would maintain medication choice and lower costs by promoting price competition. In light of physician, pharmacist and patient concerns, and in the absence of any medical benefit, and with other ways to control costs, why switch stable patients?
Michael Reilly is executive director of the Alliance for Safe Biologic Medicines, an international organization of physicians, pharmacists, patient-advocacy organizations, biologic and biosimilar manufacturers, researchers and others working together to keep patient safety at the forefront of biosimilar policy discussions. From 2002-2008 he served in the office of the secretary of the U.S. Department of Health and Human Services.
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