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National reimbursement negotiations for Carvykti® terminated without agreement, devastating Canadians with myeloma Français


News provided by

Multiple Myeloma Canada

Sep 30, 2025, 07:00 ET

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"Carvykti® literally has the potential to save my life, yet this chance is denied to me because I live in Canada." – Lorelei Dalrymple, Canadian with myeloma

MONTREAL, Sept. 30, 2025 /CNW/ - Myeloma Canada, representing the Canadian myeloma patient and care partner community, is dismayed that negotiations to achieve a listing agreement for the national reimbursement of Carvykti® (ciltacabtagene autoleucel; cilta-cel) have been terminated, without agreement, between the pan-Canadian Pharmaceutical Alliance (pCPA) and Johnson & Johnson Inc., the drug's manufacturer.

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Myeloma Canada 20th anniversary logo (CNW Group/Multiple Myeloma Canada)
Myeloma Canada 20th anniversary logo (CNW Group/Multiple Myeloma Canada)

Carvykti®, a highly effective and promising new CAR T-cell therapy (cellular immunotherapy) for myeloma patients, was first authorized for use by Health Canada in February 2023. The failure to agree on reimbursement for this groundbreaking therapy denies Canadians with myeloma the potential to extend their lives by years with possible curative results1.

Myeloma Canada is urging all provinces and territories, under the umbrella of the pCPA, and Johnson & Johnson Inc. to resume negotiations immediately – as a group or individually – and ensure timely access to this life-extending therapy for all Canadians with myeloma.

Multiple myeloma, also known as myeloma, is the second most common blood cancer in Canada. 11 Canadians are diagnosed with the disease every day, and that number has been steadily rising for over 15 years. Thanks to innovative research producing novel therapies like Carvykti®, we are witnessing an unmatched potential to improve patient outcomes. The impasse represented by last week's staggering decision is yet another example of how science is advancing at an unprecedented rate but bureaucracy is impeding revolutionary new therapies to get to those who need them. Patients are paying the price, with their lives.

"This is unacceptable", stated Martine Elias, Chief Executive Officer at Myeloma Canada. Elias added, "To say this news is absolutely devastating for myeloma patients and their loved ones, is an understatement; it's gut wrenching. The gains seen in patients receiving Carvykti® are tremendous, extending survival in terms of years, not months. How can this possibly be denied to Canadians?" Elias continued, "As shared outright with me by myeloma physicians, 'because of this decision, patients will die'. This is irrefutably and utterly reprehensible."

Carvykti® is poised to radically change the life of people with myeloma, many of whom have limited or no other options. The CARTITUDE 1 study1 evaluated outcomes of previously heavily pretreated patients – those with advanced relapsed/refractory multiple myeloma (RRMM) – who then received Carvykti® (cilta-cel). One third (33%) of patients remained alive and progression-free ≥5 years after a single infusion, without maintenance therapy.1 As stated in the report, "To our knowledge, our data provide the first evidence that cilta-cel is potentially curative in patients with RRMM."1

"As physicians, it is profoundly difficult to know that a therapy like Carvykti® exists, yet we cannot offer it to our patients", stated Dr Richard Leblanc, Hematologist & Medical Oncologist at l'Hôpital Maisonneuve-Rosemont (HMR) in Montreal, QC. Dr Leblanc continued, "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. Carvykti® gives patients the possibility of prolonged survival and valuable time with loved ones. It is deeply troubling that access to this treatment is being hindered by a halt in negotiations. For a therapy with such significant potential impact for patients with multiple myeloma, it is essential that the parties return to the negotiating table for an eventual agreement."

Carvykti® is currently reimbursed by the public system in 13 countries around the world, including Spain, Belgium and Portugal. With the decision to terminate reimbursement discussions for Canadians, lives will be lost and Canada will be falling behind other countries. This is an embarrassment for Canada and unfathomable for the Canadian myeloma population.

"As someone living with myeloma for the past 16 years and who has undergone 3 lines of therapy, it is infuriating to know that a therapy like Carvykti® exists, yet bureaucratic policies and red-tape — not scientific know-how — are stopping me, and others like me, from having access to it" declared Lorelei Dalrymple, myeloma patient and Vice-Chair of the Myeloma Canada Board of Directors. Dalrymple added, "Imagine if your life depended on a treatment therapy that's actually approved for use in Canada, but you can't be treated with it? How is this even acceptable? Canadians with myeloma deserve the same access to life-changing therapies as those in other countries. We are shamefully being left behind, and our lives are at stake." continued Dalrymple.

On behalf of the Canadian myeloma community, Myeloma Canada is appealing for discussions to be renewed, for provincial and territorial decision makers, who under the pCPA were involved in the negotiations, to reach consensus on reimbursement. Myeloma Canada vows to do all it can to have Carvykti® made available to Canadians who need it.

About multiple myeloma
Multiple myeloma , also known as myeloma, is the second most common form of blood cancer. Myeloma affects a type of immune cell called the plasma cell, found in the bone marrow. While there is currently no cure, people with myeloma are living longer and better lives, thanks to recent breakthroughs in treatment. To find a cure, more funding and research are required.

About Myeloma Canada
Myeloma Canada is the only national charitable patient organization created by, and for, Canadians impacted by multiple myeloma. The organization is driven to improve the lives of all Canadians affected by myeloma by accelerating access to the best care while advancing research toward its cure and prevention. Celebrating its 20th anniversary this year, Myeloma Canada has been making myeloma matter since its founding in 2005.

To learn more, please visitwww.myeloma.ca.

 
 1 
 Long-Term (>=5-Year) Remission and Survival After Treatment with Ciltacabtagene Autoleucel in CARTITUDE-1 Patients with Relapsed/Refractory Multiple Myeloma

SOURCE Multiple Myeloma Canada

To schedule an interview, please contact: Marcie Baron - Director, Strategic Communications Initiatives at Myeloma Canada, [email protected], Toll-free: 1-888-798-5771

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