Over the last few weeks, several decisions have been made by government authorities regarding access to and reimbursement for the latest myeloma therapies. Myeloma Canada keeps track of the decision and provide feedback when possible. To learn more, visit our drug access and coverage page. There you’ll find our Drug Access Navigator tool, information about how treatments are covered for Canadians, and more.

Note: It is not enough for any one government authority to approve or recommend a treatment for use or reimbursement. Similarly, 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.

Here is a very quick list of recent decisions: 

1. Belentamab mafodotin  

Belentamab mafodotin in combination with bortezomib and dexamethasone 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: not recommended for reimbursement 

• Canadian Drug Agency (CDA-AMC): recommended for reimbursement 

• Pan-Canadian Pharmaceutical Alliance (pCPA) : awaiting the start of price negotiations 

Belentamab mafodotin in combination with pomalidomide and dexamethasone  

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: not recommended for reimbursement 

• Canadian Drug Agency (CDA-AMC): recommended for reimbursement 

• Pan-Canadian Pharmaceutical Alliance (pCPA) : awaiting the start of price negotiations 

2. Selinexor (Quebec only) 

Selinexor as a 3rd line therapy 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: not recommended for reimbursement 

• Quebec Health ministry’s decision, QC: not registered on the list of medications for hospitals 

Selinexor as a 2nd line therapy in combination with bortezomib and dexamethasone 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: not recommended for reimbursement 

• Quebec Health ministry’s decision, QC: decision postponed (pending) 

3. DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone) 

DVRd for people who are eligible for a stem cell transplant 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: not recommended for reimbursement 

• Canadian Drug Agency (CDA-AMC): recommended for reimbursement 

• Pan-Canadian Pharmaceutical Alliance (pCPA): in active price negotiations 

DVRd for people who are not eligible for a stem cell transplant 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: evaluation in progress 

• Canadian Drug Agency (CDA-AMC): evaluation in progress 

4. IsaVRd (isatuximab, bortezomib, lenalidomide, and dexamethasone) 

IsaVRd for people who are not eligible for a stem cell transplant 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: recommended for addition to the list of medications under some conditions 

• Quebec Health ministry decision : decision postponed (pending) 

• Canadian Drug Agency (CDA-AMC): recommended for reimbursement  

• Pan-Canadian Pharmaceutical Alliance (pCPA): under evaluation for price negotiations 

5. Cilta-cel (ciltacabtagene autoleucel) – CAR T-cell therapy 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: recommended for reimbursement as a 4^th line therapy 

• Canadian Drug Agency (CDA-AMC): recommended for reimbursement as a 2^nd and 4^th line therapy 

• Pan-Canadian Pharmaceutical Alliance (pCPA): price negotiations terminated without agreement 

For more information about this decision, visit our Carvykti decision explainer.  

6. Talquetamab 

• Institut nationale d’excellence en santé et services sociaux (INESSS), QC: recommended for reimbursement 

• Canadian Drug Agency (CDA-AMC): not recommended for reimbursement 

• Pan-Canadian Pharmaceutical Alliance (pCPA): under evaluation for price negotiations 

New projects that aim to impact access to treatment

Project Orbis 

Project Orbis aims to accelerate access to oncology treatments around the world.  

What is project Orbis?   

• An international collaborative regulatory review initiative led by America’s Federal Drug Agency (FDA) (Australia, United Kingdom, Brazil, Israel, Switzerland, Singapore, and Canada) 

• Pharmaceutical regulatory agencies from these countries, including Health Canada, collaborate on regulatory review of promising new cancer drugs, aiming to better align international approval timelines and standards.  

How are drugs chosen for Project Orbis?  

• Drugs are chosen by the FDA alone. FDA reviewers can nominate new treatments based on ‘breakthrough designation’, impressive results, and unmet need. Sponsors may also request the Orbis pathway for “high impact, clinically significant” new drugs. 

Why does it matter?  

• Health Canada’s approval decision on a Project Orbis drug may not align with other partner agencies’, as HC’s decision to approve any new drug remains completely independent. Yet, Orbis reviews can still speed up our approval process by minimizing workload for Health Canada.  

• As well, the growing list of Project Orbis-reviewed drugs has become a starting point for new policy initiatives developed by various levels of government with the same goal— accelerating access to treatment for Canadians.  

Projects based on Orbis 

Two new accelerated access programs based on Project Orbis: 

1. Funding Accelerated for Specific Treatments (FAST) – Ontario 

FAST is a 3-year pilot program to start reimbursing Health Canada approved, Project Orbis-reviewed drugs immediately following positive reimbursement recommendation.  

On October 7, 2025, the Ontario government officially launched a new three-year pilot program, which will expedite access to provincial reimbursement for seven to ten Project Orbis-reviewed, Health Canada-approved cancer drugs, each year.  The FAST program will begin funding these new treatments immediately after Canada’s Drug Agency issues a positive recommendation, for the period while price negotiations at the pan-Canadian Pharmaceutical Alliance (pCPA) are ongoing.  

2. Early Negotiation Process (ENP) – pCPA 

The pan-Canadian Pharmaceutical Alliance (pCPA) is adding a new negotiation pathway similarly aiming to minimize the delay between a positive reimbursement recommendation and provincial listing. pCPA will initiate negotiations for Project Orbis-reviewed treatments following Health Canada-approval, intending to reach a price agreement and conclude negotiations at the same time as reimbursement recommendations are issued by Canada’s Drug Agency and the Institut national d’excellence en santé et en services sociaux (INESSS). This means provinces would be able to add these treatments to their public formulary right away.  

These programs have great potential to speed up timelines for drug approval/reimbursement, though there are limited details about either program currently available.  

We will keep our community updated as more information is released.