Pharmaceutical Benefits Scheme
Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where the PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as a restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost.
Ceftazidime/avibactam
Avycaz is a prescription-only medication, which was fast-tracked by the FDA due to the shortage of drugs that effectively circumvent the resistance problem. One of the active pharmacological ingredients, ceftazidime, has long been proven to be safe, which allowed the FDA to expedite its approval. The FDA relegated its use to only those patients who are refractory to other treatments because of the limited clinical safety data and also to prevent prescribers from overusing this therapy if other effective treatment exists. Additionally, the price gap between traditional therapy and Avycaz is quite large. The wholesale acquisition cost (WAC), which is the price the manufacturer will set for the wholesaler to purchase the drug, for Avycaz is $2,850 for ten 2 g vials. While this is not the price the patient pays, the cost of a single day of treatment with Avycaz is more than a full 14-day regimen of currently used medications because of the availability of generic alternatives. This financial pressure should help with the FDA regulation in restricting its use.