Some patients concerned as change to medications in Sask. drug plan approaches
Saskatchewan Biosimilars Initiative will come in on April 30
This story originally published on Jan. 22, 2023.
When Megan MacLeod was in university, she had to wrap her hands in bandages and take over-the-counter medication to manage the pain from her arthritis enough to play percussion instruments as part of her degree.
Now, with the Saskatchewan Drug Plan scheduled to shift on April 30 from biologic drugs — like the ones MacLeod takes — to more cost-effective copies called biosimilar drugs, MacLeod is fearful she may have to endure the pain again as she tests the new medication.
MacLeod, 33, from Regina, is one of the about 24,000 patients who will be forced to make the shift from one of 10 biologic drugs to biosimilars, a move the province says could could save $20 million annually.
Saskatchewan announced in late October it would start its biosimilars initiative, making it the sixth Canadian province to make the switch. The adjustment will include a range of drugs that treat conditions including Crohn's disease, arthritis, diabetes and multiple sclerosis.
According to the province, biologic drugs costing more than $10,000 per patient per year made up more than 70 per cent of the drug spending in Canada.
- Click here for a full list of pharmaceutical drugs included in the biosimilars initiative
The province says clinical studies show that biosimilars have the same efficacy and safety as their originator.
Both Diabetes Canada and Crohn's and Colitis Canada have stated they disagree with the changes, saying medication switches need to be made in conversation with the patients.
Some residents in other provinces that made the switch have reported the new drugs not being effective, while others were concerned about the resurfacing of painful flare ups they had before being put on their current medication.
MacLeod was diagnosed with juvenile rheumatoid arthritis — later called juvenile idiopathic arthritis — at 12 years old, struggling with it until she was offered a biologic drug in her early 20s. She had a total knee replacement in her early 20s as a result of her arthritis, she said.
Her condition deteriorated on the first drug she was prescribed, which she said was chosen for its low cost. Then she was prescribed Humira, a biologic, and while she still grapples with properly medicating, she said it brought a semblance of normal back to her life. She doesn't want her condition to regress if she's required to change medications.
MacLeod's describes her condition as like having the flu constantly. She said that for two years before finding a biologic that worked she could barely walk and has had to crawl on her hands and knees to get up a staircase.
"It's like trying to close your fingers like a normal person would, but feeling a softball stuck in there and being unable to do it ... and it's not just your fingers, it's potentially every joint you have in your body," she said.
"It's scary ... I've already been there and I don't want to be again."
MacLeod said she is frustrated the government is focused more "on their collective wallet than what this is going to do to people who are living with these kinds of conditions."
When asked for a response to concerns about the change to biosimilars, a spokesperson for the health ministry said in an email that exemptions are available for those who cannot remain on the biosimilars and drug plan coverage will be in place for approved exemption requests.
MacLeod said she didn't know she would be affected by the April 30 deadline until CBC posted about it on social media.
Neither did Kaitlan Lavoie, from Saskatoon, who will be shifted from Remicade — a medication she has been on since she was diagnosed with Crohn's disease in 2018 and treats a range of conditions.
They both received letters in early January acknowledging the change, more than two months after it was announced by the province.
"My big concern is going onto something new and it not helping me in the way that Remicade has helped me in the last four, going on five, years," Lavoie said, adding that she hasn't had a flare up since being on the drug.
She acknowledged that a new drug could work better for some, while for others it may not.
Biosimilars should work like original drugs: expert
Dr. Stan Bardal said while the overall change shouldn't be a cause of concern, the clinical trial process through Health Canada could mean that some drugs don't work as effectively as their more expensive equals.
He's an associate professor in the department of anatomy, physiology and pharmacology at the University of Saskatchewan.
If Health Canada tests rheumatoid arthritis, for example, they may use that data for other conditions instead of running tests for each individual condition.
Bardal said some physicians who have expressed concern about the shift in other provinces may have been concerned about how "the drugs aren't as well studied in their conditions."
"If there's no evidence in their specific conditions, it becomes a little bit harder to make that decision," he said, noting the most complaints are likely to come from conditions like inflammatory bowel disease and rheumatoid arthritis.
Remicade, for example, is used for both Crohn's disease and rheumatoid arthritis.
It's not uncommon, Bardal said, for patients to be switched from an originator drug to a cheaper, generic drug once the patent has expired. Biosimilars are held to a higher standard than generics.
Bardal said problems seem to come when someone switches from a biologic drug to a biosimilar, rather than when someone takes a biosimilar from the start.
He said it's difficult to know why people may face adverse effects with a new drug, but that it can be a nocebo effect — or the drug having different effects because you don't believe it will work. In other cases, the previous drug may have already had waning effects, he said.
"I think we have to be open to the possibility that there may be a rare few people, who for some reason that we don't understand yet because biologics have only been around for 20, 25 years … don't respond to the biosimilar," he said.
In the trials he's seen, there aren't noticeable differences between biosimilars and the original biologic drugs, otherwise Health Canada would deny their use.
He said the companies making biosimilars do their best to imitate the drugs, otherwise the money spent on trials is wasted.
The reason the drugs are cheaper, he said, is that the companies producing biosimilars don't need to spend money on research and development, as the original drug has already been created.
Corrections
- A previous version of this story referred to biosimilars as generic drugs. In fact, biosimilars are separate from the generics category.Jan 23, 2023 9:00 AM CT