Decision to fund adrenaline auto-injectors for the emergency treatment of anaphylaxis

All consultation responses received were supportive of the proposal.

We are pleased to be funding a proposal which will benefit New Zealanders and are grateful to those who took the time to share their personal experiences, or experiences of their loved ones.

Special Authority approval period

Several responses provided feedback on the Special Authority approval period:

• Responses suggested initial Special Authority approvals should be for a finite period. These responses indicated it would be appropriate to review approvals at the age of five years old.
• Other responses noted their support for a lifetime approval period.

We understand that some individuals may not require life-long access to adrenaline auto-injectors. We consider the need to review suitability of ongoing treatment is a core part of prescriber competency and this falls outside the scope of Pharmac’s funding restrictions.

We note the addition of a renewal period may create additional burden for an already stretched healthcare workforce and increase access barriers for people who require adrenaline auto-injectors. Therefore, we have not amended the approval period.

We note the lifelong approval is in line with the recommendation from the Respiratory Advisory Committee April 2022 [PDF, 545 KB].

Special authority amendments

Responses detailed the importance of appropriate education on how to use the adrenaline auto-injector and that all individuals should be provided with a written anaphylaxis plan.

We appreciate that best practice indicates all people at risk of anaphylaxis should have an action plan and receive appropriate training on when and how to use the device. We agree that this is an important consideration for prescribers, ensuring appropriate support is offered for medicines they choose to prescribe, however, we consider that the eligibility criteria are for funding purposes rather than to provide clinical guidance. We have therefore not amended the eligibility criteria to include requirements for an action plan and/or education.

To support the implementation of this funding decision, we are working with Allergy NZ, the supplier and other stakeholders to provide individuals, their whānau and healthcare professionals with suitable, culturally appropriate communications and resources.

Responses suggested that the definition of anaphylaxis be included in the criteria

We consider that healthcare professionals prescribing adrenaline auto-injectors should be prescribing within their scope of practice. We consider that the eligibility criteria are for funding purposes rather than clinical guidance and have therefore not included a definition for anaphylaxis in the eligibility criteria for adrenaline autoinjectors.

Several responses provided feedback regarding Medicare bracelets:

• Responses requested that the requirement to be wearing a Medicare bracelet be included in the eligibility criteria.
• Responses requested that Pharmac fund Medicare bracelets.

We consider that the requirement to wear a Medicare bracelet is a clinical practice decision and should be discussed between prescribers and individuals. We consider that the eligibility criteria need not include a requirement to be wearing a Medicare bracelet.

We consider that the funding of Medicare bracelets falls outside the scope of this proposal and the Combined Pharmaceutical Budget.

Amendments to hospital restriction

Responses suggested the Special Authority does not cover people who present with anaphylaxis at Emergency Departments.

We note people who present to Emergency Departments are unlikely to receive adrenaline via an EpiPen when admitted to hospital. The majority of people will be given adrenaline in one of the already funded presentations. However, we note the restrictions in Section H do not prohibit clinicians from administering an EpiPen in emergency care settings.

Several responses outlined that people should be discharged with adrenaline auto-injectors provided from the hospital pharmacy.

We note that there is no limit on the number of adrenaline auto-injectors that can be applied for in the hospital setting. When an individual is discharged from hospital, they should be provided with a prescription for the medicines they need. We consider that this could include adrenaline auto-injectors.

Responses requested we remove the Hospital Indication restrictions (the eligibility criteria for accessing adrenaline auto-injectors in Te Whatu Ora hospitals).

We consider maintaining criteria in Hospital provides a level of consistency between Section B and Section H of the Pharmaceutical Schedule. People who receive care in a Te Whatu Ora hospital for anaphylaxis would be eligible for funded access, and should receive a prescription for adrenaline auto-injectors when being discharged from hospital.

Feedback on the limit of two devices

Several responses provided feedback on limiting the number of devices:

• Responses requested that children and adolescents are provided with funded access to additional devices to be held at early learning centres/schools.
• Responses requested the limit of two devices be increased.
• Responses also considered a limit of two devices to be appropriate, highlighting that two provided flexibility on storage while minimising the number of devices that would expire rather than be used.

We note that people would be eligible for up to two funded adrenaline auto-injectors, one of which could be stored at their early learning centre/school, if desired.

We consider that further advice and assessment would be required to consider access to greater than two devices at any one time. This proposal would not prevent consideration of access to more than two adrenaline auto-injectors at a future date.

Responses requested that schools be provided with at least one device without a specified person.

We note the proposed funding mechanism (listing on the Pharmaceutical Schedule under a Special Authority) would not enable dispensing to unnamed persons.

We will provide this feedback to the Ministry of Education who we consider best placed to consider this feedback.

Prescriber restriction

Several responses highlighted the need to allow any relevant practitioner to assess an individual’s risk of anaphylaxis. Responses indicated that this would reduce potential access barriers.

The proposed eligibility in our consultation required a specialist to assess a person’s anaphylaxis risk.

