Adalimumab: What we’re proposing for dermatological 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 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. 

Adalimumab is currently funded for a range of dermatological indications, subject to Special Authority criteria(external link), those associated with dermatological conditions include: 

  • Hidradenitis suppurativa
  • Pyoderma gangrenosum
  • Behçet’s disease
  • Severe chronic plaque psoriasis 

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 dermatological 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 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 Humira if Amgevita is unable to be tolerated by a current patient, after a trial. 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 dermatological 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 Behçet’s disease to enable funded access to Amgevita as a first line biologic. More information on this application, including relevant clinical advice records, can be found through below link to the Application Tracker: 

This proposed change in access reflects a funding request that has been made to Pharmac and has previously been considered for Pharmaceutical Schedule listing. The proposed price reduction of adalimumab (Amgevita) means we are able to prioritise this for funding now.  

Behçet’s disease – first line

Pharmac received a funding application to widen access to adalimumab to enable use as a first line biologic treatment in Behçet’s disease in May 2012. PTAC, the Dermatology Subcommittee and the Ophthalmology Subcommittee have reviewed this application several times. In May 2015 [PDF, 909 KB] PTAC recommended funding for this patient group, to enable interchangeable use with infliximab if cost neutral to the cost of infliximab.   

Adalimumab has been funded for treatment of Behçet’s in people who cannot tolerate infliximab, or who have received inadequate benefit from infliximab since July 2019.

This proposal would mean that from 1 February 2022, people with Behçet’s disease would have access to a biologic treatment that can be administered at home or in the community. We estimate that approximately 5 patients would benefit from this proposal in the first year of funding. 

The criteria for funded access to adalimumab (Amgevita) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2022 to enable usage of adalimumab in the first line treatment for people with Behçet’s disease. The proposed criteria are detailed below.

Amendments to Special Authority criteria provides further information on all Special Authority changes. 

ADALIMUMAB (AMGEVITA)

Initial application — (severe Behcet's disease - severe) from any relevant practitioner. Approvals valid without further renewal unless notified for 3 months for applications meeting the following criteria:
Both All of the following:

  1. The patient has severe Behcet's disease* that is significantly impacting the patient’s quality of life (see Notes); and
  2. Either:
    1. The patient has severe ocular, neurological, gastrointestinal, rheumatological, mucocutaneous and/or vasculitic symptoms and has not responded adequately to one or more treatment(s) appropriate for the particular symptom(s) treatment with infliximab (see Notes); or
    2. The patient has severe ocular, neurological, gastrointestinal, rheumatological and/or mucocutaneous and/or vasculitic symptoms and has not responded adequately to two or more treatments appropriate for the particular symptom(s) experienced intolerable side effects from treatment with infliximab; and
  3. The patient is experiencing significant loss of quality of life; and
  4. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

Note: Behcet's disease diagnosed according to the International Study Group for Behcet's disease. Lancet 1990;335(8697):1078-80. Quality of life measured using an appropriate quality of life scale such as that published in Gilworth et al, J Rheumatol. 2004;31:931-7.

Note: Indications marked with * are unapproved indications.

Renewal

Renewal — (severe Behcet's disease) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Patient has had a good clinical response to initial treatment with measurably improved quality of life.
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Amendments to Special Authority criteria for dermatological 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
    • Special Authority renewals could be applied for by any relevant practitioner, and renewal applications would not be required for Behçet’s disease and pyoderma gangrenosum
    • 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 changes relating to specific dermatological conditions are detailed below (additions in bold, deletions in strikethrough).

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

    Note, where adalimumab criteria are interchangeable with other biologic treatments (such as etanercept or secukinumab), Pharmac would assess changes to these following a decision on adalimumab to ensure ongoing alignment of access criteria.

    Alternative brand access from 1 September 2022 for dermatological 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, 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). 

    Access to Humira after 31 August 2022 would be through new 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 criteria currently in place for Humira. No changes are proposed.

