Proposal to fund aripiprazole depot injection as an alternative antipsychotic treatment option
What we’re proposing
We are seeking feedback on a proposal to fund aripiprazole depot injection (brand name Abilify Maintena) as an alternative antipsychotic treatment option. This proposal is in response to a global supply issue with olanzapine depot injection and would provide an alternative treatment option for those affected by the supply issue.
Aripiprazole depot injection would be funded through a provisional agreement with the Supplier Lundbeck.
We welcome your feedback on this proposal. Consultation closes at 4pm, Friday 8 December, 2023 and feedback can be emailed to consult@pharmac.govt.nz
What would the effect be?
From 1 January 2024 aripiprazole depot injection would be funded for people currently accessing funded atypical antipsychotic depot injections (olanzapine, paliperidone and risperidone) who:
- have had an inadequate response, or
- have experienced intolerable side effects from prior therapy, or
- have been unable to access olanzapine depot injection due to supply issues
We understand there is clinical urgency to access aripiprazole depot injection due to the supply issues with olanzapine depot injection. To enable urgent access the stock would initially be supplied from Australia. Although it has been approved by the Australian regulator (the Therapeutics Goods Administration(external link)), the supplier has not submitted an application for approval of the Australian product to the New Zealand regulator (Medsafe(external link)). The Australian product is very similar to the version of Abilify Maintena that is approved in New Zealand, the main difference being approved indications and labelling. Abilify Maintena is approved in New Zealand for maintenance of clinical improvement in the treatment of schizophrenia.
Lundbeck (the supplier of aripiprazole depot injection) is working to supply a Medsafe-approved product as soon as possible.
This means aripiprazole depot injection would initially be supplied as an unapproved medicine under Section 29 of the Medicines Act 1981. Requirements for Health Care Professionals to supply unapproved medicines(external link) are detailed on the Medsafe website. We would continue to work with the supplier to minimise the length of time aripiprazole depot injection is supplied as an unapproved medicine.
We estimate that in the first year of listing, up to 320 people would access aripiprazole depot injection. We expect that this would increase with each year of funding, and after five years, up to 1,500 people per year would access treatment with aripiprazole depot injection.
Māori are approximately three times more likely than non-Māori to experience schizophrenia (Gibb et al, 2023(external link)). Māori are more likely to be assessed and treated under the Mental Health Act than non-Māori (Ministry of Health – Mental Health and Addition Services report 2023(external link)).
Pharmacy data indicates that over 40% of antipsychotic depot injection dispensing is for people who identify as Māori. Hauora hinengaro (mental health), is a Pharmac Hauora Arotahi (Māori health area of focus) and a priority area in the Te Pae Tata Interim New Zealand Health Plan 2022 - Te Whatu Ora website(external link).
Pacific people are approximately twice as likely than non-Pacific people to experience schizophrenia (Gibb et al, 2023(external link)). Pharmacy data indicates that over 12% of antipsychotic depot injection dispensing is for people who identify as Pacific peoples.
We anticipate that Māori and Pacific people would benefit from this proposal.
Who we think will be interested
- People with schizophrenia, their whānau, friends and caregivers.
- Healthcare professionals.
- Te Whatu Ora hospitals and other organisations who deliver services and support for people with schizophrenia. who may be treated with olanzapine, paliperidone, or risperidone depot injections.
- Pharmacies and wholesalers.
- Pharmaceutical suppliers.
About schizophrenia
Antipsychotic treatments are commonly used to treat schizophrenia. Schizophrenia is a mental health condition involving recurring episodes of psychosis. It can have a significant impact on a person’s perception, thoughts, mood, and behaviour. Schizophrenia can significantly affect a person’s ability to do everyday activities.
About aripiprazole depot injection
Aripiprazole depot injection (also known as aripiprazole long-acting injection) is a medicine used to manage and treat schizophrenia. It is administered by a healthcare professional once per month. It helps to correct a chemical imbalance in the brain associated with schizophrenia. It can also be used to lessen the chance of schizophrenia symptoms coming back.
Aripiprazole depot injection has a relatively benign side effect profile compared to other funded atypical antipsychotic depot injections, particularly related to metabolic adverse side effects.
