Drugs, Health Technologies, Health Systems
Indication: For the treatment of adult patients with active lupus nephritis who are receiving standard therapy
Sponsor: Hoffmann-La Roche Limited
Recommendation: Reimburse with conditions
Summary
What Is the Reimbursement Recommendation for Gazyva?
Canada’s Drug Agency (CDA-AMC) recommends that Gazyva be reimbursed by public drug plans for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, if certain conditions are met.
Why Did CDA-AMC Recommend Reimbursement?
The Canadian Drug Expert Committee (CDEC) concluded that Gazyva demonstrates acceptable clinical value in patients with active lupus nephritis who are receiving standard therapy and addresses the need identified by patients to preserve kidney function and reduce corticosteroid use. Given that Gazyva is expected to be an alternative treatment to belimumab, comparable clinical value to belimumab was considered to represent acceptable clinical value. This determination was sufficient for CDEC to recommend that Gazyva be reimbursed for this indication.
Evidence from 1 randomized controlled trial (the REGENCY trial) demonstrated that treatment for 76 weeks with Gazyva plus standard therapy with glucocorticoids and mycophenolate mofetil likely resulted in added clinical benefit for patients with active lupus nephritis compared with placebo plus standard therapy with glucocorticoids and mycophenolate mofetil, in terms of complete renal response (CRR) and CRR with successful prednisone taper to less than or equal to 7.5 mg/day or equivalent. Evidence from 1 indirect treatment comparison of Gazyva versus belimumab did not demonstrate significant differences in outcomes between the treatments, although it was associated with methodological limitations and imprecision. CDEC found it reasonable to consider that the drugs offer comparable value.
Which Patients Are Eligible for Coverage?
Gazyva, in combination with standard therapy, should only be covered for adult patients with a confirmed diagnosis of active lupus nephritis. Patients should have an estimated glomerular filtration rate of at least 30 mL/min/1.73 m2 and a urine protein to creatinine ratio of at least 1 g/g based on 24-hour urine collection.
What Are the Conditions for Reimbursement?
Gazyva should be reimbursed if prescribed in combination with standard therapy by clinicians with expertise and experience in treating lupus nephritis, and if the cost of Gazyva plus standard therapy does not exceed the total cost of treatment with belimumab plus standard therapy. For renewal after the initial authorization and for discontinuation, Gazyva should follow the same renewal and discontinuation criteria as belimumab, in accordance with the reimbursement criteria of each public drug plan for treating lupus nephritis.
Disease background: Lupus nephritis is a serious kidney complication of systemic lupus erythematosus (SLE), resulting in inflammation and damage that can threaten kidney function. The estimated prevalence of SLE is about 1 in 2,000 individuals in Canada; of these, approximately 50% of patients with SLE will develop lupus nephritis. Disease onset typically occurs between 16 and 55 years. SLE is about 9 times more common in females than males.
Indication and reimbursement request: Obinutuzumab (Gazyva) has been approved by Health Canada for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. The sponsor is seeking reimbursement for this patient population.
Drug under review: Obinutuzumab is a type II anti-CD20 monoclonal antibody, available as a 25 mg/mL solution for IV infusion. The recommended initial dose is 1,000 mg. For dose 2 (2 weeks after dose 1), dose 3 (week 24), dose 4 (week 26), dose 5 (6 months after dose 4), and doses thereafter (every 6 months), the recommendation is 1,000 mg administered at a rate of 100 mg per hour.
Treatment costs: At the submitted price of $5,751.73 per 40 mL vial, the annual cost of obinutuzumab is expected to be $23,007 per patient in the first year of treatment and $11,503 in subsequent years, based on the Health Canada–recommended dosage.
The patient groups (Arthritis Consumer Experts; the Kidney Foundation of Canada and Lupus Canada; and a joint submission from Lupus Ontario, the Canadian Arthritis Patient Alliance, and Arthritis Society Canada) noted the following regarding impacts of the disease, unmet needs, and important outcomes:
Patients emphasized experiencing a range of difficult-to-manage symptoms, including fatigue, skin rashes, nausea, loss of appetite, joint pain, bruising, cognitive dysfunction (brain fog), back pain, and mental health challenges. Lupus nephritis leads to chronic kidney inflammation and scarring, often progressing to kidney failure requiring dialysis or transplant.
