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
ROgivri 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.
NRSDL 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.