Adalimumab (Amgevita): Information for health care professionals

On this page

What does this mean for you

We’re pleased to announce that we are widening access to adalimumab and funding Amgevita, a citrate-free biosimilar adalimumab. We’re also making changes to the funding criteria to improve access and make it easier to apply for Special Authorities.   

Adalimumab is a biologic medicine used to treat a range of conditions including dermatological, rheumatological, gastrointestinal and ophthalmologic conditions. 

Why are we making this change

This decision means that within the first year of Amgevita being funded more than 700 New Zealanders will have improved access to funded adalimumab. In addition, we expect that the changed access criteria (extending renewal durations and enabling renewal applications by any prescriber) will reduce the administrative burden for clinicians by reducing the number of Special Authority applications that need to be completed.

Our job is to make sure New Zealanders have access to the medicines they need. Making changes like this helps us to do this by freeing up our fixed budget to fund more medicines for New Zealanders. 

Key information

New funded indications from 1 March 2022 (follow the below links to Pharmac’s Application Tracker for more information on these funding proposals):

The below currently funded indications will also have access widened from 1 March 2022: (follow the below links to Pharmac’s Application Tracker for more information on these funding proposals): 

Amgevita Special Authority criteria for all uses will change to improve access to treatment: 

  • Removal of dosing restrictions
  • Extension of Special Authority renewal periods to 2 years
  • Any relevant practitioner can apply for Special Authority renewals
  • Removal of Special Authority renewals for some conditions

Amgevita Special Authority [PDF, 212 KB]

Important dates

From now until 28 February 2022

  • There are no funding changes to adalimumab.
  • Prescribers and pharmacists should identify the people under their care who are currently using adalimumab and start to discuss the introduction of Amgevita with them.  

From 1 March 2022

  • All people currently using adalimumab will be automatically issued with an initial Special Authority number for Amgevita.
  • You should ensure that any prescription for adalimumab clearly specifies the brand of adalimumab that should be dispensed, in line with NZF guidance(external link) for the supply of biologic and biosimilar medicines.
  • Both Amgevita or Humira will be funded for existing patients and uses
    • Patients under your care who are using Humira should be changed to Amgevita. There are some exceptions to this (detailed below).
  • Only Amgevita will be funded for new patients and uses (widened access). 

From 1 October 2022

  • Amgevita
    • Only Amgevita will be funded for all uses (current and new).
  • Humira will remain funded for patients previously treated with Humira who, following discussion with their prescriber:
    • trial Amgevita and experience clinical difficulties (intolerable side effects or loss of disease control) and wish to return to Humira.
    • have Crohn’s disease or ocular inflammation and are considered at risk of disease destabilisation if there were to be any change to their treatment regimen.
  • All existing Special Authorities for Humira will expire automatically. You will need to complete a new initial Special Authority for the above patients who require ongoing funded access to Humira. 

The New Zealand Formulary has the following guidance(external link) on biological and biosimilar medicine:

When prescribing or dispensing biological medicines, the following is recommended:

  • Prescribe by brand name, rather than generic, to avoid inadvertent substitution.
  • Dispense the brand prescribed and record the batch number where possible to ensure the batch is traceable.
  • When changing to a biosimilar, clinicians should discuss the change with the patient and monitor the patient closely for the desired clinical effect and for any unexpected reactions.

Information for prescribers

From 1 March 2022, two brands of adalimumab will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, each with separate criteria for funding. This means that from 1 March 2022, all prescriptions for adalimumab should clearly specify the brand that should be supplied. 

Patients already using adalimumab 

We recommend you identify the people under your care who are currently using adalimumab and start to discuss the introduction of Amgevita with them.

All patients who received funded adalimumab prior to 1 March 2022 will automatically be issued a new Special Authority number for Amgevita. This means that if you have discussed transitioning to Amgevita with your patient, you can prescribe Amgevita immediately and complete a Special Authority renewal application to access ongoing adalimumab treatment for two years. 

For patients that require funded access to Humira during the transition period because they have not yet discussed the change with their prescriber, you should complete a Special Authority renewal application for Humira. 

Patients will have two concurrent Special Authority numbers; one for Amgevita and one for Humira. This means that, from 1 March 2022, you will need to ensure that all prescriptions for adalimumab specify the brand (Amgevita or Humira). 

New patients

From 1 March 2022, all patients who are new to treatment with adalimumab will need to start treatment with Amgevita, as per the relevant Special Authority initial criteria. 

Patients who need to return to treatment with Humira (as an alternative brand)

Patients who trial at least two doses of Amgevita (for less than six months) and experience clinical difficulty after this trial (intolerable side effects, or loss of disease control attributed to the change) can return to funded treatment with Humira.

  • Prior to 1 October 2022, this is accessed via the existing Humira renewal Special Authority criteria.
  • From 1 October 2022 a new Special Authority will be required to ensure ongoing access for these patients. 

