PCSK9 inhibitors for treating hypercholesterolaemia

Published on 01 Sep 2023
Last Updated on 02 Jan 2024

Guidance Recommendations

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

• Evolocumab 140 mg/mL solution for injection in prefilled autoinjector for treating:

  • non-familial hypercholesterolaemia (non-FH) or mixed dyslipidaemia, with atherosclerotic cardiovascular disease (ASCVD) and additional risk factors and LDL-c level above 1.8 mmol/L despite maximal tolerated lipid-lowering therapy (LLT) for at least 12 weeks; or

  • heterozygous familial hypercholesterolaemia (HeFH), with ASCVD and LDL-c level above 1.8 mmol/L despite maximal tolerated LLT for at least 12 weeks; or

  • HeFH, without ASCVD, and LDL-c level above 2.6 mmol/L despite maximal tolerated LLT for at least 12 weeks; or

  • homozygous familial hypercholesterolaemia (HoFH) with LDL-c level above 1.8 mmol/L despite maximal tolerated statin-lowering therapy for at least 12 weeks.

Funding status

Evolocumab 140 mg/mL solution for injection in prefilled autoinjector is recommended for inclusion on the MOH Medication Assistance Fund (MAF) for the abovementioned indications from 1 November 2023.

The dose of evolocumab for the treatment of non-FH or mixed dyslipidaemia and HeFH recommended for subsidy is 140 mg every 2 weeks. The dose restriction does not apply to HoFH.

Evolocumab should be used in line with the additional clinical criteria listed in the Annex.

MAF assistance does not apply to any formulations or strengths of alirocumab or inclisiran for treating hypercholesterolaemia.

PCSK9 inhibitors for treating hypercholesterolaemia (Updated 2 Jan 2024) [PDF, 165 KB]

PES Injectable drugs for treating high cholesterol (Published 1 Sep 23) [PDF, 133 KB]