Covid and RSV immunisation programs endorsed as the committee recommends new listings across oncology, cardiology and rare disease.
Vaccines dominated the Pharmaceutical Benefits Advisory Committee’s December 2025 meeting, with the PBAC recommending the inclusion of updated covid and respiratory syncytial virus vaccines on the National Immunisation Program, alongside a raft of medicine listings and amendments across multiple therapeutic areas.
The PBAC recommended the listing of the Comirnaty Omicron XBB.1.5 Covid-19 vaccine on the NIP for adults at increased risk of severe disease, including older adults and specified Aboriginal and Torres Strait Islander populations.
The recommendation is in line with updated Australian Technical Advisory Group on Immunisation (ATAGI) advice.
The committee also endorsed a platform recommendation designed to support timely access to future updated covid vaccines using the same technology, reflecting the ongoing evolution of SARS-CoV-2 variants.
“This PBAC recommendation is the first for a Covid-19 vaccine and is a necessary step to enable transition of Covid-19 vaccines from the NCVP to the NIP,” the meeting outcomes report said.
“The PBAC considered ongoing protection from Covid-19 remains important, noting Covid-19 was the leading cause of acute respiratory infection mortality in Australia between 2022 and 2024.”
While acknowledging the clinical value of vaccination, the PBAC reiterated that acceptable cost-effectiveness would depend on revised pricing through negotiations with the sponsor.
“The PBAC considered the sponsor’s economic assumptions were not appropriate and advised the analysis should use more conservative assumptions,” the committee said.
“Using the PBAC’s recommended assumptions at the sponsor’s proposed price, the PBAC considered the incremental cost-effectiveness ratio (ICER) was unacceptably high.
“On this basis, the PBAC recommended that a lower price would be required to ensure the vaccine is cost-effective in the proposed circumstances of use.”
In respiratory disease prevention, the PBAC reaffirmed its earlier recommendation for the inclusion of the Arexvy RSV vaccine on the NIP for older adults and selected Aboriginal and Torres Strait Islander cohorts.
The Committee considered the vaccine’s clinical effectiveness and cost-effectiveness acceptable at the proposed price and noted its comparability with other RSV vaccines available for this population.
Beyond immunisation, the PBAC recommended an amendment to the PBS restriction for eplerenone for the treatment of heart failure.
It found that reduced pricing and updated evidence supported broader access, citing improved tolerability compared with spironolactone and alignment with contemporary heart failure management guidelines.
In rheumatology, the committee supported a change to the PBS listing for hydroxychloroquine 200mg tablets, increasing the maximum number of repeats from one to three.
The PBAC considered that this amendment would better reflect routine specialist review intervals and improve continuity of care without a significant increase in PBS expenditure.
For spinal muscular atrophy, the PBAC recommended clarifications to the PBS restrictions for nusinersen to ensure access for children who have previously received gene therapy with onasemnogene abeparvovec outside PBS arrangements.
“This approach aligned with the PBAC’s intent to provide equitable access and the best possible clinical outcomes for all eligible children, regardless of their prior treatment pathway,” the committee said.
In oncology, the PBAC recommended a revised proposal for pembrolizumab that would allow a broad multi-cancer PBS listing for advanced and metastatic disease.
The committee supported consistency with other immunotherapy listings and endorsed the use of risk-sharing arrangements to manage overall budget impact while maintaining access for patients likely to benefit.
Related
The PBAC also recommended the PBS listing of seladelpar for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response or intolerance to ursodeoxycholic acid.
“The PBAC noted previous input from the Liver Foundation on the significant impact of PBC on quality of life,” the committee said.
“The PBAC noted it had previously considered seladelpar was as effective as obeticholic acid (OCA) at reducing markers of liver damage and improving cholestasis, with similar safety. The PBAC also noted patients treated with seladelpar reported improved itching symptoms and lower rates of PBC‑related pruritus than patients treated with OCA, and acknowledged pruritus is a significant issue for people with PBC.”
For rare disease treatment, the PBAC recommended the PBS listing of velmanase alfa for the non-neurological manifestations of alpha-mannosidosis.
The committee acknowledged the extreme rarity and devastating nature of the condition and the absence of alternative disease-modifying therapies, concluding that the medicine would address a significant unmet clinical need.
“The PBAC noted there are currently no effective pharmacological treatments available in Australia for this condition,” it said.
All PBAC recommendations are subject to successful price negotiations between sponsors and the Department of Health, Disability and Ageing, followed by approval from the federal health minister.
For the full meeting outcomes see here.