    The criteria as they relate to dermatological conditions are detailed below (new criteria shown only).

    Details about this proposal (individual indications)

    The links below go directly to specific rheumatological conditions and detail the amended Special Authority criteria and Alternative Brand criteria for each condition. 

    Behçet’s disease - severe

    Amended Special Authority criteria available above in widening access

    ADALIMUMAB (AMGEVITA)

    Initial application - Behçet’s disease - severe from any relevant Practitioner.

    Approvals valid for 6 months for applications meeting the following criteria:

    All of the following:

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

    ADALIMUMAB (HUMIRA)

    Renewal application - Behçet’s disease - severe from any relevant Practitioner.

    Approvals valid for 6 months for applications meeting the following criteria:

    1. The patient has had a good clinical response to treatment with measurably improved quality of life; and
    2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Hidradenitis Suppurativa

    Amended Special Authority criteria (additions in bold, deletions in strikethrough)

    ADALIMUMAB (AMGEVITA)

    Initial application — (Hidradenitis suppurativa) only from a dermatologist.

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

    1. Patient has hidradenitis suppurativa Hurley Stage II or Hurley Stage III lesions in distinct anatomic areas; and
    2. Patient has tried, but had an inadequate response to at least a 90 day trial of systemic antibiotics or patient has demonstrated intolerance to or has contraindications to for systemic antibiotics; and
    3. The Patient has 3 or more active lesions (g. inflammatory nodules, abscesses, draining fistulae); and
    4. The patient has a DLQI Dermatology Quality of Life Index of 10 or more and the assessment is no more than 1 month old at time of application; and
    5. Following the initial loading doses, adalimumab is to be administered at doses no greater than 40mg every 7 days. 

    ADALIMUMAB (AMGEVITA)

    Renewal — (Hidradenitis suppurativa) from any relevant practitioner only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 2 years 6 months for applications meeting the following criteria:

    All of the following:

    1. The patient has a reduction in active lesions (e.g. inflammatory nodules, abscesses, draining fistulae) of 25% or more from baseline; and
    2. The patient has a DLQI Dermatology Quality of Life Index improvement of 4 or more from baseline.
    3. Adalimumab is to be administered at doses no greater than 40mg every 7 days. Fortnightly dosing has been considered.

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application - Hidradenitis suppurativa only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 6 months for applications meeting the following criteria:

    All of the following

    1. Either:
      1. The patient has experienced intolerable side effects from adalimumab (Amgevita) following a minimum of 4 weeks treatment; or
      2. Patient has developed symptoms of loss of disease control following a minimum of 4 weeks treatment with adalimumab (Amgevita) and clinician attributes this loss of disease response to a change in treatment regimen; and
    2. Patient has received a maximum of 6 months treatment with Amgevita; and
    3. Patient has previously had a Special Authority approval for the Humira brand of adalimumab for this indication; and
    4. Adalimumab is to be administered at doses no greater than 40mg every 7 days. Fortnightly dosing has been considered. 

    ADALIMUMAB (HUMIRA)

    Renewal application - Hidradenitis suppurativa only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 6 months for applications meeting the following criteria:

    All of the following:

    1. The patient has a reduction in active lesions (e.g. inflammatory nodules, abscesses, draining fistulae) of 25% or more from baseline; and
    2. The patient has a Dermatology Quality of Life Index improvement of 4 or more from baseline; and
    3. Adalimumab is to be administered at doses no greater than 40 mg every 7 days. Fortnightly dosing has been considered.

    Pyoderma gangrenosum

    Amended Special Authority criteria (additions in bold, deletions in strikethrough)

    ADALIMUMAB (AMGEVITA)

    Initial application — (pyoderma gangrenosum) only from a dermatologist. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

    All of the following Both:

    1. Patient has pyoderma gangrenosum*; and
    2. Patient has received three months of conventional therapy including a minimum of three pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response.
    3. A maximum of 8 doses. 

