To guide its decisions on medicines delisting including those available OTC, the Department of Health has published principles set by the Pharmaceutical Benefits Advisory Committee.
The delisting principles considered appropriate by the PBAC include: Schedule 2 or 3 OTC medicine; low ex-manufacturer price; products unlikely to be highly reliant on specialist prescribing and management; and, products where the PBAC has previously considered that the evidence for the current arrangements for subsidy is not overwhelming (e.g. blood glucose test strips).
The PBAC statement includes a list of medicines that the PBAC recommended be retained on the PBS, despite also being available OTC: adrenaline, glucagon, glyceryl trinitrate, isosorbide dinitrate, salbutamol, theophylline, terbutaline, nicotine replacement therapy, nutritional products, and PBS listed products intended for IV delivery (e.g. glucose, gelatin).
The PBAC recommended that for delisting OTC products from the PBS those with an ex-manufacturer price below the PBS Concessional co-payment should be delisted from the PBS. The PBAC considered that access to these products would be unaffected by the removal of the PBS subsidy.
PBAC deferred recommending the delisting of ocular lubricants to allow the department to negotiate consistent pricing for the unit-dose and multiple-dose presentation of these products.
The PBAC also identified a set of principles for when delisting would not be appropriate, which include: high ex-manufacturer price, likely to prevent access to patients in the absence of PBS subsidy; drugs for urgent or emergency situations; products that are considered OTC only because they are not Scheduled medicines; and, drugs listed on the Palliative Care Schedule or with listings pertaining to Aboriginal or Torres Strait Islander patients.
The principles were set at its special out-of-session meeting in April, where it also considered biosimilars and the extension of the Safety Net 20 Day Rule.