Adalimumab (Amgevita & Humira): Information for health care professionals
From 1 March 2022, Amgevita, a citrate-free biosimilar adalimumab, will be funded. There will also be changes to the Special Authority for Amgevita to improve access and make Special Authority renewal applications easier.
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10 June 2022 update
Note removed about patients who had not been automatically issued with a Special Authority number for Amgevita. The Ministry of Health Sector Operations advised that this issue is resolved.
What does this mean for you
You will need to identify your patients who are currently using Humira and discuss the continuation of their adalimumab treatment using Amgevita. This is likely to involve all healthcare professionals involved in the care of a patient providing support to transition to Amgevita.
You will need to be aware of the changes to funding criteria in the coming months. This ensures that your patients have access to the right presentation of adalimumab at the right time.
Key actions for all healthcare professionals
On 1 March 2022, all people currently using adalimumab will be automatically issued with an initial Special Authority number for Amgevita. Their Humira Special Authority will remain current.
- Ensure you prescribe adalimumab by brand (either Amgevita or Humira)
- Identify patients using adalimumab and discuss the continuation of their treatment with Amgevita when their Humira Special Authority is due for renewal, or before 1 October 2022
- Go to amgevita.co.nz for resources to support you and your patients with this change
- Go to the Pharmac website for information about the changes to funding criteria for Humira
Additional actions for pharmacists
- Carefully assess prescriptions for adalimumab prior to dispensing, especially those written generically. From 1 March 2022, adalimumab should be prescribed by brand (Amgevita or Humira)
- Make sure all patients who have previously used Humira have discussed changing to Amgevita with their prescriber at their first Amgevita dispensing
- Order an Amgevita demonstration pen from the Amgevita website
From 1 March 2022
- Both Amgevita and Humira will be funded for existing patients and uses
- All people currently using adalimumab will be automatically issued with an initial Special Authority number for Amgevita. Their Humira Special Authority will remain current.
- Only Amgevita will be funded for new patients and new uses (widened access)
- Patients under your care who are using Humira should be transitioned to Amgevita. There are some exceptions to this (see below).
From 1 October 2022
- Amgevita will be the main funded brand of adalimumab for all uses (current and new).
- Special Authority criteria for Humira will change. All Humira Special Authorities active before 1 October 2022 will automatically expire.
- For continued funded access to Humira, a new initial Special Authority must be completed for all eligible patients.
- Humira will only be 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.
Prescribing adalimumab by brand
From 1 March 2022, both Amgevita and Humira will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, each with separate Special Authorities. From 1 March 2022, all prescriptions for adalimumab should clearly specify the brand to avoid inadvertent substitution or inappropriate switching between brands.
This is consistent with New Zealand Formulary guidance on the prescribing and dispensing of biologic and biosimilar medicines.
Support for healthcare professionals
Amgen, the supplier of Amgevita, is providing demonstration packs and more information on Amgevita to healthcare professionals.
The Amgevita website contains the information you and your patients need about the use of the Amgevita device. Resources are available electronically on the Amgevita website. Hard copies can also be ordered through the Amgevita website or by contacting Amgen.
The healthcare professional portal of the Amgevita website contains a wealth of educational information to support the introduction of Amgevita.
Amgen has a dedicated Medical Information line available to assist with clinical, logistical, and practical queries about Amgevita.
We are working closely with Amgen to ensure additional support is available for:
- patients needing extra help to transition to Amgevita
- patients who can’t access remote support services to support their transition.
Support for patients
The Amgevita website is the main hub of information about Amgevita and patient support resources. Free support from Amgen’s Patient Support Programme is available to assist with questions patients might have about using Amgevita.
Patients receiving Amgevita for the first time will have access to:
- A welcome pack with information about how to use Amgevita and a patient alert card.
- Information on how to access support from registered nurses via telephone and video calling to assist with using the Amgevita device.
- A sharps bin for the safe disposal of used sharps. Sharps bins are available for patients to order for home delivery via the Amgevita website or by contacting Amgen by phone.
- Ongoing support and electronic resources through the Amgevita website.
Why we made this change
More than 700 New Zealanders will have improved access to funded adalimumab in the first year of funding. In addition, the administrative burden for clinicians will be reduced for Amgevita because there’s a longer time between renewals and any prescriber can apply for a renewal.
Our job is to improve health outcomes for New Zealand. Making changes like this frees up our fixed budget to fund more medicines for New Zealanders.
The ins and outs of the adalimumab changes
Who to contact
If you have questions about using the Amgevita device, Amgevita support services, or the Amgevita website, contact Amgen:
Free phone: 0800 264 384 (0800 AMGEVITA)
If you need to report a defective product, request a replacement product, or report an adverse event, contact Amgen Medical Information:
Free phone: 0800 443 885
Processing of Special Authorities
If you have questions about the issuing of Special Authority numbers for Amgevita, contact Ministry of Health Sector Operations (0800 855 066).
Funding and access criteria
For questions about the funding of Amgevita or Humira, including any questions about Special Authority criteria, you can contact Pharmac at firstname.lastname@example.org