ADRENALINE (EPINEPHRINE)
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Neffy®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- SEQIRUS (AUSTRALIA) PTY LTD
- Condition/indication:
(therapeutic use) -
- Acute allergic reaction with anaphylaxis
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
Lodgement of required documentation: - 01/05/2026
-
Acceptance of complete documentation:
- Accepted
-
Agreement to listing arrangements: - Commenced on 13/05/2026
-
Status:
- Finalised
-
Government processes: - Commenced on 14/05/2026
-
Medicine listed on the PBS: - 01/07/2026 (see PBS schedule)
PBAC Outcome
The PBAC recommended the listing of neffy® nasal spray, a new form of adrenaline (epinephrine), for the emergency treatment of acute severe allergic reactions in children (over 4 years and 15 kg) or adults at significant risk of anaphylaxis. The PBAC considered there was a clinical need for an alternative adrenaline product to the auto-injectable form EpiPen, given previous shortages with supply of adrenaline auto-injector pens.
The PBAC welcomed input from health care organisations and a health care professional. This included input from a clinical nurse consultant and multiple consumer and medical organisations (the National Allergy Council, the Australasian Society of Clinical Immunology and Allergy (ASCIA), Allergy & Anaphylaxis Australia (A&AA), National Paediatric Medicines Forum (NPMF), Pharmaceutical Society of Australia and National Aboriginal Community Controlled Health Organisation (NACCHO)). The PBAC acknowledged that neffy was more stable to temperature variations and has a longer shelf life than EpiPen. The PBAC accepted this could result in less frequent replacements, which is particularly important for rural and remote communities.
Additionally, the PBAC noted that a needle-free option of adrenaline (epinephrine) may also be easier to carry and use for some patients. The PBAC noted the submission’s claim that adrenaline is underused in treating anaphylaxis, and delayed administration is associated with poorer clinical outcomes.
The PBAC considered that this new form of adrenaline (epinephrine) was as effective as EpiPen, in alleviating symptoms of anaphylaxis. The PBAC considered that there were potential reductions in hospital admissions from improvements in appropriate and timely use of neffy compared to EpiPen. Also, it noted potential cost savings from reduced prescription refills for expired devices. Overall, the PBAC considered a small price premium for neffy over EpiPen was justified.
The equi-effective doses of neffy and EpiPen are a one-for-one substitution:
• EpiPen 0.3 mg/0.3 mL = neffy 2 mg/0.1 mL
• EpiPen 0.15 mg/0.3 mL = neffy 1 mg/0.1 mL
The PBAC advised that the restriction wording for neffy should align with the existing restrictions except for the differences in age and weight, and noted that flow-on restriction changes to the Caution and Administrative notes for the auto-injector pens are required to acknowledge the different administration devices and techniques.