Trastuzumab Deruxtecan [Enhertu]

[MSHL] Trastuzumab deruxtecan Powder For Concentrate For Solution For Infusion 100 mg

1. Treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.

2. Treatment of HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have received two or more prior regimens, including a trastuzumab-based regimen.

3. Treatment of patients with HER2-low unresectable and/or metastatic breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with HR-positive breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.

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06/02/2026 Trastuzumab deruxtecan for unresectable or metastatic non-small-cell lung cancer whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended trastuzumab deruxtecan (T-DXd) for inclusion on the MOH List of Subsidised Drugs for treating patients with unresectable or metastatic non-small-cell lung cancer whose tumours have activating human epidermal growth receptor 2 (HER2) mutations and who have received a prior systemic therapy. The decision was based on the uncertainties in the clinical and cost effectiveness of T-DXd in the patient population, and an unacceptable pricing proposal by the company.

Clinical indication, subsidy class and MediShield Life claim limit for T-DXd are provided in the Annex.

06/02/2026 Trastuzumab deruxtecan for unresectable or metastatic HER2-positive solid tumours after at least one prior line of systemic therapy

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended trastuzumab deruxtecan (T-DXd) for inclusion on the MOH List of Subsidised Drugs for treating patients with unresectable or metastatic human epidermal growth receptor 2 (HER2)-positive solid tumours who show progression after at least one prior systemic treatment and who have no satisfactory alternative treatment options. The decision was based on uncertainties in the positioning of T-DXd relative to current management, its clinical and cost effectiveness across different cancer types, and its uncertain budget impact.

Clinical indication, subsidy class and MediShield Life claim limit for T-DXd are provided in the Annex.

13/09/2024 Trastuzumab deruxtecan for HER2-low unresectable and/or metastatic breast cancer after at least one prior line of chemotherapy

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended trastuzumab deruxtecan (T-DXd) for inclusion on the MOH List of Subsidised Drugs for treating patients with human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. The decision was based on the unfavourable cost-effectiveness of T-DXd compared with chemotherapy, and the unacceptable price-volume agreement proposed by the company.

Clinical indication, subsidy class and MediShield Life claim limit for T-DXd are provided in the Annex.

01/09/2023 Trastuzumab deruxtecan for treating HER2-positive advanced gastric cancer after two or more therapies

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended trastuzumab deruxtecan (T-DXd) for inclusion on the MOH List of Subsidised Drugs for treating human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have received two or more prior therapies. The decision was based on the unfavourable cost-effectiveness of T-DXd at the price proposed by the company compared with chemotherapy.

Clinical indication, subsidy class and MediShield Life claim limit for T-DXd are provided in the Annex.

01/09/2023 Trastuzumab deruxtecan for previously treated HER2-positive metastatic breast cancer

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended trastuzumab deruxtecan (T-DXd) for inclusion on the MOH List of Subsidised Drugs for treating human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic breast cancer after a prior anti-HER2-based regimen. The decision was based on the uncertain extent of clinical benefit and unfavourable cost-effectiveness of T-DXd at the price proposed by the company compared with alternative treatments.

Clinical indication, subsidy class and MediShield Life claim limit for T-DXd are provided in the Annex.

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Note:

General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.

Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration