Adalimumab: What we’re proposing for rheumatological conditions

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

On this page

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 rheumatological indications, subject to Special Authority criteria(external link), those associated with rheumatological conditions include: 

  • Adult-onset Stills disease
  • Ankylosing spondylitis
  • Juvenile idiopathic arthritis (oligoarticular and polyarticular)
  • Psoriatic arthritis
  • Rheumatoid arthritis 

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 rheumatological 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 rheumatological 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 a number for rheumatological conditions. 

More information on each application, including relevant clinical advice records, can be found through below links to the Application Tracker: 

 We estimate that approximately 245 people would benefit in the first year of funding as a result of these changes in access to adalimumab for rheumatological conditions.

These proposed changes in access reflect funding requests that have been made to Pharmac and have previously been considered for Pharmaceutical Schedule listing. The proposed price reduction of adalimumab (Amgevita) means we are able to prioritise these applications for funding now.  

Undifferentiated spondyloarthritis

Pharmac received a funding application to widen access to adalimumab to treat undifferentiated spondyloarthritis in December 2013. This application has been reviewed by both PTAC and the Rheumatology Subcommittee. In February 2015 [PDF, 498 KB] PTAC recommended funding for this patient population with a medium priority. More information about this funding application, including links to the relevant clinical advice records, can be found in the Application Tracker(external link).

Etanercept (a biologic treatment) has been funded for undifferentiated spondyloarthritis since 1 March 2020. This proposal would mean that from 1 February 2022, people with undifferentiated spondyloarthritis would have access to another biologic treatment which can be administered at home or in the community. We estimate that approximately 55 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 include people with undifferentiated spondyloarthritis (proposed new criteria shown only):

ADALIMUMAB (AMGEVITA)

Initial application — (undifferentiated spondyloarthritis) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has undifferentiated peripheral spondyloarthritis* with active peripheral joint arthritis in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
  2. Patient has tried and not responded to at least three months of each of methotrexate, sulphasalazine and leflunomide, at maximum tolerated doses; and
  3. Any of the following:
    1. Patient has a CRP level greater than 15 mg/L measured no more than one month prior to the date of this application; or
    2. Patient has an ESR greater than 25 mm per hour measured no more than one month prior to the date of this application; or
    3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months. 

Note: Indications marked with * are unapproved indications 

ADALIMUMAB (AMGEVITA)

Renewal — (undifferentiated spondyloarthritis) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Either:

  1. Following initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
  2. The patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response in the opinion of the treating physician.

    The application(external link)for adalimumab for the treatment of undifferentiated spondyloarthritis in the second line(external link) (after etanercept) would be superseded by this proposal and would therefore be removed from further consideration. 

    Inflammatory bowel disease associated arthritis (IBD-A)

    Pharmac received a funding application to widen access to adalimumab to treat inflammatory bowel disease associated arthritis in December 2013. This application has been reviewed by PTAC and the Rheumatology Subcommittee of PTAC several times. In February 2015 [PDF, 498 KB] PTAC recommended funding for this patient population with a medium priority. More information on this application, including links to the relevant clinical advice records, can be found in the Application Tracker(external link).

    This proposal would mean that from 1 February 2022, people with inflammatory bowel disease associated arthritis would have access to a biologic treatment which can be administered at home or in the community. We estimate that about 60 people 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 include people with inflammatory bowel disease associated arthritis (IBD-A) (proposed new criteria shown only):

    Inflammatory bowel arthritis – axial

    ADALIMUMAB (AMGEVITA)

    Initial application — (inflammatory bowel arthritis – axial) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

    All of the following

    1. Patient has a diagnosis of active ulcerative colitis or active Crohn’s disease; and
    2. Patient has axial inflammatory pain for six months or more; and
    3. Patient is unable to take NSAIDs; and
    4. Patient has bilateral sacroiliitis demonstrated by radiological imaging; and
    5. Patient has not responded adequately to prior treatment consisting of at least 3 months of an exercise regime supervised by a physiotherapist; and
    6. A BASDAI of at least 6 on a 0‑10 scale completed after the 3 month exercise trial, but prior to ceasing any previous pharmacological treatment 

    ADALIMUMAB (AMGEVITA)

    Renewal — (inflammatory bowel arthritis – axial)

    Approvals from any relevant Practitioner. Approvals valid for 2 years for applications where treatment has resulted in an improvement in BASDAI of 4 or more points from pre-treatment baseline on a 10 point scale, or an improvement in BASDAI of 50%, whichever is less.

