Alberta Announces Forced Biosimilar Substitution Policy for Half its Patients
December 13, 2019
Health Minister Tyler Shandro Announces Policy that Eliminates Physician and Patient Choice of Biologic Medicine for Half of Albertans
EDMONTON- the Government of Alberta announced that it will begin forcibly switching 26,000 patients from their physician-chosen biologic medicines to government-chosen biosimilars beginning July 1st, 2020. These patients include 22,000 Albertans with diabetes, 2,000 with Crohn’s disease or ulcerative colitis, 1,400 with rheumatic diseases, 750 with multiple sclerosis, 450 with low white-blood cell counts and 35 with plaque psoriasis, according to the Alliance for Safe Biologic Medicines (ASBM).
ASBM is a global coalition of physicians and patient advocates, including 14 Canadian organizations and more than 50 European patient advocacy groups, that has worked closely with Canadian advocacy organizations in recent years to share physician and patient perspectives with policy makers.
Only half of Albertan patients- those on public pharmacare plans- will be subject to the forced-switching policy. Patients on private health plans, including Ministry of Health officials, will not be forced to switch. Children and pregnant women are also exempted. “For the affected patients, Health Minister Tyler Shandro is supplanting the role traditionally played by their physician’s medical judgment” says ASBM executive director Michael Reilly. “In effect this creates two groups of Albertans- one who get medicine prescribed by their physician, and another who get medicine prescribed by politicians.’
The decision follows a similar announcement from British Columbia last May which has drawn sharp criticism from physician and patient advocacy organizations, who object to the switching of stable patients for non-medical reasons. Representatives from the gastroenterology specialty and main GI patient groups were notably absent at the scheduled announcement. According to Crohn’s and Colitis Canada, which held a rally December 1st to raise awareness of the impending policy announcement, patients have sent in more than 11,000 letters urging the Alberta government to reconsider its position.
While biosimilars are safe and effective near-copies of the biologic medicines they mimic, unlike generics, they are not identical to their originator products. This fact means that their automatic substitution is rarely practiced among the advanced nations of the world. In a 2017 survey, 83% of Canadian physicians considered it very important or critical that they decide the most suitable biologic for their patient. 64% were uncomfortable with a third party switching a patient’s biologic medicine for non-medical (e.g. cost) reasons, as occurs in the B.C. and Alberta policies.
In its interview with Minister Shandro on the policy, the Globe and Mail cites the success of biosimilars in Europe, but fails to note that European countries overwhelmingly reject forced substitution policies like those of B.C. and Alberta.
“In the vast majority of European countries, the decision of which biologic product to prescribe remains with the physician and the patient, and they are free to choose between multiple products, including the originator, and these are reimbursed. ” says Reilly. “Building physician and patient confidence in biosimilars has been the key to their success, not forced switching. Simply ending reimbursement of the originator product by a government fiat is not a policy in European countries.”
Europe is the global leader in biosimilar approvals and commercialization, with more than 60 biosimilar products approved and the largest share of the world’s biosimilar market. European countries have seen market shares as high as 43% for biosimilars approved post-2013, and as high 91% for older products.
“Minister Shandro says this policy is intended to help create a sustainable biosimilar market, yet it moves Alberta in precisely the opposite direction from the thriving biosimilar markets of Europe,” Reilly observes. “Canadian provinces wishing to emulate Europe’s success should reject forced-substitution and instead look to Europe’s proven substitution policies- in which many products are reimbursed and allowed to compete, creating downward price pressures and high biosimilar uptake rates without sacrificing physician and patient control of treatment decisions.”
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contact: media@safebiologics.org
Robust pharmacovigilance is also important to increase biosimilar confidence and uptake, said Schneider: “With the reliance on analytics over clinical trials for market approval there is a need for real-world evidence, including strong pharmacovigilance programs. There is general agreement that these programs are not sufficiently strong, including in Europe. This would support the need for a common language with which we communicate clinical experience with biologics and biosimilars – for example, a global system of distinguishable non-proprietary names, as the WHO has proposed.”
