Adalimumab: What we’re proposing for gastrointestinal 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.

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 gastrointestinal 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 Crohn’s disease 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 gastrointestinal 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 gastrointestinal 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 530 people would benefit in the first year of funding as a result of these changes in access to adalimumab for gastrointestinal 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.  

Ulcerative colitis

Pharmac received a funding application to widen access to adalimumab to treat ulcerative colitis in September 2013. This application has been reviewed by PTAC and the Gastrointestinal Subcommittee of PTAC several times. In November 2019 [PDF, 559 KB] PTAC recommended funding for this patient population with a low 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 ulcerative colitis would have access to a biologic treatment which can be administered at home or in the community. We estimate that about 130 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 moderate to severe ulcerative colitis (proposed new criteria shown only):

Ulcerative colitis - moderate to severely active

ADALIMUMAB (AMGEVITA) 

Initial application – (ulcerative colitis - moderate to severely active) only from a gastroenterologist.

Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. Patient has histologically confirmed ulcerative colitis that is moderate to severely active; and
  2. Either:
    1. Patient’s SCCAI score is greater than or equal to 4; or
    2. Patient’s PUCAI score is greater than or equal to 65; and
  3. Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior therapy with immunomodulators and systemic corticosteroids; and
  4. Surgery (or further surgery) is considered to be clinically inappropriate.

ADALIMUMAB (AMGEVITA)

Renewal (ulcerative colitis - moderate to severely active) from any relevant Practitioner. 

Approvals valid for 2 years for applications where:

  1. The SCCAI score has reduced by 2 points or more from the SCCAI score since initiation on adalimumab; or
  2. The PUCAI score has reduced by 30 points or more from the PUCAI score since initiation on adalimumab.

The application(external link) for use of adalimumab as a second line treatment (after infliximab) for ulcerative colitis would be superseded by this proposal and would therefore be removed from further consideration. 

Crohn’s disease – dose escalation

Pharmac received a funding application to widen access to adalimumab to allow dose escalation for people with Crohn’s disease in January 2018. PTAC and the Gastrointestinal Subcommittee have reviewed this application. In November 2019 [PDF, 559 KB] PTAC recommended widened access to adalimumab to enable dose escalation in the treatment of Crohn’s disease 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 Crohn’s disease would have access to higher doses of adalimumab (eg weekly doses), if their clinician considered it appropriate. It is expected that clinicians would make this decision after carefully considering a patient’s response to fortnightly dosing, with consideration given to performing therapeutic drug monitoring to establish the requirement for increased dosing frequencies. This would be a clinical decision by the treating prescriber and would not be included in the funding criteria.

We estimate that about 340 people would benefit from this proposal in the first year of funding. 

We propose removing reference to dosing restrictions from the criteria for funded access to adalimumab (Amgevita) from 1 February 2022 (additions in bold, deletions in strikethrough). These changes would be made to Section B and Part II of Section H C and Section H.

Special Authority changes for Crohn’s disease – adults are shown only. Amendments to Special Authority criteria provides information on all Special Authority changes and the proposed changes to Crohn’s disease – children and Crohn’s disease - fistulising:

Crohn’s disease – adults

ADALIMUMAB (AMGEVITA)

Initial application — (Crohn's disease - adults) only from a gastroenterologist.

Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. Patient has severe active Crohn's disease; and
  2. Any of the following:
    1. Patient has a Crohn’s Disease Activity Index CDAI score of greater than or equal to 300; or
    2. Patient has extensive small intestine disease affecting more than 50 cm of the small intestine; or
    3. Patient has evidence of short gut syndrome or would be at risk of short gut syndrome with further bowel resection; or
    4. Patient has an ileostomy or colostomy and has intestinal inflammation; and
  3. Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior systemic therapy with immunomodulators at maximum tolerated doses (unless contraindicated) and corticosteroids; and
  4. Surgery (or further surgery) is considered to be clinically inappropriate.

ADALIMUMAB (AMGEVITA)

Renewal — (Crohn's disease - adults)

From any relevant practitioner only from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 2 years 6 months for applications where meeting the following criteria:

All of the following Both:

  • Either:
    • Applicant is a gastroenterologist; or
    • Applicant is a Practitioner and confirms that a gastroenterologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
  1. Any of the following
    1. CDAI score has reduced by 100 points from the CDAI score when the patient was initiated on adalimumab; or
    2. CDAI score is 150 or less; or
      Both:
    3. The patient has demonstrated an adequate response to treatment, but CDAI score cannot be assessed.; and
      1. Applicant to indicate the reason that CDAI score cannot be assessed; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

The application for dose escalation of infliximab for treatment of Crohn’s disease(external link) remains under consideration by Pharmac. The application for rescue therapy in severe Crohn’s disease(external link) 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. PTAC and the Rheumatology Subcommittee of PTAC have reviewed this application 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 adalimumab. 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:

All of the following:

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

Amendments to Special Authority criteria for gastrointestinal 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
  • Removing criteria considered to represent administrative burden

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 gastrointestinal conditions are detailed as follows (additions in bold, deletions in strikethrough):

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

Crohn’s disease – children

ADALIMUMAB (AMGEVITA)

Initial application — (Crohn's disease - children) only from a gastroenterologist.

