Amended and new PBS listings for adrenaline autoinjectors

• On 1 September 2021, the Pharmaceutical Benefits Scheme (PBS) listings for adrenaline (epinephrine) 150 micrograms and 300 micrograms were amended.
  The listings increased the maximum quantity from one to two and added a caution regarding the different administration techniques of different brands.

• On 1 September 2021, three new PBS listings were added to the PBS for adrenaline (epinephrine) autoinjectors for acute allergic reaction with anaphylaxis.

  Anapen Junior 150 and Anapen 300 are new brands that are ‘a’ flagged substitutes for existing PBS-listed brands of adrenaline (epinephrine)150 micrograms and 300 micrograms. Adrenaline (epinephrine) 500 micrograms (Anapen 500) is a new strength.

• The 500 microgram strength is new to the PBS as only the 150 mcg and 300 mcg strengths have ever been listed.

  This new strength replaces the standard medical management of two 300 microgram adrenaline (epinephrine) autoinjectors for heavier patients.

• Anapen has a different administration technique to that of existing PBS-listed brands (Adrenaline Jr Mylan, Adrenaline Mylan, EpiPen Jr. and EpiPen).

  Even though Anapen is a brand equivalent to existing PBS-listed brands, patients require specific training for each autoinjector.

Amended listings

On 1 September 2021, two PBS listings for adrenaline autoinjectors for acute allergic reaction with anaphylaxis were amended:^1,2

• adrenaline (epinephrine) 150 micrograms/0.3 mL pen device (Adrenaline Jr Mylan and EpiPen Jr)
• adrenaline (epinephrine) 300 micrograms/0.3 mL pen device (Adrenaline Mylan and EpiPen)

The amendments included an increased maximum quantity from one to two, and changes to the caution message and notes.¹ See Table 1 for a summary of the details.

New listings

On 1 September 2021, three new listings were added to the PBS for adrenaline autoinjectors for acute allergic reaction with anaphylaxis.¹

Two listings are new brands for existing strengths that were ‘a’ flagged with existing brands:¹

• adrenaline (epinephrine) 150 micrograms/0.3 mL pen device (Anapen Junior 150); ‘a’ flagged with Adrenaline Jr Mylan and EpiPen Jr
• adrenaline (epinephrine) 300 micrograms/0.3 mL pen device (Anapen 300); ‘a’ flagged with Adrenaline Mylan and EpiPen

One listing is a new strength:¹

• adrenaline (epinephrine) 500 micrograms/0.3 mL pen device (Anapen 500).

See Table 1 for a summary of the details.

Anapen Junior 150 and Anapen 300 were previously listed on the PBS in July 2010 and removed in January 2017 at the request of the former sponsor.²

Table 1: Adrenaline (epinephrine) amended and new PBS listings

a. Can be prescribed by nurse practitioners.¹

At their November 2020 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the new brand of adrenaline (epinephrine) for listing on the PBS. They stated that the listings would:²

• increase the availability of adrenaline (epinephrine) autoinjectors to treat anaphylaxis and address stock concerns due to having one supplier in Australia
• address under-dosing and/or repeated 300 microgram usage in the treatment of anaphylaxis for patients weighing ≥ 60 kg (see Table 2 for dosing based on weight and approximate age).

The PBAC noted that Anapen 500 is a new strength that replaces the standard medical management of two 300 microgram autoinjectors for patients weighing ≥ 60 kg.²

The PBAC recommended a brand equivalent PBS listing of Anapen to assist in the timely dispensing of adrenaline (epinephrine) during stock shortages. Despite the differing administration techniques of non-Anapen and Anapen products, the PBAC considered patients with sufficient anaphylaxis education and training resources would be able to administer different devices appropriately.²

The PBAC recommended the new listings on a cost-minimisation basis – that is, similar efficacy and cost – compared to existing PBS-listed brands. As Anapen is a substitute for other adrenaline (epinephrine) autoinjectors, there are no expectations for market growth.²

