What is Carvykti®?

Carvykti® (ciltacabtagene autoleucel, or cilta-cel) is a type of CAR T-cell therapy, a personalized immunotherapy designed to treat multiple myeloma. It’s been shown to help patients live longer, including those who have exhausted other treatment options, with some remaining in remission for more than five years after a single infusion.

Drug approval and reimbursement processes: a very brief summary 

Health Canada approved Carvykti® in early 2023, which means the treatment was deemed safe and effective for use in Canada. But approval is only the first step. Before a drug can be publicly funded, it is reviewed by Canada’s Drug Agency (CDA) and the Institut national d’excellence en santé et services sociaux (INESSS) and recommended for reimbursement (or not).

After a positive reimbursement recommendation, the drug undergoes a pricing negotiation through the pan-Canadian Pharmaceutical Alliance (pCPA) between the provinces/territories and the drug manufacturers to determine the cost of the drug to be paid by public drug plans. Once the negotiation is complete, it is then up to the provinces to list the drug on their drug formularies.

What happened with Carvykti®? 

Recently, negotiations between the pCPA and Carvykti®’s manufacturer, Johnson & Johnson Inc., were stopped, and no agreement was reached. The reasons why negotiations were terminated are not publicly disclosed. As a result, Carvykti® is currently not covered by publicly funded drug plans, which means the only way to receive this therapy would be through a clinical trial, or pay out of pocket outside of the country. Ultimately, this leaves patients with little choice until provinces, territories, and the manufacturer return to the negotiating table, or another indication is submitted to Health Canada, and the process begins again.

This result puts Canada behind other countries like Spain, Belgium, and Portugal, where Carvykti® is already publicly reimbursed.

Note: Unsuccessful or unpursued negotiations do not mean a Health Canada-approved treatment with a positive reimbursement recommendation will never be publicly funded, but these results complicate and delay the process. 

Now what? 

Thanks to our advocacy campaign, we sent more than 5,500 letters to Members of Parliament and Ministers of Health across the provinces and territories, urging them to put pressure on decision-makers to return to the negotiating table. Myeloma Canada is now committed to meeting with decision-makers and making patients’ voices heard to ensure access to innovative, life-changing treatments like Carvykti®.

Our email campaign has concluded. Stay tuned for future updates if you’d like to take action and support our advocacy efforts.

You have made your voice heard in the press. Here are just a few of the media hits you’ve contributed to:

• “Canadians fighting rare cancer may have to pay 600k for last ditch treatment.” – Halifax City News
• “The bureaucracy slowing down access to life-saving drugs” – The Decibel podcast from the Globe & Mail
• “Blood cancer patients plead officials to resume pricing talks for cutting-edge treatment” – The Globe & Mail

Further action

While Canadians affected by myeloma have made their voice heard, our advocacy team has been hard at work. They have been in contact with several political leaders, health ministers, the manufacturer, and pCPA representatives, urging them to take action on this issue.

In summary:

– 5638 emails were sent to Ministers of Health, and provincial and territorial representatives 
– 28 responses were received (that we know of) 
– 6 meetings were held or scheduled between elected representatives and members of the Canadian myeloma community