ABSTRACT
Australia's Medicare provides comprehensive healthcare coverage for all residents. Australia's Pharmaceutical Benefits Scheme PBS# controls prices of drugs that are reimbursed under its scheme. Therapeutic referencing is an essential part of the Australian reimbursement system. The PBS classifies drugs in therapeutic classes and determines a single reimbursement rate for all drugs in the class when they are deemed essentially equivalent. Australia has been one of the first countries to implement strict cost-effectiveness requirements as part of its pricing and reimbursement approval process. For some therapeutic sub-groups the PBS has defined a Therapeutic Group Premium (TGP). Individual drugs in those drug groups are considered similar in efficacy and safety. A risk sharing agreement was reached where Overall Survival (OS) data was to be gathered through a patient registry. Upon availability of the OS data, Bristol-Myers Squibb (BMS) is required to pay a rebate when the data fall short of the claims made during price negotiations.
