Decision to widen access to aripiprazole long-acting injection, ferric carboxymaltose, methylnaltrexone bromide, adalimumab, etanercept, secukinumab and infliximab

Medicines Decision

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What we’re doing

We're pleased to announce we are widening access to a number of medicines, from 1 November 2024, as follows:  

  • Access to aripiprazole depot injection will be widened to include more people with schizophrenia and other psychotic disorders in the community and in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.
  • Access to ferric carboxymaltose will be widened to include people with iron deficiency anaemia and chronic inflammatory disease in the community, subject to eligibility criteria.
  • Access to methylnaltrexone bromide will be widened to include people with opioid induced constipation in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.
  • Access to some funded biologics (adalimumab, etanercept, secukinumab and infliximab) will be widened to include people with severe chronic localised genital or flexural plaque psoriasis in the community and in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.

The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding boost covers medicines for both cancer and non-cancer health conditions. This decision is a result of that budget increase.

This decision was subject to a consultation letter dated 10 July 2024. We’re grateful for the feedback we received in response to the consultation on this proposal. Each section of this notification includes:

  • the changes we have made in response to your feedback
  • a summary of the main themes raised for each medicine
  • our response to the themes raised.

Aripiprazole long-acting depot injection for schizophrenia and other psychotic disorders

What does this mean for people?

From 1 November 2024, access to aripiprazole depot injection (brand name Abilify Maintena) will be widened to include more people with schizophrenia and other psychotic disorders, subject to eligibility criteria.

We anticipate that approximately 580 additional people will benefit in the first year of funding, increasing to about 950 people per year by year five.

Any changes to the original proposal?

We received feedback from health care professionals and other health sector stakeholders.

In response to the feedback, we have updated the funding criteria for aripiprazole depot. These changes widen access further than initially proposed in consultation. We have included individuals with ‘other psychotic disorders’, as well as made some changes so that aripiprazole depot can be accessed regardless of metabolic syndrome risk or previous atypical antipsychotic depots used. These changes mean that the aripiprazole depot access criteria will be aligned with the access criteria for other funded atypical antipsychotic depot injections.

Overall, we received supportive feedback. A summary of the feedback and our responses to this are detailed below.

Who we think will be most interested

  • People with schizophrenia or other psychotic disorders, their whānau, friends and caregivers.
  • Healthcare professionals who are involved in the treatment of schizophrenia and other psychotic disorders.
  • Other organisations who deliver services and support people with schizophrenia and other psychotic disorders.
  • Health New Zealand | Te Whatu Ora hospitals.
  • Pharmacies and wholesalers.
  • Pharmaceutical suppliers.

Detail about this decision

Access to aripiprazole depot injection (brand name Abilify Maintena) in both Section B and Part II of Section H of the Pharmaceutical Schedule will be widened from 1 November 2024 as follows:

Changes to the criteria from consultation are marked in bold and strikethrough.

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Either:

1. Both:

1.1 The patient has or is at high risk of metabolic syndrome; and

1. Either:

1.1. The patient has had an initial Special Authority approval for risperidone depot injection, paliperidone depot injection or olanzapine depot injection; or

1.2. All of the following:

1.2.1. The patient has schizophrenia or other psychotic disorder; and

1.2.2. The patient has received treatment with oral atypical antipsychotic agents but has been unable to adhere; and

1.2.3. The patient has been admitted to hospital or treated in respite care, or intensive outpatient or home-based treatment for 30 days or more in last 12 months; or

1. Both:

1.1 The patient has had an initial Special Authority approval for risperidone depot injection, paliperidone depot injection or olanzapine depot injection; and

1.2 Patient has tried but has experienced an inadequate response to, or intolerable side effects from, prior therapy with risperidone depot injection, paliperidone depot injection or olanzapine depot injection; or

2. The patient has been unable to access olanzapine depot injection due to supply issues with olanzapine depot injection, or otherwise would have been started on olanzapine depot injection but has been unable to due to supply issues with the olanzapine depot injection.

Notes: The Olanzapine depot injection Special Authority criteria that apply to criterion 2 in this Aripiprazole Special Authority application are as follows:

  • The patient has had an initial Special Authority approval for paliperidone depot injection or risperidone depot injection; or
  • All of the following:
  • The patient has schizophrenia; and
  • The patient has not been able to adhere tried but failed to comply with treatment using oral atypical antipsychotic agents; and
  • The patient has been admitted to hospital or treated in respite care, or intensive outpatient or home-based treatment for 30 days or more in the last 12 months.