The disease and its treatment impose substantial physical, emotional, and socioeconomic burdens, leading to significant limitations in daily functioning. The burden of lupus nephritis extends beyond patients to their caregivers, who often face significant emotional stress and logistical challenges when coordinating care.
Unmet needs include affordable, pregnancy-safe treatments with fewer side effects, simpler administration, better preservation of kidney function, and reduced reliance on long-term, high-dose corticosteroids. Current treatment challenges include addressing infusion-related work disruptions; treatment refrigeration requirements; long travel distances; specialist shortages; long wait times; and high out-of-pocket costs for medications, travel, and allied health support.
The clinician groups (the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus and the Toronto Lupus Program and Nephrology colleagues) and the clinical experts consulted by CDA-AMC noted the following regarding unmet needs arising from the disease and place in therapy for the drug under review:
Current lupus nephritis therapies achieve remission in less than 50% of patients, based on the literature and clinical practice, and are associated with substantial relapse rates. Rituximab may be used off-label and is generally reserved for refractory disease, as B-cell depletion may be incomplete.
Current treatment regimens may involve nephrotoxicity, frequent monitoring, and complex administration, which may pose challenges in rural or remote settings. Many therapies are associated with significant short-term and long-term adverse events, and few options are considered safe during pregnancy, highlighting the need for more effective, safer, and accessible treatments.
The participating public drug programs raised potential implementation issues related to considerations for initiation, renewal, discontinuation, and prescribing of therapy, as well as care provision issues.
With a vote of 15 in favour to 0 against, the Canadian Drug Expert Committee (CDEC) recommends that obinutuzumab be reimbursed for the treatment of adults with active lupus nephritis, only if the conditions listed in Table 1 are met.
Table 1: Reimbursement Conditions and Reasons
Reimbursement condition | Reason | Implementation guidance |
|---|---|---|
Initiation | ||
1. Treatment with obinutuzumab can be initiated for the treatment of active lupus nephritis if all of the following conditions are met: 1.1. adult patient with confirmed diagnosis of active lupus nephritis 1.2. eGFR ≥ 30 mL/min/1.73 m2 1.3. UPCR ≥ 1 g/g based on 24‑hour urine collection. | The REGENCY study enrolled adults (aged ≥ 18 years) with biopsy-confirmed active lupus nephritis, specifically class III or IV disease, with or without concomitant class V involvement. In addition, patients enrolled in the REGENCY study were required to exhibit significant proteinuria, defined as a UPCR ≥ 1 g/g based on a 24-hour urine collection at screening. The REGENCY study excluded patients with an eGFR < 30 mL/min/1.73 m2. | Diagnosis of lupus nephritis must be confirmed by kidney biopsy. CDEC noted that patients with pure class V lupus nephritis were excluded from the REGENCY trial. CDEC acknowledged that the 2025 EULAR treatment guidelines note a shift away from class-based treatment with a broader focus on active disease. Therefore, as suggested by the clinical experts consulted, obinutuzumab may be a treatment option in patients with pure class V lupus nephritis, given its efficacy in mixed proliferative and membranous lupus nephritis (class III or IV with class V). |
2. The maximum duration of initial reimbursement is 12 to 18 months. | The treatment effects of obinutuzumab were evaluated at 76 weeks (18 months) in the REGENCY trial. | The duration of initial authorization for obinutuzumab could be similar to belimumab, as per the reimbursement criteria for each public drug plan. |
Renewal | ||
3. For renewal after initial authorization, obinutuzumab should be renewed in a similar manner to belimumab, as per the reimbursement criteria for each public drug plan for the treatment of lupus nephritis. | There is no evidence that obinutuzumab should be held to a different standard than belimumab when considering renewal. | — |
Discontinuation | ||
