ABSTRACT
The subcommittee of the Pharmaceutical Benefits Advisory Committee reviews pharmaco-economic submissions that manufacturers need to prepare to qualify for reimbursement. 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. In 2007 the Australian government introduced a change in the therapeutic referencing system under the “PBS Reform” package. Australia has been one of the first countries to implement strict cost-effectiveness requirements as part of its pricing and reimbursement approval process. Bristol-Myers Squibb agreed to a 100% rebate beyond the agreed subsidization caps to mitigate the uncertainties in the nature and magnitude of Opdivo’s incremental clinical benefit in Australian clinical practice and the risk of its use beyond disease progression. Australia’s Medicare provides comprehensive healthcare coverage for all residents. Medicare provides reimbursement based on an established Medicare Benefits Schedule and provides 100% coverage for inpatient care and outpatient general practitioner consultations.
