The Pharmaceutical Benefits Scheme and implications for paediatric prescribing

Aims:   To evaluate the impact of the Pharmaceutical Benefits Advisory Committee (PBAC) decisions on access to medicines listed on the Pharmaceutical Benefits Scheme (PBS) for children.
Methods:   We analysed all public summary documents from PBAC meetings from July 2005 to November 2006 and compared these with the Therapeutic Goods Administration (TGA) recommendations for children for the same medicine. Main outcome measures stratified by age, the total number of medicines for specific indications (accepted and rejected) by therapeutic class; estimated cost to the PBS per annum for each medicine recommended for listing; comparison of TGA-approved product information and PBS listing for recommended medicines.
Results:   Of the 102 medicines for specific indications considered by the PBAC, 7% (7/102) of submissions were for new paediatric indications. Most submissions (60%, 61/102) did not specify age for the PBS recommendation and were for conditions which only affect adults. Listings which specifically included children were more likely to have a positive PBAC recommendation. Of the six recommended medicines for children, four were estimated to cost between $10–30 million per year. There was fair concordance between PBS- and TGA-approved product information for age (kappa 0.21) but in 46%, PBAC recommendations were for age-unrestricted listing compared with adults-only use in the TGA-approved product information.
Conclusion:   Access to new subsidised medicines for children in Australia lags behind adults because most applications to the PBAC for new medicines are for conditions which only affect adults. PBS processes facilitate access for children to new medicines by avoiding age restrictions.