Trastuzumab

[SDL] Trastuzumab Biosimilar (Herzuma) Injection 440 mg

[SDL] Trastuzumab Biosimilar (Ogivri) Injection 440 mg

[MSHL] Trastuzumab Powder For IV Infusion 440 mg

1. For cancer treatment in line with HSA registered indication(s).

2. Pertuzumab in combination with trastuzumab and chemotherapy for HER2-positive metastatic or locally recurrent breast cancer, in patients without prior treatment for metastatic disease. Treatment with pertuzumab should be stopped if disease progresses.

3. Pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of high-risk (with positive nodes) HER2 positive early breast cancer for a maximum duration of 1 year.

4. Pertuzumab in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2 positive locally advanced, inflammatory or early stage (tumour >2 cm in diameter or node positive) breast cancer for 4 to 6 cycles. Following surgery, patients may continue with trastuzumab with or without pertuzumab for a total of 1 year of anti-HER2 treatment.

5. For the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine in patients who have received one or more prior anti-HER2-based regimens in the metastatic setting.

[MSHL] Trastuzumab Solution For SC Injection 600 mg/5 mL

1. For cancer treatment in line with HSA registered indication(s).

2. Pertuzumab in combination with trastuzumab and chemotherapy for HER2-positive metastatic or locally recurrent breast cancer, in patients without prior treatment for metastatic disease. Treatment with pertuzumab should be stopped if disease progresses.

3. Pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of high-risk (with positive nodes) HER2 positive early breast cancer for a maximum duration of 1 year.

4. Pertuzumab in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2 positive locally advanced, inflammatory or early stage (tumour >2 cm in diameter or node positive) breast cancer for 4 to 6 cycles. Following surgery, patients may continue with trastuzumab with or without pertuzumab for a total of 1 year of anti-HER2 treatment.

5. For the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine in patients who have received one or more prior anti-HER2-based regimens in the metastatic setting.

[MSHL] Trastuzumab biosimilar Powder For IV Infusion 440 mg

1. For cancer treatment.

2. Pertuzumab in combination with trastuzumab and chemotherapy for HER2-positive metastatic or locally recurrent breast cancer, in patients without prior treatment for metastatic disease. Treatment with pertuzumab should be stopped if disease progresses.

3. Pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of high-risk (with positive nodes) HER2 positive early breast cancer for a maximum duration of 1 year.

4. Pertuzumab in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2 positive locally advanced, inflammatory or early stage (tumour >2 cm in diameter or node positive) breast cancer for 4 to 6 cycles. Following surgery, patients may continue with trastuzumab with or without pertuzumab for a total of 1 year of anti-HER2 treatment.

5. For the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine in patients who have received one or more prior anti-HER2-based regimens in the metastatic setting.

[MSHL] Trastuzumab biosimilar Powder For Concentrate For Solution For Infusion 150 mg, 420 mg

1. For cancer treatment.

Legend

This section shows the following:

• Subsidy Scheme and Clinical Indication (where applicable) of drugs listed in the MOH List of Subsidised Drugs

• Subsidised brands of vaccines recommended in the National Immunisation Schedules listed in the MOH Subsidised Vaccine List

• Cancer Drug and Clinical Indication listed in the MediShield Life Cancer Drug List

As this website is updated monthly, please refer to MOH List of Subsidised Drugs, MOH Subsidised Vaccine List or MediShield Life Cancer Drug List for the most updated information.

01/09/2020 Trastuzumab for treating HER2-positive breast and gastric cancers

The Ministry of Health’s Drug Advisory Committee has recommended:

• Trastuzumab biosimilar (Ogivri) 440 mg powder for IV injection for treating:

  • HER2-positive early or metastatic breast cancer, or

  • HER2-positive metastatic gastric cancer

  in line with its registered indications;

• The removal of trastuzumab reference biologic (Herceptin) 440 mg powder for IV injection from the Medication Assistance Fund (MAF) for all indications; and

• Not to list the new subcutaneous formulation of Herceptin (600 mg solution for injection) on the Standard Drug List (SDL) or MAF in view of unfavourable cost effectiveness compared with Ogivri at the price proposed by the manufacturer.

Patients receiving Ogivri must have evidence of HER2-gene amplification as demonstrated by immunochemistry or fluorescence in situ hybridization (FISH) in the tumour tissue.

Ogivri must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 50% or with symptomatic heart failure.

Subsidy status

[R] Ogivri 440 mg powder for injection is recommended for inclusion on the MOH Standard Drug List (SDL) for the abovementioned indications from 1 September 2020. The MAF listing of Herceptin will cease on 1 March 2021.

[NR] SDL subsidy does not apply to any other trastuzumab biosimilars (such as Herzuma 150 mg and 440 mg powder for injection), or to any formulations or strengths of Herceptin.

Legend

This section displays recommendation from the MOH Drug Advisory Committee for subsidy and appropriate use of the drug as extracted from the Agency for Care Effectiveness (ACE) Drug Guidances. As this website is updated monthly, please refer to the ACE website for the most updated information.

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