Key Messages
- Canada’s Drug Agency (CDA-AMC) recommends that Enhertu be reimbursed by public drug plans for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+ or in situ hybridization [ISH]-negative) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least 1 endocrine therapy in the metastatic setting and who are not considered suitable for further endocrine therapy as the next line of therapy if certain conditions are met.
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The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Enhertu demonstrates acceptable clinical value compared with chemotherapy in adult patients with unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer who have received at least 1 endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of therapy. This determination was sufficient for pERC to recommend that Enhertu be reimbursed. Given that Enhertu is expected to be an alternative to chemotherapy, acceptable clinical value refers to added value versus chemotherapy.
Evidence from a clinical trial demonstrated that, compared with chemotherapy, Enhertu likely results in added clinical benefit in progression-free survival (PFS) in adults with HR-positive metastatic breast cancer (MBC) with low or ultralow HER2 expression who have received 1 or more lines of endocrine-based therapy and no previous chemotherapy for MBC. Overall survival (OS) was consistent with the results observed in the PFS analysis, suggesting a trend toward superiority for Enhertu. Compared to chemotherapy, Enhertu met some of the identified patient needs as it likely delays disease progression and may prolong survival.
- Enhertu should only be covered for patients with HR-positive disease who have received at least 1 endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of therapy. Patients should have a good performance status and must not have symptomatic spinal compression, clinically active central nervous system metastases, current interstitial lung disease (ILD) or pneumonitis, or received prior chemotherapy for advanced or MBC.