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Global Forum | April 2015 Australia Weighs in on “What Lies Ahead 2015” Richard Day MD FRACP Clinical Pharmacology, St Vincent’s DIA Fellow DIA Global Forum Regional Editor for Australia/New Zealand The number one concern for the Australian pharmaceutical industry in 2015 is access to high cost and targeted medicines. This is not a new concern ‘down under,’ however the costs for these innovative, and generally effective medicines, are sky-rocketing and the national payer, the Australian Government, is looking for budget savings and grows seemingly more uncertain of the value proposition for some of these medicines. The well-established and, heretofore, ground-breaking national scheme for assessing “incremental cost effectiveness based on cost per QALYS” is not coping as well as it used to with the rush of new medicines, most notably for oncology (some with up to phase 2 data only or studies with outcomes of uncertain utility such as progression-free survival), viral infections, cystic fibrosis, inflammatory diseases and rare disorders. The principle underlying our national approach has been that the payer is buying “health outcomes,” not just the pharmaceutical product. The cost effectiveness calculations for some of these new products approaches previously acceptable benchmark levels (around $AUS 45,000/QALY) but, if approved, You Need to Know 49