4. Obinutuzumab should be discontinued in a similar manner to belimumab, as per the reimbursement criteria for each public drug plan for the treatment of lupus nephritis. | There is no evidence that obinutuzumab should be held to a different standard than belimumab when considering discontinuation | — |
Prescribing | ||
5. Obinutuzumab should be prescribed by clinicians with expertise and experience in treating lupus nephritis. | This is meant to ensure that obinutuzumab is prescribed for appropriate patients and that adverse effects are managed in an optimized and timely manner. | — |
6. Obinutuzumab should be used in combination with standard therapy. | In the REGENCY study, obinutuzumab was used concomitantly with glucocorticoids and MMF. | CDEC noted that the definition of standard therapy may differ in clinical practice. Obinutuzumab in combination with standard therapy may be accessed as an initial treatment for lupus nephritis. CDEC noted that failure of prior therapy is not required for initiation of obinutuzumab, as optimal response may be achieved by early disease control based on clinical expert input. Obinutuzumab should not be reimbursed when used in combination with belimumab. There is no evidence to support the use of obinutuzumab in combination with belimumab for the treatment of lupus nephritis. |
Pricing | ||
7. The total cost of obinutuzumab plus standard therapy should be negotiated so that it does not exceed the total cost of treatment with the belimumab plus standard therapy for the same indication. | Based on the committee's assessment of the evidence, obinutuzumab plus standard therapy is expected to have clinical value that is comparable to belimumab plus standard therapy. Therefore, the total cost of obinutuzumab plus standard therapy should be no more than the cost of belimumab plus standard therapy. | The CDA-AMC analysis is based on public list prices for all treatments. Further price reductions may be required if there are price arrangements (discounts) currently in place for any treatment included in the economic analysis. |
CDA-AMC = Canada’s Drug Agency; CDEC = Canadian Drug Expert Committee; eGFR = estimated glomerular filtration rate; EULAR = European Alliance of Associations for Rheumatology; ICER = incremental cost-effectiveness ratio; MMF = mycophenolate mofetil; QALY = quality-adjusted life-year; SAE = serious adverse event; UPCR = urine protein to creatinine ratio.
aFor the statement regarding the size of the price reduction required, band 1 = 1% to 24%, band 2 = 25% to 49%, band 3 = 50% to 74%, and band 4 = 75% or greater.
Based on the clinical evidence, CDEC concluded that obinutuzumab demonstrates acceptable clinical value in patients with active lupus nephritis who are receiving standard therapy. Given that obinutuzumab is expected to be an alternative treatment to belimumab, comparable clinical value to belimumab was considered to represent acceptable clinical value. Overall, the committee determined that obinutuzumab offers clinical value comparable to that of belimumab.
Evidence from 1 randomized controlled trial (the REGENCY trial; N = 271) demonstrated that treatment for 76 weeks with obinutuzumab plus standard therapy with glucocorticoids and mycophenolate mofetil likely resulted in added clinical benefit for patients with lupus nephritis compared with placebo plus standard therapy with glucocorticoids and mycophenolate mofetil, in terms of complete renal response (CRR) and CRR with successful prednisone taper to less than or equal to 7.5 mg/day or equivalent. The proportion of patients who achieved CRR at week 76 was 46.4% in the obinutuzumab group versus 33.1% in the placebo group, with an adjusted between-group difference of 13.40% (95% confidence interval [CI], 1.95% to 24.84%; P = 0.0232; threshold for significance, P = 0.05). At week 76 in the REGENCY study, 42.7% of patients in the obinutuzumab group achieved CRR with successful prednisone taper to less than or equal to 7.5 mg/day or equivalent versus 30.9% in the placebo group, for a difference of 11.88% (95% CI, 0.57% to 23.18%; P = 0.0421). Based on the REGENCY study, treatment with obinutuzumab plus standard therapy likely resulted in an increase in the proportion of patients with serious adverse events (SAEs) compared with placebo plus standard therapy, although the clinical relevance of this increase is uncertain. CDEC acknowledged that, according to the experts consulted, the safety findings through week 76 showed that obinutuzumab had an overall adverse event (AE) profile consistent with what is known for this drug class.
