New arrangements for migalastat (Galafold®)
From 1 September 2024, all existing LSDP patients receiving migalastat (Galafold®) Fabry disease can access this medicine through the Pharmaceutical Benefits Scheme (PBS).
More details about the changes to migalastat (Galafold®) are in this fact sheet: New arrangements for migalastat (Galafold®) – information for patients.
Accessing medicine through the LSDP
If you are eligible, you can get certain medicines subsidised under the LSDP.
Your treating physician will fill in the LSDP application form and submit it to the LSDP.
Your treating physician must provide copies of all required test results and a clinic letter as evidence of your condition. These must be less than 12 months old.
View the application forms and other relevant documents for your condition:
- Gaucher disease (type 1)
- Fabry disease
- Mucopolysaccharidosis type I (MPS I)
- Mucopolysaccharidosis type II (MPS II)
- Mucopolysaccharidosis type IVA (MPSIVA)
- Mucopolysaccharidosis type VI (MPS VI)
- Pompe disease (infantile-onset and late-onset)
- Hereditary tyrosinaemia type 1 (HT1)
- Late-infantile onset Batten disease (CLN2)
- Perinatal- and infantile-onset hypophosphatasia (HPP)
- Infantile-onset lysosomal acid lipase deficiency (LAL-D)
Approval process
After your treating physician submits your application, we will:
- check the application is complete
- assess your eligibility
- notify your treating physician of our decision within 30 days.
We process most applications within 7 days.
If we approve your application, your treating physician must reapply for you every year. This ensures you can continue to receive LSDP-subsidised treatment.
For more details about the application process, see LSDP for treating physicians.
How your medicine gets to you
Once we approve your application, we will order your medicine from the supplier. They will ship your medicine to a hospital pharmacy, or other pharmacy of your choice, to dispense to you.
Due to the high cost of LSDP medicines, we only order one month’s supply of medicine at a time.
Other people can pick up your LSDP medicines.
If you are receiving your LSDP medicine through an infusion at a hospital, suppliers can send LSDP medicine directly to the hospital, just before you attend (as per hospital procedure).
Costs
The Australian Government provides LSDP medicines at no cost to the patient. LSDP medicines are not part of the Pharmaceutical Benefits Scheme (PBS), so PBS patient co-payments do not apply.
Your pharmacy might charge you a fee for cold transport and handling of your medicines as required. They must tell you about this cost up front and you must agree to it before the pharmacy dispenses the LSDP medicines. They cannot charge you any other co-payment or fee.
Annual reapplication process
Treating physicians must review patients receiving LSDP medicines every year. This ensures LSDP patients are:
- still eligible for the program
- taking the medicine as prescribed
- responding to the medicine in the expected way.
Each disease has different tests that should be done each year. You can find the required tests in the LSDP patient test results spreadsheet for each condition.
Your treating physician must submit to us:
- test results
- a signed reapplication form showing you are still eligible to receive the subsidised medicine
- a clinic letter less than 12 months old outlining your recent medical and surgical history and general description of your health status
- the completed patient test results spreadsheet.
If you have any concerns about why certain tests are needed, or how often, discuss this with your treating physician.
Your obligations
To stay eligible for subsidised medicines through the LSDP, you must:
- continue to regularly see your treating physician regularly during your treatment
- take your medicines as prescribed by your treating physician
- tell your treating physician immediately if you start to experience any adverse effects while using your LSDP medicine
- have any required tests for reapplication each year
- sign your consent on the reapplication form each year
- if applicable, store your LSDP medicine according to the instructions on the labelling or leaflet accompanying the medicine
- tell your treating general practitioner and/or treating physician if you believe your medicine may be compromised in any way
- continue to qualify for Medicare (be an Australian citizen or permanent resident).
Resources
Read our printable fact sheet for patients.
See LSDP resources for more guidelines, forms and fact sheets about the program.
