Mosunetuzumab SC (Lunsumio SC)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Lunsumio subcutaneous (SC) be reimbursed by public drug plans “as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy,” if certain conditions are met.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that it is uncertain whether Lunsumio SC demonstrates acceptable clinical value in “adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy.” Given that Lunsumio SC is expected to be an alternative option for third-line and beyond therapy, acceptable clinical value refers to at least comparable value relative to other third-line and beyond therapies relevant in the context in Canada. Direct evidence from 1 clinical trial (GO29781) showed that treatment with Lunsumio SC resulted in response rate benefits considered clinically meaningful and durable by the CDA-AMC consulted experts and suggested potential survival benefits. Evidence from an indirect treatment comparison (ITC) suggested that overall survival (OS) and response outcomes with Lunsumio SC may be broadly comparable to other third-line and beyond therapies, although results were uncertain and mixed across comparisons. Uncertainty remains due to the single-arm study design, limited comparative evidence, and imprecision in indirect estimates. pERC concluded that, although the evidence suggests mosunetuzumab SC monotherapy has uncertain clinical value, given the rarity and severity of the condition the drug may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value.
• pERC discussed the direct and indirect evidence and the clinical experts’ input and noted that the overall evidence suggested that Lunsumio SC may address a significant unmet clinical need, offering a chemotherapy-free, fixed-duration treatment with manageable safety profile that can be given in an outpatient setting, and is readily available, particularly for patients with limited access to existing therapies.
• pERC noted significant unmet nonclinical needs and health inequities among patients with relapsed or refractory follicular lymphoma (r/r FL). pERC also noted that Lunsumio SC may improve access to care, as it can be provided off the shelf and administered outside specialized centres, potentially reducing travel, clinic visits, and reliance on tertiary care services, particularly for patients in rural or underserved settings. The committee considered the IV and SC formulations of Lunsumio to have comparable efficacy and safety and therefore preferred the SC formulation, while allowing flexibility based on patient preference and for individuals who may require IV administration due to substantial injection site reactions.
• Based on all of the preceding considerations, pERC recommended that Lunsumio SC be reimbursed.
• Lunsumio SC should only be covered for adults with histologically confirmed r/r FL (grades 1 to 3a) who have received at least 2 prior lines of systemic therapy, including an anti-CD20 therapy and an alkylating agent, and who have good performance status. Lunsumio SC should not be covered for patients with nonfollicular indolent lymphoma or a disease with central nervous system involvement.
• Lunsumio SC should be prescribed by clinicians experienced in managing hematologic malignancies and bispecific antibody-related complications, and given in settings with access to tocilizumab and appropriate supportive care. Reimbursement should be for a fixed duration of 8 or 17 cycles as per the drug’s product monograph and should be discontinued upon the occurrence of complete response, unacceptable toxicity, or disease progression. Re-treatment may be considered for patients whose disease relapses after a treatment-free interval of at least 6 months following completion of the initial treatment course.
• The total cost of Lunsumio should not exceed the total cost of treatment with the least costly relevant chemotherapy comparator for the same indication.
• Important budget impact considerations and organizational implications must be addressed for health systems to be able to adopt Lunsumio.