However, we understand that not all people at risk of anaphylaxis have access to a specialist and that this requirement might create access inequities. Therefore, we have amended the criteria, based on the feedback provided, to allow any relevant practitioner to assess a person’s risk of anaphylaxis. We consider this better reflects the multi-disciplinary nature and skills of our healthcare service and would support more equitable access.

Feedback on replacement devices

Responses noted challenges regarding how prescribers and dispensers would deem that replacement devices are being prescribed appropriately after expiry or use.

We note that the funding restrictions only allow new devices to be dispensed following expiry or use.

We consider it to be the responsibility of prescribing clinicians and dispensing pharmacists to ensure the funding restrictions for funded access to replacement devices have been met as part of their prescribing and dispensing competencies.

Suggested that a replacement scheme would avoid wastage and sought clarification as to how people should dispose of used and unused devices.

We note that all used or expired medicine and medical devices should be returned to pharmacies to ensure appropriate disposal. We will pass the feedback regarding a replacement scheme on to the supplier. Any replacement scheme would be at the discretion of the supplier.

Concerns regarding the requirement of general practice to access funded devices

Several responses noted the access barrier resulting from the need to see a general practitioner, nurse or pharmacist prescriber for a special authority application and prescriptions.

• Responses suggested a pharmacist only mechanism for access to adrenaline auto-injectors
• Request for pharmacists to be able to renew Special Authority
• Extending relevant prescriber to include pharmacist
• Request for Pharmacists to be able to resupply auto-injectors

We note that access is enabled via Special Authority. To help minimise the potential access issues, applications can be applied for by any relevant practitioner and would be valid without the need for further renewal.

Further consideration is needed to determine a potential pathway to enable dispensing at a pharmacy without a prescription. However, to enable timely access we have decided to fund adrenaline auto-injectors, where a prescription is required to access adrenaline auto-injectors.

This does not preclude future considerations for widening of access to adrenaline auto-injectors, including the option of removing the Special Authority at a future date.

Educational/implementational support

Several responses provided feedback on the education and implementation support required as part of this funding decision:

• Responses outlined the need for education to ensure effective use of device, including education for whanau/family
• Request for supply of training devices to General Practice centres and pharmacies
• Suggestion that Pharmac funds online learning modules to support schools and other public facilities on how to administer the chosen brand
• Suggestion that listing should be paired with co-designed health literacy initiatives to enhance compliance and improve outcomes for out of hospital anaphylaxis

We are really grateful for the considered and constructive feedback provided on how we can support equitable access and responsible use of adrenaline auto-injectors. We are working with Allergy NZ, the supplier and other stakeholders to develop a comprehensive implementation plan for this decision. This includes:

• understanding the current support and resources available
• the provision of training devices to support education.

We note that a number of organisations, including The Australasian Society of Clinical Immunology and Allergy (ASCIA) have developed resources, including ones aimed at educational institutions (https://www.allergy.org.au/schools-childcare(external link))

Other feedback

Response notes the need to monitor changes in prescribing habits to ensure that people who experience non-anaphylaxis allergic reactions are not receiving inappropriate prescriptions and access.

We appreciate the feedback, however, we consider that prescribers are expected to act within their scope of practice and prescribe to those who are at risk of anaphylaxis and eligible for treatment. We note that Pharmac is not the body that monitors prescribing competency.

Responses noted the importance of ensuring that there are age-appropriate auto-injector devices available

This proposal includes two strengths of adrenaline auto-injector to ensure there are age-appropriate treatment options available.

Responses noted the importance of ensuring there is a steady and reliable supply chain

Ensuring ongoing supply of medicines is a core part of our work. The supplier (Viatris) supplies a range of medicines to Aotearoa New Zealand and we will continue to work closely to ensure ongoing supply of adrenaline auto-injectors.

Responses requested the extension of expiry dates for devices due to the high wastage volume

We are aware the expiry date of adrenaline auto-injector devices can vary. We have contractual provisions in place to ensure a minimum of six months’ shelf life on products supplied via the Annual Invitation to Tender. We intend to work with the supplier to ensure devices dispensed have as long a shelf life as possible.

Responses requested Pharmac increase funded prescription validity to 6 months

Current prescription validity for subsidised supply of medicine requires the prescription to be dispensed within three months of the date the prescription was written. This applies to all medicines on the Pharmaceutical Schedule with the exception of oral contraceptives. We have not made any changes to this proposal as a result of this feedback.

Responses requested that Pharmac considers funding prescriber consultations through Te Whatu Ora funding for people at high risk of anaphylaxis.

Any decision related to the funding of general practice consultation visits is outside Pharmac’s scope and we have not made any changes to this proposal as a result of this feedback.

Responses suggested criteria be changed to enable general practitioners to prescribe where someone has a genetic disorder/diagnosis for a condition that has an elevated risk of anaphylaxis

We note the proposed eligibility criteria currently allows funded access to people with a high risk of anaphylaxis, and we consider that this would fall within the intent of the proposed criteria.