OPDIVO Subcutaneous Formulation Receives Positive Reimbursement Recommendation in Quebec
Key Insights
INESSS (search) has issued a positive recommendation for reimbursement of OPDIVO SC (nivolumab subcutaneous injection) across multiple solid tumor indications in Quebec.
The subcutaneous formulation, approved by Health Canada in May 2025, can be administered in minutes compared to traditional IV infusion, offering greater flexibility for patients and healthcare systems.
OPDIVO SC is approved for use across eight solid tumor types including renal cell carcinoma (search), melanoma (search), NSCLC, and head and neck cancers in various treatment regimens.
Bristol Myers Squibb (search) Canada announced that the Institut national d'excellence en santé et en services sociaux (INESSS (search)) has issued a positive recommendation for the reimbursement of OPDIVO SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorized solid tumor indications where intravenous OPDIVO is currently reimbursed. This milestone decision represents a significant step toward broader patient access to the recently approved subcutaneous formulation and reinforces its value within Canada's evolving oncology care landscape.
Clinical Advantages and Administration
The subcutaneous formulation of nivolumab, approved by Health Canada in May 2025, can be administered in minutes, offering an alternative route of administration that could support time savings in clinic for eligible patients and more flexible use of healthcare resources. The INESSS (search) recommendation builds on the recognized therapeutic value of intravenous OPDIVO and reflects confidence in the clinical efficacy and safety of OPDIVO SC.
"The availability of a subcutaneous option like OPDIVO SC across several tumor types introduces added flexibility in how we deliver immunotherapy," said Montreal-based hematologist-oncologist Dr. Normand Blais. "It presents an opportunity to adapt care pathways in ways that take into account both system-level demands and patient needs—an important balance as we continue to evolve cancer care."
Patient and Healthcare System Benefits
Healthcare professionals emphasize the practical advantages of the subcutaneous formulation for both patients and healthcare delivery. Annie Bombardier, RN, CSIO(C), a Montreal-based oncology nurse, highlighted the patient-centered benefits: "As nurses, we see every day the time and energy that cancer treatment demands of patients and their families. The option to receive OPDIVO subcutaneously means less time connected to an IV and more time for patients to focus on what matters most to them. This advancement supports both patient needs and the efficiency of our healthcare system."
Approved Indications and Treatment Regimens
OPDIVO SC is approved for use across currently authorized solid tumor indications in monotherapy, in the maintenance phase following combination with ipilimumab (YERVOY), and in combination regimens with chemotherapy or tyrosine kinase inhibitors. The approved indications include:
- Renal cell carcinoma
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- MSI-H/dMMR colorectal cancer (prior treatment)
- Esophageal and gastroesophageal junction cancers
- Gastric, GEJ, and esophageal adenocarcinoma
Market Access and Future Outlook
Elaine Phillips, General Manager of Bristol Myers Squibb (search) Canada, emphasized the significance of the INESSS (search) recommendation: "This positive recommendation from INESSS is an important step toward expanding access to innovative treatment options for patients in Quebec. The subcutaneous formulation of OPDIVO reflects our ongoing commitment to delivering scientific innovation that respond to real-world needs. We look forward to continued work with healthcare partners across Canada to enable timely access to OPDIVO SC—supporting sustainable care that meets both patient needs and the healthcare system."
The positive recommendation signals recognition of the subcutaneous formulation's potential to align with healthcare system needs through an alternative mode of immunotherapy delivery, potentially transforming how cancer care is delivered across multiple tumor types in Quebec.