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J&J's Remicade losing ground in Quebec health plan despite court victory

Allison Martell and Allison Lampert

TORONTO/MONTREAL, Nov 13 (Reuters) - Johnson & Johnson's Remicade, a blockbuster drug that treats autoimmune disorders, has steadily lost market share among patients enrolled in the Canadian province of Quebec's public drug program, even after a court ruling reinstated full coverage in January, a Reuters analysis of government data shows.

The plan's administrator stopped covering Remicade, J&J unit Janssen's version of the drug infliximab, for some new patients in February 2017, in favor of cheap near-copies called biosimilars, mainly Pfizer Inc's version of infliximab, called Inflectra. In January, a Quebec court ordered it to resume coverage.

Remicade's eroding market share underscores a gradual shift underway in Canada, where biosimilars have been slowly catching on with doctors and patients. The drug is under pressure elsewhere - in the third quarter, total global sales fell 17.6%.

Canadian governments have sought to boost the use of biosimilars as they try to bring down drug costs.

In case of infliximab, biosimilars' market share rose to 11.4% in January 2019, from 0.7% in February 2017, according to Reuters analysis of data provided by the Quebec plan's administrator, the Régie de l'assurance maladie du Québec (RAMQ). (Graphic: https://tmsnrt.rs/2q5Nfen)

Resuming coverage of Remicade, as the court ordered, did not reverse Pfizer's gains. By August 2019, 13.4% of 2,164 patients were on the biosimilar: a single patient on Merck & Co Inc's biosimilar, Renflexis, with the rest on Pfizer's biosimilar.

That left some 86.6% of the market to J&J, down from nearly 100%. About 3.7 million people are enrolled in the plan.

Though Canada has about 2% of global drug sales, it had 16% of Remicade sales in 2017, about C$1 billion ($755.8 million), according to the country's Competition Bureau.

Janssen said Remicade's re-listing was part of its "commitment to preserve patient and physician choice."

"We strongly believe the use of biosimilars in Canada should be based on what physicians determine is in the best interest of their patients rather than being driven by efforts that restrict treatment choice in any way," the company said in a statement.

Janssen said it is proposing agreements with Canadian governments to "provide the cost savings being sought."

"TOO LATE"

Louis Bessette, a rheumatologist and professor at Université Laval in Quebec, said doctors in Quebec have gained more experience with biosimilars, and the court ruling did not change his prescribing choices.

"We prescribe them more and more," he said of biosimilars. "I think for Janssen it was too late, and there's no coming back."

But Bessette noted that overall, patients are generally unwilling to switch to biosimilars.

Those patients look to be the new frontier for Canadian governments: In May, the province of British Columbia said it would require thousands of patients on its public drug plan to switch to biosimilars. Health Canada says biosimilars are just as safe and effective, but some drugmakers and patient groups have pushed back.

So far, Quebec has no switching policy. And Pfizer remains frustrated with slow biosimilar uptake in Canada.

"This slow uptake undermines the potential value that biosimilars can offer and the savings they can bring to the health care system," Pfizer said in a statement.

Pfizer said its internal data shows a recent decline in the number of new patients prescribed Inflectra, which the company attributes to the January court ruling. Comparing March to September 2019 to March 2017 to February 2019, they said, new enrollments dropped 30%.

The RAMQ data obtained by Reuters shows that growth prescriptions for Inflectra and Remicade leveled off in early 2018. It is not clear what is behind this trend, which predates the court ruling.

One possible explanation is competition from new drugs. Waqqas Afif, a gastroenterologist at McGill University Health Center in Montreal, said doctors are prescribing Takeda Pharmaceutical Co Ltd's Entyvio and Janssen's Stelara to some patients instead of infliximab.

Quebec's health ministry said in a statement it is working on a biosimilar policy but declined to go into detail on the options it is considering. ($1 = 1.3231 Canadian dollars)

(Editing by Denny Thomas and Lisa Shumaker)