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A vial of Remicade at the Mount Sinai Hospital in Toronto.

Chris Donovan/The Globe and Mail

Quebec’s highest court has ordered the provincial government to restore full public coverage of Remicade, an expensive rheumatoid-arthritis medication the province had stopped funding for new patients as part of its quest to control prescription-drug spending.

The decision is a victory for Remicade-maker Janssen, a unit of the pharmaceutical giant Johnson & Johnson, and a blow to the Quebec government’s efforts to steer patients toward a new class of cheaper near-copycat drugs called biosimilars.

In a ruling released last month, the Quebec Court of Appeal found the province’s former health minister violated procedural fairness when, in February, 2017, he halted coverage of Remicade for patients who had never before taken the infused medication, which also treats Crohn’s disease, ulcerative colitis and a handful of other chronic ailments.

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Quebec, like every other province except Prince Edward Island, had decided that, for new patients, it would pay only for the less-expensive biosimilar versions of infliximab, the drug that Janssen sells under the brand-name Remicade.

Patients who were already taking Remicade were allowed to keep doing so.

The three-judge panel did not comment on the merits of delisting Remicade. Rather, it concluded the Quebec government should have given Janssen formal notice and an opportunity to respond before making the change.

“This shortcoming justifies, in this case, quashing the minister’s decision,” Justice Mark Schrager wrote in the Jan. 16 ruling.

The province’s Ministry of Health did not respond by deadline to a question about whether it would appeal the decision. On Monday, Quebec published a note reinstating coverage of Remicade for new patients.

Teresa Pavlin, a spokeswoman for Janssen, said the company was pleased with the court’s decision. “We are also pleased that Remicade is now available for new patients in the province of Quebec; this continues our commitment to preserve patient and physician choice,” she wrote in an e-mail.

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Although the appeal court made its decision on narrow procedural grounds, the ruling could have a wide impact on the future of money-saving biosimilars in Quebec and across the country.

“I think it’s going to cause further confusion,” said Ned Pojskic, the pharmacy strategy leader at Green Shield, a not-for-profit benefits carrier that promotes biosimilars. “What’s our policy direction? Why are we having such inconsistencies? If even governments can’t figure it out, why do you expect the physicians to do so?”

Remicade, Canada’s top-selling drug by revenue, is the first blockbuster biologic to lose its patent protection and face biosimilar competition, making it an important test case for Canada’s fledgling biosimilar industry.

In 2017, seven of 10 provinces, including Quebec, spent more money on Remicade than on any other prescription drug. Quebec spent about $120-million on Remicade that year.

The biosimilar versions of infliximab sell for about half the public or “list" price of Remicade, although the real price of Remicade is lower in some provinces because of confidential discount deals. Quebec has a policy that means it will only pay for the equivalent of the lowest-cost version of a drug.

Biosimilars are almost – but not quite – generic versions of biologic drugs. Unlike conventional pills, biologics are complex, large-molecule drugs manufactured from living cells. They are impossible to replicate perfectly.

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For that reason, biosimilars are not automatically interchangeable with their brand-name counterparts, which means physicians have to pro-actively prescribe the cheaper versions if biosimilars hope to gain a foothold in this country.

Most of Canada’s public drug plans, along with a handful of private insurers, have tried to force doctors’ prescribing pens by refusing to cover Remicade for new patients.

So far, they haven’t had much success. Janssen has retained a stranglehold on the Canadian infliximab market, largely because of a suite of tactics The Globe and Mail uncovered in an investigation last year. Those tactics included taking the Quebec government to court.

“I think it’s unfortunate,” said Jim Keon, the president of Biosimilars Canada, a division of the industry group that represents generic drug companies. “Prices and cost will only come down through competition – meaningful competition. That has to come from biosimilars.”

With files from Tu Thanh Ha

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