12 April 2021

New adrenaline autoinjector listings to ease supply woes

Allergies Clinical Immunology

New Epipen alternatives have a ‘substantially different’ administration technique, requiring patient training, says PBAC.


Patients over 60kg with anaphylaxis now have access to a higher dosage adrenaline autoinjector, with a device delivering 500mcg (Anapen500, Allergy Concepts) recently added to the Australian Register of Therapeutic Goods.

Two other Anapen devices – alternatives to the well-known EpiPen autoinjectors – were also added to the register, a development the sponsor said would give prescribers and patients choice and reassurance amid ongoing shortages of adrenaline autoinjectors.

The Australian supply has been plagued by uncertainty for years, including a period in late 2019 where the company that imported EpiPens said it had “run out” of its paediatric device. At the time, the TGA allowed the conditional release of a batch contaminated with a very low-level of pralidoxime to address the shortage.

There have also been recent reports the COVID-19 pandemic exacerbated supply problems, with pharmacies struggling to source devices that have expiration dates past July.

The Australasian Society of Clinical Immunology and Allergy said the three devices are expected to be listed on the PBS by September, following the Pharmaceutical Benefits Advisory Committee (PBAC)’s recommendation in its November 2020 meeting.

In its meeting notes, the PBAC advised that at the pharmacy level, the 150mcg and 300mcg Anapen devices could be substituted with the other dose-equivalent devices available (EpiPen and Mylan) for treatment of acute allergic reaction with anaphylaxis, but there was no substitute adrenaline autoinjector at the 500mcg strength.

However, it warned prescribers should not give “Anapen and non-Anapen products” to the same patient without first training them in their use.

Although EpiPens and the new Anapen autoinjectors appear superficially similar, they have “substantially different administration techniques”, according to NPS MedicineWise.

“The Anapen autoinjector is triggered by depressing a red button with the thumb, whereas the EpiPen device is held mid-section — with the thumb and fingers forming a fist — and triggered by pressing firmly into the outer mid-thigh.”

PBAC has also recommended nurse practitioners be able to prescribe the new autoinjectors, similar to the recommendations for EpiPen.

Allergy Concepts managing director Martin Naef said the devices’ inclusion on the register is a step towards meeting a major finding of the Parliamentary Inquiry into Allergies and Anaphylaxis.

“One of the key Committee findings from the Parliamentary Inquiry was the need for the introduction of alternative adrenaline autoinjectors to the Australian market, to prevent future stock shortages,” Mr Naef said in a press release.

“We are excited to be the only company in Australia offering a complete product line for all Australians – from children weighing 15kg right up to adults weighing 60kg or more.”

Read more: Product CMI

More from TMR