Pharmaceutical Evaluation Section
The Pharmaceutical Evaluation Section (PES) of the Pharmaceutical Benefits Branch of the Commonwealth Health Department is responsible for the evaluation of applications for listing drugs on the PBS. It receives applications for the listing of all new drugs and new indications for marketed drugs from the drug’s sponsor. An application must be submitted to the department eight to 12 weeks before the PBAC meeting for consideration at its subsequent meeting.
Since January 1993, applications for listing of drugs must include both clinical trial results and economic evaluations. Both internal and contracted outside experts evaluate the application. It is examined for accuracy, quality, the methods and limitations of any economic modelling used, and gener-alizability . The evaluation generally takes six to seven weeks. This assessment is provided to the ESC, the PBAC and the company concerned. Companies may then provide a brief written response to the assessment, which is also reviewed by the PBAC as part of its decision-making process.