Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative

VANCOUVER, Sept. 18, 2019 /CNW/ - On September 5, 2019, the BC government announced phase two of its Biosimilars Initiative, informing patients prescribed the originator biologic drug, Remicade® (infliximab), to treat inflammatory bowel disease (Crohn's disease and ulcerative colitis) that this medication will no longer be covered by the province, and that they must switch to a biosimilar infliximab, either Inflectra® or Renflexis®.¹ This means that patients have only six months to meet with their gastroenterologist to discuss switching their medication and to start a replacement product. The sweeping change in coverage is driven by the government's decision to generate significant healthcare savings from switching patients' medication rather than negotiating with the makers of the originator biologic to lower their prices.

Biologics are medicines created from living cells and are used to treat a variety of conditions, such as Crohn's disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, and growth deficiencies, to name a few. Biosimilars are highly similar to an originator biologic, but different enough to be sold under their own brand name. Because these drugs are made from living cells, it is impossible to create an identical copy regardless of the use of the exact same manufacturing conditions, ingredients, and process.² This is a stark comparison to generic drugs, which are made up of chemicals that can be reproduced with the same active ingredient as the original brand name product.³

Health Canada considers a biosimilar to be safe, effective, and of good quality, and highly similar to the originator biologic it references. For a number of reasons, including that the biosimilar companies do not have to invest in discovery and clinical trials, these medicines provide lower-cost options for public payers. However, as the originator biologics are now off-patent, the companies that own these products are willing to negotiate lower prices. Unfortunately, public drug plans prefer to support a biosimilar market.

It is important to note that biosimilars, unlike generic medications, are not interchangeable with the innovator biologic medication. Health Canada set the bar, saying, "Biosimilars are not generic biologics and many characteristics associated with the authorization process and marketed use for generic pharmaceutical drugs do not apply. Authorization of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic drug." Be wary of anyone who calls biosimilars "biogeneric", as this is an unacceptable, made-up word for these products.

Health Canada further states that the treating physician, in consultation with the patient, should make the decision to switch a patient after taking into account available clinical evidence.

Canada is the only country in the world to have comprehensive patient support programs paid for by the pharmaceutical companies. This means patients receiving intravenous infusions will need to switch to another group and location to receive their treatment, which could add further stress as they adjust to a new location of care and a new support staff.

The change in coverage is estimated to affect 1,700 patients. This is in addition to about 20,400 British Columbians diagnosed with ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis affected from phase one of the Biosimilars Initiative. This population includes pediatric patients, while pregnant patients may be provided exceptional coverage following approval of request from PharmaCare's Special Authority branch.⁴

The Biosimilars Working Group, a diverse cohort of health patient groups dedicated to ensuring the best outcomes for patients, welcomes the BC government's expansion for access to healthcare services, such as full coverage for the fecal calprotectin test and increased funding for nursing support. However, the cost-driven objective of the forced-switch policy is worrisome as it fails to put physician wisdom, patient choice, appropriateness of care, accessibility, and affordability at the forefront of health policy. Patients should only switch if they decide that this is the best course of action for their conditions, with consultation from their treating physician.

Gail Attara, President & CEO of the Gastrointestinal Society, and member of the Biosimilars Working Group, shared that, "Every disease area is unique and each needs to be treated differently. Patients with limited therapeutic options should not be lumped together with those who have a broader range of options available to them. Many people depend on public coverage and only a select few have private health plans that do better."⁵

Surveys conducted on various healthcare stakeholders, including patients, physicians, family caregivers, and the public, in Canada and abroad, reveal synonymous conclusions that treatment decisions should remain between a patient and their physician. Health Canada also encourages patients to speak with their treating physician about switching.⁶

In 2017, five patient organizations collaborated on a project that surveyed Canadian patients with inflammatory diseases about their perspectives on biologics and biosimilars. Of the 657 individuals surveyed, a vast majority reported being opposed to a forced switch for non-medical reasons.

"We are deeply concerned about the risks associated with a switch. Already, patients with loss of vision depend on accessibility and informed consent when being administered treatments. Furthermore, patients who are stable on a biologic treatment should not be made to potentially jeopardize their safety and quality of life with a mandated switch," said Louise Gillis, National President of the Canadian Council of the Blind.

Biosimilars in oncology are expected to increase in the Canadian market and the implementations made by the BC government concern many cancer patients. "While we are aware of the value of biosimilars, the Canadian Cancer Survivor Network believes that patients who are being successfully treated by biologics should not be forced to switch. Any such decisions should be made by patients in consultation with their clinicians," shared Jackie Manthorne, President & CEO of the Canadian Cancer Survivor Network.

The BC Ministry of Health precipitates the need to increase biosimilar uptake due to best practices in the European market, having had over a decade of experience with these products. The Alliance for Safe Biologic Medicines (ASBM), an international and multi-stakeholder organization comprised of healthcare groups, patients, physicians, and biotechnology companies, responded to the BC announcement by releasing a fact sheet analyzing the claims purported by the provincial government.⁷ "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. No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in BC and only very few countries use a procurement process that will reimburse a single product that wins the bid," said Michael Reilly, Executive Director of ASBM.⁸

The Biosimilars Working Group will continue to raise the importance of patient choice and evidence-based decision making with policymakers. To lean more about this group and to stay up-to-date with biosimilars research and policies, please visit www.biosimilaroptions.ca and follow @BiosimilarsWG on Twitter.

Working Group Members Participating in This Media Release:
Alliance for Safe Biologic Medicines
Canadian Cancer Survivor Network
Canadian Council of the Blind
Canadian Society of Intestinal Research
Gastrointestinal Society

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¹ Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.

² Biologics and Biosimilars. GI Society page. Available at: https://badgut.org/information-centre/a-z-digestive-topics/biosimilars-pamphlet/. Accessed 2019-09-11.

³ Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17. Accessed 2019-09-11.

⁴ Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.

⁵ Gail Attara, "Balancing Act: Cost Containment vs. Patient Health Outcomes," GI Society Canadian Society of Intestinal Research, available at https://badgut.org/balancing-act/, Accessed 2019-09-11.

⁶ Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17 Accessed 2019-09-11.

⁷ ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies. Alliance for Safe Biologic Medicines page. Available at: https://safebiologics.org/wp-content/uploads/2019/08/ASBM-Factsheet-BC-vs-EU-Substitution.pdf. Accessed 2019-09-11.

⁸ ASBM Raises Concerns for Patients as BC Gov't Expands Biologics Forced-Switch Policy. Alliance for Safe Biologics page. Available at: https://safebiologics.org/2019/09/asbm-raises-concerns-for-patients-as-bc-govt-expands-biologics-forced-switching-policy/. Accessed 2019-09-12.

SOURCE Biosimilars Working Group

please contact Gail Attara, president & chief executive officer of the Gastrointestinal Society, at [email protected], 604-873-4876.