It took Denise Ford almost five years to find out what was wrong with her daughter.
The symptoms began when Shayna was about three years old. Doctors said she was just intolerant to a lot of foods, so Ford got her daughter’s diet “down to a science,” eliminating gluten, dairy, soy, nuts, anything that could be making her sicker.
But by the second grade, Ford could tell Shayna’s problems were more than just food intolerances. Her iron levels were dangerously low. She was tired, “in horrendous pain.” Her complexion was grey and her stomach was swollen. She was having trouble walking.
“She was just so sick,” said the mother of two, who lives in Kitimat, B.C., with her family. “She stopped growing.”
When Shayna was finally diagnosed with Crohn’s disease a month before she turned eight, her mother said “it was just in time.”
After a couple of months on nutritional therapy, Shayna was prescribed Remicade, a biologic drug given in infusions. Ford noticed a difference after the first dose.
“By the time we got to the second infusion, she was already a new kid.”
But on Feb. 20, Shayna got her last infusion of Remicade.
Last year, Ford said, the family was “blindsided” by the news that the B.C. government would no longer be funding Remicade and other biologic drugs, notoriously expensive medications that treat Crohn’s, colitis, diabetes and various types of arthritis. Instead, they would be funding cheaper drugs known as biosimilars — close copies of the original biologics, but not exactly the same.
Without the coverage, each infusion of Remicade would cost Ford around $3,000, she said. On March 5, Crohn’s and colitis patients will join other B.C. patients who have already made the switch to biosimilars.
Ford considered moving back to Alberta, where Remicade was still covered — but in Dec. 2019, Alberta made the same announcement B.C. had in May. Now Ontario is the latest province to look into a similar initiative, beginning consultations with stakeholders in Nov. 2019, according to an emailed statement from a government spokesperson.
In the statement, the spokesperson would not confirm or deny recent media reports that the province will officially go forward with a biosimilar initiative. It said the government is still consulting with stakeholders.
When Alberta announced it was moving to biosimilars, it cited savings of as much as $380 million over four years.
Shayna’s first infusion of a biosimilar, Renflexis, is on March 6, and Ford is afraid that her daughter is being used as a “guinea pig” for a drug that might not work for her. Going through puberty is already causing Crohn’s flare-ups, and Ford fears her daughter, going on 14 now, will start losing weight again during a critical growing period in her life.
Ford said Shayna’s doctor, a specialist in Edmonton, has told her it’s not a big deal, that he’s not worried. For most who switch, it’s not drastic. But Ford would rather not take her chances.
“It really is a huge decision that I don’t actually get to make.”
It’s often dubbed a “forced switch.”
That’s because many patients can’t afford biologics without the coverage.
Forced switches to biosimilars are controversial in public spheres. That’s because biologics and biosimilars aren’t the same. They’re, well, similar — similar enough to be approved by Health Canada, but not exactly the same. Both the companies that make biologics and advocacy groups for the patients who take them have been public in their criticism of provinces looking to fund biosimilars instead of the reference drugs — the original drugs the biosimilars are modelled after.
After Alberta’s announcement, Janssen Inc., which makes Remicade, a biologic drug that treats a variety of diseases including rheumatoid arthritis and Crohn’s disease, put out a public statement criticizing the move.
In an email on Feb. 28, a spokesperson relayed a similar message:
“We strongly believe that treatment decisions should be based on what a physician determines is in the best interest of each patient; not driven by government policies that restrict treatment options.”
Of course, as the sole maker of a drug, companies that make biologics have a vested interest in keeping their market share. Studies have shown that once a biosimilar for a drug hits the market, use of the original drug tends to drop — as does its price.
When Alberta made its announcement in 2019, Health Minister Tyler Shandro said biologics cost the government $238 million in 2018-19, representing 19 per cent of drug spending, but less than two per cent of patients.
In June 2019, in a statement reacting to the B.C. announcement, Janssen Inc. said it made multiple proposals over three years to save the government money on its drugs, but that these were rejected.
A biosimilar isn’t like the generic version of a medication, because biologics are not chemical compounds. Instead, they are biologically engineered using living cells. This means that any attempt to replicate them may come close, but will never replicate the exact molecular structure of the original biologic.
