A
Agalsidase Alfa [Replagal]
Availability of ACE Drug Guidance
Yes
Biologics Drug Information Overview
No
Subsidy Information and Financing Scheme
Medical Assistance Fund
Active ingredient: Agalsidase Alfa
General information
Subsidy Information and Financing Scheme
[MAF] Agalsidase alfa (Replagal) Concentrate For Solution For Infusion 3.5 mg/3.5 mL
Additional clinical criteria applies
For enzyme replacement therapy in patients with Fabry disease.
Diagnosis of Fabry disease must be confirmed by the demonstration of specific deficiency of alpha-galactosidase enzyme activity in the blood or white cells, or the presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity.
Drug Guidance for Subsidy
04/06/2024 Enzyme replacement therapies for Fabry disease
The Ministry of Health’s Drug Advisory Committee has recommended:
Agalsidase alfa 3.5 mg/3.5 mL concentrate for solution for infusion as an enzyme replacement therapy in patients with Fabry disease. The treatment may be initiated only in:
a) Male patients with classical Fabry disease; or
b) Male patients with non-classical Fabry disease, or female patients with classical or non-classical Fabry disease, who have signs/symptoms of organ involvement (e.g. kidney, heart or nervous system) consistent with Fabry disease and which are not fully explained by other pathology.
Funding status
[R] Agalsidase alfa 3.5 mg/3.5 mL concentrate for solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 August 2024.
[R] Agalsidase alfa should be used in line with the additional clinical criteria listed in the Annex.
[NR] MAF assistance does not apply to agalsidase beta for treating Fabry disease.
General Availability in Public Healthcare Institution
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
Availability information
Formulation | Public Healthcare Institution |
|---|---|
Replagal Concentrate For Solution For Infusion 3.5 mg/3.5 mL |
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Registered Product(s) Information
Clinical and product info
Clinical info | Product Info |
|---|---|
Information under the Indication, Dosage and Contraindication sections are extracted from the relevant Package Insert/Patient Information Leaflet of the product available on HSA Infosearch. For more information, please refer to the product's Package Insert/ Patient Information Leaflet available on HSA Infosearch. The information provided is for informational purposes only, and is not exhaustive. The information provided is not a substitute for professional medical advice. Please consult a qualified healthcare provider for any medical advice. | Information available here are product details as registered with the HSA. As this website is updated monthly, please refer to HSA Infosearch for the most updated product information. |
Intravenous
* Clinical information is available for this product.