The indirect evidence from a network meta-analysis (NMA) of obinutuzumab plus standard therapy versus belimumab plus standard therapy was associated with limitations and did not demonstrate significant differences in efficacy outcomes between the treatments for the indication under review. Therefore, the evidence did not suggest greater benefits with obinutuzumab versus belimumab. While acknowledging the uncertainty, CDEC found it reasonable to consider that the drugs offer comparable value. Harms and health-related quality of life outcomes were not included in the submitted NMA; therefore, it remains unknown if differences exist between treatments for these outcomes.
Further information on the committee’s discussion of clinical value is provided in the Summary of Deliberation section.
The determination of acceptable clinical value was sufficient for CDEC to recommend reimbursement of obinutuzumab. As part of the deliberation on whether to recommend reimbursement, the committee also considered unmet clinical need, unmet nonclinical need, and health inequity. Information on this discussion is provided in the Unmet Clinical Need and Distinct Social and Ethical Considerations domains in the Summary of Deliberation section.
Because CDEC recommended that obinutuzumab be reimbursed, the committee also deliberated on whether reimbursement conditions should be added to address important economic considerations, health system impacts, or social and ethical considerations, or to ensure clinical value is realized. The resulting reimbursement conditions, with accompanying reasons and implementation guidance, are stated in Table 1.
CDEC considered all domains of value of the deliberative framework before developing its recommendation: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on health systems. For further information on the domains of value, refer to Expert Committee Deliberation at Canada’s Drug Agency.
The committee considered the following key discussion points, organized by the 5 domains of value.
Appropriate comparators: CDEC identified combination therapy as the current standard initial treatment for lupus nephritis, consistent with clinical expert input and contemporary guideline recommendations. This reflects a recent shift in the 2025 guidelines toward earlier use of more intensive, multitargeted regimens. Recommended approaches include glucocorticoids in combination with 1 of the following: mycophenolic acid analogue (MPAA) or low-dose cyclophosphamide (CYC) plus belimumab (considered the most clinically relevant comparator), MPAA plus an off-label calcineurin inhibitor (CNI), or MPAA plus obinutuzumab. Single-agent therapy with glucocorticoids plus MPAA or low-dose CYC may still be used in select circumstances, such as when combination therapy is unavailable, not tolerated, or declined by the patient. CDEC acknowledged that at the time of the REGENCY study, single-agent therapies were considered the standard of care, according to the clinical experts and previous clinical guidelines.
Efficacy versus placebo: One phase III, randomized, double-blind, placebo-controlled trial (the REGENCY trial; N = 271) evaluated obinutuzumab plus standard therapy versus placebo plus standard therapy in adults with class III or IV (± class V) lupus nephritis over 76 weeks. At week 76, a statistically significant greater proportion of patients achieved CRR with obinutuzumab versus placebo (46.4% versus 33.1%; adjusted between-group difference = 13.4%; 95% CI, 1.95 to 24.84; P = 0.0232). Proteinuria response also favoured obinutuzumab. Mean change from baseline in estimated glomerular filtration rate (eGFR) numerically favoured obinutuzumab but did not reach statistical significance. Limitations included a 76-week duration in a chronic condition, wide CIs, absence of Canadian sites, and reliance on surrogate renal outcomes rather than long-term kidney failure end points.
Clinical importance of treatment effects: The committee recognized that obinutuzumab demonstrates clinically meaningful effects for patients with lupus nephritis, particularly in preserving kidney function and reducing corticosteroid use, which are important outcomes for patients. While many of the observed treatment effects were slightly above the clinically meaningful difference suggested, these benefits still represent meaningful improvements, according to the clinical experts. Current lupus nephritis therapies achieve remission in less than 50% of patients, based on the literature and clinical practice, and the condition is associated with substantial relapse rates. CDEC noted that several surrogate outcomes, including CRR, proteinuria, and eGFR, are supported by observational evidence and may be reasonable indicators of treatment benefit. However, the absence of evidence on important long-term outcomes remains an evidence gap. CDEC noted that long-term data beyond 76 weeks would strengthen confidence in sustained efficacy. The clinical experts suggested that treatment discontinuation may be considered on a case-by-case basis after sustained remission (typically ≥ 3 to 5 years of maintenance treatment), which is characterized by a marked reduction in proteinuria and stable eGFR.
