R
Risdiplam
Availability of ACE Drug Guidance
Yes
Biologics Drug Information Overview
No
Subsidy Information and Financing Scheme
Medical Assistance Fund
Active ingredient: Risdiplam
General information
Subsidy Information and Financing Scheme
[MAF] Risdiplam Powder For Oral Solution 0.75 mg/mL
Additional clinical criteria applies
Treatment of symptomatic Type 1, 2 or 3 spinal muscular atrophy (SMA) in patients who are/were 18 years of age or under at the time of initial treatment with risdiplam or nusinersen.
Treatment of symptomatic Type 1, 2 or 3 SMA in patients aged 19 years or above who had not initiated treatment with risdiplam or nusinersen prior to 19 years of age despite onset of signs/symptoms of SMA.
Treatment of pre-symptomatic SMA in patients who are/were under 3 years of age at the time of initial treatment with risdiplam or nusinersen.
Treatment of SMA in patients who have experienced a regression in a developmental state despite treatment with gene therapy.
Drug Guidance for Subsidy
04/06/2024 Nusinersen and risdiplam for treating spinal muscular atrophy
The Ministry of Health’s Drug Advisory Committee has recommended:
Risdiplam 0.75 mg/mL powder for oral solution for treating:
Symptomatic Type 1, 2 or 3 spinal muscular atrophy (SMA) in patients who are/were 18 years of age or under at the time of initial treatment with risdiplam or nusinersen;
Symptomatic Type 1, 2 or 3 SMA in patients aged 19 years or above who had not initiated treatment with risdiplam or nusinersen prior to 19 years of age despite onset of signs/symptoms of SMA;
Pre-symptomatic SMA in patients who are/were under 3 years of age at the time of initial treatment with risdiplam or nusinersen; and
SMA in patients who have experienced a regression in a developmental state despite treatment with gene therapy.
Funding status
[R] Risdiplam 0.75 mg/mL powder for oral solution is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indications from 1 August 2024.
[R] Risdiplam should be used in line with the additional clinical criteria listed in the Annex.
[NR] MAF assistance does not apply to nusinersen for treating SMA.
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 |
|---|---|
Powder For Oral Solution 0.75 mg/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. |
Oral / Enteral
* Clinical information is available for this product.