British Columbians on certain drugs for arthritis and diabetes will have six months to transition to equivalent less-costly drugs, as the province expands use of “biosimilars.”
The move is expected to save $96 million over the first three years.
Biosimilars are developed after the patent for the original bio-engineered drugs, known as biologics, expire. They are highly similar copies of the original brand-name drugs, but cost 25 to 50 per cent less.
The province says its goal is to use the savings to cover the cost of new or expensive drugs still under patents.
Effective today, the B.C. Health Ministry is adding three biologic drugs for coverage.
Biologics are made using living organisms — yeast or bacteria, for example — to produce proteins that are purified to treat various health conditions.
Given by injection, biologics are prescribed to control immune-system responses and treat chronic diseases including diabetes, inflammatory bowel disease, psoriasis, rheumatoid arthritis and some forms of cancer.
“B.C. is leading the country by promoting the widespread use of biosimilars, which have been proven to work just as safely and effectively as higher-priced biologics,” said Health Minister Adrian Dix, who is making the announcement at the B.C. legislature this morning.
“No one has done this in Canada and really not in North America either, so it’s a major shift.”
Dr. John Esdaile, a Vancouver rheumatologist and scientific director for Arthritis Research Canada, applauded the announcement, saying many have been “badgering” the province to make the move.
“It’s a great day for British Columbians,” said Esdaile. “This will be a very safe transition for our patients.”
Even with the original biologic, no two batches are identical, he said, adding B.C. has been spending money it doesn’t need to spend on expensive biologics, instead of using biosimilars that are proven to work just as well.
Esdaile says in Europe, biosimilars have saved the health-care system billions of dollars.
Cheryl Koehn, who has had rheumatoid arthritis for decades and is president of Arthritis Consumer Experts, says the transition is “long overdue” and great news for patients.
Across Canada, Health Canada-approved biosimilar versions of off-patent biologics are prescribed for new patients with new prescriptions.
B.C. will be the first province, however, to mandate that more than 24,000 long-time patients already using original biologics, now off-patent, transition to the biosimilar version.
Earlier this year, Dix himself transitioned from a long-acting insulin called Lantus to a biosimilar called Basaglar for his Type 1 diabetes. He was one of 18,000 British Columbians on the original biologic.
“I am one of the people affected by this,” said Dix. “If I’m asking to other people to do it, I have to lead.
The health minister says even though the biosimilar drug is virtually the same and taken in the same way, “it’s still a moment when you make the transition,” said Dix. “I have some empathy for that. For some people, it will take time to adjust to the idea of change.”
About 20,400 British Columbians living with ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis will be required to work with their doctors to transition their prescriptions from the biologic drug to the biosimilar version by Nov. 22.
“They will have to work through their doctor as I did,” said Dix. “That’s why we are giving people six months.”
Afterwards, PharmaCare will no longer provide coverage for the original biologic drug for these diseases. In exceptional cases, a doctor or prescriber can request coverage for the original drug for medical reasons through PharmaCare’s special authority branch. That will be reviewed by physician-led advisory committees.
About 2,700 Crohn’s and ulcerative colitis patients will also be transitioning to a biosimilar option in the coming months, according to the Health Ministry. Further information for gastroenterology patients will be available this summer, said Dix.
Under the move to biosimilars:
• Rheumatology patients will transition from the entanercept biologic Enbrez to the biosimilar Brenzys or Erelzi
• Dermatology and rheumatology patients will transition from the infliximab biologic Remicade to the biosimilar Inflectra or Renflexis
• Endocrinology patients will transition from insulin glargine biologic Lantus to the biosimilar Basaglar
• Gastrointestinal patients will transition from the infliximab biologic Remicade to the biosimilar Inflectra or Renflexis, with more information to come in the coming months.
B.C. says it is following evidence-based results from several countries with a decade of experience with biosimilars. Canada’s biosimilars and biologics are both more expensive.
Use of the Infliximab biosimilar for rheumatoid arthritis and inflammatory bowel disease, for instance, in European countries and Norway and Sweden is 50 to 95 per cent, whereas in Canada, it was eight per cent in 2018, according to the Health Ministry.
The original biologic drug infliximab (Remicade — Janssen) has a biosimilar drug called Inflectra and Remsima, which has been on the market for about four years. It has a combined five to 10 per cent use in Canada compared to 98 per cent use in Norway, 90 per cent in the United Kingdom, and 85 per cent in Scotland.
As a result, in 2017, Canada spent more than $1.1 billion on Remicade when it could have paid a fraction of that price, said Dix.
“It’s been intensely studied in other jurisdictions,” said Dix. “The switch makes sense.”
With the savings from biosimilars, Pharmacare will cover the cost of:
• the drug Jardiance (empagliflozin), used to manage Type 2 diabetes and now listed as a limited coverage benefit under PharmaCare. About 22,000 patients are forecast to benefit from this new coverage. It will cost the province about $4.1 million this fiscal year and $18.9 million over three years.
• the psoriatic arthritis drug Taltz (ixekizumab), as a limited coverage benefit.
As well, the criteria will be expanded for existing arthritis drugs, such as extending coverage periods. Drugs affected include DMARDs, certolizumab, leflunomide, rituximab, tocilizumab and tofacitinib. That will help more British Columbians living with arthritis to find the treatment option that works best for them, says the Health Ministry.
The province said it has consulted with and has support from prescribers and patient groups, including endocrinologists, the B.C. Society of Rheumatologists, Doctors of B.C., a national organization called Arthritis Consumer Experts, Canadian Arthritis Society, B.C. Pharmacy Association, Neighbourhood Pharmacy Association, regional health authorities, Health Canada, Canadian Agency for Drugs and Technologies in Health, Patented Prices Medicine Review Board and the pan-Canadian Pharmaceutical Alliance.
— Cindy E. Harnett, Times Colonist