Once the patent for the original biologic expires, other drug companies are free to attempt to make their own versions. (Remicade was approved for use in Canada in 2001, and its biosimilars were approved around 15 years later.) But because of the nature of the drugs, the biosimilars will never be exactly the same as the original biologic.
For some patients, those small differences could mean the world, according to Mina Mawani, president and CEO of Crohn’s and Colitis Canada. The organization has been vocal in its advocacy against forced switches to biosimilars — in February, it put out a public letter urging the Ontario government to reconsider a potential policy that would make patients switch to cheaper biosimilars.
According to a report from the Globe and Mail late last month, Ontario will be the latest province to switch its funding from biologics to biosimilars in a bid to save millions of dollars. The provincial government would not confirm the report, but said consultations with stakeholders are still ongoing.
Mawani said the organization is “absolutely supportive” of biosimilars being brought to market, and of newer patients trying them out. What they disagree with is a “non-medical switch,” especially for patients who have spent years trying to find an effective treatment.
She said in rheumatology, there are many more treatment options, more biologics and biosimilars. “If you fail on one, you can go on another.”
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But with bowel diseases, there are only a few options.
“Patients will go on a biologic, fail on that one and go on another,” she said. “If people are on the originator biologic and they’re stable … why do a non-medical switch?”
However, biologics cost the government a lot, and experts say that funding biosimilars instead could save health-care systems funds that could be used elsewhere.
And with an aging population, money is on the mind of those trying to manage the growing costs of providing health care in Canada. In 2018, Ontario’s Financial Accountability Office found that the province was not on track to keep up with the health care needs of its citizens.
Early this year, a paper by two University of Alberta researchers examined both the legal and ethical issues surrounding so-called forced switches to biosimilars. The paper, which was funded by Crohn’s and Colitis Canada, found that while the provinces are legally allowed to make the switch, it does raise some ethical issues for the doctors of patients on biologics.
University of Alberta health researcher Blake Murdoch, who co-authored the paper with Health Law Institute research director Timothy Caulfield, said a doctor’s duty to find the best treatment for their patient means that they can’t advocate for a switch to a biosimilar based solely on cost.
“If a physician believes that switching to a biosimilar could create a situation where (the patient was) in remission, and then they could relapse … they would have an obligation to raise that with the patient.”
And if the doctor believes the unfunded biologic would be better for their patient, it’s their job to recommend that one, said Murdoch.
He said that while there’s a lot of scientific evidence that biosimilars won’t cause issues for most patients switching, there’s also research that shows there may be gaps in that evidence. In other words, it depends on who you ask.
He said clinician opinions on biosimilars vary depending on disease — for example, surveys of doctors showed that those addressing gastrological diseases like Crohn’s were more wary of biosimilars than those treating arthritis, perhaps because the former are still less understood.
“There’s evidence that (biosimilars) are definitely working, but there is still controversy,” Murdoch said.
Like Shayna, Debbie Aschwanden’s life was changed by a biologic.
After two years of being in pain, the Williams Lake resident was diagnosed with Crohn’s and colitis in her 20s and put on Remicade in 2010. But after the B.C. government’s announcement in May 2019, Aschwanden’s doctor decided to switch her early so they could see how she would fare on a biosimilar.
In Sept., they tried Inflectra. After two infusions, Aschwanden said it was clear the drug was not for her — it gave her migraines and essentially kick-started a flare-up of her original symptoms. She is now on Renflexis, the biosimilar Shayna will be switching to, and she describes it as “OK-ish.” She said she can tolerate it, but “I felt better on Remicade.”
Aschwanden said she found it frustrating to have to switch from the treatment that had kept her disease, already a stressful thing to manage, at bay for a decade. But initially, she said she wasn’t worried; she didn’t expect the biosimilar to be as bad as it was.
“What I thought was, ‘Well, I guess it must be an OK drug if they’re gonna do this.’ ”
Aschwanden said she’s also frustrated because she knows that in many cases — her own included — the company that makes Remicade is paying for part of the drug, meaning the government isn’t covering the whole cost.
As Alberta and Ontario make transitions of their own, Aschwanden said she hopes they look to B.C. and proceed with caution, perhaps with a more tiered system so patients who have been on biologics for a long time aren’t forced to switch.
“If we’re gonna have all these malfunctions and issues on … these biosimilars then we’re gonna be plugging up the ER in different places more because we’re not doing very well,” she said.
With files from The Canadian Press and Madeline Smith