Pricing Negotiations for CAR-T Therapy Carvykti Collapse in Canada, Leaving Multiple Myeloma Patients Without Access
核心洞察
Pricing negotiations between the pan-Canadian Pharmaceutical Alliance (搜索) and Johnson & Johnson for Carvykti, a CAR-T therapy for multiple myeloma (搜索), collapsed in September after nearly two years of discussions.
The therapy, approved by Health Canada in February 2023, has a sticker price of $632,455 and showed remarkable results with 33% of heavily pretreated patients remaining alive and progression-free at five years.
Nearly 1,000 Canadian multiple myeloma (搜索) patients and caregivers have launched a letter-writing campaign urging officials to resume negotiations for the potentially curative treatment.
Nearly 1,000 Canadians with multiple myeloma (搜索) and their caregivers have launched an unprecedented advocacy campaign after pricing negotiations for a groundbreaking CAR-T therapy collapsed, leaving patients without access to a treatment that could extend their lives by years.
The campaign targets the failed negotiations between the pan-Canadian Pharmaceutical Alliance (搜索) (pCPA) and Johnson & Johnson for Carvykti (ciltacabtagene autoleucel), a personalized immunotherapy that Health Canada approved in February 2023 but remains unavailable to Canadian patients nearly three years later.
Negotiations Reach Impasse After Two Years
Pricing discussions for Carvykti terminated in September 2025 without agreement, nearly two years after negotiations began on November 10, 2023. The therapy carries a sticker price of $632,455 in Canada, though the final cost would be lower with confidential discounts typically negotiated by the pCPA.
"Negotiations are two-way streets and all negotiating parties play an important role in reaching agreements," said Mauro Chies, CEO of the pCPA, in a statement. "Should Janssen Inc. want to come back to the table and re-engage in a negotiation, they can submit an unsolicited proposal, which we would welcome."
The pCPA operates on a consensus model requiring all provincial, territorial, and federal drug plans to agree on pricing. The organization saved Canadian public plans nearly $4 billion last year through confidential discounts on brand-name drugs.
Remarkable Clinical Results Drive Patient Advocacy
The CARTITUDE-1 study demonstrated unprecedented results for Carvykti in heavily pretreated patients with relapsed/refractory multiple myeloma (搜索). One-third (33%) of patients remained alive and progression-free at five years after a single infusion, without maintenance therapy.
"To our knowledge, our data provide the first evidence that cilta-cel is potentially curative in patients with RRMM," according to the study report.
Martine Elias, executive director of Myeloma Canada (搜索), described the negotiation failure as "absolutely devastating." She noted that 955 patients and their supporters had sent 2,140 letters to politicians across the country as of Sunday afternoon.
"Patients are waiting for it. They need it," Elias said. "Many patients are at the stage in their treatment where they have no more options."
CAR-T Technology Offers Personalized Treatment
Carvykti represents a type of CAR-T therapy already publicly funded in Canada for some leukemias and lymphomas. The treatment involves drawing a patient's blood, genetically engineering their T-cells (搜索) to attack myeloma cells, then infusing the personalized therapy back into the patient in a single treatment.
Dr. Richard Leblanc, hematologist and medical oncologist at l'Hôpital Maisonneuve-Rosemont in Montreal, emphasized the therapy's potential impact. "In the CARTITUDE-1 study, many patients who had exhausted every other treatment remained in remission for years after a single infusion — results we have never seen before in myeloma."
Disease Burden and International Access
Multiple myeloma (搜索), the second most common blood cancer (搜索) in Canada, affects 11 Canadians daily, with diagnoses steadily rising for over 15 years. The disease impacts plasma cells (搜索) found in bone marrow, and while treatments have improved survival, no cure currently exists.
Carvykti is already publicly reimbursed in 13 countries worldwide, including Spain, Belgium, and Portugal, highlighting Canada's lag in providing access to innovative therapies.
Patient advocate Lorelei Dalrymple, who has lived with myeloma for 16 years and undergone three lines of therapy, expressed frustration at the situation. "Carvykti literally has the potential to save my life, yet this chance is denied to me because I live in Canada," she said.
Industry Response and Path Forward
Johnson & Johnson's Alaine Grand, vice-president of market access and strategic customers, indicated the company remains open to individual provincial negotiations. "We will continue working with willing provinces – whether individually or as a group – in efforts to secure product listing agreements for their constituents," she stated.
However, Dr. Darrell White, a hematologist at the Queen Elizabeth II Health Sciences Centre in Halifax and chair of the Canadian Myeloma Research Group, advocated for maintaining the national approach through the pCPA to ensure patients in smaller provinces aren't excluded.
"It's very disappointing from the patient point of view," Dr. White said. "CAR-T, frankly, is just one of many advances. There's nothing all that magical about it, but it certainly is a very good treatment. I think we will have it eventually. It's just very slow in Canada compared to what's available in the U.S."
The advocacy campaign represents a critical moment for Canadian healthcare access, as patients with limited treatment options await resolution of the pricing impasse that could determine their survival prospects.