    Inflammatory bowel arthritis – peripheral

    ADALIMUMAB (AMGEVITA)

    Initial application — (inflammatory bowel arthritis – peripheral) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

    Both:

    1. Patient has a diagnosis of active ulcerative colitis or active Crohn’s disease; and
    2. Patient has active arthritis in at least four joints from the following: hip, knee, ankle, subtalar, tarsus, forefoot, wrist, elbow, shoulder, sternoclavicular; and
    3. Patient has tried and not responded to at least three months of methotrexate or azathioprine at a maximum tolerated dose; and
    4. Patient has tried and not responded to at least three months of sulphasalazine at a maximum tolerated dose; and
    5. Any of the following:
      1. Patient has a CRP level greater than 15 mg/L measured no more than one month prior to the date of this application; or
      2. Patient has an ESR greater than 25 mm per hour; or
      3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months. 

    ADALIMUMAB (AMGEVITA)

    Renewal — (inflammatory bowel arthritis – peripheral) Approvals from any relevant practitioner. Approvals valid for 2 years for applications where:

    Either:

    1. Following initial treatment, patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
    2. Patient demonstrates at least a continuing 30% improvement in active joint count from baseline in the opinion of the treating physician.

    The application(external link) for use of infliximab as a treatment of inflammatory bowel disease associated arthritis (IBD-A) disease remains under consideration by Pharmac.

    Rheumatoid arthritis – Special authority changes to joint count and CRP levels

    Pharmac received a funding application to widen access to adalimumab for the treatment of rheumatoid arthritis in November 2019. The funding application requested the following changes to be made to the Special Authority for adalimumab:

    • Reduce the required number of active joints for access to adalimumab and etanercept from 20 to 15
    • Remove the requirement for a C-reactive protein (CRP) level to be greater than 15 mg/L

    The Rheumatology Subcommittee reviewed this application in May 2021 [PDF, 184 KB] and recommended changes be made to the access criteria of both adalimumab and etanercept (as first line biologic treatments for rheumatoid arthritis patients) with a high priority. More information on this funding application, including links to the relevant clinical advice records, can be found in the Application Tracker.(external link)

    This proposal would mean that, from 1 February 2022 more people with rheumatoid arthritis would have access to adalimumab or etanercept treatment. We estimate that approximately 130 additional patients would benefit from this proposal in the first year of funding. 

    The criteria for funded access to adalimumab (Amgevita), and etanercept (Enbrel) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2022:

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

    ADALIMUMAB (AMGEVITA) / ETANERCEPT

    Initial application — (rheumatoid aArthritis - rheumatoid) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

    Either:

    1. Both:
      1. The patient has had an initial Special Authority approval for [adalimumab / etanercept ] for rheumatoid arthritis; and
      2. Either:
        1. The patient has experienced intolerable side effects; or
        2. The patient has received insufficient benefit from to meet the renewal criteria for rheumatoid arthritis; or
    2. All of the following:
      1. Patient has had severe and active erosive rheumatoid arthritis (either confirmed by radiology imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
      2. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
      3. Patient has tried and not responded to at least three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose; and
      4. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate at maximum tolerated doses; and
      5. Any of the following Either:
        1. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with the maximum tolerated dose of ciclosporin; or
          Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with intramuscular gold; or
        2. Patient has tried and not responded to at least three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with oral or parenteral methotrexate; and
      6. Either:
        1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 15 swollen, tender joints; or
        2. Patient has persistent symptoms of poorly controlled and active disease in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip. and
      7. Either:
        1. Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or
        2. C-reactive protein levels not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

    ADALIMUMAB (AMGEVITA) / ETANERCEPT

    Renewal — (rheumatoid aArthritis - rheumatoid)  from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

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

    1. Either:
      1. Applicant is a rheumatologist; or
      2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
    2. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
    1. Either:
      1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
      2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.
    1. Either:
      1. Adalimumab to be administered at doses no greater than 40 mg every 14 days; or
      2. Patient cannot take concomitant methotrexate and requires doses of adalimumab higher than 40 mg every 14 days to maintain an adequate response.

