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.
Antibody-drug conjugate
Brentuximab vedotin was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on August 19, 2011 for relapsed HL and relapsed sALCL and conditional Marketing authorization from the European Medicines Agency in October 2012 for relapsed or refractory HL and relapsed or refractory sALCL. Trastuzumab emtansine (ado-trastuzumab emtansine or T-DM1) was approved in February 2013 for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with trastuzumab (Herceptin, Genentech and Roche) and a taxane chemotherapy. The newest ADC, Inotuzumab ozogamicin, was approved by the European Commission as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) on June 30, 2017 under the trade name Besponsa®(Pfizer/Wyeth). On August 17, 2017 Inotuzumab ozogamicin was also approved by the US FDA for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)