Why Nova Scotians with inflammatory bowel disease are worried about drug plan change

The Nova Scotia government is touting a drug plan change as a way to save money, but the move was "scary" for some inflammatory bowel disease (IBD) patients.

Shannon Stevenson of Bedford, N.S., has been dealing with Crohn's disease for about 13 years after she was diagnosed at university when she was 20. Crohn's and ulcerative colitis are the main forms of inflammatory bowel disease.

The province's announcement earlier this month that Nova Scotians using certain biologic drugs covered by Pharmacare would have a year to switch to a version that is biologically similar — so-called biosimilars — caught her by surprise, she said.

"It's kind of scary because you realize how much power the government actually has over your health choices," Stevenson said Friday.

"I understand the safety of biosimilars … it's just the forced switch from somebody who is currently stable in their disease, to another medication that may or may not work."

Drugs known as biologics contain complex molecules created from living sources or their cells. Examples include insulin, growth hormones and antibodies.

But they are expensive, which is why multiple areas like British Columbia, Alberta, Quebec, New Brunswick and Northwest Territories have made the switch to biosimilars.

When the patents for popular biologics expire, smaller companies create biosimilars by finding new ways to produce the drugs. While biosimilars are federally regulated and "highly similar" to biologics, they're not identical, like a generic version would be. 

Of the four biologics covered by the province for inflammatory bowel disease patients, two (Humira and Remicade) are being switched to biosimilars. That means if biosimilars don't work for some patients, they have only two biologic options left.

After about a decade of stability, Stevenson said symptoms began flaring up again over the past year, this time in her esophagus. She felt exhausted, and had inflammation in her throat making it hard to talk.

Her case is especially complicated since she's part of the five per cent of patients who have the disease appear in her stomach and above, Stevenson said.

Stevenson said her doctor explained she'd developed antibodies to the original biologic she'd been on, and switched her to Humira a few months ago.

She has started to feel better — but is now faced with the dilemma of staying on Humira and paying for it out of pocket next year, or starting the lengthy, painful and uncertain "onboarding" process of moving to a biosimilar.

"I think everybody who is in this situation's kind of panicking,'" Stevenson said.

"To make that choice between cost and your health, and your health staying consistently in remission, it's concerning. It feels like a choice you shouldn't have to make."

Stevenson brought her concerns to Health Minister Michelle Thompson before the provincial announcement, alongside people from the Crohn's and Colitis Canada non-profit organization. 

Kate Lee, vice-president of research on patient programs at Crohn's and Colitis Canada, said there's evidence that one in 10 patients who are switched to biosimilars could face major negative effects.

Although they "don't know why," Nova Scotia has the highest rate of inflammatory bowel disease patients in the country, Lee said. She said there are about 16,000 patients in Nova Scotia, so that means 1,600 people could have real trouble switching drugs.

"It might end up being more costly to the government …. they may have to be rushed to the hospital, they may have to undergo surgery," Lee said.

While Nova Scotia's release on the switch said tens of thousands of Canadians have safely switched to a biosimilar drug, Lee said their survey of more than 100 British Columbia IBD patients in early 2020 shows that about half of those who switched reported a change in their health.

Those 52 per cent of patients developed symptoms like frequent bowel movements, more trips to the doctor and days off work, Lee said, and while these may have subsided with time, pain "can be quite excruciating" for these patients.

Lee said many of these patients were actually switched to the remaining limited biologics still covered in B.C., which did not lead to the cost-saving governments are looking for. 

Extensions may be granted: province

Both Stevenson and Lee are hoping to convince Nova Scotia to allow exemptions for certain inflammatory bowel disease patients with complicated cases to remain on their current biologics, and not switch to a biosimilar.

A statement from the province's Department of Health and Wellness on Friday said they "did not make this decision lightly," and consulted with stakeholders like prescribers, patient advocacy groups including Crohn's and Colitis Canada, and regulators.

"Feedback has been largely supportive though we understand there may be a range of reactions to this announcement," the statement said.

When asked whether individual patients stay on biologics if their doctor requests it, the department said prescribers can apply for exceptions for their patients for consideration on a case-by-case basis "and extensions may be granted that would allow some patients to transition at a different time."