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

Medicines Consultation Closes 30 Jul

What we’re proposing

We want to hear from you about a proposal to widen access to the following medicines, from 1 November 2024:

Aripiprazole depot (long-acting) injection for people with schizophrenia

Ferric carboxymaltose for iron deficiency anaemia in people with chronic inflammatory disease

Methylnaltrexone bromide for people in hospital with opioid induced constipation

Funded biologics (adalimumab, etanercept, secukinumab and infliximab) for people with severe, chronic, localised genital or flexural plaque psoriasis.

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 proposal is the second of many that we’re working on to put our budget increase into action.

Media release: Funding boost means more medicines for more New Zealanders

Feedback to this consultation will help us decide how we progress this proposal. Consultation closes at 4:00 pm, Tuesday 30 July 2024 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

The proposal would allow more New Zealanders to access these medicines from 1 November 2024.

  • Access to aripiprazole depot injection would be widened to include more people with schizophrenia in the community and in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.
  • Access to ferric carboxymaltose would be widened to include people with iron deficiency anaemia and chronic inflammatory disease in the community and in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.
  • Access to methylnaltrexone bromide would be widened to include people with opioid induced constipation outside of a palliative care setting in Health New Zealand | Te Whatu Ora Hospitals, subject to eligibility criteria.
  • Access to some funded biologics (adalimumab, etanercept, secukinumab and infliximab) would 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. 

We expect approximately 6,000 people in New Zealand would use these medicines in the first year of funding. After 5 years approximately 8,200 people would benefit.

Effects on the health sector

This proposal would reduce the number and length of stays in hospital for people accessing these medicines.

We continue to engage with our health sector partners, including Health New Zealand | Te Whatu Ora to implement new funding decisions.

Who we think will be interested

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

Aripiprazole depot injection for schizophrenia

About 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 a 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 mild side effect profile compared to other funded atypical antipsychotic depot injections, particularly metabolic adverse side effects.

Why we’re proposing this

We received a funding application for aripiprazole depot injection for schizophrenia in August 2015. We have received clinical advice on this application a number of times, most recently in September 2021. The (then) Mental Health Subcommittee of PTAC recommended that this application be funded with a medium priority.

The clinical advice told us that, in general, people with schizophrenia have substantial mental and physical health needs. On average, people with schizophrenia often die 10 years earlier than the general population. Māori and Pacific people have higher rates of schizophrenia than the general population.

Our advisors told us that although there are a number of treatment options, these can be limited by side effects. Some of these side effects can have substantial impacts. There can be issues in accessing these medicines, and issues relating to adherence related to intolerable side effects. In addition, our clinical advisors considered that for some people aripiprazole has additional benefits above currently funded antipsychotic agents.

We funded aripiprazole depot injection from 1 January 2024 for a small group of people with schizophrenia. This decision responded to a global supply issue with alternative treatments. You can read more about the decision on our website. This proposal would fund aripiprazole depot injection for more people with schizophrenia.

Decision for the 1 January 2024 listing of aripiprazole depot injection

You can find more information about this application, including clinical advisory committee advice, on the Pharmac Application Tracker.

Application Tracker | Aripiprazole long-acting injection(external link)

Details about our proposal

Access to aripiprazole depot injection would be widened in Section B of the Pharmaceutical Schedule from 1 November 2024 as follows.

The current Special Authority criteria and Hospital restriction for aripiprazole depot injection would be amended as follows (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 12 months without renewal unless notified for applications meeting the following criteria:

Either Any of the following:

  1. Both: 
    1. The patient has or is at high risk of metabolic syndrome; and
    2. Either:
      1. The patient has had an initial Special Authority approval for risperidone depot injection, paliperidone depot injection or olanzapine depot injection; or
      2. All of the following:
        1. The patient has schizophrenia; and
        2. The patient has received treatment with oral atypical antipsychotic agents but has been unable to adhere; and
        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
  2. Both:
    1. The patient has had an initial Special Authority approval for risperidone depot injection, paliperidone depot injection or olanzapine depot injection; and
    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
  3. 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.

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 compared with pre-aripiprazole depot initiation than prior to the initiation of an atypical antipsychotic depot injection.

The note in the current criteria would still apply to criterion three.