Initial approvals will be valid without further renewals required.

We have also made some small wording updates to the access criteria for paliperidone one-monthly depot and risperidone depot injections to include reference to aripiprazole depot in criterion 1 (to accommodate changing between funded atypical antipsychotic depots), and to update the language used to describe adherence to oral treatments.

We intend to remove the renewal criteria for other funded depots in future. Removing renewal criteria requires changes in the systems the healthcare sector uses for funded medicines. This means we need to consider when we make changes so we don’t disrupt people’s access to funded medicines.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are summarised below:

Theme

Pharmac comment

Supportive of the proposal. Aripiprazole depot injection has improved people’s quality of life.

We are pleased to be progressing a proposal which will benefit New Zealanders.   

Supportive of removing the renewal criteria. This would be a practical step that would benefit people receiving aripiprazole depot injection and prescribers.

We are pleased to be progressing a proposal which supports access to this treatment.

Requests to fund aripiprazole depot injection for other psychotic conditions, such as bipolar and schizoaffective disorder.

Feedback also highlighted that aripiprazole is outlined in guidelines for the treatment of mood disorder, treatment resistant depression, Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD).

 

Based on this feedback, we have updated the access criteria to include “or other psychotic disorder”. This is consistent with other funded atypical antipsychotic depots.

We understand other psychotic disorders includes conditions that have positive symptoms (such as hallucinations) and negative symptoms (such as withdrawal and blunted social interactions).

Aripiprazole depot injection is currently Medsafe approved for maintenance of schizophrenia(external link). Prescribing for other psychotic disorders would be unapproved and prescribing would need to be in line with Section 25 of the Medicines Act 1981.(external link)

We have not received a funding application for any atypical antipsychotic depots for the treatment of mood disorder, treatment resistance depression, PTSD or OCD. We would welcome a funding application for these indications.

Considered the proposed criterion (the patient has or is at high risk of metabolic syndrome) to be inappropriate, as it could require people to experience adverse side effects before being eligible for aripiprazole depot injection.

 

Based on this feedback we have removed the criterion about metabolic syndrome. This is consistent with the access criteria to other funded antipsychotic depots.

People requested even wider access for aripiprazole depot injection, to promote consumer and clinician choice. This included people who:

  • have received benefit from oral aripiprazole
  • want an injectable medicine rather than an oral medicine.

·          

 

Consumer choice is important. The eligibility criteria are in place to target funded treatment to those who are expected to benefit most from depot treatment. We apply eligibility criteria because of the big difference in price between oral and depot formulations.

Pharmac works within a fixed budget, which means that we need to make difficult choices about which items to fund within the available budget.

We would welcome a funding application to widen access further to aripiprazole depot (and/or other anti-psychotic depots). This application would need to detail the anticipated health benefit that a choice between presentations would provide.

Request to fund longer acting forms of antipsychotic drugs, including a two-monthly aripiprazole depot injection.

We have not received a funding application for this presentation. We would welcome a funding application for this.

Ferric carboxymaltose for iron deficiency anaemia in chronic inflammatory disease

What does this mean for people?

From 1 November 2024, access to ferric carboxymaltose (brand name Ferinject) injections for infusion will be widened to include people with iron deficiency anaemia in chronic inflammatory disease. Any relevant practitioner can apply for access, specialist input will not be required.

We anticipate that approximately 700 additional people will benefit in the first year of funding, increasing to about 1,000 people per year by year five.

Any changes to the original proposal?

We received feedback from health care professionals and other health sector stakeholders. No changes were made to the proposal for ferric carboxymaltose following consultation.

Overall, we received supportive feedback, with some requests for widened access for people with heart failure. A summary of the feedback and our responses to this are detailed below.

Who we think will be most interested

  • People with iron deficiency anaemia in chronic inflammatory disease, their whānau, friends and caregivers.
  • Healthcare professionals who are involved in the treatment of iron deficiency anaemia.
  • Other organisations who deliver services and support for people with chronic inflammatory disease.
  • Health New Zealand | Te Whatu Ora hospitals.
  • Infusion services.
  • Pharmacies and wholesalers.
  • Pharmaceutical suppliers.

