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When Olivia Roman was a pre-teen, she started to notice alarming changes in her digestive system.
Every time she ate, she felt sick. She had no energy, and began throwing up after nearly every meal. Then she started losing weight.
Roman was diagnosed with Crohn’s disease at the age of 11, and spent her early teenage years relying on an overnight feeding tube to manage the painful, incurable digestive condition.
“At school everyone’s having lunch and I’m just, like, there with nothing — and then I go home and I eat while I sleep, through my nose,” the now-20-year-old recalled.
Everything changed once Roman started taking a biologic drug called Remicade. Part of a complex, cutting-edge class of medications, the Johnson & Johnson medication is given to her every eight weeks through an intravenous infusion, and now enables the university student to eat almost every type of food and lead an active, social life.
But starting this spring, the Ontario government is forcing Roman and all other patients on biologics to switch from drugs they know are working to similar ones that are also expected to keep their illness at bay — all part of similar cost-saving measures which have already rolled out in seven other Canadian jurisdictions.
Proponents of what are known as “biosimilar” drugs say massive financial savings and similar effectiveness of the drugs makes them worth the switch at a population level. Critics question just how much cash they’ll save long-term, and whether it’s worth forcing patients to swap trusted therapies for the uncertainty of a different drug, however effective it might be.
Meanwhile hundreds of thousands of Canadians suffering from chronic, often-debilitating conditions — including auto-immune diseases like Crohn’s, ulcerative colitis, diabetes, and rheumatoid arthritis — are getting caught in the middle.
“What if I’m not like most people? That’s something that I don’t really feel the need to find out, nor do I want to find out,” said Roman, who spoke to CBC News at her childhood home in Caledon, Ont.
Ontario’s planned switchover, and the hesitation felt by Canadians like Roman, is just the latest chapter in a years-long saga with stakeholders on all sides of the debate, from rival drugmakers to frugal government officials to wary patient advocates and physicians.
Like generics, but more complex
The issue has heated up as more biosimilars have become available. Patents on the original biologic drugs continue to expire, allowing other companies to begin manufacturing similar options and offer them at a cheaper price.
It’s a bit like generic drugs — more-affordable alternatives to brand-name products — but in the case of biologics versus biosimilars, the processes and differences are more complex.
While many drugs are made through basic chemical reactions, like simply mixing ingredients together in a lab, biologics involve growing specially-engineered cells in carefully-controlled conditions, which can then develop proteins that will be used to make specific treatments.
That means each product is unique even though they work the same way to treat various diseases. Dr. Paul Moayyedi, president of the Canadian Association of Gastroenterology, likened it to growing the same variety of apple in two different orchards; while the apples will be similar in taste, appearance, and health benefits, slightly different growing conditions will yield slightly different end results.
New patients who’ve never tried either type of drug experience roughly the same outcomes regardless of the medication, with a similar proportion experiencing reduced symptoms, Moayyedi explained.
“If you choose a group of people who are doing well on their biologic and then force them to switch, most do fine, just as most people wouldn’t care that an apple had changed slightly,” he said. “But a few do not do well.”
WATCH | Ontario latest province switching from biologics to biosimilars:
Ontario is the latest province to switch to cheaper, similar drug options for people with autoimmune diseases like Crohn’s and arthritis. While the government expects millions in savings from the change, some patients and doctors worry the drugs won’t be as effective for everyone.
Major savings for governments
In Ontario, as of March 31, all drug benefit recipients who are on biologics are transitioning to Health Canada-approved biosimilar versions of each drug, at no cost. Those include people now on brand-name products for a variety of conditions, including Copaxone, Enbrel, Humalog, Humira, Lantus, NovoRapid, Remicade, and Rituxan.
“Patients will continue receiving the same high-quality treatment, while allowing the government to fund more new drug therapies, bring innovation to the health care system and continue its work to deliver better, connected patient care,” said Sylvia Jones, deputy premier and minister of health, in a statement released last December.
The nine-month transition period ends on Dec. 29, meaning most patients must be switched over to a different-but-similar drug unless they receive a case-by-case exemption from their health care provider. (Some patients also get financial support from different drugmakers, as the out-of-pocket costs can be thousands of dollars for each round of medication.)
Ontario’s drug coverage transition follows seven other provinces and territories making similar cost-saving swaps, including British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.
Alberta, which transitioned patients 18 and up to switch to biosimilar drugs by mid-2022, noted that the original biologic options were going up in cost by nearly 14 per cent each year, made up a large portion of provincial drug spending, and cost more than $262 million in the 2019 to 2020 fiscal year alone.
Switching to biosimilars is anticipated to save between $227 million and $380 million over four years once fully implemented, reads the province’s website.
