Biosimilar drugs could save B.C. millions
As three health-care professionals and a patient educator who are on the front line of arthritis treatment and care in British Columbia, we want to respond to an op-ed a week ago from the executive director of a U.S.-based alliance of pharmaceutical industry, physicians and patient members regarding a new advanced treatment for chronic disease patients.
First, some Canadian background on the issue: Provincial, territorial and private health insurers are under increasing pressure to deliver the latest treatments and care for our aging population, who often live with at least one, if not several, chronic diseases. For tens of thousands living with autoimmune forms of chronic diseases in B.C., a cornerstone of medication therapy is biologics. Biologics are medicines taken by IV or self-injection and are made up of large protein molecules derived from living cells.
There are now two versions of biologics — “originators” and “biosimilars,” which are near identical copies — which enter the market after an originator patent expires and are roughly half the price of their originator.
Biosimilars represent an opportunity to significantly reduce government health-care costs while maintaining good health outcomes. They have been available in Canada since 2014, yet provincial governments across Canada have not implemented substitution policies (as they do with generic medications) to save hundreds of millions of dollars of their annual budgets.
Instead, they have continued to pay full price for two of the originators (Remicade and Enbrel), even though their patents expired several years ago. Why, when the use of biologics has been higher in Canada than in most comparable international markets (seven out of the top 10 highest cost medications in Canada were biologics) and when our provincial drug formularies have the most to gain from unrealized biosimilar savings?
What we have learned in the past year is that barriers to provincial drug formulary implementation of biosimilar transition policy may include business practices of at least two biologic originator manufacturers and “no forced switch” lobbying by special interest patient and physician groups who claim that well controlled transitions from the off-patented originators to their biosimilars is unsafe and ineffective.
However, 90-plus high-quality, mostly non-industry funded research studies prove otherwise.
Transition policy has been implemented safely and effectively with thousands of patients who have autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, gastrointestinal and bowel diseases in many countries in Europe. Registries of these patients on biosimilar therapies report on their continued safe and effective use at leading scientific meetings several times each year, and have done so over the past five years.
In 2017, Health Canada considered well-controlled switches from the biologic originator to a biosimilar to be acceptable in approved indications. As of last year, Health Canada recommended that a decision to transition a patient being treated with the originator to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient, taking into account any policies of the relevant jurisdiction such as transition policy being contemplated by public drug plans.
Perhaps the most important, yet least discussed, aspect of biosimilars is how evidence-based provincial drug-plan transition policy could help more patients (not just those lucky enough to get coverage for an originator), the health-care system, and society, including:
Savings from biosimilars can streamline “special access criteria.” Currently, patients must try to fail treatment on older, less-expensive medications. Because biosimilars are significantly less expensive, public and private drug formularies can remove the need for patients to fail on some of these older therapies before approving reimbursement for a biologic;
Savings generated from biosimilars transition policy implementation could be reinvested into public drug formulary budgets, making it possible to add new medications coming into the marketplace and, by doing so, expanding patient medication choice and improving outcomes for more patients;
Savings from biosimilars could be invested into non-medication types of care that patients need, such as specialized nursing, counselling, physiotherapy and occupational therapy, among other important elements of an inflammatory arthritis treatment plan.
The time for all provincial governments to implement biosimilar transition policy is overdue.
Across the country, hundreds of millions of dollars have been spent unnecessarily rather than on improving reimbursement access to new and existing treatments and building better models of care for all Canadians living with chronic diseases.
Dr. John Esdaile is scientific director of Arthritis Research Canada and a professor in the Department of Medicine at the University of B.C.; Cheryl Koehn is president of Arthritis Consumer Experts; Dr. Kam Shojania is the head of the Division of Rheumatology at UBC, and medical director of the Mary Pack Arthritis Program at Vancouver Coastal Health Authority; Aslam Anis is director of the Centre for Health Evaluation and Outcome Sciences and a professor in UBC’s School of Population and Public Health.