We are proposing to remove the renewal criteria as part of this proposal. Eligibility criteria are used to target funding and we do not consider the current renewal criteria currently targets funding. If approved, we would consider removing the renewal criteria from other atypical antipsychotic depot eligibility criteria in future.

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.

Ferric carboxymaltose for iron deficiency anaemia in chronic inflammatory disease

About iron deficiency anaemia in chronic inflammatory disease

Iron deficiency anaemia is a condition that happens when a person’s body doesn’t have enough iron. Without enough iron, their body can’t make enough haemoglobin. Haemoglobin is the special part of a red blood cell that allows the blood to carry oxygen around the body. People with anaemia can feel tired, weak, and be short of breath.

Inflammation is an important process that allows the body to heal after injury or infection. However, sometimes inflammation can go on for too long or it can happen in healthy tissues. This causes chronic inflammatory diseases such as rheumatoid arthritis or inflammatory bowel disease.

In people with chronic inflammatory diseases, a person’s iron levels can appear normal, even if they are anaemic and don’t have enough iron. 

About ferric carboxymaltose

Ferric carboxymaltose is a medicine that provides people with iron. Up to 1,000 mg of iron is given as a single infusion over 15 minutes. It can quickly reverse iron deficiency anaemia in people where oral iron preparations (or tablets) haven’t worked or cannot be used. It can be administered in a non-hospital setting.

Why we’re proposing this

We received a funding application for ferric carboxymaltose for iron deficiency anaemia in chronic inflammatory disease in August 2020. We have received clinical advice on this application a number of times, most recently in November 2022. The Haematology Advisory Committee recommended that this application be funded with a high priority.

Our clinical advisors have told us that there are challenges in diagnosing iron deficiency in people with chronic inflammation. In addition, there can be issues with accessing ferric carboxymaltose in primary care, as currently specialist approval is required for funded access. Our advisors told us there is an unmet health need in people with chronic inflammatory conditions and iron deficiency anaemia. 

Māori women are more likely to experience iron deficiency anaemia than the general population in New Zealand. This proposal would support care closer to home for people needing ferric carboxymaltose, rather than requiring people to travel to hospital.

You can find more information about this application, including clinical advisory committee advice, on the Pharmac Application Tracker

Application Tracker | Ferric carboxymaltose for anaemia for people with an inflammatory disease(external link)

We are seeking advice on a funding application for ferric carboxymaltose for hereditary haemorrhagic telangiectasis (HHT). You can find more information about this application on the Pharmac Application Tracker. 

Application Tracker | Ferric carboxymaltose for hereditary haemorrhagic telangiectasis (HHT)(external link)

Details about our proposal

Access to iron (as ferric carboxymaltose) (brand name Ferinject) would be widened in Section B of the Pharmaceutical Schedule from 1 November 2024 as follows.

The current Special Authority criteria for iron (as ferric carboxymaltose) for serum ferritin less than or equal to 20 mcg/L would be removed and replaced with the following criteria:

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.

We are not proposing changes to the eligibility criteria in Part II of Section H of the Pharmaceutical Schedule. We consider iron deficiency anaemia in people with chronic inflammatory disease are already eligible for ferric carboxymaltose in hospitals.

The current Special Authority criteria and Hospital Indication Restriction that allows access to iron (as ferric carboxymaltose) for ‘iron deficiency anaemia’ would not be affected by this change.

Methylnaltrexone bromide for opioid induced constipation in hospital

About opioid induced constipation

Constipation refers to persistent, difficult, infrequent, or incomplete defecation (the process of having a bowel movement). Constipation may involve pain, an inability to pass a bowel movement after straining or pushing, or no bowel movements for more than 3 days.

Opioids are a type of medicine which are used to treat pain. However, treatment with opioids can result in a person becoming constipated. People being treated with opioids are often inpatients in hospital being treated for conditions causing pain and are often immobile in bed because of their illness or injury. Immobility also causes constipation.

Constipation causes distress, has a negative impact on quality of life, and may also lead to life-threatening complications such as bowel perforation due to faecal impaction. Using opioids when people are sick in hospital with other things, and are bedbound, can combine to make constipation that is difficult to treat.

