What the LSDP is
The Life Saving Drugs Program (LSDP) pays for specific essential medicines to treat patients with ultra-rare and life-threatening diseases.
Most medicines in Australia are subsidised through listing on the Pharmaceutical Benefits Scheme (PBS). Funding for medicines on the LSDP is separate to the PBS.
The LSDP covers medicines if:
- they are clinically effective, but not cost effective enough to list on the PBS
- they treat life threatening and ultra-rare conditions (defined as 1 case per 50,000 people or fewer in the Australian population)
- the pharmaceutical company (sponsor) applies for an LSDP listing.
Note: If a LSDP medicine is subsequently listed on the PBS, then the medicine can continue to be funded under the LSDP for such period as is required to facilitate the transition to supplying the medicine under the PBS while also ensuring continuity of supply to patients.
Because these medicines are critical for patients, we assess all applications within 30 days. We process most applications in around 8 days.
LSDP medicines
This table lists the medicines covered under the LSDP and the conditions they treat. Click to view LSDP guidelines and forms for each condition.
| Medicine(s) | Condition |
|---|---|
Agalsidase alfa (Replagal®) Agalsidase beta (Fabrazyme®) | Fabry disease |
Imiglucerase (Cerezyme®) Velaglucerase (VPRIV®) Taliglucerase (Elelyso®) Eliglustat (Cerdelga®) | Gaucher disease (type 1) |
| Nitisinone (Orfadin® and Nityr™) | Hereditary tyrosinaemia type 1 (HT1) |
| Cerliponase alfa (Brineura®) | Late-infantile onset Batten disease (CLN2) |
| Laronidase (Aldurazyme®) | Mucopolysaccharidosis type I (MPS I) |
| Idursulfase (Elaprase®) | Mucopolysaccharidosis type II (MPS II) |
| Elosulfase alfa (Vimizim®) | Mucopolysaccharidosis type IVA (MPSIVA) |
| Galsulfase (Naglazyme®) | Mucopolysaccharidosis type VI (MPS VI) |
| Asfotase alfa (Strensiq®) | Perinatal- and infantile-onset hypophosphatasia (HPP) |
Alglucosidase alfa (Myozyme®) Avalglucosidase alfa (Nexviazyme®)
|
|
| Sebelipase alfa (Kanuma®) | Infantile-onset lysosomal acid lipase deficiency (LAL-D) |
How the LSDP works
Several groups of people work together on the LSDP program.
- Australian Government Department of Health and Aged Care – we fund and administer the program, and order medicines to be delivered to the patient’s nominated pharmacy.
- Pharmaceutical companies – apply to list relevant medicines on the LSDP, if their PBS application was rejected; supply medicines to participating pharmacies.
- Life Saving Drugs Program Expert Panel (the Panel) – considers applications to list new medicines on the program; advises the Chief Medical Officer; reviews the drugs after 2 years.
- Chief Medical Officer – recommends to the Minister for Health and Aged Care if a medicine should be listed on the LSDP or not.
- Treating physicians – check if patients are eligible; prescribe the medicines; complete and submit application forms; complete the annual review paperwork.
- Pharmacists (usually at hospitals) – dispense medicines to patients according to the program rules.
- Patients – take the medicine according to their doctor’s instructions, and follow the program requirements about regular reviews.
Patient eligibility criteria
To get a medicine under the LSDP, you must:
- be eligible according to the criteria in the LSDP guidelines for your condition
- participate in regular assessment to help us check how effective the medicine is; if you do not want to participate, you must have a valid reason why not
- not have any other medical condition that might make the drug less effective (this includes complications of the primary condition)
- be eligible to receive Medicare benefits.
Patient reviews
We regularly review patient eligibility for the program, as set out in the relevant LSDP guidelines.
This is generally 12 months after starting the medicine, and every 12 months after that. However, the Panel may ask doctors to submit patient data more often.
Treating physicians must send in a reapplication for each patient by 1 May every year.
Medicines criteria and reviews
Medicines must also meet eligibility criteria to be listed on the LSDP.
The Panel reviews how medicines are performing 2 years after listing. This ensures they are delivering the expected benefits and can continue to be funded.