Australia TGA/PBAC Approval → What is the PBAC?

The Pharmaceutical Benefits Advisory Committee (PBAC) are an independent committee of experts whose primary goal is to advice the Minister of Health on which medicines and medicinal products should be subsidised under the PBS. They also look after the subsidisation of vaccines under the National Immunisation Program (NIP). No new medications can be added to the PBS without a positive recommendation from the PBAC.

The PBAC committee is made up of doctors, health professionals, health economists and consumer representatives. The committee will receive submissions from companies/organisations that would like their novel discoveries to be listed on the PBS. PBAC consists of two sub committees; Dug Utilisation Sub Committee (DUSC) and Economic Sub Committee (ESC). The DUSC evaluates the estimated usage and financial cost of medicines, while the ESC considers clinical and economic evaluations of medicines submitted and advises PBAC on these aspects.

The committee will meet three times in a calendar year to discuss the applications and decides on the new PBS additions.
The committee will take into consideration clinical efficacy, safety and cost-effectiveness of the medication under review in comparison to other options. The criteria used by the committee are outlined below:

• Health benefit in comparison to other available drugs (effectiveness, safety)
• Cost vs benefit analysis
• Financial implications on the PBS & impact on the health budget
• The severity of the condition the medication is used to treat
• Presence of other effective substitutes
• Ability to target therapy to populations that will benefit most
• Amount of clinical evidence, cost effectiveness and uptake that is available
• Equity
• “Rule of Rescue” – Supplementary to other criteria in exceptional circumstances
• No other alternative treatments are available
• Condition is severe, progressive and expected to lead to premature death
• Health condition applies to a very limited number of patients.