About methylnaltrexone bromide

Methylnaltrexone bromide is a medicine that is used to treat constipation caused by opioids. It works by blocking the ability of opioids to cause constipation, without stopping their ability to treat pain.

Why we’re proposing this

We received a funding application for methylnaltrexone bromide for opioid-induced constipation in hospitalised patients outside of palliative care in September 2018. We have received clinical advice on this application a number of times, most recently in February 2023. At this meeting, the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended methylnaltrexone bromide be funded in hospital with a low priority.

The clinical advice we received told us that people who have opioid induced constipation have a high health need when other laxatives don’t work or are not appropriate. Our clinical advisors recommended that methylnaltrexone bromide should not be funded for use in the community setting outside of a palliative care setting.

You can find more information about this application, including clinical advisory committee advice, on the Pharmac Application Tracker

Application Tracker | Methylnaltrexone bromide for opioid-induced constipation for people not in palliative care(external link)

Details about our proposal

Access to methylnaltrexone bromide (brand name Relistor) would be widened in Part II of Section H of the Pharmaceutical Schedule from 1 November 2024. A new indication of opioid induced constipation outside of palliative care would apply subject to the criteria outlined below (new criteria only are shown below):

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.

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

Biologics for severe chronic localised genital or flexural plaque psoriasis

About genital or flexural psoriasis

Psoriasis is a long-term inflammatory condition that affects a person’s skin. It can make a person’s skin scaly, itchy, and red, affecting their quality of life. Severe psoriasis can cause significant medical and psychological problems - increasing a person’s risk of death.

Flexural psoriasis is a type of psoriasis that affects a person’s skin folds, such as their armpits, elbows or knees. Genital psoriasis affects a person’s genital area.

About funded biologics

Biologics are the name for types of medicine derived using biotechnology from yeast, plant, bacterial or animal cells. They are used to treat a range of conditions, including plaque psoriasis.

We currently fund the biologics adalimumab, etanercept, secukinumab and infliximab for several diseases including severe, chronic whole body plaque psoriasis and psoriasis of the face, hand, or foot. They would all be funded for genital or flexural psoriasis in addition to their current funded indications.

About biologic medicines

Why we’re proposing this

We received a funding application for adalimumab for severe chronic localised flexural or genital psoriasis in November 2021. We received clinical advice on this application from our Dermatology Advisory Committee in June 2023. They recommended widening access with a high priority.

Our clinical advisors have told us that people who have severe genital or flexural psoriasis have no specialised treatment options. Currently they must apply creams and treatments directly to the skin. Applying treatments can take lots of time every day and doesn’t always work in severe cases.

Although the original application was for adalimumab, the Dermatology Advisory Committee considered access should be widened for all biologics funded for plaque psoriasis. This currently includes adalimumab, etanercept, secukinumab and infliximab.

A very small number of people receive funded access via our Named Patient Pharmaceutical Assessment (NPPA) pathway. This proposal would provide wider access and reduce the administration burden for prescribers. This would give people who meet the eligibility criteria faster access to treatment.

You can find more information about this application, including clinical advisory committee advice, on the Pharmac Application Tracker.

Application Tracker | Widening access to biologics for severe, localised flexural or genital psoriasis(external link)

Details about our proposal

Access to adalimumab (brand name Amgevita), etanercept (brand name Enbrel), secukinumab (brand name Cosentyx) and infliximab (brand name Remicade) would be widened in Section B of the Pharmaceutical Schedule from 1 November 2024. New criteria for flexural or genital psoriasis would be added to the ‘Severe, chronic plaque psoriasis’ indication subject to the eligibility criteria outlined below (relevant criteria only are shown below, additions in bold). The criteria shown below are for adalimumab, however the new criteria outlined below in bold would be added for etanercept, secukinumab and infliximab.

Special Authority for Subsidy

Initial application — (Plaque psoriasis – severe chronic) only from a dermatologist or any 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 Either:
      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 Either:

  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. The patient has experienced a DLQI improvement of 5 or more, when compared with 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.

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.

The current Special Authority criteria and Hospital Indication Restriction that allows access to funded biologics for other conditions would not be affected by this change.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4:00 pm, Tuesday 30 July 2024.

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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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.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.