Quebec's INESSS Recommends Gazyva for Lupus Nephritis
On June 3, 2026, the Institut national d'excellence en santé et en services sociaux (INESSS) issued a positive recommendation for the public reimbursement of Gazyva (obinutuzumab) for the treatment of persons with active lupus nephritis who are receiving standard therapy. The announcement was made by Hoffmann-La Roche Limited (Roche Canada) on June 25, 2026.
This recommendation marks a significant step toward broader patient access in Quebec, following a similar positive recommendation from Canada's Drug Agency on May 6, 2026, and Health Canada's authorization in January 2026. Provincial jurisdictions will ultimately decide on public reimbursement.
Clinical Evidence Supporting the Decision
The INESSS decision was underpinned by data from the phase III REGENCY study. The trial demonstrated that nearly half of the participants (46.4%) receiving Gazyva in combination with standard therapy achieved a complete renal response, compared to 33.1% on standard therapy alone. Additionally, the study showed a statistically significant reduction in corticosteroid use and an improvement in proteinuric response.
Impact on Patients in Canada
In Canada, lupus affects approximately 1 in 1,000 people. Among those with lupus, nearly 40% develop lupus nephritis, a kidney-specific form of systemic lupus erythematosus (SLE). Lupus nephritis occurs when the immune system attacks the kidneys, potentially leading to impaired kidney function or kidney failure. Globally, the condition affects more than 1.7 million people, predominantly women of colour and usually of childbearing age. Currently, there is no cure.
Roche's Commitment to Access
“This positive recommendation from INESSS is an important milestone towards equitable access for patients with active lupus nephritis in Quebec,” said Simon Yunger, Vice-President, Value, Pricing and Reimbursement at Roche Canada. “This decision underscores the clear therapeutic value Gazyva delivers. Roche Canada remains fully committed to working with Quebec and all provincial and territorial jurisdictions to ensure Gazyva is made available swiftly through public drug plans.”
Roche Canada stated it is delighted that INESSS recognized the clinical evidence and benefit of Gazyva. The file now proceeds to the pan-Canadian Pharmaceutical Alliance (pCPA) for pricing negotiations, with Roche focused on securing broad public and private drug plan coverage across all provinces and territories.
About Lupus Nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys. It is characterized by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can accelerate nephron loss and, if untreated, may lead to progressive loss of kidney function. Even with current treatments, up to one-third of patients progress to end-stage kidney disease, where dialysis or transplant are the only options, and life expectancy and quality of life are substantially reduced.
