'I don't want to regress': Patients, doctors divided on Alberta's move to change biologic drug coverage

Earlier this month, the Alberta government announced it would change drug coverage for approximately 26,000 residents in an effort to save a significant sum ofmoney approximately $380 million over the next four years.

At issue is coverage for Albertans who have diabetes, rheumatoid arthritis and Crohn's disease.

Those individuals have until July 1, 2020to make a switch from biologic drugs to biosimilardrugs. Residents who are on private drug plans or are paying out of pocket won't be affected. The change also won't apply to children or pregnant women.

The change has provoked anxiety among Albertanswho worry that the health impacts they struggled with for years prior to trying a drug like Remicademight return when they switch medications.

"The Remicade, it was fantastic that's why I'm so adamant and very apprehensive about losing this," saidTom Rechenmacher, 58, who has been on the drug for five years. "It took so darn long for me to get back to normal and I don't want to regress."

Rechenmachervoted for the United Conservative Party but is upset by the government's plans.

"To say I'm disappointed is an understatement," he said.

"I've been a conservative my whole life. But for them to start getting involved with my life and other peoples' lives, well, I don't know."

'It's not fair at all'

Having taken Remicade for eight years, Edmonton resident Annalee Heidl, 32, is alsoworried about how her body will react to a new drug.

"You can't put a price on your health. The government is trying to save money but, at the end of the day, how would they feel if it was turned around on them and they were sick?" Heidl said. "It's not fair at all."

The government has told those concerned about the upcoming switch that medical experts were consulted and evidence from Europe has indicated that switching is safe.

In addition, any patient whose doctor shows a valid clinical reason against a switch to biosimilarswill be granted an exception, the government said.

"I sympathize with patients who are naturally anxious about the change, they deserve good information," reads a statement provided to CBC News, attributed toAlberta Health Minister Tyler Shandro. "Biosimilars are safe and appropriate;they're equivalent to biologics."

The government has also pointed to the example of British Columbia, which is currently in the process of transitioning patients on biologics to biosimilars.

'Patients are going to get sick'

Critics of the move, like the non-profit Crohn's and Colitis Canada, agree that biosimilar drugs are safe and effective.

However, they emphasize that switching from biologics to biosimilars for non-medical reasons is "not in the best interest of patients."

"We have evidence that showcases that some of these patients are going to get sick," said Mina Mawani, president and CEO of the non-profit. "If you think about getting sick, you're thinking about more visits to emergency, more hospitalizations, more surgeries. That's going to cost the health-care system."

Though the government has offered exemptions,Mawani said the system currently in place was not capable of ensuring everyone will get the support they need.

"What Iheard in the [Dec. 12] press conference was that, 'Everyone [in British Columbia] who needs an exemption is being exempted,'" Mawani said. "That's not true. We actually have patients who said, I've not been exempted. They just came back and said no."

British Columbia experience

Debbie Aschwanden, 42, is a resident of Williams Lake, B.C.

She said she was diagnosed with Crohn's disease and colitis in 2010 and was so sick that she could hardly function.

"When I started taking Remicade, it was life-changing. I was so sick, and when I started taking that, it was totally life-changing," she said. "It was working good. I was on it for 10 years."

As part of British Columbia'stransition to biosimilars,Aschwandensaid she was switched off Remicade in September.

"The first dosage when I had the first biosimilar was OKbut then, as soon as two hours after the treatment, I got a whopper of a headache for seven solid days," she said. "The same thing the second round. Then this time, I got super sick, like having Crohn's. I had a big flare and it didn't go away for seven complete days."

Aschwandensaid her doctor took her off the biosimilar, but she will have to try a second biosimilar before being allowed to go back on Remicade.

"Right now, I'm in limbo and I'm waiting to get approved for the second biosimilar to see how it will affect me or work for me," she said.

Aschwanden said she was frustrated because things had been going so well on Remicade, and now her "life has been turned upside down."

"I get that it's saving money, but it's not really, because then we're in and out of the doctors, trying to find ways to cope with it," she said. "We go through enough with the disease, let alone adding all this extra stress."

Mixed medical opinions

Dr. Remo Panaccione, anexpert in inflammatory bowel disease (IBD) andprofessor at the University of Calgary, says individual patients respond to the medication in different ways, regardless of how similar it is.

He also said not enough time has passed to determine whether or not the switch has been effective, asrheumatological and dermatological indications only began in B.C. in May, and at the end of September for patients with IBD,

"It's early days," Panaccione said. "If the minister of health in British Columbia or Alberta has data that these patients are being followed systematically and they're doing fine, we'd love to see that data."

