Clinical economics analysis perspectives

Section 1 of the guidelines establishes the context of the submission. It asks for a description of the drug, its use on the PBS and the therapies that wiU be co-administered or substituted. Section 2 asks for the best available evidence on the clinical performance of the drug, including the scientific and statistical rigour of randomised trials, and a preliminary economic evaluation based on evidence from the randomised trials. Section 3 describes when extrapolation beyond the preliminary economic evaluation maybe made and how adjustments can be made in a modelled economic evaluation. Section 4 requests a financial analysis from the perspective of the PBS and government health budgets. 

---