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Erosion of Physician and Patient Treatment Choice Continues - Alliance for Safe Biologic Medicines Raises Concerns for Patients as British Columbia Expands Biologics Forced Switching Policy

VANCOUVER, British Columbia , Sept. 10, 2019 /PRNewswire/ -- On September 5th , the Government of British Columbia (BC) announced that it would be forcibly switching 1,700 patients with Inflammatory Bowel Disease (IBD) from their current biologic medicine to alternative versions of the treatment, the government's choice of preferred "biosimilar" products, and cease the reimbursement of their current biologic medicine. The announcement follows a May 27th mandate that 20,700 arthritis, psoriasis, and diabetes patients would be forcibly switched from their existing medicines to the government's choice of preferred biosimilar products.  This forced switching policy was presented as a trade-off for the government's agreement to grant reimbursement for new innovative medicines, although no new IBD medications have been added to the B.C. public formulary. The policy disregards important scientific considerations for patients on biologic medicines and most alarmingly, eliminates patient choice, 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.

Biologics are made using living cells and as a result, may inspire unwanted immune reactions.  For that reason, changing from one product to another is widely considered to be a decision to be made by the treating doctor in consultation with the patient.  Biosimilars are highly similar, but not identical, to the original medicines, thus, the forced switch of them is a rarity among advanced nations and banned throughout much of Europe and the United States .

"Biosimilar competition and the use of biosimilars can be an effective way to reduce health costs, but potential savings need not, and should not, override patient and physician control of treatment decisions," says ASBM executive director Michael Reilly . "European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. Switching from an originator to a biosimilar or between biosimilars remains a clinical decision best made by the treating physician."

Higher uptake rates of biosimilars in Europe have been touted by B.C. Health Minister Adrian Dix as a rationale for the force-switching policy, but it is important to note that Europe has almost universally rejected forced switching as a cost-control mechanism, says Reilly: "No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in B.C. and only very few countries use a procurement process that will reimburse a single product that wins the bid." He directs interested parties to a fact sheet developed by ASBM, which contrasts the B.C. policy to those of Europe and dispels misconceptions.

ASBM has twice conducted large-scale surveys of European physicians on biosimilar policy issues. In 2013, ASBM surveyed 479 prescribers in 5 countries, and shared the results with several Ministries of Health, the European Commission, and the World Health Organization as these regulators developed biosimilar policy. Results from a 2019 survey of 575 physicians in six countries will be released this fall.

Reilly emphasized the sharp contrast between the unique forced-switching policy of B.C. and biosimilar policies in Western Europe , which are built on the principles of education, competition, and physician autonomy:

"Nearly all of Western Europe allows physicians to choose between multiple competing products, while encouraging the voluntary prescribing of biosimilars. Only in Denmark and in a few Eastern European countries do we find forced biosimilar switching policies with physician and patient choice eliminated and only one product reimbursed. Canadian patients deserve first-rate health care; this policy moves them in the opposite direction and we respectfully urge the B.C. government to reconsider it."

Other patient advocacy organizations have echoed these concerns. The Gastrointestinal Society, representing the quarter-million Canadians with IBD, released a statement supporting physician and patient control of treatment decisions: "While cost is an important factor for a sustainable healthcare system, when it comes to the selection of treatment, reimbursement policies must recognize and respect the physician's right to prescribe based on clinical evidence and a patient's right to choose the therapy that is best for them." The statement also emphasized the organization's belief "that the onus is on payers (government or private) to negotiate with manufacturers of innovative biologics and their biosimilars to protect options for patient care."

According to the Better Pharmacare Coalition, a group composed of 28 B .C. based patient advocacy organizations and charities, "B.C. is one of the only jurisdictions paying list price [the price before negotiated rebates and discounts are applied] for Remicade® in Canada , as the negotiated listing price agreement ended and BC PharmaCare refuses to negotiate with the manufacturer on a discounted rate."

Crohn's and Colitis Canada, which recently conducted cross- Canada surveys of patients and caregivers, gastroenterologists and IBD nurses, also released a statement citing concerns with the B.C. policy. "Crohn's and Colitis Canada is a research-based organization. We took the time to carefully review our position on biosimilars and particularly on related non-medical switching policy in order to represent our patients thoughtfully and responsibly," says Mina Mawani , President and CEO of Crohn's and Colitis Canada. "Our position that a non-medical switch policy is not in the best interest of patients is based on what we've learned these past few months."

Canadian physicians surveyed have also expressed strong concerns: According to a 2017 survey of 403 Canadian biologic prescribers, 64% were not comfortable with a third party switching a patient's biologic medicine for non-medical (e.g. cost) reasons. 83% considered it "very important" or "critical" that prescribing physicians decide the most suitable biologic for their patients.

"Physicians should have the option to prescribe biosimilars, or any other safe and effective biologic. What is at stake here is who gets to make that decision," Reilly said. "Will it remain the physician and patient - as in Europe , the U.S., and most advanced nations - or will the government restrict choice and force stable patients to switch to a particular government -favored product du jour - whether it be an originator or a biosimilar?"

Media Contact: media@safebiologics.org

SOURCE Alliance for Safe Biologic Medicines