Approvals valid for 3 months for applications meeting the following criteria:
All of the following:

  1. Paediatric patient has severe active Crohn's disease; and
  2. Either:
    1. Patient has a Paediatric Crohn's Disease Activity Index (PCDAI) score of greater than or equal to 30; or
    2. Patient has extensive small intestine disease; and
  3. Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior systemic therapy with immunomodulators at maximum tolerated doses (unless contraindicated) and corticosteroids; and
  4. Surgery (or further surgery) is considered to be clinically inappropriate. 

ADALIMUMAB (AMGEVITA)

Renewal — (Crohn's disease - children) from any relevant practitioner only from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist.

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

All of the following:

Either:

  • Applicant is a gastroenterologist; or
  • Applicant is a Practitioner and confirms that a gastroenterologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
  1. Any of the following:
    1. PCDAI score has reduced by 10 points from the PCDAI score when the patient was initiated on adalimumab; or
    2. PCDAI score is 15 or less; or
    3. The patient has demonstrated an adequate response to treatment, but PCDAI score cannot be assessed.
      1. Applicant to indicate the reason that PCDAI score cannot be assessed; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days.

Crohn’s disease – fistulising

ADALIMUMAB (AMGEVITA)

Initial application — (Crohn’s disease - fistulising) only from a gastroenterologist.

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

All of the following:

  1. Patient has confirmed Crohn’s disease; and
  2. Any of the following:
    1. Patient has one or more complex externally draining enterocutaneous fistula(e); or
    2. Patient has one or more rectovaginal fistula(e); and or
    3. Patient has complex peri-anal fistula
  3. A Baseline Fistula Assessment has been completed and is no more than 1 month old at the time of application; and
  4. The patient will be assessed for response to treatment after 4 months’ adalimumab treatment (see Note).

Note: A maximum of 4 months’ adalimumab will be subsidised on an initial Special Authority approval for fistulising Crohn’s disease.

ADALIMUMAB (AMGEVITA)

Renewal — (Crohn’s disease - fistulising) from any relevant practitioner only from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist.

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

All of the following:

  1. Either:
    1. Applicant is a gastroenterologist; or
    2. Applicant is a Practitioner and confirms that a gastroenterologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
  2. Either:
    1. The number of open draining fistulae have decreased from baseline by at least 50%; or
    2. There has been a marked reduction in drainage of all fistula(e) from baseline as demonstrated by a reduction in the Fistula Assessment score, together with less induration and patient-reported pain.

Alternative brand access from 1 September 2022 for gastrointestinal 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 Crohn’s disease 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 gastrointestinal conditions are detailed as follows:

Crohn’s disease – adult

ADALIMUMAB (HUMIRA)

Initial application - Crohn’s disease (Adult) from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 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, 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 Crohn’s and is considered to be at risk of severe disease destabilisation if there were to be a change to current 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 - Crohn’s disease (Adult) from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Any of the following:
    1. CDAI score has reduced by 100 points from the CDAI score when the patient was initiated on adalimumab; or
    2. CDAI score is 150 or less; or
    3. The patient has demonstrated an adequate response to treatment, but CDAI score cannot be assessed; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days

Crohn’s disease – children

ADALIMUMAB (HUMIRA)

Initial application – Crohn’s disease (Children) from a gastroenterologist or any relevant practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 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, 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 Crohn’s and is considered to be at risk of severe disease destabilisation if there were to be a change to current treatment; and
    4. Patient has previously had a Special Authority approval for the Humira brand of adalimumab for this indication; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days. 

ADALIMUMAB (HUMIRA)

Renewal – Crohn’s disease (Children) from a gastroenterologist or any relevant Practitioner on the recommendation of a gastroenterologist.

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

Both:

  1. Any of the following:
    1. PCDAI score has reduced by 10 points from the PCDAI score when the patient was initiated on adalimumab; or
    2. PCDAI score is 15 or less; or
    3. The patient has demonstrated an adequate response to treatment, but PCDAI score cannot be assessed; and
  2. Adalimumab to be administered at doses no greater than 40 mg every 14 days

Crohn’s disease – fistulising

ADALIMUMAB (HUMIRA)

Initial application - Crohn’s disease (Adult) from a gastroenterologist or Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 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, 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 Crohn’s and is considered to be at risk of severe disease destabilisation if there were to be a change to current 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 – Crohn’s disease (Fistulising) from a gastroenterologist or any relevant Practitioner on the recommendation of a gastroenterologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Either:
    1. The number of open draining fistulae have decreased from baseline by at least 50%; or
    2. There has been a marked reduction in drainage of all fistula(e) from baseline as demonstrated by a reduction in the Fistula Assessment score, together with less induration and patient-reported pain; and
  2. Adalimumab is to be administered at doses no greater than 40 mg every 14 days.

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