Advocates fear Canada won’t be ready for drug that slows progression of Alzheimer’s

A compelling new drug to treat Alzheimer’s disease in its early stages is being considered a turning point in the treatment of the degenerative disease, but Canada may not be ready to take advantage of it.

Clinical trial data for the drug Donanemab, developed by the pharmaceutical company Eli Lilly, reported that it slowed cognitive decline by 60 per cent versus a placebo.

The Alzheimer Society of Ontario is optimistic about release of this data but fears the province won’t be ready.

“It’s important to stress these drugs are not cures for Alzheimer’s disease. You still have it. It’s not a cure. It’s not a vaccine. It can potentially extend your cognitive function,” said Kyle Fitzgerald, Director of Government Relations with the Alzheimer Society.

The drug was found to be most effective or showed a reduction in cognitive decline was significantly greater for people with mild cognitive impairment or in the earliest stage of Alzheimer’s disease.

If these treatments are approved for use in Canada, to be effective, “we need to get them to people as early as possible,” said Fitzgerald.

“Currently, you’re looking at anywhere from 12 to 18 months to see a dementia specialist in Ontario. That’s simply too long.”

Most Ontario patients aren’t officially diagnosed with Alzheimer’s

The Alzheimer Society recently commissioned research that showed if a disease-modifying therapy came to Ontario, like Donanemab, the wait time to receive a diagnosis would be seven-and-a-half years.

“That’s longer than many people who seek a diagnosis will live and far too long to make effective use of treatments,” said Fitzgerald.

He explained that most people in Ontario do not get a definitive diagnosis of Alzheimer’s disease. They get a probable diagnosis through the completion of a memory or cognitive assessment.

“They don’t actually get, nor could they get, a publicly-funded PET scan to confirm that diagnosis. If and when we have pharmacological interventions or treatments, we would need to radically scale up our pet scan capacity to confirm … the likely pathology of Alzheimer’s disease,” Fitzgerald added.

“The unfortunate reality is the industry has done its part; people living with dementia have done their part by signing up for clinical trials. Now we’re waiting for healthcare systems and, by extension, the governments that fund them to do their part and prepare for what we know is coming. We know this is coming, and we’re running out of time.”

There are just under 300,000 people currently living with dementia in Ontario, and that number is expected to triple within the next 30 years.

“By the time we get to 2050, that’s going to be just under a million people who are living with Alzheimer’s disease or another form of dementia.”

Concerns raised about Canadians having access to various drugs

Dr. Carmela Tartaglia, a cognitive neurologist and a scientist with the Krembil Brain Institute, said buying an extra six months that the drug could offer dementia patients is phenomenal.

“We get lost in that saying, ‘Well, how much time are you buying people?’ but who are we to judge? Keeping you in your state for an extra four to six months where you can enjoy time with your family. You are not dependent during that time. That’s very precious. And I think we shouldn’t underestimate that.”

Dr. Tartaglia said she is also concerned with Canadians being able to access these drugs due to a delay in diagnosing dementia and Alzheimer’s.

“There is going to be a very small window of time where you will be able to get this drug — you have to be in very mild stages of the disease. And you have to be fairly healthy in terms of you can’t have that many other things going on,” she explained.

“It’s not going to be easy for the Canadian healthcare system to get the right drug to the right person at the right time.”

She adds the problem within Canada would not only be the delay in diagnosing but the delivery of the drug.

“Even before these drugs came onto the Canadian landscape, we knew that Canada is not ready for disease-modifying therapies, especially these types.”

“The drug needs infusion … We don’t have many infusion centers. [And] the medications need follow up with MRI [and] there’s a huge backlog, especially since COVID-19. To have access to MRIs and you need to be followed for extended periods of time because there are risks associated with these drugs,” Dr. Tartaglia said.

Eli Lilly has not yet submitted the drug for approval within Canada, but the company tells CityNews they are looking forward to working with stakeholders to provide patients with appropriate access.

“Lilly is working with regulators around the world to accelerate submissions given the positive data read-out — the exact timeline for Canada is being evaluated, and Lilly will share updates as soon as they are available,” the company said in a statement.

Fitzgerald said he expects it will be submitted within the next six to 12 months, and the Alzheimer Society is fairly confident it will be approved.

“This is an amazing development, but we can’t forget about the hundreds of thousands of people who are going to still be living with Alzheimer’s disease not eligible for treatment,” he added.

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Another drug to slow the progression of Alzheimer’s, Lecanemab or Leqembi, was just approved by the Food and Drug Administration (FDA) in the U.S. and is currently under review from Health Canada.

Health Canada would not comment on the status of a drug under review.

“The timing for the completion of Health Canada’s review depends on many factors, including but not limited to a need for additional data, discussions with the sponsor, and requirements for updates to safety information,” a spokesperson said.

There are currently no treatments for Alzheimer’s disease itself approved for use in Canada.

The Ontario Ministry of Health acknowledge the wait lists for surgeries, procedures and diagnostics have been increasing year after year.

“Our government is not okay with the status quo and we know more needs to be done,” read their statement. “That is why earlier this year we launched Your Health. This plan includes the bold action we are taking to reduce wait times and bolster our healthcare workforce to make it easier and faster for patients to access the care they need.”

“None of us think this is the miracle cure. We’re enthusiastic that it’s kind of like the first ones out, which makes us very optimistic,” added Dr. Tartaglia.

“We hope it’ll increase the enthusiasm, the passion for finding disease-modifying drugs for these diseases.”