Adalimumab: What we’re proposing for ophthalmologic conditions

We want to hear from people on a proposal that would give more New Zealanders funded access to adalimumab.

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We want to hear from people on a proposal that would give more New Zealanders funded access to adalimumab.

We are seeking feedback on a proposal to make changes to the funded brand of adalimumab, from Humira to a citrate-free biosimilar adalimumab called Amgevita from 1 February 2022 through a provisional agreement with Amgen (New Zealand) Limited. Adalimumab is a biologic medicine used to treat a range of rheumatology, gastrointestinal, dermatological, and other autoimmune conditions. 

If the proposal is approved a number of changes would occur from 1 February 2022. This would include awarding Principal Supply Status to a biosimilar adalimumab product (Amgevita) and widening access to this treatment for a number of ophthalmologic conditions. 

A summary of the changes includes: 

  • A biosimilar adalimumab (Amgevita, supplied by Amgen) would be funded from 1 February 2022 
  • All people who start on adalimumab treatment after 1 February 2022 would receive Amgevita 
  • People with ocular inflammation (chronic and severe) who are receiving treatment with the currently listed brand of adalimumab (Humira) before 1 February 2022 would need to be considered for a move to Amgevita before 31 August 2022 
  • We understand there may be some people who need to move back to, or remain on, Humira. Humira would remain listed for these circumstances, subject to funding criteria for these people following consultation with their prescriber 

Feedback on this consultation will help us to understand if any changes should be made to this proposal. Consultation closes at 5 pm on Wednesday, 22 September 2021. Feedback can be emailed to consult@pharmac.govt.nz

Widening access for ophthalmologic conditions

Changing to a biosimilar adalimumab means that more New Zealanders would be able to access adalimumab.

As part of the proposal to award Principal Supply Status, Pharmac is proposing to widen access to Amgevita for a range of uses, including for ocular inflammation (chronic and severe) to enable funded access to Amgevita treatment as a first line biologic. This proposed change reflects requests for funding that have been made to Pharmac and we have considered through our exceptions process (waivers and NPPA).

This proposal would mean that from 1 February 2022, people with ocular inflammation (either chronic or severe) would have access to a biologic treatment which can be administered at home or in the community.

The proposed initial application Special Authority changes for Ocular inflammation – chronic or severe are shown below (additions in bold, deletions in strikethrough) and would be made to the criteria for funded access to adalimumab (Amgevita) from 1 February 2022 in Section B and Part II of Section H.

Amendments to Special Authority criteria provides information on all Special Authority changes and the proposed renewal application changes to Ocular inflammation – chronic or severe.

Ocular inflammation – chronic

ADALIMUMAB (AMGEVITA)

Initial application — (chronic Ocular inflammation - chronic) from any relevant practitioner.

Approvals valid for 4 months for applications meeting the following criteria:

  1. Either:
    1. Both:
      The Patient has had an initial Special Authority approval for infliximab for chronic ocular inflammation; or and
      Either:
      The patient has experienced intolerable side effects from infliximab; or
      The patient has received insufficient benefit from infliximab to meet the renewal criteria for infliximab for chronic ocular inflammation; or
    2. Both:
      1. Patient has severe uveitis uncontrolled with treatment of steroids and other immunosuppressants with a severe risk of vision loss; and
      2. Any of the following:
        1. Patient is 18 years or older and Treatment with at least two other immunomodulatory agents has proven ineffective; or
        2. Patient is under 18 years and Treatment with methotrexate has proven ineffective or is not tolerated at a therapeutic dose; or
        3. Patient is under 8 years and Treatment with steroids or methotrexate has proven ineffective or is not tolerated at a therapeutic dose; or disease requires control to prevent irreversible vision loss prior to achieving a therapeutic dose of methotrexate.

    Ocular inflammation – severe

    ADALIMUMAB (AMGEVITA)

    Initial application — (severe Ocular inflammation - severe) from any relevant practitioner.

    Approvals valid for 4 months for applications meeting the following criteria:
    Either:

    Both:

    1. The Patient has had an initial Special Authority approval for infliximab for severe ocular inflammation; and or
      Either:
      1. The patient has experienced intolerable side effects from infliximab; or
      2. The patient has received insufficient benefit from infliximab to meet the renewal criteria for infliximab for severe ocular inflammation; or
    2. Both:
      1. Patient has severe, vision-threatening ocular inflammation requiring rapid control; and
      2. Any of the following:
        1. Treatment with high-dose steroids (intravenous methylprednisolone) followed by high dose oral steroids has proven ineffective at controlling symptoms; or
        2. Patient developed new inflammatory symptoms while receiving high dose steroids; or
        3. Patient is aged under 8 years and treatment with high dose oral steroids and other immunosuppressants has proven ineffective at controlling symptoms.

    Amendments to Special Authority criteria for ophthalmologic conditions

    We are also proposing changes to the adalimumab (Amgevita) Special Authority criteria for currently funded indications to improve access to adalimumab treatment.

    This would include:

    • Special Authority renewal periods would be extended from 6 months to 2 years
    • There would be no dosing restrictions for people using Amgevita

    These changes would be made to the current access criteria for patients from 1 February 2022. They would be specific to the Amgevita brand of adalimumab.