In support of its plan, the Alberta government has also cited statements from Crohn's and Colitis UK and the European Crohn's and Colitis Organization. But Panaccione said the latter also recommended any decision to switch to biosimilars should be directed by national guidelines.

"If we default to that position, we do have a national guideline. It was published in September," he said. "It says no problems [with biosimilar drugs], but we're against a non-medical switch."

In its statement to CBC, the government also said claims that patients are at risk stemmainly from a paper by five Alberta physicians.

"All five disclosed past payments from Janssen, the maker of Remicade," the email reads. "That doesn't mean their work can't be valid, but it's a reminder that this issue involves a company trying to hold onto a lucrative market and avoid competition."

Panaccione acknowledged he had received payments from Janssen, but added he received payments from the company who madebiosimilarsas well.

"We disclosed it in the paper and it's part of our academic appointments. We have disclosures on file at the university and with Alberta Health Services that we update annually," he said. "We're not conflicted one way. Unfortunately, we're broadly conflicted. But that's the nature of what we do."

Panaccione said more than a dozen gastroenterologists in Alberta sent letters of concern to the minister of health arguing against the policy.

"If they don't want to take that, because maybe we have skin in the game, there are gastrointestinal leaders and IBD experts across the country that have sent personal correspondences to the minister warning of the risk," he said.

Charles Bernstein at the University of Manitoba andEric Benchimolat the University of Ottawaconfirmed to CBC that they had sent correspondences to the Alberta government warning against the switch.

John Marshall at McMaster University and Alain Bitton at McGill University also sent correspondences, Panaccione said.

Dispute over research paper

The paper in question, written by Panaccione along with four other professors at Alberta universities, asserts that the evidence to support the safety of non-medical switching in patients with IBD is of "low to very low quality; in fact, existing data suggests a potential risk of harm."

The paper also says anon-medical switch policy is expected to cause more than 60 avoidable surgeries in Alberta.

In his email, Shandro said the paper was unpublished and has not been peer-reviewed and was therefore not a validated source of evidence, but Panaccione disagreed.

"The paper actually has been peer reviewed and has been accepted for publication [in the Journal of the Canadian Association of Gastroenterology],"Panaccione said. "The people that have been involved in that paper, three of us have masters of epidemiology from Harvard. So I think we know what we're doing."

The government has pushed back against that paper, saying it initially took its findings seriously.

"I asked for it to be reviewed by the Institute of Health Economics," Shandro wrote. "The CEO of IHE, Dr. Chris McCabe, described the paper as systematically flawed and said its conclusions were meaningless."

In an interview with CBC, McCabe said the evidence currently in the public domain does not provide any reason to believe there is any difference in the effectiveness or safety of biosimilars compared to the original products.

"The paper is based on an inappropriate meta-analysis of two studies and the extrapolation of the results of that in ways that are not consistent with best practice," McCabe said.

Though Panaccione's research was accepted into the Journal of the Canadian Association of Gastroenterology, McCabe said it did not change his interpretation of the paper.

"There's a lot of flawed research out in the peer-reviewed literature. Peer review is an imperfect system but we haven't come up with a better one yet," McCabe said. "The limitations I've identified are identified from a different skill set than a clinician's skill set. They're to dowith the skills required to appropriatelysynthesize data.

"Most clinicians do not have advanced training in these areas, so mistakes are likely to be made."

Canadian position

Dr.Paul Moayyedi, a gastroenterology professor at McMaster University who has published more than 150 peer-reviewed articles and is one of the authors of the Canadian statement on biosimilars,said he has not accepted money from industry and therefore has no conflicts.

"[This debate] is complex, that's for sure. But I do feel that B.C. and Alberta's position, which I understand as essentially forcing a switch, it's not the best way to go about it from a clinical perspective," he said.

"I can certainly see why they'd want to do it but I'm really focused on evidence and we don't have the evidence yet to make sure it's safe to do that. As such, I'd really prefer for a more thoughtful, gradual switch."

Moayyedisaid he's further concerned due to the fact that Janssen,the makers of Remicade one of the biologics for Crohn's patients impactedsaid it had reached out to the government to offer the product at a cost comparable to biosimilars.

Moayyedisaid his opinion may change as more evidence accrues but that at this juncture, he is advising against the government's current strategy.

"The government clearly has an agenda, which is to save money, and they believe this is the right way to do it," he said.

"Of course, they want patients to get better as well. But to me, it's important to have a proper dialogue that's respectful, really takes both of these things into account and heavily involves patients."