Applying for an LSDP medicine for your patient
Treating physicians can apply for LSDP medicines for their patients. You must submit a completed initial application form and supporting documents.
The patient must meet both:
- general eligibility criteria
- disease-specific eligibility criteria, as outlined in the relevant guidelines.
To apply, you must email us:
- a completed initial application form for the specific disease
- copies of all required test results as evidence (results must be less than 12 months old)
- a clinic letter (less than 12 months old) outlining the patient’s recent medical and surgical history, and a general description of their health status.
Approval process
We prioritise new applications. If the application is urgent, please tell us why in the covering letter and mark it as urgent.
We will:
- assess the application to confirm it is completed correctly and includes all the required information
- confirm with Services Australia that the patient is eligible for Medicare
- compare the individual test results to the specifications in the disease guidelines
- assess the documentation to confirm the patient meets the eligibility criteria
- confirm the prescribed dose is appropriate based on the patient’s characteristics (for example, age or weight)
- work out the number of vials or tablets needed for each dose
- seek internal expert advice as needed for complex applications
- collate information and seek approval from the LSDP approval delegate.
If an application is incomplete, we will let you know and put the application on hold until you respond.
If an application is complete, we will tell you the outcome within 30 days. We process most applications within 8 days, and the most urgent applications within 48 hours.
New arrangements for migalastat (Galafold®)
From 1 September 2024, all existing LSDP patients accessing migalastat (Galafold®) for the treatment of Fabry disease can access their medicine through the Pharmaceutical Benefits Scheme (PBS). Transitional arrangements will be in place to enable existing migalastat patients to transition to accessing their treatment through the PBS. Migalastat (Galafold®) will not be available through the LSDP for new patients from 1 September 2024.
More details about the changes to access to migalastat is in this fact sheet: New arrangements for migalastat (Galafold®) – information for prescribers.
Annual reapplication process
You must reassess each of your patients on the program every year. This ensures patients:
- remain eligible for the program
- comply with the requirements for ongoing treatment
- are reviewed by their treating physician (at least) annually.
Complete a disease-specific reapplication form for each patient receiving LSDP medicines each year. Patients must sign the reapplication consent form each year to agree to ongoing data collection for review purposes.
Managing changes
You must tell us immediately if a patient’s eligibility changes at any time during treatment. You must also inform us about other changes such as:
- dose changes – please include the new dose and clinical justification
- ceasing treatment
- patient travel plans
- a change in treating physician (if your patient is changing treating physician for longer than 3 months, complete the change in treating physician form. If the change in treating physician is for less than 3 months, please email us).
If your patient restarts treatment after a break, complete a disease-specific reapplication form.
Find out more about your obligations in the treating physician fact sheet.
Clinical trials
You must tell us if your patient is taking part in a clinical trial. In most cases, this will not affect a patient’s eligibility to access LSDP medicines.
Home infusions
If your patient wishes to start home infusions, they must contact you.
You must determine if the patient is medically stable. This means that any infusion-associated reactions are well controlled before home infusion commences.
Most home infusion services are funded by the medicine sponsor (pharmaceutical company) and provided by a contracted nursing agency. You will need to contact the sponsor to complete an enrolment form, which includes patient consent.
Not all LSDP medicines can be delivered by a home infusion service. See the guidelines for specific information.
Fact sheet
Life Saving Drugs Program – Fact sheet for treating physicians
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