This article originally appeared in the Toronto Star on September 30, 2023.
Long wait times for new medicines in Canada, averaging two years, hinder patient access and limit life sciences investments.
Nolan Caskanette was only six weeks old when his mother, Kerri Beirnes, noticed he couldn’t lift his head during tummy time — something his sister Fiona had done easily when she was the same age. By the time Nolan was diagnosed with spinal muscular atrophy (SMA) type 1 at six months old, he was already in extreme respiratory distress due to a virus and needed a tracheostomy to clear his airway and a gastrostomy tube for feeding.
SMA is a rare genetic neuromuscular disease that causes muscles to weaken over time. Beirnes says that before treatments became available for SMA, most patients with type 1 didn’t live to see their second birthday.
Fortunately, only a few months before Nolan was diagnosed, a new treatment for SMA was approved in Canada and he was given early access by a pharmaceutical company through a compassionate use program. Today, although he still needs an electric wheelchair and 24/7 monitoring of his airway, six-year-old Nolan goes to school, plays in a bowling league, and is an avid Spider-Man fan.
While Nolan’s story is a powerful example of why it’s important to ensure fast access to approved new treatments, it’s not the reality for many patients. Canadian patients wait two years, on average, for access to new drugs through their public drug plans, which is a year longer than patients in most peer countries. This delay not only harms patients and their loved ones, it also limits Canada’s attractiveness for future life sciences investments, clinical trials, and drug launches.
Canada’s complex drug access process
The long wait times for access to new medicines are due to the complexities within Canada’s public drug access process. The process starts with a drug submission to Health Canada, which evaluates the safety, efficacy, and manufacturing quality of a new drug. Once Health Canada approves a drug, health technology assessment (HTA) agencies make funding recommendations to Canada’s public drug plans.
“For many patients, every month that goes by without access to an approved new treatment has the potential to decrease their quality of life and, in the worst cases, lead to loss of life.”
After the HTA assessment is complete, the pan-Canadian Pharmaceutical Alliance (pCPA) leads drug pricing negotiations on behalf of public drug plans, including with provincial, territorial, and federal governments. Finally, once a negotiation is completed, patients must wait until their province or territory puts the drug on their formulary, which outlines the specific drugs that are covered under their plan. Only then can patients gain access to the medication.
It takes an average of 732 days for a Health Canada-approved drug to be listed on a public drug plan. Patients deserve better.
Speeding up access for patients
Governments have an immediate opportunity to significantly reduce wait times for new drugs by addressing unnecessary delays in two key steps of the process.
First, governments who participate in a pCPA negotiation need to commit to listing drugs on their formularies within 30 days of a completed negotiation. While the delay in how quickly new drugs get listed after a negotiation varies from 51 to 247 days depending on the province, in all cases these periods serve no purpose and are too long for patients in need of life-saving or life-improving innovative treatments.
Secondly, governments can eliminate the 119-day delay between when the Canadian Agency for Drugs and Technologies in Health issues a recommendation for a drug and the pCPA starts its review of that drug. That’s almost four months of dead time with no progress for patients.
Giving hope to patients
A 2022 Conference Board of Canada report found that if Canadians living with five types of cancer had been able to access breakthrough treatments in the last decade, there would have been up to 226,445 life years gained and $5.9 billion in potential economic value.
For many patients, every month that goes by without access to an approved new treatment has the potential to decrease their quality of life and, in the worst cases, lead to loss of life. Governments must eliminate these unnecessary wait times so that six-year-old Nolan’s story becomes the norm, and not the exception, for Canadians accessing cutting-edge new treatments.