Access to CAR-T therapy, a cell-based, living treatment for some cancers, has recently become a controversial topic in Canada. That same therapy has a powerful impact on especially aggressive blood cancers. Patients like Jas Velic face enormous barriers to reaching this life-saving treatment in time — or at all. After CAR-T therapy’s initial global rollout, Health Canada approved their own CAR-T solution, the Carvykti variant, on February 9th, 2023. It hasn’t been an easy road to public funding.
CAR-T therapy entails connecting a patient’s own white blood cells cancer-fighting abilities by genetically modifying them to recognize and attack cancer cells. Its inventors were recently awarded a Canada Gairdner International Award, highlighting its promise. Right now, CAR-T therapy is funded publicly in Canada for specific leukemias and lymphomas. For many, the road to access this life-saving treatment is still an uphill battle.
Velic observed the kind of strident blood cancer that accelerated his decline. His oncologist explained that CAR-T therapy was his only real chance at survival. He faced significant challenges in the meantime as Carvykti attempted to make its way through Canada’s complicated drug approval process. In an oral history preserving their ordeal, Velic opened up about the heavy heaviness of this wait.
“It’s a lot of sleepless nights.” – Mr. Velic
In fact, Carvykti is already being reimbursed in 13 other countries, including the United States, Spain, and Belgium. This deep divide really shines a bright light on the incredible inefficiencies in Canada’s process for getting new drugs onto public plans. The process involves multiple entities: Health Canada, Canada’s Drug Agency, and the pan-Canadian Pharmaceutical Alliance (pCPA).
The pCPA negotiates public reimbursement for manufacturer’s products, and thus is responsible for negotiating discounts with manufacturers. For almost two years, we fought tooth and nail with Johnson & Johnson Innovative Medicine to get Carvykti approved. Unfortunately, those negotiations broke down in September 2023. Alaine Grand, speaking on behalf of the pCPA, praised the transparency in their negotiations, while recognizing the challenges they were up against.
“We had been very transparent as to what our limitations were for a very long time through those negotiations.” – Alaine Grand
Statistics reveal that on average, Canadians wait 906 days from Health Canada approving a drug until at least one province lists it for public funding. By contrast here in America, patients can pick up the latest lifesaving new meds the very day they get approved by FDA. This mismatch begs an important question about the commitment to improving the health of patients versus the value of bureaucratic process.
“Access to life-saving treatments should never be dictated by profit margins or political agendas.” – Ms. Velic
Watchdogs are sounding the alarm on these repetitive nationwide lags. Dr. Stewart’s point was that once a drug is determined to be ineffective, the answer should not take years to arrive at.
“If the answer is no, then it shouldn’t take two years to come to that conclusion.” – Dr. Stewart
This lag-time can be truly heartbreaking for patients fighting to survive from serious and often terminal illnesses. Velic asked why people in the United States on Medicare can receive CAR-T therapy without this kind of delay.
“People in the States with their Medicare are getting Car-T.” – Mr. Velic
These same advocates continue to scream for creative solutions to fast track the drug approval process. Arima Ventin called them out as pathways that keep new treatments from waiting in bureaucratic line.
“We would encourage them to look for innovative pathways so that drugs aren’t just waiting in the queue.” – Arima Ventin
Mina Tadrous highlighted another critical issue: late submissions from manufacturers significantly contribute to delays. Her findings indicate that late submissions were responsible for 49 percent of all delayed times in public reimbursement. Indeed, this trend held true through 2018-2023.
“The pCPA process should be held up as a pretty awesome way that the provinces, when they work together, are able to do better things.” – Mina Tadrous
The circumstances involving CAR-T therapy and other vital, potentially life-saving medicines lead to crucial questions about the healthcare Canadians have access to. Delays of care in life-saving therapies could be harmful and even fatal. Patients whose health is deteriorating experience true harm during these lags.
