Mosunetuzumab IV (Lunsumio)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Lunsumio 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 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 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 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 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 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 may address a significant unmet clinical need, offering a chemotherapy-free, fixed-duration treatment with manageable safety profile that is readily available, particularly for patients with limited access to existing therapies.
• pERC noted that there are significant unmet nonclinical needs and health inequities for patients with relapsed or refractory follicular lymphoma (r/r FL). pERC considered the IV and subcutaneous (SC) formulations of Lunsumio to have similar efficacy and safety, and therefore preferred the SC formulation, while allowing flexibility for patient preference and for those who may need IV due to significant injection site reactions.
• Based on all of the preceding considerations, pERC recommended that Lunsumio be reimbursed.
• Lunsumio 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 should not be covered for patients with nonfollicular indolent lymphoma or a disease with central nervous system involvement.
• Lunsumio 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.