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.
Medical uses of bicalutamide
Bicalutamide has a small risk of elevated liver enzymes and hepatotoxicity at dosages of 50 mg/day and above. As a result, it is recommended that liver function tests periodically be performed. The risk of elevated liver enzymes and liver failure with bicalutamide appears to be much smaller than with cyproterone acetate, which is the most widely used antiandrogen in transgender women in Europe and elsewhere in the world. In the United States, one of the only countries where cyproterone acetate has not been approved for medical use, the relatively weak and non-selective antiandrogen spironolactone is commonly used in transgender women instead. Bicalutamide is a favorable alternative option to these antiandrogens in transgender females.