    Note: Indications marked with * are unapproved indications. 

    Renewal — (pyoderma gangrenosum) only from a dermatologist or Practitioner on the recommendation of a dermatologist.

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

    All of the following:

    1. Patient has shown clinical improvement; and
    2. Patient continues to require treatment; and
    3. A maximum of 8 doses.

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application - Pyoderma gangrenosum only from a dermatologist

    Approvals valid for 6 months for applications meeting the following criteria:

    All of the following:

    1. Either:
      1. The patient has experienced intolerable side effects from adalimumab (Amgevita) following a minimum of 4 weeks treatment; or
      2. Patient has developed symptoms of loss of disease control following a minimum of 4 weeks treatment with adalimumab (Amgevita) and clinician attributes this loss of disease response to a change in treatment regimen; and
    2. Patient has received a maximum of 6 months treatment with Amgevita; and
    3. Patient has previously had a Special Authority approval for the Humira brand of adalimumab for this indication; and
    4. A maximum of 8 doses. 

    ADALIMUMAB (HUMIRA)

    Renewal application - Pyoderma gangrenosum  only from a dermatologist

    Approvals valid for 6 months for applications meeting the following criteria:

    Both:

    1. The patient has demonstrated clinical improvement and continues to require retreatment; and
    2. A maximum of 8 doses.

    Plaque psoriasis – severe chronic

    Amended Special Authority criteria (additions in bold, deletions in strikethrough)

    ADALIMUMAB (AMGEVITA)

    Initial application — (Plaque psoriasis - severe chronic) only from a dermatologist.

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

    Either:

    1. Both:
      1. The Patient has had an initial Special Authority approval for etanercept for severe chronic plaque psoriasis; and
      2. Either:
        1. The Patient has experienced intolerable side effects from etanercept; or
        2. The Patient has received insufficient benefit from etanercept to meet the renewal criteria for etanercept for severe chronic plaque psoriasis; or
    2. All of the following:
      1. Either:
        1. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (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; and
      2. Patient has tried, but had an inadequate response (see Note) to, 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 Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment 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. ; and
      4. The most recent PASI or DLQI assessment is no more than 1 month old at the time of application. 

    Note: "Inadequate response" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 10, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment. 

    ADALIMUMAB (AMGEVITA)

    Renewal — (Plaque psoriasis - severe chronic) from any relevant practitioner only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 2 years 6 months for applications meeting the following criteria:

    All of the following:

    1. Either
      1. Applicant is a dermatologist; or
      2. Applicant is a Practitioner and confirms that a dermatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and

    Either:

    1. Both:
      1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
      2. Either:
        1. Following each prior adalimumab treatment course The patient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-adalimumab treatment baseline value; or
        2. Following each prior adalimumab treatment course The patient has a Dermatology Quality of Life Index (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. Following each prior adalimumab treatment course The patient has 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. Following each prior adalimumab treatment course The patient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-adalimumab treatment baseline value.
    1. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Note: A treatment course is defined as a minimum of 12 weeks adalimumab treatment

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application - (Psoriasis - severe chronic plaque) only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 6 months for applications meeting the following criteria:

    All of the following:

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

    ADALIMUMAB (HUMIRA)

    Renewal application (Psoriasis - severe chronic plaque)  only from a dermatologist or Practitioner on the recommendation of a dermatologist.

    Approvals valid for 6 months for applications meeting the following criteria:

    Both:

    1. Either:
      1. Both:
        1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
        2. Either:
          1. Following each prior adalimumab treatment course the patient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-adalimumab treatment baseline value; or
          2. Following each prior adalimumab treatment course the patient has a Dermatology Quality of Life Index (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. Following each prior adalimumab treatment course the patient has 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. Following each prior adalimumab treatment course the patient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-adalimumab treatment baseline value; and
    2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

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