Drug maker urges patients to speak out as Alberta, Ontario consider switch to cheaper biosimilars

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Ontario and Alberta are looking at following British Columbia’s lead in forcing patients to switch to cheaper drugs called biosimilars, prompting the maker of Canada’s most lucrative drug to send letters directly to patients in both provinces asking them to voice any concerns about the change to provincial politicians.

Ontario Health Minister Christine Elliott told The Globe and Mail on Thursday that her government will launch consultations on a biosimilar switching policy before the end of the year, while a spokesman for Alberta’s Health Minister said that province would unveil a new policy later this year.

Both governments said it was too early to say whether they will mimic the B.C. plan, which, while expected to save nearly $100-million over three years, has drawn the ire of some gastroenterologists and a prominent charity for patients with inflammatory bowel disease.

Janssen Inc., a unit of Johnson & Johnson, has already pushed back against potential policy changes in Ontario and Alberta, warning patients by mail that their provincial governments are considering de-listing Remicade, a pricey biologic that treats rheumatoid arthritis and Crohn’s disease, in favour of its biosimilar near-copies.

"Requiring stable patients to switch from REMICADE to a biosimilar for no medical reason is of great concern and we believe that patients should have a voice in decisions regarding their treatment,” the Oct. 29 Alberta letter reads, in part. “Should you wish to voice your concerns regarding any policy decision in Alberta, please contact your Member of Legislature (MLA.)”

Janssen also sent a letter to B.C. patients, dated Nov. 4, explaining that, as of Jan. 1, the company would no longer be able to provide financial assistance to patients who have provincially funded drug coverage as a result of the government’s decision to stop covering Remicade.

After reviewing the letters, Health Canada determined that Janssen’s Alberta and Ontario letters neither broke federal drug-promotion rules, nor misrepresented the department’s position on biosimilars, spokesman André Gagnon said by e-mail.

However, the letter to B.C. patients did misrepresent the department’s position, Mr. Gagnon said – a transgression that Health Canada has rebuked Janssen for in the past.

B.C. Health Minister Adrian Dix criticized Janssen’s tactics, which he said were aimed at guarding market share for Remicade.

“I’m obviously concerned," Mr. Dix said, “that confidential patient information that’s held in trust by pharmaceutical companies is being used for other purposes than originally intended."

Jennifer McCormack, a spokeswoman for Janssen, said by e-mail that the letters were distributed by a third party that provides administrative services for Janssen’s patient-support program, BioAdvance.

“We did not access patient addresses and contact information,” she said.

Ms. McCormack added that the company wanted to ensure patients understood that they would lose access to the support services provided by Janssen if other provinces followed B.C.'s lead.

Remicade is part of a class of drugs known as biologics, which are complex medications manufactured in living organisms and injected or infused into patients.

They are also expensive: Three of the top five prescription drugs in terms of public spending in Canada are biologics.

At the top of that list is Remicade, also known as infliximab, an IV infusion that treats rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

According to the Canadian Institute for Health Information, government drug plans across the country spent a total of $498.1-million, or $28,947 a patient, on Remicade in 2017 – despite the availability of biosimilar versions that sell for about half the list price.

(List prices do not reflect the secret discount deals that are now commonplace in the pharmaceutical industry. Janssen has said in the past that it offered a confidential lower price to the provinces, including B.C., but B.C. rejected the offer in favour of promoting biosimilars.)

Ms. Elliott said her government intends to consult widely before making any decisions about switching patients.

“We’re concerned about the 5-per-cent annualized growth in our [Ontario Drug Benefit] program. It’s not sustainable,” Ms. Elliott said. “So we’re looking at alternatives to see if a change from biologics to biosimilars is something that might work for Ontario.”

Health Canada and other drug regulators around the world say biosimilars are as safe and effective as the original drugs they mimic, and many European countries have either forced or cajoled patients to switch en masse to cheaper near-copies of Remicade.

As of the end of last year, biosimilars accounted for 98 per cent of the infliximab used in Norway, 92 per cent in Britain, 78 per cent in Sweden and 60 per cent in France, according to the Patented Medicine Prices Review Board, Canada’s drug-pricing regulator.

In Canada, that figure was 8 per cent.

However, Janssen is not alone in arguing that drug choices should be left to patients and their doctors.

Crohn’s and Colitis Canada, a national charity and patient advocacy group, and the Canadian Association of Gastroenterology recently published a joint position paper opposing the non-medical switching of patients from Remicade to a biosimilar.

Paul Moayyedi, a professor of gastroenterology at McMaster University and lead author of the new paper, said the evidence-based recommendation is rooted in two randomized, double-blinded, placebo-controlled trials that found inflammatory bowel disease patients were slightly more likely to fail treatment or require an increased dose after switching from Remicade to a biosimilar.

Neither trial found a statistically significant difference on its own, but when their results were pooled, Dr. Moayyedi said there was enough of a concern to warrant caution.

“We don’t really have the evidence to mandate a switch at this stage,” he said. "It isn’t clear that’s the right thing to do.”

While Crohn’s and Colitis Canada accepts funding from pharmaceutical companies, including Janssen and the companies that make biosimilar versions of infliximab, Dr. Moayyedi and his co-authors declared no financial conflicts of interest relevant to the new position statement.