In AstraZeneca Pty Ltd v Minister for Health and Ageing  FCA 487, the Federal Court dismissed AstraZeneca’s case against members of the Pharmaceutical Benefits Advisory Committee and the Minister for Health and Ageing, which challenged a declaration by the Minister to include rosuvastatin 40mg (Crestor) in a high-potency statin therapeutic group containing rosuvastatin and atorvastatin. The effect of a therapeutic group is that the PBS listed price of a drug in a therapeutic group is subject to reference pricing and is capped at the lowest price of a drug in the therapeutic group.
AstraZeneca argued in their case that the Minister should have considered whether a pharmaceutical item or a particular dosage form was interchangeable with another pharmaceutical item or a particular dosage form in the same therapeutic group. In this regard, AstraZeneca contended that Crestor 40mg tablets were not “interchangeable on an individual patient basis” with the equivalent dose of atovastatin because the equivalent dose to Crestor 40mg was Lipitor 120mg but the maximum allowable dosage of atorvastatin according to the TGA-approved product information available was 80mg.
In dismissing AstraZeneca’s case, the Federal Court held that “an assessment of interchangeability… must consider the interchangeability of drugs, not particular doses of drugs or of individual pharmaceutical items.” Justice Buchanan held that the Minister was correct in basing her determination on whether the drug rosuvastatin was interchangeable on an individual patient basis with the drug atorvastatin.