Outcomes of new medicine applications
The Pharmaceutical Benefits Advisory Committee (PBAC) must consider a medicine before it is included on the Life Saving Drugs Program (LSDP).
The PBAC must accept it as clinically effective but reject it for Pharmaceutical Benefits Scheme (PBS) listing because it fails to meet the required cost effectiveness criteria.
The LSDP Expert Panel (the panel) considers all applications for new medicines seeking listing on the LSDP, which provides advice to the Commonwealth Chief Medical Officer (CMO). The CMO advises the Minister for Health and Aged on medicines proposed to be listed on the LSDP.
The panel considered this application on 24 June 2022 and 14 October 2022. On 1 April 2023 sebelipase alfa was listed on the LSDP. Read the sebelipase alfa outcome statement.
Sebelipase alfa will be reviewed once an agreed number of patients have been accessing the medicine through the LSDP for 12 months or 5 years after listing, whichever comes first.
The panel considered eliglustat on 18 February 2022, 24 June 2022 and out of session. On 1 April 2023 eliglustat was listed on the LSDP. Read the 2022 eliglustat outcome statement.
In July 2017, before the panel was established, the CMO approved the listing of eliglustat on the LSDP. The department and the sponsor could not agree on the listing criteria at that time. The sponsor asked the panel to reconsider this application in November 2019. The panel deferred its decision until the outcomes from the Gaucher disease LSDP medicines review were known. Read the 2019 outcome statement.
The panel considered this application on 18 February 2022 and 24 June 2022. On 1 September 2022 avalglucosidase alfa was listed on the LSDP. Read the avalglucosidase alfa outcome statement.
Avalglucosidase alfa will be reviewed in late 2024 as part of the 24 month review process.
The panel considered a reapplication on 10 October 2021. On 1 May 2022 asfotase alfa was listed on the LSDP. Read the asfotase alfa outcome statement.
Asfotase alfa will be reviewed in mid-2024 as part of the 24 month review process.
The CMO previously considered this medicine before July 2018, when the Government introduced the panel and other changes. Read the previous asfotase alfa outcome statement.
The panel considered this application on 17 October 2018. On 1 May 2019, cerliponase alfa was listed on the LSDP. Read the cerliponase alfa outcome statement.
Cerliponase alfa was reviewed in late 2021 as part of the 24 month review process.