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Adrenaline (Epinephrine)

Recommended ImmunologyAuthority RequiredNot applicable line 💬 consumer voice

Emergency treatment of acute severe allergic reactions in children or adults at significant risk of anaphylaxis.

3
Submissions
1 resub
2020–26
On the record
—
ICER range
Cost-min
Cost basis

Decisions on record

2 decisions
  • Meeting Mar 2026 Recommended Acute allergic reaction emergency treatment of acute severe allergic reactions in children or adults at significant risk of anaphylaxis
  • Meeting Jul 2024 Recommended Acute allergic reaction with anaphylaxis

Access path

3 submissions · public record
  1. Nov 2020
    Recommended · restricted

    vs EpiPen, EpiPen Junior, Adrenaline Mylan, Adrenaline Junior…

  2. Jul 2024
    Recommended · restricted

    Comparator changed: EpiPen, EpiPen Junior, Adrenaline Mylan, Adrenaline Junior Mylan →…

  3. Mar 2026
    Recommended · restricted

    Comparator changed: EpiPen Jr, EpiPen, Anapen Jr 150, Anapen 300, Adrenaline Jr Viatris…

  4. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the listing of neffy® nasal spray, a new form of adrenaline (epinephrine), as a General Schedule listing for the emergency treatment of acute severe allergic reactions in children or adults at significant risk of anaphylaxis. The PBAC considered that this new form of adrenaline (epinephrine) was equivalent to the auto-injectable form, EpiPen, in terms of alleviating symptoms of anaphylaxis.PSD · Mar 2026
However, the PBAC considered that there were potential reductions in hospital admissions from improvements in appropriate and timely use of neffy compared to EpiPen, and potential cost savings from reduced prescription refills for expired devices, for which a small price premium over EpiPen was justified.PSD · Mar 2026
Economic analysis
6.316.33 The submission requested an approved ex-manufacturer price (AEMP) of $ for neffy, redacted content representing a % increase over the EpiPen price of $67.19. The requested premium redacted content was not derived directly from any of the WTP, CMA, or CCA approaches. Instead, it has been determined by the sponsor, with the economic analyses used to provide supportive justification.PSD · Mar 2026
6.326.34 The primary analysis was a WTP estimate derived from a DCE quantifying consumer preferences for neffy’s attributes. Two supplementary analyses were presented: a CMA based on reduced utilisation due to the extended shelf-life of neffy, and a CCA evaluating the potential reduction in post-anaphylaxis hospitalisations with the increased utilisation of neffy.PSD · Mar 2026
Clinical claim
6.286.30 The Sub-Committees accepted the submission’s claim that neffy is non-inferior in terms of effectiveness, and non-inferior but with different safety compared with AAIs, supported by PK/PD and safety data for patients aged 4 years and older who weighed more than 15 kgs.PSD · Mar 2026
6.296.31 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Mar 2026
Consumer comments
5.2 The PBAC noted and welcomed the input from a medical organisation (1) via the Consumer Comments facility on the PBS website. The joint comment from Allergy & Anaphylaxis Australia (A&AA), the Australasian Society of Clinical Immunology and Allergy (ASCIA) and the National Allergy Council supported the listing of Jext Jr and 5PSD · Jul 2024

Cost-effectiveness

No ICER calculated. Submission used cost-minimisation approach (CMA), cost-consequence analysis (CCA), and discrete choice experiment (DCE) with willingness-to-pay (WTP) estimates rather than a conventional cost-utility analysis.

The Sub-Committees considered that the magnitude of any clinical benefit was uncertain and the extent of the requested price premium may not be reasonable. PBAC · 2026

Decision context

PopulationChildren aged 4 years and over (weighing ≥15 kg) or adults at significant risk of anaphylaxis, assessed by a clinical immunologist, allergist, paediatrician, or respiratory physician, or discharged from hospital/emergency department after treatment for anaphylaxis.

Submission history

3 entries
DecidedOutcomeComparatorICEREvidence
Mar 2026 Recommended · restricted adrenaline auto-injectors (EpiPen, EpiPen Jr., Adrenaline Viatris, Adrenaline Viatris Jr., Anapen) — Single-arm
Jul 2024 Recommended · restricted EpiPen Jr, EpiPen, Anapen Jr 150, Anapen 300, Adrenaline Jr Viatris, Adrenaline Viatris — RCT · Pharmacokinetics, ease of handling, safety
Nov 2020 Recommended · restricted EpiPen, EpiPen Junior, Adrenaline Mylan, Adrenaline Junior Mylan — Cost-minimisation · Cost-minimisation

Consumer voice

Jul 2024

A joint comment from three medical organisations supported the listing of Jext Jr and Jext as an additional treatment option that reduces supply shortage risk, while noting the need for updated resources to educate healthcare professionals and patients about device administration, with associated costs and time requirements.

The joint comment from Allergy & Anaphylaxis Australia (A&AA), the Australasian Society of Clinical Immunology and Allergy (ASCIA) and the National Allergy Council supported the listing of Jext Jr and Jext, highlighting the new listing would offer an additional treatment option for patients and reduces the risk of supply shortages. Consumer comments · PSD
access to new treatment optionssupply securitytreatment education and trainingimplementation costs

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients with significant anaphylaxis risk requiring auto-injector emergency treatment; TGA label covers all anaphylaxis cases broadly.

Listed in law

Federal Register of Legislation

PBS listings commencing 1 Jun 2026 were made by these 5 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.

DeterminationMadeStatus
PB 58 of 2026 28 May 2026 In force PDF ↗
PB 58 of 2026 28 May 2026 In force PDF ↗
PB 59 of 2026 28 May 2026 In force PDF ↗
PB 60 of 2026 28 May 2026 In force PDF ↗
PB 60 of 2026 28 May 2026 In force PDF ↗