Nova Scotia officials, meanwhile, anticipated savings of roughly $13 million a year through a switchover, dropping down from an annual price tag of $44 million.
The Canadian Generic Pharmaceutical Association (CGPA), whose Biosimilars Canada division represents pharmaceutical companies that produce biosimilar drugs, makes no secret about its efforts to lobby governments to make the switch.
Jim Keon has been the CGPA’s president for more than two decades. He told CBC News that while biologics can cost tens or even hundreds of thousands of dollars per year, per patient, the biosimilars on the market sell from 25 to 50 per cent less.
The organization told Ontario officials the province was “missing” savings of $3 million each week by maintaining biologics instead of reimbursing for the use of biosimilars instead. “Clearly, we were advocating for this,” he added.
Some medical experts have previously told CBC News that, so far, provincial rollouts have been successful, with no negative impacts on safety or efficacy since B.C. first implemented a transition in 2018.
‘Why would you switch a stable patient?’
But for individual patients, it can feel a bit like rolling the dice. While chances are people won’t experience a poor reaction to a different drug, the uncertainty before a forced switch is at the heart of patients’ resistance, advocates say.
Alberta resident Sophia Khan, who had a portion of her intestines surgically removed to combat Crohn’s disease, was among thousands of residents told to switch from a biologic to a biosimilar two years ago.
She had a positive experience, but said the real issue for patients is the lack of choice. For a small proportion of individuals, the evidence does suggest they won’t have the same response to a different medication, Khan said.
One Alberta senior suffering from rheumatoid arthritis, for instance, told CBC News in 2020 that her switch from a biologic to a biosimilar left her with new symptoms and debilitating pain.
“So that opens up the question: Why would you switch a stable patient?” Khan questioned.
Moayyedi and other researchers analyzed several trials while developing a 2019 position statement on the use of biosimilars for inflammatory bowel disease (IBS), written on behalf of his association and the advocacy group Crohn’s and Colitis Canada.
One trial discussed in the paper found worsening disease rates were lower with an original drug compared to a biosimilar, while another cohort study suggested patients who switched from a biologic to a biosimilar to treat their IBS were more likely to discontinue treatment.
“Any chance of losing your response to treatment is something that should be discussed, and really isn’t being discussed enough in the zeal to try and move as many people as possible onto the cheaper option,” Moayyedi said.
He also suggested savings may be lower than expected if a proportion of patients require more medical visits or future medication switches to mitigate renewed symptoms, and questioned why there isn’t a bigger focus on making biologics more affordable to begin with.
A published study out of Denmark, however, suggests that there are “no obvious changes” in overall use and costs of healthcare services after this kind of switch, at least for certain patients.
The country started switching people to biosimilars in 2016, and a team of Danish researchers later found that while costs associated with outpatient services went up around seven per cent, costs of admissions dropped by more than half — though the study only looked at people with inflammatory arthritis, not other auto-immune conditions.
Patients can struggle to find effective treatments
Though questions linger, there’s been global momentum for biosimilars in recent years.
The U.S. Food and Drug Administration has approved more than two dozen biosimilars in the last decade — though it was a bumpy road to get there.
“That’s in part because of concerns raised by patients … but also because brand-name biologics have successfully kept biosimilars from entering the market, through a combination of legal actions to extend the life of their patents and incentives that make it more attractive to offer the brand-name biologic on a formulary than a biosimilar,” reported STAT News in 2021.
Biosimilars have been used more often across Europe, and the European Medicines Agency (EMA) recently deemed the drugs interchangeable.
Given their overall effectiveness, Moayyedi doesn’t have concerns about using biosimilars for newly-diagnosed patients, but stressed those who are already doing well on a particular drug should simply be allowed to stay on it.
Some patients and medical experts are also raising concerns about the possibility that people switching back and forth between drugs might lead their bodies to develop an immune response that renders the treatments ineffective if they have to go back to their original medication, with more research needed to understand whether that’s actually the case.
Hesitation before swapping drugs
For Roman, one of nearly 300,000 Canadians coping with some kind of IBS, even a slim possibility that her symptoms will return was cause for concern after she was officially informed about Ontario’s switchover by mail in mid-March.
“There’s no information, it’s just like they’re just telling me about the money,” she said, holding the government letter in the kitchen of her family’s home. “They’re not telling me how it’ll work — for me.”
Roman also has multiple allergies alongside her Crohn’s disease, making her particularly hesitant about trying any new medications. It’s also hard for her to shake the memories of the isolation and feeding tubes she endured in her early teens. And, she stressed, paying out of pocket to stay on Remicade isn’t an option, since it’s thousands of dollars for each eight-week treatment.
Patients just want choice, said Roman, who added that the government could have improved the biosimilar transition process, “to not treat my life and my livelihood as some money-saving measure.”