    Note, the removal of dosing restrictions for patients with Rheumatoid Arthritis is specific to Amgevita and has not been assessed for etanercept (Enbrel).

    The application(external link) requesting a reduction in the number of prior immunosuppressant agents (disease modifying anti-rheumatic drugs – DMARDs) that must be trialled prior to funded access to adalimumab and/or etanercept remains under consideration by Pharmac.

    Amendments to Special Authority criteria for rheumatological 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
    • There would be no dosing restrictions for people using Amgevita
    • Removal of renewal criteria for Adult-Onset Still Disease to enable approval without renewal

    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 rheumatological 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 infliximab), Pharmac would assess changes to these following a decision on adalimumab to ensure ongoing alignment of access criteria (excluding changes to Rheumatoid Arthritis detailed above).

    Alternative brand access from 1 September 2022 for rheumatological 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 rheumatological conditions are detailed below (new criteria shown only).

    Details about this proposal (individual rheumatological indications)

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

    Ankylosing Spondylitis

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

    ADALIMUMAB (AMGEVITA)

    Initial application — (ankylosing spondylitis) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

    Either:

    1. Both:
      1. The Patient has had an initial Special Authority approval for etanercept for ankylosing spondylitis; 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 ankylosing spondylitis; or
    2. All of the following:
      1. Patient has a confirmed diagnosis of ankylosing spondylitis for more than six months; and
      2. Patient has low back pain and stiffness that is relieved by exercise but not by rest; and
      3. Patient has bilateral sacroiliitis demonstrated by radiology imaging plain radiographs, CT or MRI scan; and
      4. Patient's ankylosing spondylitis has not responded adequately to treatment with two or more non-steroidal anti-inflammatory drugs (NSAIDs), in combination with anti-ulcer therapy if indicated, while patient was undergoing at least 3 months of a regular exercise regimen for ankylosing spondylitis; and
      5. Either:
        1. Patient has limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by the following Bath Ankylosing Spondylitis Metrology Index (BASMI) measures: a modified Schober's test of less than or equal to 4 cm and lumbar side flexion measurement of less than or equal to 10 cm (mean of left and right); or
        2. Patient has limitation of chest expansion by at least 2.5 cm below the following average normal values corrected for age and gender (see Notes); and
      6. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 6 on a 0-10 scale.

    Notes: The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment and  The BASDAI measure must be no more than 1 month old at the time of initial application.
    Average normal chest expansion corrected for age and gender:

    18-24 years - Male: 7.0 cm; Female: 5.5 cm

    25-34 years - Male: 7.5 cm; Female: 5.5 cm

    35-44 years - Male: 6.5 cm; Female: 4.5 cm

    45-54 years - Male: 6.0 cm; Female: 5.0 cm

    55-64 years - Male: 5.5 cm; Female: 4.0 cm

    65-74 years - Male: 4.0 cm; Female: 4.0 cm

    75+ years - Male: 3.0 cm; Female: 2.5 cm

    ADALIMUMAB (AMGEVITA)

    Renewal — (ankylosing spondylitis) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications where meeting the following criteria:

    All of the following:

    1. Either:
      1. Applicant is a rheumatologist; or
      2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
    1. Following 12 weeks’ initial treatment and for subsequent renewals, Treatment has resulted in an improvement in BASDAI of 4 or more points from pre-treatment baseline on a 10 point scale, or an improvement in BASDAI of 50%, whichever is less.; and

    3        Physician considers that the patient has benefited from treatment and that continued treatment is appropriate; and

    4        Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application- Ankylosing spondylitis only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. 

    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
    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- Ankylosing spondylitis only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. 

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

    1. Both:
      1. Treatment has resulted in an improvement in BASDAI of 4 or more points from pre-treatment baseline on a 10 point scale, or an improvement in BASDAI of 50%, whichever is less; and
      2. Adalimumab is to be administered at doses no greater than 40 mg every 14 days.

