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- Agalsidase Beta [Fabrazyme®]
A
Agalsidase Beta [Fabrazyme®]
Subsidy Information and Financing Scheme
No
Drug Guidance
Yes
Post-marketing information
No
Summary of Biologics
No
Active ingredient: Agalsidase Beta
General information
Subsidy Information and Financing Scheme
Not Applicable
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.
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.
Legend list
Indicator | Legend |
|---|---|
R | Recommended for subsidy |
NR | Not recommended for subsidy |
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
Drug availability
Formulation | Public Healthcare Institution |
|---|---|
Fabrazyme® Injection, Powder, For Solution 37 mg/35 mg vial |
|
Fabrazyme® Injection, Powder, For Solution 5.5 mg/5 mg vial |
|
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. |