Detail about this decision

Access to iron (as ferric carboxymaltose) (brand name Ferinject) in Section B of the Pharmaceutical Schedule will be widened from 1 November 2024. The full eligibility criteria for ferric carboxymaltose will be as follows:

Special Authority for Subsidy

Initial application – (Anaemia) from any relevant practitioner. Approval valid for 3 months for applications meeting the following criteria:

All of the following:

  1. Patient has been diagnosed with anaemia; and
  2. Any of the following
    1. Serum ferritin level is 20 mcg/L or less; or
    2. Both:
      1. Serum ferritin is between 20 and 50 mcg/L; and
      2. C-Reactive Protein (CRP) is at least 5 mg/L; or
    3. Patient has chronic inflammatory disease with symptoms of anaemia despite normal iron levels; and
  3. Any of the following:
    1. Oral iron treatment has proven ineffective; or
    2. Oral iron treatment has resulted in dose-limiting intolerance; or
    3. Rapid correction of anaemia is required.

Renewal – (Anaemia) from any relevant practitioner. Approval valid for 3 months for applications meeting the following criteria:

Both:

  1. Patient continues to have anaemia with a serum ferritin level of 20 mcg/L, or less or between 20 and 50 mcg/L with CRP of at least 5 mg/L, or has chronic inflammatory disease with symptoms of anaemia despite normal iron levels; and
  2. A trial (or re-trial) with oral iron is clinically inappropriate.

Initial application — (iron deficiency anaemia) only from an internal medicine physician, obstetrician, gynaecologist, anaesthetist or medical practitioner on the recommendation of a internal medicine physician, obstetrician, gynaecologist or anaesthetist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

  1. Patient has been diagnosed with iron-deficiency anaemia; and
  2. Any of the following:
    1. Patient has been compliant with oral iron treatment and treatment has proven ineffective; or
    2. Treatment with oral iron has resulted in dose-limiting intolerance; or
    3. Patient has symptomatic heart failure, chronic kidney disease stage 3 or more or active inflammatory bowel disease and a trial of oral iron is unlikely to be effective; or
    4. Rapid correction of anaemia is required.

Renewal — (iron deficiency anaemia) only from an internal medicine physician, obstetrician, gynaecologist, anaesthetist or medical practitioner on the recommendation of a internal medicine physician, obstetrician, gynaecologist or anaesthetist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

  1. Patient continues to have iron-deficiency anaemia; and
  2. A re-trial with oral iron is clinically inappropriate.

There are no changes to the current criteria for the ‘iron deficiency anaemia’ indication detailed above.

Our response to what you told us

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

Theme

Pharmac comment

Supportive of proposal. It would improve health outcomes and reduce hospitalisations.

We are pleased to be progressing a proposal that will benefit New Zealanders.  

Request to fund ferric carboxymaltose for people with heart failure who are iron deficient, but not anaemic.

 

The proposal under consideration was specifically to widen access for people with iron deficiency anaemia and inflammation of chronic disease.

We plan to seek further advice from our clinical advisors at an upcoming meeting on the use of ferric carboxymaltose in this setting.

Methylnaltrexone bromide for opioid induced constipation in hospital

What does this mean for people?

From 1 November 2024, methylnaltrexone bromide (brand name Relistor) will be funded for people with opioid induced constipation in hospital.

We anticipate that over 4,300 additional people will benefit from methylnaltrexone bromide each year. We also anticipate that there will be substantial health sector savings as people are likely to spend less time in hospital.

Any changes to the original proposal?

We received feedback from health care professionals and other health sector stakeholders. The feedback received was supportive, no changes were made to the proposal for methylnaltrexone bromide following consultation.

A summary of the feedback and our responses to this are detailed below.

Who we think will be most interested

  • People in hospital with opioid induced constipation, their whānau, friends and caregivers.
  • Healthcare professionals who are involved in the treatment of opioid induced constipation.
  • Other organisations who deliver services and support for people in hospital.
  • Health New Zealand | Te Whatu Ora hospitals.
  • Pharmacies and wholesalers.
  • Pharmaceutical suppliers.

Detail about this decision

Access to methylnaltrexone bromide (brand name Relistor) in Part II of Section H of the Pharmaceutical Schedule will be widened from 1 November 2024. The full eligibility criteria for people in hospitals will be as follows:

Restricted

Initiation — (Opioid induced constipation outside of palliative care)

Limited to 14 days treatment

All of the following:

  1. Individual has opioid induced constipation; and
  2. Oral and rectal treatments for opioid induced constipation, including bowel-cleansing preparations, are ineffective or inappropriate; and
  3. Mechanical bowel obstruction has been excluded.

Restricted

Initiation — (Opioid induced constipation)

Both:

  1. The patient is receiving palliative care; and
  2. Either:
    1. Oral and rectal treatments for opioid induced constipation are ineffective; or
    2. Oral and rectal treatments for opioid induced constipation are unable to be tolerated.

