Adrenaline (Epinephrine)
Emergency treatment of acute severe allergic reactions in children or adults at significant risk of anaphylaxis.
Decisions on record
- 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
- Nov 2020Recommended · restricted
vs EpiPen, EpiPen Junior, Adrenaline Mylan, Adrenaline Junior…
- Jul 2024Recommended · restricted
Comparator changed: EpiPen, EpiPen Junior, Adrenaline Mylan, Adrenaline Junior Mylan →…
- Mar 2026Recommended · restricted
Comparator changed: EpiPen Jr, EpiPen, Anapen Jr 150, Anapen 300, Adrenaline Jr Viatris…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the General Schedule Authority Required (Telephone/Online) listing of a new form of adrenaline (epinephrine) acid tartrate 150 micrograms/0.15 mL auto-injector (AI) (Jext Jr®) and 300 micrograms/0.3 mL AI (Jext®) under the same circumstances as the currently listed adrenaline (epinephrine) 150 microgram/0.3 mL (EpiPen®Jr, Anapen®Jr 150 and Adrenaline Jr Viatris®) and 300 micrograms/0.3 mL AI (EpiPen®, Anapen®300 and Adrenaline …PSD · Jul 2024
6.2 The PBAC considered that the claims of non-inferior comparative effectiveness and safety were acceptable based on the TGA Delegate’s Overview (DO). The PBAC noted that the TGA evaluator recommended approving the registration of Jext Jr and Jext.PSD · Jul 2024
5.7 While the submission did not present an economic approach, the submission requested the same approved ex-manufacturer price (AEMP) for Jext Jr and Jext as the existing listings of adrenaline 150 and 300 AI brands respectively.PSD · Jul 2024
5.8 The PBAC previously recommended Anapen 300 and Anapen 500 on a cost- minimisation basis to EpiPen; and Anapen Jr 150 to EpiPen Jr (paragraph 9.2, adrenaline PSD, November 2020).PSD · Jul 2024
5.5 The submission claimed non-inferior comparative effectiveness and safety of Jext compared with Anapen and EpiPen based on the pharmacokinetic (PK), pharmacodynamics (PD) and safety data. The TGA evaluator found no significant issues between Jext and Anapen and EpiPen and recommended approving the registration of Jext Jr and Jext, subject to resolution of outstanding issues regarding GMP clearance.PSD · Jul 2024
5.6 The PBAC considered that the claims of non-inferior comparative effectiveness and safety were supported by the assessment of the data by the TGA.PSD · Jul 2024
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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| 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
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
Similar precedents
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.