Pharmaceutical Benefits Advisory Committee

The PBAC is an independent expert body appointed by the Australian Government under the National Health Act 1953; no new medicine can be listed on the Pharmaceutical Benefits Scheme without a positive PBAC recommendation. It assesses comparative effectiveness and cost-effectiveness, publishes Public Summary Documents for every decision, and negotiates risk-sharing and managed-access arrangements for expensive cancer drugs with uncertain evidence. The PBS is one of the oldest universal medicines subsidy schemes and its rejections and deferrals of high-cost oncology drugs are closely watched by companies and patient groups. Registration by the TGA must precede or run in parallel with PBAC consideration.