The current Special Authority criteria and Hospital Indication Restriction that allows access to methylnaltrexone bromide for opioid induced constipation for people receiving palliative care is not affected by this change.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main theme raised in feedback and our response to the feedback received are summarised below:

Theme

Pharmac comment

Supportive of proposal. This would result in significantly reduced hospital stays and fewer investigations / interventions for patients with opioid-induced constipation.

We are pleased to be progressing a proposal that will benefit people who experience opioid induced constipation in hospital.

Biologics for severe chronic localised genital or flexural plaque psoriasis

What does this mean for people?

From 1 November 2024, the biologic medicines adalimumab (brand name Amgevita), etanercept (brand name Enbrel), secukinumab (brand name Cosentyx) and infliximab (brand name Remicade) will be funded for people severe, chronic, localised genital or flexural plaque psoriasis.

We anticipate that approximately 115 additional people will benefit in the first year of funding, increasing to about 165 people per year by year five.

Any changes to the original proposal?

We received feedback from health care professionals and other health sector stakeholders. No changes were made to the proposal following consultation.

The feedback received was supportive. A summary of the feedback and our responses to this are detailed below.

Who we think will be most interested

  • People with genital or flexural plaque psoriasis, their whānau, friends and caregivers.
  • Healthcare professionals who are involved in the treatment of genital or flexural plaque psoriasis.
  • Other organisations who deliver services and support for people with plaque psoriasis.
  • Health New Zealand | Te Whatu Ora hospitals.
  • Infusion services.
  • Pharmacies and wholesalers.
  • Pharmaceutical suppliers.

Detail about this decision

Access to adalimumab (brand name Amgevita), etanercept (brand name Enbrel), secukinumab (brand name Cosentyx) and infliximab (brand name Remicade) in Section B and Part II of Section H of the Pharmaceutical Schedule will be widened from 1 November 2024 as follows (adalimumab criteria shown; relevant changes to each medicine’s criteria will be updated):

Special Authority for Subsidy

Initial application — (Plaque psoriasis – severe chronic) only from a dermatologist or any relevant practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

Either:

  1. Both:
    1. Patient has had an initial Special Authority approval for etanercept for severe chronic plaque psoriasis; and
    2. Either:
      1. Patient has experienced intolerable side effects; or
      2. Patient has received insufficient benefit to meet the renewal criteria for etanercept for severe chronic plaque psoriasis; or
  2. All of the following:
    1. Any of the following:
      1. Patient has “whole body” severe chronic plaque psoriasis with a PASI score of greater than 10, where lesions have been present for at least 6 months from the time of initial diagnosis; or
      2. Patient has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; or
      3.  Patient has severe chronic localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months from the time of initial diagnosis, and with a Dermatology Life Quality Index (DLQI) score greater than 10; and
    2. Patient has tried, but received insufficient therapeutic effect from, or has experienced intolerable side effects from, at least three of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
    3. A PASI assessment or DLQI assessment has been completed for at least the most recent prior treatment course but no longer than 1 month following cessation of each prior treatment course and is no more than 1 month old at the time of application.

Renewal — (Plaque psoriasis – severe chronic) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following:

  1. Both:
    1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
    2. Either:
      1. The patient has experienced a 75% or more reduction in PASI score, or is sustained at this level, when compared with the pre-treatment baseline value; or
      2. The patient has a DLQI improvement of 5 or more, when compared with the pre-treatment baseline value; or
  2. Both:
    1. Patient had severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot at the start of treatment; and
    2. Either
      1. The patient has experienced a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the treatment course baseline values; or
      2. The patient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
  3. Both:
    1. Patient had severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
    2. Either:
      1. The patient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
      2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to baseline DLQI prior to commencing adalimumab.

Our response to what you told us

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

Theme

Pharmac comment

Supportive of the proposal. This proposal would help a number of people with limited funded treatment options.

Responses highlighted the severity of the condition and the impact this can have on individuals. This treatment will be life changing for many people.

We are pleased to be progressing a proposal which would improve the lives of people with severe, chronic, localised genital or flexural plaque psoriasis.

 

Hope this proposal would not reduce the priority of funding other medicines for skin conditions, such as eczema (atopic dermatitis).

Proposals for other medicines for skin conditions remain on Pharmac’s Options for Investment list. Progression of this proposal does not stop us progressing other proposals in the future, provided we have budget available.

More about the Option for Investment list

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.