Alberta senior says province's move to change biologic drug coverage has left her in agony

Last year, the Alberta government announced plans to change drug coverage for about 26,000 residents in an effort to save about $380 million over the next four years.

Albertans who have diabetes, rheumatoid arthritis and Crohn's disease were told they had until July 1 to make a switch from biologic drugs to biosimilar drugs, though as a result of the COVID-19 pandemic that date was extended until Jan. 15, 2021.

The change provoked anxiety among some Albertans, who worried their health challenges might return after having years of success on drugs like Remicade.

"It took so darn long for me to get back to normal and I don't want to regress," said 58-year-old Tom Rechenmacher at the time, who had responded well to treatment on Remicade.

The exact timing of the switch is up to the doctor and the patient, but some Albertans, including Rechenmacher, have transitioned prior to next year's deadline.

For Rechenmacher, who switched to a biosimilar in mid-July, the switch has gone well.

"By all accounts I've been doing very well with it. I hope it continues," he said. "I guess my apprehension was all for naught."

But others are not having the same level of success.

'I feel really abandoned'

Calgary resident Bodil Petersen, 86, has rheumatoid arthritis.

Petersen's illness used to make her so sick that she couldn't even get out of bed. For 22 years, Remicade relieved that pain.

But in advance of the 2021 deadline, Petersen's drugs were switched from Remicade to Inflectra.

"This new stuff, it doesn't work. I can't sit still, because my old body's aching everywhere," Petersen said. "What can I do? Because I feel really abandoned."

Since switching drugs, Petersen has started keeping a list of her new symptoms. She said she has aches in her hands that she described as feeling like a toothache.

Once, while sitting, she felt a pain in her shoulder blades. She screamed, because it felt like a knife was being slid into her back.

"I'm just not myself. It's totally changing my whole personality. Because I'm pragmatic, whatever comes up I handle it," Petersen said.

"Now, I cry two or three times a day because it affects my emotions, my nervous system."

Annette Reed, Petersen's daughter, said the switch in drugs has led to a physical and mental decline.

"She is sobbing, almost inconsolably sometimes, which is nothing like what she is," Reed said.

Exception requests

The government has said any patient whose doctor shows a valid clinical reason against a switch to biosimilars will be granted an exception.

"Exception requests are reviewed on a case-by-case basis by a team of specialist physicians knowledgeable about that clinical area," said Tom McMillan, a spokesperson with Alberta Health, in an email. "Exemptions have been granted in some areas, including for a rheumatological drug.

"To date, only six exception requests for a rheumatological drug have been denied."

Reed said her mother applied for an exception through her doctor, but was rejected.

"Her doctor put the application through but heard back that it was not accepted," she said.

Petersen said she's overwhelmed with her symptoms and just wants her old medicine back.

"I think they should at least have some compassion and let me have my medicine back so I can live a decent life without pain all the time," she said. "That's my story. I've tried everything."

McMillan said if a request is denied, the request can be resubmitted if the patient's status changes or new information becomes available.

"We'd absolutely [resubmit]. She's desperate — this is no life for her," Reed said. "She's at her wit's end."

Medical position

In his email, McMillan said that Health Canada has stated that biologics and biosimilars are equally safe and effective.

"Biosimilars provide a clinically effective treatment option and cost-saving alternative to the higher-priced originator biologic," he wrote.

Critics of Alberta's switch from biologics to biosimilars do not dispute that biosimilar drugs are safe and effective, but have cautioned that some patients will get sick.

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, has argued for a more gradual switch based on additional data.

"I can't see any data that helps me understand whether this is safe or not," he said. "The limited information that we do have suggests that [among] those switched, this could actually be harmful, in that you'll have more people failing from the switch than they would if they just carried on on the originator.

"In contrast, those starting the drug new [seems] to work as well as the originator, as best we can tell."

Moayyedi said the difference in reaction between Rechenmacher and Petersen illustrated a range of potential outcomes from the switch.

"Of course, even if you've done well [on Remicade] for 28 years, it could mean that 29 years would be your year to relapse anyways," he said. "But there is concern that the two [described] are exactly what we would predict from this data.

"Yes, the majority of people will do just fine, and a significant minority will get a relapse that they wouldn't have had they stayed on the originator."

Last year, the Alberta government cited statements from Crohn's and Colitis UK and the European Crohn's and Colitis Organization in support of its plan, while also pointing to the example of British Columbia.

At the time, the non-profit Crohn's and Colitis Canada said it agreed that biosimilars were safe and effective but said that switching for non-medical reasons was "not in the best interest of patients."

Under the Alberta government's plan, residents who are on private drug plans or are paying out of pocket aren't affected, and the change also doesn't apply to children or pregnant women.