Our clinical advisors have told Pharmac that benefits from aripiprazole depot injection would be experienced by Māori, who experience higher rates of metabolic syndrome, diabetes, and cardiovascular disease relative to non-Māori.
Why we’re proposing this
Supply issues with Olanzapine depot injection
There is a global supply issue affecting the olanzapine depot injection. This supply issue is disrupting treatment for many people currently accessing olanzapine depot injection.
The impact of treatment disruption for people who are administered olanzapine depot injection is very high. Treatment disruption can lead to a relapse in symptoms for the person, impacting their whānau, and cause increased risk of hospitalisation. The supply issue is anticipated to continue for the next six to nine months.
There are funded alternative antipsychotic depot injections available to help people affected by the supply issue; however, we understand they may not be suitable for everyone, and some would have already been tried, in many cases.
Pharmac’s clinical advisors have outlined that, while not everyone on olanzapine depot injection would be able to switch to aripiprazole depot injection, the availability of aripiprazole depot injection would help some people affected by the olanzapine depot injection supply issue by providing an additional alternative treatment option.
More details on the olanzapine depot injection supply issues are on the Pharmac website(external link).
Funding for aripiprazole depot injection for a wider group of people with schizophrenia
We understand that there would remain a clinical need for people with schizophrenia who are not currently using atypical depot injections but have adherence challenges to oral atypical antipsychotics. This proposal (to fund aripiprazole depot injection for people receiving other atypical depot injections as an alternative antipsychotic treatment option) would not prevent Pharmac from considering aripiprazole depot injection for a wider group.
We have an active funding application for aripiprazole depot injection(external link) that includes a wider group. This application has been ranked on the Options for Investment list which means it is a treatment we would like to fund.
Unfortunately, Pharmac is unable to give a definitive timeframe for if, or when, a decision to fund aripiprazole depot injection for a wider group will be made.
The priority of funding choices can change over time depending on the relative health benefits, amount of funding available, success of negotiations with suppliers, new clinical data, and the variety of other funding applications.
Details about our proposal
Aripiprazole (Abilify Maintena) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2024, as follows:
| Chemical | Formulation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Aripiprazole | Inj 300 mg vial | Abilify MaintenaS29 | 1 | $273.56 |
| Aripiprazole | Inj 400 mg vial | Abilify Maintena S29 | 1 | $341.96 |
Abilify Maintena would have protection from delisting and subsidy reduction until 1 January 2027.
Aripiprazole depot injection would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:
Special Authority for Subsidy:
Initial application from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- Patient has a current Special Authority approval for olanzapine depot injection, risperidone depot injection or paliperidone depot injection; and
- Either
- Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior therapy with olanzapine depot injection, risperidone depot injection or paliperidone depot injection; or
- Patient has been unable to access olanzapine depot injection due to supply issues with olanzapine depot injection, or otherwise would have been initiated on olanzapine depot injection but has been unable to due to supply issues with olanzapine depot injection.
Renewal from any relevant practitioner. Approvals valid for 12 months where the initiation of aripiprazole depot injection has been associated with fewer days of intensive intervention than prior to the initiation of an atypical antipsychotic depot injection.
A similar restriction would apply in Part II of Section H of the Pharmaceutical Schedule.
As noted earlier the stock initially being supplied would come from Australia and although it has been approved by the Australian regulator (the Therapeutics Goods Administration(external link)), the supplier has not submitted an application to obtain approval for the Australian product from the New Zealand regulator (Medsafe(external link)). Lundbeck (the supplier of aripiprazole depot injection) is working to supply a Medsafe approved product as soon as possible.
This means the supply, sale and prescribing of aripiprazole depot injection would need to meet the requirements in Section 29 of the Medicines Act 1981. Requirements for Health Care Professionals related to supply of unapproved medicines(external link) are detailed on the Medsafe website.
We know supplying a medicine under section 29 is not ideal. We will continue to work with the supplier to minimise the length of time aripiprazole depot injection is required to be supplied as an unapproved medicine.
To provide feedback
Send us an email: consult@pharmac.govt.nz by 4pm, Friday 8 December, 2023
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.
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