Applying for an LSDP medicine for your patient
As the treating physician, you determine whether your patient is eligible for treatment under the LSDP by completing and signing the relevant application form.
As LSDP medicines are expensive and the Australian Government provides them at no cost to the patient, we carefully check patient eligibility.
The patient must meet both:
- basic eligibility criteria
- condition-specific eligibility criteria, as outlined in the relevant guidelines.
To apply, you must email us:
- a fully 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 outlining your patient’s recent medical and surgical history, and a general description of their health status.
Eculizumab (Soliris®) for treatment of paroxysmal nocturnal haemoglobinuria (PNH) can now be accessed on the Pharmaceutical Benefits Scheme (PBS). For more information see our fact sheet for prescribers.
Once we receive the complete application, we check and process it.
We prioritise new or urgent applications. If the application is urgent, please mark it ‘Urgent’ and provide the reason in your covering letter.
For each application, we:
- check the application is completed correctly and all the required information is there
- confirm with Services Australia that the patient is eligible for Medicare
- compare the individual test results to the specifications in the disease guidelines
- check 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)
- calculate the number of vials/tablets required for each dose
- seek further 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 notify you and put the application on hold until you respond.
Where an application is complete, we will notify you of our decision within 30 days.
After we approve an application, we contact the nominated pharmacy to confirm that they are willing to handle and supply the LSDP medicine(s).
If a pharmacy has not supplied LSDP medicines before, we tell them about their obligations under the program.
Where required, the medicine’s sponsor (pharmaceutical company) can arrange training on how to administer the LSDP medicine correctly.
Annual reapplication for existing patients
We require each patient on the program to be reassessed every year. This ensures that patients:
- remain eligible for the program
- comply with the requirements for ongoing treatment
- are reviewed by their treating physician (at least) annually.
You must tell us if it is not clinically possible for a patient to complete a test by the 1 May deadline. You can order tests at any point in the 12-month period (where appropriate).
Patients need to sign the consent form each year to agree to ongoing data collection for review purposes.
By 1 May every year, you must email us:
- the completed reapplication forms
- copies of all test results as evidence of ongoing eligibility
- the relevant spreadsheet with the patient’s results
- a clinic letter outlining the patient's recent medical and surgical history, and general description of their health status.
In some cases you may need to submit data more frequently. See the guidelines for each condition for details.
For late-onset Pompe disease patients, you must send us the following test results after the first 6 months of treatment, and annually after that:
- 6-minute walk test
- forced vital capacity.
You must tell us immediately if a patient’s eligibility changes at any time during treatment.
If you want to change the patient’s dose, email us and include:
- the requested new dose
- the clinical justification for the request.
Generally, we only subsidise up to the maximum dose allowed in the guidelines. Where a dose increase is outside of the guidelines, we will need to consider the request carefully. You must provide appropriate supporting evidence.
You must notify us of dose decreases or increases so that we can order the correct amount for the patient.
Changing or ceasing treatment
If you become aware that your patient wishes to change or cease treatment, email us immediately.
Patients must adhere to the treatment regime and continue to meet the relevant eligibility criteria to get ongoing subsidised treatment.
Your patient must tell you if they are going to travel and it will affect access to their medication.
The patient must notify you of the dates of travel. It is your responsibility to:
- ensure that the patient is fit to travel and will continue to meet the ongoing eligibility requirements of the LSDP
- notify us via email
- arrange for a treating physician at the new location (this includes domestic and overseas travel)
- ensure the patient understands that they may have to pay out-of-pocket costs when travelling outside Australia.
You must notify us if you are ceasing care of an LSDP patient.
If a new treating physician takes over the care of the patient, they must submit a new initial application form to us. This is because the treating physician must independently determine the patient’s eligibility and sign the relevant declarations. They do not need to provide test results again if you already provided them within the previous 12-month period. They should note this in their cover letter.
Temporary transfer of care during leave
You can temporarily transfer or share care with colleagues if you are taking leave (for example, due to holidays or illness).
This arrangement does not require a formal transfer of care from one physician to another if it is for less than 3 months.
Please advise us of the temporary arrangements via email, including:
- temporary physician details
- start date
- end date.
This ensures we know the best contact for clinical matters relating to the patient.
In most cases, participation in a clinical trial will not affect a patient’s eligibility to access LSDP medicines. However, treating physicians are required to advise LSDP if their patient is participating in a clinical trial.
Restarting after a break
If your patient has had a break from LSDP treatment for any reason and wants to restart, you must submit a reapplication form.
We order LSDP medicines directly from the supplier, who then ship to the patient’s chosen pharmacy. This is usually a hospital pharmacy, but can be a community pharmacy (for details, see LSDP for pharmacists).
Due to the high cost of LSDP medicines, we only order 1 month’s supply of medicine for each patient at a time.
Changing a nominated hospital or pharmacy
Patients wishing to change their hospital or pharmacy must first contact you, as their treating physician, to check that:
- you have prescribing rights for that hospital
- the nominated pharmacy agrees to provide LSDP medicines.
If you do not have prescribing rights at that hospital, you may need to arrange for a proxy to prescribe for them on your behalf.
As the treating physician, you must then notify us of the new pharmacy so we can arrange delivery to the new location.
If your patient wishes to start home infusions, they must contact you.
As the treating physician, you need to determine if the patient is medically stable. This means that any infusion-associated reactions are well controlled before home infusion.
The 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 via a home infusion service. Please refer to the guidelines for specific information.
There are currently 7 medicines available for home infusion:
- agalsidase alfa (Replagal®)
- agalsidase beta (Fabrazyme®)
- idursulfase (Elaprase®)
- imiglucerase (Cerezyme®)
- taliglucerase (Elelyso®)
- velaglucerase (VPRIV®)
- avalglucosidase alfa (Nexviazyme®).