    Arthritis – oligoarticular course juvenile idiopathic

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

    ADALIMUMAB (AMGEVITA)

    Initial application — (Arthritis - oligoarticular course juvenile idiopathic) only from a named specialist or rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:
    Either:

    1. Both:
      1. The patient has had an initial Special Authority approval for etanercept for oligoarticular course juvenile idiopathic arthritis (JIA); 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 oligoarticular course JIA; or
    2. All of the following:
      1. To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
      2. Patient has had oligoarticular course JIA for 6 months duration or longer; and
      3. Any of the following:
        1. At least 2 active joints with limited range of motion, pain or tenderness after a 3-month trial of methotrexate (at the maximum tolerated dose); or
        2. Moderate or high disease activity (cJADAS10 score greater than 1.5) with poor prognostic features after a 3-month trial of methotrexate (at the maximum tolerated dose); or
        3. High disease activity (cJADAS10 score greater than 4) after a 6-month trial of methotrexate.

    ADALIMUMAB (AMGEVITA)

    Renewal — (Arthritis - oligoarticular course juvenile idiopathic) from any relevant practitioner only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

    Both:

    1. Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
    1. Either
      1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
      2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application (Arthritis – oligoarticular course juvenile idiopathic) only from a named specialist, rheumatologist, or Practitioner on the recommendation of a named specialist or rheumatologist.

    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.

    ADALIMUMAB (HUMIRA)

    Renewal application (Arthritis – oligoarticular course juvenile idiopathic) only from a named specialist, rheumatologist, or Practitioner on the recommendation of a named specialist or rheumatologist.

    Approvals valid for 6 months for applications where the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

    Arthritis – polyarticular course juvenile idiopathic

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

    ADALIMUMAB (AMGEVITA)

    Initial application — (Arthritis - polyarticular course juvenile idiopathic) only from a named specialist or rheumatologist.

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

    Either:

    1. Both:
      1. The Patient has had an initial Special Authority approval for etanercept for polyarticular course juvenile idiopathic arthritis (JIA); 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 polyarticular course JIA; or
    2. All of the following:
      1. To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
      2. Patient has had polyarticular course JIA for 6 months duration or longer; and
      3. Any of the following:
        1. At least 5 active joints and at least 3 joints with limited range of motion, pain or tenderness after a 3-month trial of methotrexate (at the maximum tolerated dose); or
        2. Moderate or high disease activity (cJADAS10 score of at least 2.5) after a 3-month trial of methotrexate (at the maximum tolerated dose); or
        3. Low disease activity (cJADAS10 score between 1.1 and 2.5) after a 6-month trial of methotrexate. 

    ADALIMUMAB (AMGEVITA)

    Renewal — (Arthritis - polyarticular course juvenile idiopathic) from any relevant practitioner only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist.

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

    Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and

    Either

    1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
    2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline. 

    Alternative brand access (replacement criteria shown) 

    ADALIMUMAB (HUMIRA)

    Initial application (Arthritis - polyarticular course juvenile idiopathic) only from a named specialist, rheumatologist, or Practitioner on the recommendation of a named specialist or rheumatologist.

    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.

    ADALIMUMAB (HUMIRA)

    Renewal application (Arthritis - polyarticular course juvenile idiopathic) only from a named specialist, rheumatologist, or Practitioner on the  recommendation of a named specialist or rheumatologist. 

    Approvals valid for 6 months for applications where the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

    Arthritis – Psoriatic

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

    ADALIMUMAB (AMGEVITA)

    Initial application — (Arthritis - psoriatic) only from a rheumatologist.

