Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals.

This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS, see are determined.

Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.

Your question to the PBAC

I would like to ask the Pharmaceutical Benefits Advisory Committee (PBAC) why repeat prescriptions of the adrenaline auto-injectors, EpiPen and EpiPen Jr, are not available. Anaphylactic risk is a lifelong condition, which will not change much over time. The auto-injectors also have a short half-life so the need to see the doctor for a new prescription every six months just to maintain a supply of a rarely used emergency drug seems inappropriate. A review every couple of years would be reasonable.

Kristen Pearson
Maroondah Hospital
Ringwood East, Vic.

PBAC response

Both EpiPen formulations were recommended for listing on the basis of acceptable cost-effectiveness overall, although the estimates of incremental cost-effectiveness were both high and uncertain. The PBAC therefore recommended a rigorous Pharmaceutical Benefits Scheme (PBS) listing that would prevent use in those instances where cost-effectiveness had not been demonstrated.

To maximise the cost-effective use of the products, the PBAC sought to minimise the number discarded due to the short expiry date by limiting the number of auto-injectors that can be prescribed. Consequently, it recommended that the maximum quantity be limited to one auto-injector for adults and two auto-injectors for patients under 17 years of age, and that no repeats apply.

Data presented to the PBAC indicated that listing with these restrictions would meet the clinical needs of most patients given that on average, the number of auto-injectors required per patient per year (as a replacement for either a used or an expired auto-injector) would be covered by one prescription.

With respect to the short expiry date, I have been advised by the manufacturer that most auto-injectors will expire around 12 months after being dispensed, but it is actively pursuing ways of extending the expiry dates.