Tezepelumab (Tezspire)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Tezspire be reimbursed by public drug plans as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Tezspire demonstrates acceptable clinical value compared with appropriate comparators dupilumab and mepolizumab. Given that Tezspire is expected to be an alternative to dupilumab, omalizumab, and mepolizumab, acceptable clinical value refers to an at least comparable value versus 1 or more of these drugs. Evidence from a clinical trial showed that Tezspire with intranasal corticosteroids for 52 weeks reduced the size and burden of nasal polyps in patients with severe CRSwNP inadequately controlled by oral corticosteroids and/or surgery. Evidence from an indirect comparison suggests that treatment with Tezspire and dupilumab results in similar improvements in symptoms and overall disease burden. Compared with mepolizumab, Tezspire was associated with further reductions in disease burden as well as a lower need for surgery or systemic corticosteroids. However, the indirect comparisons were very uncertain because of methodological limitations, differences between trials, and uncertainty in the overall results, which make definitive conclusions challenging. Also, there was no comparison between Tezspire and omalizumab.
• CDEC noted that there are unmet clinical needs with existing treatments and challenges with accessing them. Dupilumab requires additional monitoring for potential safety issues and injection every other week, which may be burdensome to patients. It was also not yet available on the public drug plans at the time of the committee meeting. Mepolizumab is publicly available but requires prior polyp surgery. A biosimilar version of omalizumab is available for CRSwNP in some jurisdictions, but its use can be impractical because it requires an immunoglobulinE level assessment. With acceptable clinical value and potentially simpler requirements, Tezspire could address current unmet needs.
• Tezspire should only be covered for patients with severe CRSwNP who are taking intranasal corticosteroids and have persistent symptoms despite recent treatment with oral corticosteroids and/or with a history of nasal polyp surgery.
• Tezspire should only be reimbursed if prescribed by physicians with experience in managing biological treatment and expertise with severe CRSwNP, the person is not receiving another biologic for CRSwNP, and the drug program cost of Tezspire does not exceed the drug program cost of treatment with the least costly biologic reimbursed for this indication.
• Important budget impact considerations must be addressed for health systems to be able to adopt Tezspire.