Proposal to list adrenaline auto-injectors for emergency treatment of severe anaphylaxis
We are seeking feedback on a proposal to fund adrenaline auto-injectors.
What we’re proposing
We are seeking feedback on a proposal to fund adrenaline auto-injectors for emergency treatment of severe anaphylaxis through Pharmac’s annual tender process.
Adrenaline auto-injectors were included in the 2021/22 Annual Invitation to Tender. As the tender process is still in progress, the brand name(s), pricing and timing for this listing are still to be determined.
Consultation closes 5pm Tuesday 11 October 2022 and feedback can be emailed to email@example.com.
What would the effect be?
This proposal would mean people at risk of anaphylaxis who meet the eligibility criteria would have access to a funded adrenaline autoinjector for use in an emergency. Funding would enable dispensing of up to two devices per person.
We estimate that in the first year up to 12,000 people per year would be eligible for funded adrenaline auto-injectors, increasing to 17,000 people per year after five years.
Although we do not know how many people are at risk of anaphylaxis by ethnicity, we understand that the hospitalisation rate for food-related anaphylaxis is higher for Māori than for non-Māori. This rate is also higher for Pacific peoples than for non-Pacific peoples. This proposal would also benefit people living rurally, as it may take longer for emergency services to attend following an anaphylaxis reaction.
People who currently self-fund their own supply of adrenaline auto-injectors may be eligible for funded treatment. Some people may be purchasing directly from a pharmacy (as a Pharmacist-Only medicine) and others may access on prescription. This proposal would mean that people would need to visit their GP for a prescription and Special Authority approval to access funded adrenaline auto-injectors.
Any relevant practitioner would be able to apply for a Special Authority approval. To minimise the administrative burden on prescribers and dispensing pharmacists, approvals would be valid for an individual’s lifetime with no renewal required.
Who we think will be interested
- People who have previously had an anaphylaxis reaction or are at high risk of an anaphylaxis, their caregivers, whānau and communities
- Groups who advocate for and/or support people at risk of severe anaphylaxis
- Respiratory and allergy specialists, emergency responders, primary care professionals and others involved in the management of severe anaphylaxis
- Community and hospital pharmacies
- Pharmaceutical suppliers and wholesalers
About adrenaline auto-injectors
Adrenaline is a natural occurring hormone in the body that acts on the nervous system. It has a range of uses, including in the emergency treatment of anaphylaxis.
There are a range of adrenaline products listed on the Pharmaceutical Schedule. We have heard from advocacy groups and clinicians that none of these products provide a suitable option in an emergency first aid setting. We understand that funding adrenaline auto-injectors would provide an easy to use treatment for people to give themselves or to be used by anyone in an emergency.
Currently adrenaline auto-injectors can be purchased through pharmacies without the need of a prescription.
Severe anaphylaxis is used to describe a severe allergic reaction, often from food or venom (such as a bee sting). Severe anaphylaxis is a medical emergency and, in rare cases, can result in death.
Why we’re proposing this
Pharmac and our clinical advisors have assessed the funding application for adrenaline autoinjectors on a number of occasions. We understand there is an unmet health need for people requiring anaphylaxis treatment.
Most recently, in April 2022 the Respiratory Advisory Committee recommended that adrenaline auto-injectors be funded with a high priority for the treatment of anaphylaxis, subject to the eligibility criteria proposed below.
You can see the history of the application and the advice we’ve received through our Application tracker..(external link)
You can read more about the Committees’ assessment of the clinical evidence for this proposal in the clinical advice record [PDF, 545 KB].
The Respiratory Advisory Committee considered that, in addition to treating people who are experiencing anaphylaxis, the funding of adrenaline auto-injectors would also positively impact on the health-related quality of life for individuals, their caregivers and whānau.
We are proposing to fund adrenaline auto-injectors now as we have updated clinical advice and a suitable tender bid. This combined with our recent budget uplift has enabled us to progress this proposal.
Details about our proposal
As part of Pharmac’s 2021/22 Annual Invitation to Tender, Pharmac sought bids for the supply of a number of medicines that are not currently listed on the Pharmaceutical Schedule, including adrenaline auto-injectors.
The funded brand(s), pricing and timeframes for listing would be confirmed as part of a tender decision. Any products listed through the Tender would have Principal Supply Status until 30 June 2025.
Adrenaline auto-injectors would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from a date to be determined, subject to the following eligibility criteria:
Special Authority for Subsidy
Initial – (anaphylaxis) application from any Relevant Practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
- Patient has experienced a previous anaphylactic reaction which has resulted in presentation to a hospital or emergency department; or
- Patient has been assessed to be at significant risk of anaphylaxis by, or on the recommendation of a relevant specialist; and
- Patient is not to be prescribed more than two devices in initial prescription.
Note: Limit of two devices for first prescription. Additional prescriptions limited to replacement of up to two devices prior to expiry, or replacement of used device for treatment of anaphylaxis.
This proposal would require patients visit their GP for a prescription. We appreciate this would change how some people access treatment and could impact primary health services. We would like to hear from patients and the health sector about these impacts. We are also keen to hear what implementation activities we could provide to help support the correct usage of this treatment, particularly for Māori and Pacific communities.
To provide feedback
Send us an email: firstname.lastname@example.org by 5pm Tuesday 11 October 2022.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
Your feedback may be shared
Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.
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