The change in maximum quantity aligns the listing with guidelines from the Australasian Society of Clinical Immunology and Allergy (ASCIA). Two devices per prescription are routinely recommended to allow one device to be with the patient (or for parental use at home for younger children) and one device to be available for use at school or an early childhood education or care centre.⁴ This amendment resulted in flow-on changes to the listings for adrenaline (epinephrine) 150 micrograms (Item 8679R; brands Adrenaline Jr Mylan and EpiPen Jr.) and 300 micrograms (Item 8698T; brands Adrenaline Mylan and EpiPen) from 1 September 2021.^1,2

Anapen Junior 150 and Anapen 300 should be considered equivalent for substitution at the point of dispensing (ie, ‘a’ flagged) with existing PBS-listed brands of adrenaline (epinephrine) and their corresponding doses. 

Anapen 500 should not be considered equivalent for substitution at the point of dispensing with other adrenaline (epinephrine) autoinjectors as it is the only available PBS-listed product at this strength.²

Many medicines are available on the PBS under different brands. The Schedule of Pharmaceutical Benefits uses ‘a’ flags to indicate where different brands are considered equivalent for the purposes of substitution at the point of dispensing.

The current practice of ‘a’ flagging in the Schedule of Pharmaceutical Benefits denotes that brand substitution may be undertaken by pharmacists at the point of dispensing without differences in clinical effect.⁵

Avoid prescribing Anapen and non-Anapen autoinjectors to the same patient without training from the prescriber. Pharmacists should ensure patients are educated on the product differences.¹

Figure 1: Anapen and EpiPen administration techniques^6,7

These images have been reproduced with permission from ASCIA.

When writing a prescription, prescribers may tick the ‘brand substitution not permitted’ box if they want to ensure the patient receives a particular brand of medicine.⁸

ASCIA recently updated the weight recommendations for adrenaline (epinephrine) dosing.⁹ The update is based on the safety of adrenaline (epinephrine) for children at the recommended doses, supported by international expert consensus^10-13 and Australian guidelines.¹⁴

Table 2: Adrenaline (epinephrine) dosing for treatment of acute allergic reaction with anaphylaxis^4,9

^a The dose recommendations are based on expert opinion regarding recommended dose for weight and clinical trials of injected adrenaline (epinephrine) for children, which is currently at variance with the product information leaflet.

^b Adrenaline (epinephrine) is not recommended for children weighing less than 7.5 kg as the risk of fatal anaphylaxis for children of this age is very low.

There are no restrictions to prescribing Anapen 500 for patients below the recommended weight of 50 kg to allow prescribers flexibility in dosing.²

The Early Supply Rule does not apply to Anapen, as with EpiPen, due to its recurrent episodic use and the clinical imperative to ensure ongoing supply.²

Ensure all patients have an Anaphylaxis Action Plan.^4,15

Advise patients that:

• three new adrenaline (epinephrine) autoinjector products are now available on the PBS for emergency anaphylaxis treatment¹
• Anapen Junior 150 is a brand equivalent to Adrenaline Jr Mylan and EpiPen Jr.²
• Anapen 300 is a brand equivalent to Adrenaline Mylan and EpiPen²
• Anapen 500 is a new strength with no brand equivalent product
• the active ingredient in all of these products is identical^16-20
• Anapen has a different administration technique to that of other adrenaline (epinephrine) autoinjectors¹
• preschools or schools need to be informed of a child’s adrenaline autoinjector prescription, along with an updated Anaphylaxis Action Plan illustrating the use of the device prescribed.⁹

Device training for Anapen is available through Allergy Concepts Australia, ASCIA and Allergy & Anaphylaxis Australia.

For any questions or concerns about Anapen, call the Allergy Concepts Australia hotline on 1800 761 964.

• NPS MedicineWise Brand equivalence – ‘a’ flagging explained
• Australian Prescriber Updated anaphylaxis guidelines: management in infants and children
• Australasian Society of Clinical Immunology and Allergy ASCIA Action Plans and First Aid Plans for Anaphylaxis