British Columbia is expecting to save nearly $100-million over the next three years by becoming the first province in Canada to force patients to switch from publicly funded – and expensive – drugs for diabetes, rheumatoid arthritis and Crohn’s disease to cheaper versions called biosimilars.
Biosimilars are near-copies of biologics, a category of drugs that, unlike conventional pills, are manufactured from living organisms and usually delivered by injection or IV infusion.
Biologics also tend to have high prices: Three of the top-five prescription drugs in terms of public spending in B.C. are biologics.
“Biologic drugs continue to be a growing pressure for public drug plans," B.C. Health Minister Adrian Dix said as he unveiled his government’s new biosimilar policy on Monday. "If we continue to spend more and more of our finite health dollars on biologics, it restricts our ability to provide coverage for existing drugs ... not to mention hindering our ability to list any new drugs.”
As patents have expired on blockbuster biologics such as Remicade (also known as infliximab) and Enbrel (also known as etanercept), many European countries have tweaked their public drug-insurance programs to cover primarily less-expensive biosimilars, saving hundreds of millions of dollars.
But Canada, with its fractured public-private system for covering prescription drugs, has hesitated to promote biosimilars in the same way – in part because of opposition from some patient advocacy groups and pharmaceutical companies, including Remicade-maker Janssen, that say patient choice should be paramount.
A Globe and Mail investigation last year found that Janssen, a unit of the pharmaceutical giant Johnson & Johnson, deployed sophisticated tactics designed to disparage biosimilars and thwart their uptake in Canada.
In the fourth quarter of last year, only 8 per cent of the infliximab sold in Canada was a biosimilar, compared with 98 per cent in Norway, 92 per cent in the United Kingdom, 78 per cent in Sweden and 60 per cent in France, according to the federal drug-pricing regulator.
Under B.C.’s new policy, most of the 5,100 patients who still receive public coverage for original Remicade and Enbrel – both of which treat rheumatoid arthritis and related diseases – will have six months to switch to a biosimilar. B.C. covers drugs for people on social assistance, and has an income-based plan for others. Only a small number of workplace insurance plans have required patients to switch.
About 18,000 diabetics on government-sponsored Lantus, a long-acting form of insulin, will have to switch to a biosimilar in the same time period, after which the original versions will no longer be publicly covered, although some exceptions will be allowed.
The 2,700 B.C. patients who take Remicade for Crohn’s disease or ulcerative colitis will have a few months longer to make the switch, Mr. Dix said.
The B.C. government estimates that transitioning patients off Remicade, Enbrel and Lantus will save $96.6-million over three years.
Mr. Dix announced the changes a few months after he himself voluntarily switched to a biosimilar version of insulin to treat his Type 1 diabetes.
“I have empathy for people in those circumstances,” Mr. Dix said, acknowledging that patients might be nervous about using a less-expensive version of their drug.
A Type 1 diabetic’s relationship with insulin is “fairly intimate,” he added. "It’s what keeps you alive."
But Mr. Dix said his transition to Basaglar, a biosimilar that costs 24 per cent less than Lantus, was seamless.
John Esdaile, a rheumatologist and the scientific director of Arthritis Research Canada, encouraged other provinces to follow B.C.
“Huge experience in Europe has shown no difference whatsoever in safety concerns or efficacy of the 28 biosimilars that are in use in Europe," Dr. Esdaile said.
Near copies of off-patent biologic drugs are called biosimilars – not biosames – because it is impossible to replicate perfectly drugs that are made from living organisms. Each batch differs in microscopic ways, even within the same brand.
Opponents of using public coverage policies to force patients to switch have expressed concerns that biosimilars might not work as well, although Health Canada has said well-controlled switches are safe and effective.
The patient group Crohn’s and Colitis Canada, which ran a “No Forced Switch” letter-writing campaign in 2016 and 2017, said that, in general, it supports governments finding ways to save money.
But the well-being of patients with incurable and often debilitating diseases should come first, said Mina Mawani, the group’s chief executive officer.
“Crohn’s and Colitis Canada believes that treatment decisions should be made in the best interest of the patient’s health,” Ms. Mawani said by e-mail.
Mr. Dix said the savings generated from B.C.'s new approach to biosimilars would be plowed back into the drug budget, allowing coverage of more prescription medications, including Jardiance for diabetes, and Taltz for psoriatic arthritis.
He said B.C.'s biosimilar plan provides a template for what the country could accomplish with a national pharmacare program.
A federal advisory council is expected to reveal its blueprint for pharmacare next month, but the idea faces many political hurdles, including a federal election this fall.
“When people talk about saving money through national systems, they’re talking about taking steps like this – practical steps that ensure patient safety and that broaden access,” Mr. Dix said.