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

    1. Both:
      1. The Patient has had an initial Special Authority approval for etanercept or secukinumab for psoriatic arthritis; and
      2. Either:
        1. The Patient has experienced intolerable side effects from etanercept or secukinumab; or
        2. The Patient has received insufficient benefit from etanercept or secukinumab to meet the renewal criteria for etanercept for psoriatic arthritis; or
    2. All of the following:
      1. Patient has had severe active psoriatic arthritis for six months duration or longer; and
      2. Patient has tried and not responded to at least three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose; and
      3. Patient has tried and not responded to at least three months of sulfasalazine at a dose of at least 2 g per day or leflunomide at a dose of up to 20 mg daily (or maximum tolerated doses); and
      4. Either:
        1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen, tender joints; or
        2. Patient has persistent symptoms of poorly controlled and active disease in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
      5. Any of the following:
        1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than one month prior to the date of this application; or
        2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
        3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

    ADALIMUMAB (AMGEVITA)

    Renewal — (Arthritis - psoriatic) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

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

    1. Either:
      1. Applicant is a rheumatologist; or
      2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
    1. Either:
      1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active swollen joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
      2. The Patient demonstrates at least a continuing 30% improvement in active swollen joint count from baseline and a clinically significant response to prior adalimumab treatment in the opinion of the treating physician.
    1. Adalimumab to be administered at doses no greater than 40 mg every 14 days. 

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application – (Arthritis - psoriatic) only from a named specialist, rheumatologist, or Practitioner on the recommendation of a named specialist or rheumatologist.

    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 - (Arthritis - psoriatic only from a named specialist, rheumatologist, or Practitioner on the recommendation of a named specialist or rheumatologist.

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

    Both:

    1. The patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior adalimumab treatment in the opinion of the treating physician; and
    2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

    Arthritis – Rheumatoid

    Amended Special Authority criteria available above in widening access

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application – (Arthritis – rheumatoid) only from a rheumatologist, or Practitioner on the recommendation of a rheumatologist.

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

    All of the following:

    1. One of the following:
      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. Either
      1. Adalimumab to be administered at doses no greater than 40 mg every 14 days; or
      2. Patient cannot take concomitant methotrexate and requires doses of adalimumab higher than 40 mg every 14 days to maintain an adequate response.

    ADALIMUMAB (HUMIRA)

    Renewal application – (Arthritis – rheumatoid) only from a rheumatologist, or Practitioner on the recommendation of a rheumatologist.

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

    All of the following:

    1. The patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior adalimumab treatment in the opinion of the treating physician; and
    2. Either:
      1. Adalimumab to be administered at doses no greater than 40 mg every 14 days; or
      2. Patient cannot take concomitant methotrexate and requires doses of adalimumab higher than 40 mg every 14 days to maintain an adequate response.

    Stills disease – Adult onset

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

    ADALIMUMAB (AMGEVITA)

    Initial application — (Still's disease - adult-onset (AOSD)) only from a rheumatologist.

    Approvals valid without renewal for 6 months for applications meeting the following criteria:

    Either:

    1. Either:
      1. The patient has had an initial Special Authority approval for etanercept and/or tocilizumab for adult-onset Still's disease (AOSD); or
        The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the HML rules; and
      2. Either:
        1. The Patient has experienced intolerable side effects from etanercept and/or tocilizumab; or
        2. The Patient has received insufficient benefit from at least a three-month trial of etanercept and/or tocilizumab such that they do not meet the renewal criteria for AOSD; or
    2. All of the following:
      1. Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19:424-430); and
      2. Patient has tried and not responded to at least 6 months of glucocorticosteroids at a dose of at least 5 mg/kg, non-steroidal anti-inflammatory drugs NSAIDs and methotrexate; and
      3. Patient has persistent symptoms of disabling poorly controlled and active disease. 

    Renewal — (adult-onset Still's disease) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

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

    Both:

    1. Either:
      1. Applicant is a rheumatologist; or
      2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
    2. The patient has a sustained improvement in inflammatory markers and functional status.

     

    1. The patient has a sustained improvement in inflammatory markers and functional status.

     

    Alternative brand access (replacement criteria shown)

    ADALIMUMAB (HUMIRA)

    Initial application - Still's disease – Adult onset only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

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

    All of the following:

    1. Both:
      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.

    ADALIMUMAB (HUMIRA)

    Renewal application - Still's disease – Adult onset only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

    Approvals valid for 6 months for applications where the patient has demonstrated a sustained improvement in inflammatory markers and functional status. 

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