Certainty of the evidence: The certainty of the evidence was rated as moderate for both efficacy and safety outcomes, based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments. Some limitations were noted, including potential performance or detection bias related to AEs, relatively high treatment discontinuation rates, and missing data for certain outcomes. External validity was somewhat constrained, as representation of patients with pure class V disease, severe renal involvement, or differing baseline proteinuria levels were limited in the REGENCY study. However, CDEC acknowledged that the included study population was broadly representative of many patients seen in clinical practice, according to the clinical experts.
Efficacy compared to comparators: The sponsor submitted an indirect treatment comparison (ITC) in the form of an NMA comparing obinutuzumab versus belimumab. CDEC observed that the ITC lacked definitive conclusions about relative efficacy due to variability in patient characteristics, outcome definitions, and assumptions within the analytical network, and results did not demonstrate significant differences in efficacy outcomes between the treatments for the indication under review. While acknowledging the uncertainty, CDEC found it reasonable to consider that the drugs offer comparable value. No evidence was submitted for comparisons between obinutuzumab and regimens containing relevant calcineurin inhibitors or CYC, although patients may be receiving these in clinical practice in Canada.
Harms: CDEC noted that obinutuzumab likely results in an increase in the proportion of patients with SAEs, the clinical importance of which is uncertain. Patients in the obinutuzumab group experienced numerically more SAEs and grade 3 to 5 AEs than patients in the placebo group. However, CDEC acknowledged that, according to the experts consulted, these harms are considered manageable in clinical practice and consistent with the known safety profile of B cell–targeted therapy.
Unmet needs: The committee concluded that obinutuzumab may address some of the unmet needs for patients living with lupus nephritis. The results from the phase III REGENCY study showed clinically meaningful improvements in CRR and CRR with successful prednisone taper to less than or equal to 7.5 mg/day or equivalent, which may meet patients’ goals to improve response rates and reduce corticosteroid use.
Clinical value: The committee concluded that obinutuzumab offers meaningful clinical value, particularly for patients seeking to reduce corticosteroid exposure. Although some uncertainties remain regarding longer-term outcomes, the treatment’s efficacy and patient-centred benefits support its use as a valuable option in the management of lupus nephritis compared with appropriate comparators.
Input on unmet clinical need: Patients identified a need for treatments that protect kidney function, reduce flares, and improve daily functioning (including pain and fatigue reduction), all of which impact work, social life, and independence. Preserving kidney function and avoiding dialysis or transplant were consistently identified as core priorities. Avoiding progression was described as essential for maintaining independence, employment, and long-term life planning.
Severity of the disease: The committee considered lupus nephritis to be a serious condition that is associated with a high risk of progression to chronic kidney disease. Clinical experts noted that current treatment options often fail to achieve adequate disease control, resulting in substantial relapse over time.
Availability of treatment options: Combination therapies can be limited by nephrotoxicity, frequent monitoring, and burdensome administration, particularly for patients in rural or remote areas. Many options carry significant short-term and long-term AEs, and few are considered safe during pregnancy. Overall, there is a clear need for more effective, safer, and accessible treatments that provide sustained disease control and reduce treatment burden.
Input on unmet nonclinical need: CDEC acknowledged that patients and clinicians highlighted several important nonclinical challenges, including the high cost of treatments; frequent hospital visits; disruption to work and daily life; limited access to specialists; and logistical burdens such as travel, infusion schedules, and refrigeration requirements for self-injectors. Patients and caregivers also reported substantial emotional, social, and financial impacts.
Equity considerations: CDEC noted that lupus nephritis is more common among Asian, Black, Hispanic, and Indigenous populations. Patients from racialized groups, such as those who identify as Black or Hispanic (recognizing that Hispanic identity can overlap with any race, including white), are at higher risk of progression to kidney failure than white patients. These disparities reflect both biological factors and structural barriers, such as delayed diagnosis, reduced specialist access, and socioeconomic inequities related to income, education, and systemic racism.
