AdrenalineAdrenaline
Self-administered intramuscular injection for emergency treatment of anaphylaxis in adults and juveniles.
Decisions on record
- Meeting Nov 2021 Withdrawn Anaphylaxis no PSD
- Meeting Nov 2020 Deferred Acute allergic reaction with anaphylaxis no PSD
- Meeting Nov 2020 Recommended Acute allergic reaction with anaphylaxis no PSD
- Meeting Mar 2018 Recommended Anaphylaxis
- Meeting Mar 2018 Deferred Anaphylaxis
- Meeting Jul 2016 Recommended Anaphylaxis
- Meeting Mar 2016 Not recommended Anaphylaxis
- Meeting Nov 2011 Recommended Anaphylaxis prevention no PSD
2 earlier decisions
- Nov 2010 Deferred Severe allergic reactions no PSD
- Mar 2010 Recommended Severe, allergic reactions no PSD
Access path
- TGA registered · Adrenaline
TGA label equal than the PBS population
- Mar 2016Not recommended
unacceptably high cost compared with comparator (approximately forty times greater AEMP than adrenaline ampoule), lack…
- ↻ resubmittedJul 2016Recommended
Comparator changed: adrenaline ampoule → EpiPen
- Mar 2018Recommended · restricted
Comparator changed: EpiPen → EpiPen, EpiPen Jr
- Mar 2018Deferred
Comparator changed: EpiPen → EpiPen, EpiPen Jr
From the public summary
5.1 The PBAC recommended the temporary General Authority Required listing of Emerade (adrenaline, 300 mcg and 150 mcg auto injectors) on the Pharmaceutical Benefit Schedule (PBS) to address the shortage supply issue for the PBS listed adrenaline auto injectors.PSD · Mar 2018
5.2 The PBAC considered that there is a clinical need for the supply of an adrenaline auto-injector to be maintained on the PBS. The PBAC considered that the listing should remain during the validity of the Section 19A(1) approval by the TGA. For a longer term listing of the product, a submission to the PBAC would be required.PSD · Mar 2018
6.5 The minor submission did not present an economic comparison or state on what basis it was seeking listing for EpiPen and EpiPen Jr on the Prescriber Bag.PSD · Mar 2016
6.6 The current Approved Ex-Manufacturer Price (AEMP) for EpiPen and EpiPen Jr is $''''''''''''' per injection. The submission requests the same AEMP for the Prescriber Bag listing. The AEMP of the form of adrenaline currently listed on the Prescribers Bag is $'''''''''''''' for five ampoules.PSD · Mar 2016
6.4 The submission claimed superior ease and timeliness of administration and decreased risk of overdosing to adrenaline ampoule. The PBAC considered this claim to be difficult to assess due to inadequate evidence.PSD · Mar 2016
4.8 On the other hand, most of the organisations and individuals also acknowledged the current shortage of EpiPen®. The PBAC specifically noted anecdotal reports that some patients were relying on expired products due to the shortages. For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Mar 2018
Cost-effectiveness
No economic evaluation conducted; this is a minor submission regarding brand equivalence and listing conditions only.
The PBAC also considered the clarity and quality of the educational materials and the samples of autoinjector provided, did not sufficiently minimise the risk for a possible medication misadventure due to the different administration techniques. PBAC · 2018
Decision context
PopulationAdults and juveniles currently prescribed or likely to be prescribed an adrenaline auto-injector for emergency treatment of anaphylaxis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended · restricted | EpiPen, EpiPen Jr | — | Cost-minimisation · Cost-minimisation |
| Mar 2018 | Deferred | EpiPen | — | Single-arm · Usability |
| Jul 2016 | Recommended | EpiPen | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Not recommended | adrenaline ampoule | — | Single-arm · Other |
Consumer voice
Six organisations (Asthma Australia, ASCIA, Allergy & Anaphylaxis Australia, Pharmacy Guild of Australia, Australian Pharmaceutical Industries, and Mylan Australia) provided input highlighting concerns about potential confusion from different administration devices and emphasising the importance of training and education, while also acknowledging the current shortage of EpiPen® and anecdotal repor
There was a strong emphasis on the importance of training and education for the new device if the PBAC was to recommend AdrenaJect® for brand substitution at the pharmacy level. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify adrenaline auto-injector for emergency anaphylaxis treatment in adults and juveniles; PBAC adds clinical context but no population restriction.