Decision to fund aripiprazole depot injection

We are pleased to announce a decision to fund aripiprazole depot injection from 1 January 2024.

This decision is in response to a global supply issue with olanzapine depot injection and provides an alternative antipsychotic treatment option for those affected by the supply issue.

What we’re doing

From 1 January 2024 aripiprazole depot injection will be funded for people who have accessed funded atypical antipsychotic depot injections (olanzapine, paliperidone and risperidone) and:

  • have experienced an inadequate response from prior therapy, 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. Stock of aripiprazole depot injection will initially be supplied from Australia. This stock has been approved by the Australian regulator (the Therapeutics Goods Administration(external link)). However, it has not been approved by the New Zealand regulator (Medsafe(external link)). 

This means aripiprazole depot injection will initially be supplied as an unapproved medicine(external link) under Section 29 of the Medicines Act 1981. Requirements for Health Care Professionals to supply unapproved medicines are detailed on the Medsafe website(external link). We are working closely with the supplier of aripiprazole depot injection, Lundbeck, to minimise the length of time aripiprazole depot injection is supplied as an unapproved medicine. 

The Australian product is very similar to the version of Abilify Maintena that is approved in New Zealand. The main difference is the approved indications and labelling. Abilify Maintena is approved in New Zealand for maintenance of clinical improvement in the treatment of schizophrenia. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 24 November 2023. You can read more about schizophrenia and aripiprazole depot injections in the consultation letter. 

We received lots of feedback which highlighted the benefit this decision would have. We also received feedback expressing a desire for wider access. We’re really grateful to everyone who took the time to share their support and provide us with feedback. 

There have been no changes to the original proposal following consultation. All consultation feedback received, and our responses, have been summarised at the end of this notification letter.

Who we think will be most 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 .
  • Pharmacies and wholesalers.
  • Pharmaceutical suppliers.

Detail about this decision

Aripiprazole (Abilify Maintena) will 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 MaintenaS29

1

$341.96

Abilify Maintena will have protection from delisting and subsidy reduction until 1 January 2027.

Aripiprazole depot injection will 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:

  1. Patient has a current Special Authority approval for olanzapine depot injection, risperidone depot injection or paliperidone depot injection; and
  2. Either:
    1. Patient has tried but has experienced an inadequate response to, or intolerable side effects from, prior therapy with olanzapine depot injection, risperidone depot injection or paliperidone depot injection; or
    2. 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 will apply in Part II of Section H of the Pharmaceutical Schedule. 

Our response to what you told us

We’re really grateful for the time people took to respond to consultation. A summary of the main themes raised in feedback and our responses to the feedback received are set out below. 

Theme

Pharmac comment

Support for the funding of aripiprazole monthly depot injection. Responses highlighted:

  • better care and quality of life for people requiring treatment
  • better clinical outcomes (such as better metabolic outcomes for people)
  • aripiprazole depot injection has a lower risk of many side effects and provides an additional choice of treatment
  • many Māori would benefit from this proposal, from the lower risk of side effects
  • aripiprazole depot injection would provide a safe and effective treatment option for people with schizophrenia 
  • the proposal provides another treatment option for those impacted by the olanzapine supply issue.

We are pleased to progress a proposal that would improve the health outcomes of New Zealanders with mental health disorders.

This feedback aligns with the expert advice we have received and what we have heard from the sector.

Eligibility criteria

Requests to fund aripiprazole depot injection in the first line depot setting people who:

  • are contraindicated to or at high risk of metabolic side effects with risperidone, olanzapine or paliperidone depot injections.
  • have experienced an inadequate response or side effects to olanzapine or risperidone oral therapy
  • have experienced an inadequate response or intolerable side effects to typical depot injections
  • have responded well to aripiprazole oral tablets but are experiencing adherence challenges.

We appreciate there is an unmet health need for people with schizophrenia and other mental health disorders.

This decision has been made to help reduce the impact of the olanzapine supply issue. Additionally, it provides an alternative treatment option to currently funded atypical antipsychotic depot injections.

We have received a funding application for aripiprazole depot injection(external link) which includes treatment for people with schizophrenia as a first line depot treatment. The funding application is ranked this on our Options For Investment List(external link). This means it is something we would like to fund when we have available budget.

Requests for the funding criteria to require people to have experienced a positive response to oral aripiprazole before initiating aripiprazole depot injection

We understand there are important considerations for clinical practice when considering changing to aripiprazole depot injection from another medicine.

We are supporting the availability of clinical guidance materials so that healthcare professionals are aware of key considerations for prescribing and administering aripiprazole depot injection

Funding an unapproved medicine

Feedback highlighted the prescribing requirements:

  • for medicines prescribed and supplied under Section 29 of the Medicines Act 1981.
  • for people treated under the Mental Health Act 1992 unable to provide informed consent.

Information regarding the requirements for prescribing and supplying unapproved medicines under Section 29 of the Medicines Act 1981 is available here(external link).

We understand there are additional requirements under the Mental Health Act 1992 when an individual is unable to provide informed consent, such as the requirement for a second clinical opinion under Section 59 of the Act. We understand further guidance on treatment under the Mental Health Act 1992 and requirements for consensual and non-consensual treatment are available in Section 10 of theGuidelines to the Mental Health (Compulsory Assessment and Treatment) Act 1992(external link).

Acknowledging that initial unapproved supply under Section 29 of the Medicines Act 1981 would not allow Nurse Practitioners to prescribe aripiprazole depot injection

We acknowledge that unapproved supply under Section 29 is not ideal. We are working closely with the supplier of aripiprazole depot injection, Lundbeck, to make a New Zealand approved product available as soon as possible.

Availability of medicines

Feedback highlighted the importance of ongoing supply for aripiprazole depot injection.

Our supply agreements have contractual requirements to ensure minimum stock holdings in New Zealand and provide ongoing supply. We have a dedicated contract management team who work closely with suppliers to ensure medicines are available for New Zealanders.

Cost of atypical antipsychotic depot injections

A response asked for clarification of the cost of aripiprazole depot injection compared to paliperidone depot injection.

The list price of paliperidone depot injection and aripiprazole depot injection are similar. However, paliperidone is subject to a confidential rebate. This means the price we have negotiated for paliperidone is lower than the public price on the Pharmaceutical Schedule.

There is no rebate for aripiprazole depot injection. This means the price on the Pharmaceutical Schedule is the price we pay.

Support for healthcare professionals and people receiving aripiprazole depot injection

Feedback requested the supplier provide educational materials for clinicians, dispensers, and people receiving aripiprazole depot injection.

We are supporting the availability of clinical guidance materials for healthcare professionals and information for people receiving aripiprazole depot injections.

While the product supplied is unapproved for use in New Zealand, we understand the supplier cannot actively promote the use of the product in New Zealand. We acknowledge that unapproved supply under Section 29 is not ideal. We are working closely with the supplier of aripiprazole depot injection, Lundbeck, to make a New Zealand approved product available as soon as possible

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.