Significant unmet nonclinical need or health inequity: Patient group input identified the need for affordable therapies and easier administration (e.g., reduced travel and dosing frequency). CDEC noted that obinutuzumab may offer a less frequent injection schedule compared with IV belimumab, potentially reducing disruption to work. CDEC acknowledged that chronic IV treatment burden and work disruption are common across many long-term conditions and not unique to lupus nephritis.
Ethical implications: CDEC noted that a lupus nephritis diagnosis requires a kidney biopsy, which may create access barriers. The committee acknowledged the ethical importance of equitable access to diagnosis and treatment, particularly given the structural barriers and disproportionate disease burden faced by racialized populations and patients in rural or remote areas.
Key findings of the economic evaluation: Based on evidence reviewed for this submission, CDEC identified considerable uncertainty in the cost-effectiveness of obinutuzumab plus standard therapy in comparison with belimumab plus standard therapy due to methodological limitations associated with the sponsor’s ITC. Therefore, no definite conclusion can be drawn regarding the relative efficacy of obinutuzumab plus standard therapy in comparison with belimumab plus standard therapy. The CDEC deliberation found it reasonable to consider them comparable in clinical value. If there are no differences in health outcomes between obinutuzumab plus standard therapy and belimumab plus standard therapy, then the total treatment cost of obinutuzumab plus standard therapy to the health system should not exceed that of belimumab plus standard therapy for the treatment of patients with active lupus nephritis who are receiving standard therapy.
Other considerations: CDEC noted that the Canadian patent for belimumab (Benlysta) is scheduled to expire on October 5, 2026, and reimbursement of such a generic would impact the price of obinutuzumab. The potential impact of such a price change was not assessed in the economic review. In addition, CDEC noted that patients with pure class V lupus nephritis were excluded from the REGENCY trial. Clinical expert feedback suggested that these patients may still benefit from obinutuzumab plus standard therapy in clinical practice. The cost-effectiveness of obinutuzumab plus standard therapy in individuals with pure class V lupus nephritis is unknown.
Anticipated budget impact: It is predicted that 1,916 patients would be eligible for obinutuzumab plus standard therapy by year 3 of reimbursement; of these, 433 patients are expected to receive obinutuzumab plus standard therapy. The estimated incremental budget impact of reimbursing obinutuzumab plus standard therapy is predicted to be approximately $6 million over the first 3 years, with an expected expenditure of $14 million on obinutuzumab.
To make its recommendation, the committee considered the following information (links to the full documents for the review can be found on the project webpage):
the CDA-AMC review of the clinical and pharmacoeconomic evidence submitted by the sponsor, as well as relevant ethical issues related to obinutuzumab (refer the Main Report and Supplemental Material document)
the sponsor’s comments on the draft report and the CDA-AMC responses
patients' perspectives gathered by 3 patient groups (Arthritis Consumer Experts; the Kidney Foundation of Canada and Lupus Canada; and a joint submission from Lupus Ontario, the Canadian Arthritis Patient Alliance, and Arthritis Society Canada) (refer to the Patient and Clinician Group Input document)
input from 2 clinician groups (the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus and the Toronto Lupus Program and Nephrology colleagues) (refer to the Patient and Clinician Group Input document)
input from public drug programs that participate in the reimbursement review process (refer to the Supplemental Material document)
input from 2 clinical experts with expertise in the management of lupus nephritis consulted by CDA-AMC.
Dr. Peter Jamieson (Chair), Dr. Kerry Mansell (Vice-Chair), Sally Bean, Daryl Bell, Dan Dunsky, Dr. Ran Goldman, Dr. Trudy Huyghebaert, Dr. Dennis Ko, Dr. Christine Leong, Dr. Alicia McCallum, Dr. Srinivas Murthy, Dr. Nicholas Myers, Dr. Krishnan Ramanathan, Dr. Marco Solmi, Carla Velastegui, Dr. Edward Xie, and Dr. Peter Zed
Meeting date: Wednesday, February 25, 2026
Regrets: One expert committee member did not attend.
Conflicts of interest: None
ISSN: 2563-6596
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