N.B. drug plan changes have some inflammatory bowel disease patients, doctors concerned

In about 30 years of living with ulcerative colitis, 54-year-old Guy Hbert of Moncton has tried quite a few different medications.

Some have helped a bit, he said, while some seem to have added to his health problems.

A national advocacy group for people with conditions like Hbert's is raising a red flag that replacement drugs now being adopted by New Brunswick's drug plans may add problems for some patients.

"The studies in Crohn's and colitis, for whatever reason, are indicating that perhaps there's an increased chance of flaring up after you switch from a biologic to a biosimilar," said Dr. Eric Benchimol, chair of Crohn's and Colitis Canada's scientific and medical advisory council.

The New Brunswick Health Department announced in April that several biologic medications whose patents have expired would no longer be covered under provincial drug plans as of Nov. 30. They are being replaced with similar, cheaper versions.

The original medications include Lovenox, Humira, Enbrel, Remicade, Lantus, Humalog, Rituxan and Copaxone.

They have been used to treat plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, diabetes, multiple sclerosis and several other conditions.

About 3,000 of the 135,000 people covered by New Brunswick's drug plans were taking the medications in question as of last spring, according to the Health Department.

Most have already switched, a spokesperson for the department said this week.

But Benchimol urged the province to extend the transition period.

"What we're asking for," he said, "is that it's done carefully, that it's done slowly and that we work with the government to try to figure out who should get switched and who should not."

"You really need at least 12 months," Benchimol said.

In announcing the plan to transition to biosimilars, the Health Department noted that patients in B.C. and Alberta had been "safely" transitioned to biosimilars over the previous couple of years and thatbiosimilars have been used "extensively" in Europe for over 15 years.

But Benchimol, a pediatric gastroenterologist and epidemiologist in Toronto, said he and his colleagues have been "hearing a lot of stories of that switch causing problems and patients falling through the cracks."

Benchimol also expressed concern about other impacts on patients, some of whom have "gone through a lot" before they began taking these particular biologic drugs.

The prospect of switching "makes them very anxious and very nervous understandably," he said.

Some have already tried several other biologics unsuccessfully.

"You shouldn't rock the boat if things are going well," said Benchimol. "That is a very dangerous situation to be in."

Hbert said his doctors have not yet raised the possibility of his switching to a biosimilar from Humira, which he only began taking last spring.

He sees his doctors at least once a month and his most recent appointment was just last week.

Hbert said Humira has helped him a little, especially after his dosage was upped to a second injection per week.

But his condition is still severe, he said, and is compounded by several other health issues, including arthritis and diabetes.

Some days, Hbert said, he wakes up and can't move because he's in so much pain or his stomach is bloated "like a balloon."

He wears a diaper when he leaves the house and still has accidents once or twice a week.

But mentally, he's in a much better place than he has been in the past.

Colitis nearly drove him to suicide at one point, he said.

He'd been out on a Friday night and lost control of his bowels. Strangers around him noticed he'd accidentally soiled himself and began laughing at him.

Hbert's reaction was to get into his car and drive as fast as he could.

He was doing about 230 km/h and aiming for a culvert to crash into and end his life when his phone lit up with a call from his daughter. That's whenhe hit the brakes.

The following Monday morning, he poured his heart out to a social worker and began a process of emotional healing.

Despite his ongoing health issues, Hbert said he still has some faith in medical science.

If his doctors want him to switch to yet another drug, Hbert said, he'll probably do it.

Health Minister Dorothy Shephard acknowledged that news of the switch is "concerning."

"I probably would be concerned if my drug was going to be switched," she said at a news conference Wednesday.

"But you know, we use generic drugs as easily as we do other brands. And this is in the same context."

However, Benchimol noted that unlike generic versions of other types of drugs, biosimilars are slightly different from the original biologic drugs they're replacing, which are made from DNA in different laboratories, using different processes.

A body that's used to getting the original may respond to the new drug as if it's something that needs to be fought off. In some cases, he said,patients have had allergic or immune-type reactions.

"I've had patients myself that have missed a dose that's when you get the antibodies to the drug happening."

Slight variations also occur between batches of original biologics, noted the Health Department on its website, which also statesthat dozens of studies have found no"significant differences in safety, efficacy or immunogenicity after switching compared to patients who were not switched."

Shephard said the province will work with health-care providers and the public"to ensure they're getting the results they need," adding "it's going to take a while for us to see full implementation."

Some patients will continued to be covered for original biologics if they get special authorization, according to the Health Department's website.

Biosimilars are "as effective as patented initial drugs," and can save the drug plans "a considerable amount of money," Shephard said.

The department's projected savings are $10 million a year on total drug plan costs of about $220 million.