Adrenaline autoinjectors approved by the TGA, including a new 500mcg one, provide more choice to patients who have been impacted by supply shortages and manufacturing delays
Anapen 300®, Anapen 500® and Anapen 150 Junior® (Anapen Junior) adrenaline (epinephrine) autoinjectors have been listed on the ARTG for the emergency treatment of anaphylaxis due to insect stings, food or other allergens.
This TGA approval provides people weighing 60kg and over living with anaphylaxis with access to a 500mcg adrenaline autoinjector dose for the first time, as well as further product choice for those of all ages at risk of anaphylaxis.
Anapen Junior and Anapen 300 were previously listed on the PBS but removed in January 2017 at the request of the former sponsor.
Existing adrenaline autoinjectors in Australia prior to their re-listing include the EpiPen, EpiPen Junior, Adrenaline Mylan and Adrenaline Junior Mylan.
Allergy & Anaphylaxis Australia (A&AA) CEO Maria Said welcomed the TGA approval of the autoinjectors.
“It is important for an individual at risk of anaphylaxis, and their treating doctor, to discuss adrenaline injector device options, and to choose a device that best suits their needs,” stated Ms Said.
“Having the Anapen 500mcg dose available to those weighing 60kg and over in Australia, is an important step forward.
“The listing of Anapen also provides welcome relief to those at risk of anaphylaxis, who have long been reliant upon one device, and severely impacted during manufacturing delays, product recalls, or supply shortages.
“Previously, Australians needed to use expired devices for life-threatening emergencies if they occurred during stock shortages.
“Furthermore, those who were diagnosed with anaphylaxis during shortages were left with no life-saving medication,” Ms Said explained.
Having another supplier guarantees an alternative device option, should we experience a shortage of one adrenaline injector or the other.
Sponsor Allergy Concepts co-founder and Managing Director, Martin Naef, said the inclusion of Anapen on the ARTG represents a major milestone in meeting a key 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.
“The introduction of Anapen represents the first significant step towards addressing this serious public health issue,” said Mr Naef.
“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.
“This marks an important innovation milestone in the management of allergy and anaphylaxis in this country, and reinforces Allergy Concepts’ commitment to providing more treatment options and solutions to Australian healthcare professionals, and their patients.”
The PBAC recommended the General Schedule Authority Required PBS listing of the three products at their November 2020 meeting.
It is expected that Anapen 300®, Anapen 500® and Anapen 150 Junior® will be listed on the PBS in September 2021, according to the Australasian Society of Clinical Immunology and Allergy (ASCIA).
The Anapen auto-injector is intended for immediate self-administration by an individual with a history of anaphylaxis, and is designed to deliver a single dose of 150/300/500 micrograms of adrenaline (epinephrine).
Each Anapen device is designed to deliver a single, intramuscular dose of adrenaline to the outer-mid thigh, and has a shelf life of up to 24 months.
Anapen has a significantly different administration technique to other auto-injector devices. The autoinjector is triggered by pushing a red button with the thumb. Device training and education will be available through Allergy Concepts, A&AA and ASCIA, for patients and carers.
However the PBAC decided Anapen 300® should be treated as equivalent to Epipen and Adrenaline Mylan; and that Anapen 150 Junior® should be treated as equivalent to Epipen Jr and Adrenaline Jr Mylan.
While the PBAC noted the differences in administration techniques of Anapen, EpiPen and Adrenaline Mylan, it considered that patients with sufficient anaphylaxis education/training resources would be able to administer different devices appropriately.