Agalsidase Alfa [Replagal]

[MAF] Agalsidase alfa (Replagal) Concentrate For Solution For Infusion 3.5 mg/3.5 mL

1. 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.

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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.

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.

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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