Key Messages
- Canada’s Drug Agency (CDA-AMC) recommends that Enhertu be reimbursed by public drug plans for second-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2–based regimen, if certain conditions are met.
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CDA-AMC previously reviewed Enhertu for the second-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2–based regimen and issued a recommendation of time-limited reimbursement. This is a reassessment based on additional evidence to address the uncertainties in the original data. This recommendation supersedes the previous recommendation for this drug and indication dated April 23, 2025.
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The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommended that Enhertu continue to be reimbursed by the participating drug programs in accordance with the initiation, discontinuation, and prescribing criteria that were previously recommended. The sponsor has satisfied the reassessment requirements, and the time-limited condition has been removed from the recommendation.
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Evidence from a clinical trial showed that Enhertu likely results in added clinical benefit in overall survival (OS) and may delay disease progression, compared with ramucirumab plus paclitaxel, in patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2–based regimen. Evidence from an indirect treatment comparison suggested that Enhertu may offer survival and disease control benefits compared to leucovorin (folinic acid), fluorouracil, and irinotecan (FOLFIRI), paclitaxel, irinotecan, and docetaxel. However, the clinical value was uncertain due to the methodological limitations of the indirect comparisons.
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Enhertu meets some patient needs, given that it is an alternative treatment option that may offer benefits in disease control and life prolongation.
- Enhertu should only be covered to treat adult patients with unresectable locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have previously received anti-HER2–based treatment for locally advanced or metastatic disease, are in relatively good health, and do not have symptomatic spinal cord compression, clinically active central nervous system metastases, or current interstitial lung disease (ILD) or pneumonitis.
- Enhertu should only be reimbursed if it is prescribed by clinicians with experience and expertise in treating gastric or GEJ adenocarcinoma and if the cost of Enhertu is reduced.