Humira Special Authority [PDF, 190 KB]

Patients that can stay on Humira

Patients with Crohn’s disease or ocular inflammation who are considered to be at risk of disease destabilisation or vision loss if there were to be a change in treatment regimen can continue on funded treatment with Humira without trialling Amgevita first.

  • Prior to 1 October 2022, this is accessed via the existing Humira renewal Special Authority criteria.
  • From 1 October 2022 a new Special Authority will be required to ensure ongoing access for these patients. 

All existing Special Authority numbers for Humira will be cancelled on 1 October 2022. This means a new Special Authority (initial) is needed for patients who require access to Humira beyond 1 October 2022 (as the alternative brand). This also means that all dispensing of Humira (including repeats) under the existing Special Authorities need to be completed prior to 1 October 2022. 

Humira Special Authority [PDF, 190 KB]

Management of patients who don’t meet the Special Authority criteria for Humira 

Pharmac’s Exceptional Circumstances Framework is available to consider funding for patients considered to have exceptional circumstances that cannot access adalimumab treatment with the specific brand of adalimumab they require using Special Authority criteria. This may be for patients who either cannot trial Amgevita or are unable to complete the required timeframe for a trial (eg minimum of two doses, and maximum of six months, having initiated on Amgevita before 1 October 2022). 

Each application will be individually assessed. 

More information about the Exceptional Circumstances Framework is available on the Pharmac website. This may require either a Special Authority waiver application, or a Named Patient Pharmaceutical Assessment (NPPA) application depending on your patients’ circumstances. 

Information for dispensers

We recommend you identify the people under your care who are currently using adalimumab and start to discuss the introduction of Amgevita with them.

Any script that doesn’t have the adalimumab brand specified (either Humira or Amgevita) should be carefully assessed. You should check that any patient receiving Amgevita for the first time has discussed this change with their prescriber and is comfortable with the change. 

We will be providing a Brand Switch Fee to pharmacists to reimburse them for their time supporting this change, including time spent providing education and information to patients. 

All existing Special Authority numbers for Humira will be cancelled on 1 October 2022. This means a new Special Authority (initial) is needed for patients who require access to Humira beyond 1 October 2022 (as the alternative brand). This also means that all dispensing of Humira (including repeats) under the existing Special Authorities need to be completed prior to 1 October 2022.

Support for the introduction of Amgevita

We received feedback about the support that is currently available for people using adalimumab. We are working closely with Amgen, the supplier of Amgevita, to ensure ongoing access to support for patients using adalimumab treatment and healthcare professionals .

Over the coming months, healthcare professionals involved with the prescribing and supply of adalimumab should receive information and resources from Amgen. This will include demonstration devices and information packs for prescribers, nurses, and pharmacists in advance of the transition period, as well as information packs that healthcare professionals can give to patients.

Healthcare professionals will have access to Amgen’s medicines information line for assistance with clinical, logistical and practical queries about Amgevita. We are also exploring the availability of in-person nursing for people who require extra help with their introduction to Amgevita. 

A number of educational resources about biologics and biosimilars are already available, and more resources will be made available over the coming months. Information about the resources available can be found on the adalimumab section of the Pharmac website. The Pharmac website is the most up to date source of information and resources about the introduction of Amgevita to New Zealand. 

More information on what patients who are prescribed Amgevita will receive 

New Zealand clinical experts are supportive of this change

Before we made this decision, we sought advice from clinical experts who treat people with adalimumab and experts who critically appraise the strength and quality of evidence for new treatments. 

Clinical advisors looked at the clinical evidence for biosimilar adalimumab, and Amgevita. Details of what was discussed by clinical experts can be found in the full records of those meetings:

Additional advice was sought regarding the changes to Special Authority access and communication activities to support awareness and implementation of the changes to adalimumab treatment. You can find more details of what was discussed by our clinical experts in the full records of those meetings: 

We also sought advice on the use and feel of the Amgevita device. This feedback indicated that Amgevita looks and functions similarly to Humira. The injection volume and needle size of Amgevita is the same as the currently available Humira product. 

Medsafe has approved Amgevita for use in New Zealand

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, approves medicines for use in New Zealand and evaluates all biosimilar medicines before they are funded in New Zealand.

To ensure a biosimilar works and is safe, Medsafe examines the information about the quality of the biosimilar, the evidence of how it was developed and how patients respond to it. This ensures a biosimilar has no important differences from the reference biologic. As Amgevita is Medsafe approved, it has gone through this review to check it is as effective and safe as Humira.  

Read more about how Medsafe assesses biosimilar medicines(external link)

International usage of Amgevita

Amgevita is used extensively in other countries and has been available in countries throughout Europe since 2017. This availability is based on the evidence of Amgevita’s biosimilarity to Humira with respect to comparative pharmacodynamic, pharmacokinetic and toxicology data.   

Amgevita is also approved for use by the FDA in the United States, by Health Canada for use in Canada, the EMA in Europe, and the TGA in Australia. 

Resources for clinical staff

Read the full decision to widen access and award principal supply for adalimumab (Amgevita)

Who to contact

If you have any questions, you can email us at enquiry@pharmac.govt.nz