    The proposed renewal application Special Authority changes for Ocular inflammation – chronic or severe are shown below (additions in bold, deletions in strikethrough). These would be made to the criteria for funded access to adalimumab (Amgevita) from 1 February 2022 in Section B and Part II of Section H.

    Ocular inflammation – chronic 

    ADALIMUMAB (AMGEVITA)

    Renewal — (chronic Ocular inflammation - chronic) from any relevant practitioner.

    Approvals valid for 2 years 12 months for applications meeting the following criteria:

    Both:

    Any of the following:

    1. The patient has had a good clinical response following 12 weeks’ initial treatment; or
    2. Following each 2 year 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
    3. Following each 2 year 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old. and
    1. Adalimumab to be administered at doses no greater than 40 mg every 14 days. 

    Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if adalimumab is withdrawn.

    Ocular inflammation – severe

    ADALIMUMAB (AMGEVITA)

    Renewal — (severe Ocular inflammation - severe) from any relevant practitioner.

    Approvals valid for 2 years 12 months for applications meeting the following criteria:
    Both:

    Any of the following:

    1. The patient has had a good clinical response following 3 initial doses; or
    2. Following each 2 year 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
    3. Following each 2 year 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old.
    1. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if adalimumab is withdrawn.

    Alternative brand access from 1 September 2022 for ophthalmologic conditions

    From 1 February 2022, patients receiving treatment with Humira would need to move to Amgevita. This change would be carefully managed by treating clinicians, working closely with primary care, the patient, their family, whānau, and caregivers. 

    Based on clinical advice received, we anticipate that most existing patients who take adalimumab would be able to change to the Amgevita brand of adalimumab. However, Pharmac has identified that there may be some people with ocular inflammation who are at higher risk of experiencing severe adverse clinical outcomes associated with loss of disease control. 

    Clinicians would be able access funded treatment with Humira via Special Authority for patients that do not tolerate treatment after a trial with Amgevita (if appropriate and safe to consider further treatment with adalimumab) or where a clinician considers that changing to Amgevita would put their patient at risk of severe disease destabilisation (no trial required). 

    Access to Humira after 31 August 2022 would be through Special Authority criteria. These criteria would replace the current Special Authority access criteria from 1 September 2022, and a new Special Authority application would need to be made for these patients following discussion with their doctor.

    Renewal criteria would remain consistent with the renewal criteria currently in place for Humira. No changes are proposed.

    To dispense and claim a subsidy, the correct brand would need to be prescribed for each patient. Special Authority approvals would not be interchangeable. 

    The criteria as they relate to ophthalmology conditions are detailed as follows:

    Ocular inflammation – chronic

    ADALIMUMAB (HUMIRA)

    Initial application - (Ocular inflammation – chronic) from any relevant Practitioner.

    Approvals valid for 12 months for applications meeting the following criteria:

    All of the following:

    1. Any of the following:
      1. The patient has experienced intolerable side effects from adalimumab (Amgevita) following a minimum of 4 weeks treatment, and a maximum of 6 months treatment with Amgevita; or
      2. Patient has developed symptoms of loss of disease control following a minimum of 4 weeks treatment with Amgevita, and a maximum of 6 months treatment with Amgevita and clinician attributes this loss of disease response to a change in treatment regimen; or
      3. Patient has severe uveitis and is considered to be at risk of vision loss if they were to change treatment; and
    2. Patient has previously had a Special Authority approval for the Humira brand of adalimumab for this indication; and
    3. Adalimumab to be administered at doses no greater than 40 mg every 14 days. 

    ADALIMUMAB (HUMIRA)

    Renewal application (Ocular inflammation – chronic) from any relevant Practitioner.

    Approvals valid for 12 months for applications meeting the following criteria:

    1. Any of the following
      1. The patient has had a good clinical response following 12 weeks initial treatment; or
      2. Following each 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
      3. Following each 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old; and
    2. Adalimumab is to be administered at doses no greater than 40 mg every 14 days.

    Ocular inflammation – severe

    ADALIMUMAB (HUMIRA)

    Initial application (Ocular inflammation – severe) from any relevant Practitioner.

    Approvals valid for 12 months for applications meeting the following criteria:

    All of the following:

    1. Any of the following:
      1. The patient has experienced intolerable side effects from adalimumab (Amgevita) following a minimum of 4 weeks treatment, and a maximum of 6 months treatment with Amgevita; or
      2. Patient has developed symptoms of loss of disease control following a minimum of 4 weeks treatment with Amgevita, and a maximum of 6 months treatment with Amgevita and clinician attributes this loss of disease response to a change in treatment regimen; or
      3. Patient has severe uveitis and is considered to be at risk of vision loss if they were to change treatment; and
    2. Patient has previously had a Special Authority approval for the Humira brand of adalimumab for this indication; and
    3. Adalimumab to be administered at doses no greater than 40 mg every 14 days. 

    ADALIMUMAB (HUMIRA)

    Renewal application – (Ocular inflammation – severe) from any relevant Practitioner.

    Approvals valid for 12 months for applications meeting the following criteria:

    1. Any of the following
      1. The patient has had a good clinical response following 3 initial doses; or
      2. Following each 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
      3. Following each 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old; and
    2. Adalimumab is to be administered at doses no greater than 40 mg every 14 days.

    Return to the main adalimumab consultation