Drugs, Health Technologies, Health Systems

Reimbursement Recommendation

Obinutuzumab (Gazyva)

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.

Review Background

Highlights of Input From Interested Parties

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:

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:

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.

Recommendation

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.

Rationale for the Recommendation

Clinical Value

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.

Developing the Recommendation

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.

Summary of Deliberation

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.

Clinical Value

Unmet Clinical Need

Distinct Social and Ethical Considerations

Economic Considerations

Impacts on Health Systems

Sources of Information Used by the Committee

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):

CDEC Information

Members of the Committee

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