Adalimumab changes: What patients need to know
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What does this mean
We are making changes to the funding of adalimumab. We will be funding Amgevita which is a citrate-free biosimilar adalimumab. We are also increasing access to Amgevita so more New Zealanders can benefit from adalimumab treatment. If you are currently taking adalimumab, these changes are likely to affect you.
The introduction of Amgevita from 1 March 2022 means you will likely need to continue your adalimumab treatment using Amgevita. This means moving from Humira to Amgevita with support from your doctor. There are some exceptions to this for Crohn’s disease and inflammation of the eye (sometimes called uveitis). If you experience difficulty after trialling Amgevita, you may also be able to return to Humira.
You should talk about these changes with your doctor, specialist, pharmacist or other health professional you trust, when you see them next. They can discuss what this change will mean for you.
Amgevita is a citrate-free biosimilar brand of adalimumab
Adalimumab is a biologic medicine used to treat a range of different conditions. Biologic medicines are a type of medicine that are made from living organisms, such as a yeast, bacteria or animal cell.
Amgevita is a ‘biosimilar medicine’. This means it is a very similar version of a biologic medicine. Humira is a reference biologic medicine, meaning it was the first brand of adalimumab to be made available for use. It is likely the brand of adalimumab that you are familiar with.
Because biologic medicines are made from living organisms, they can vary naturally. This can result in small differences in the medicine, even between different batches of the same biologic. These small differences do not affect the safety of the medicine or how effective it is. There are likely to be small differences between a reference biologic and a biosimilar, similar to the small differences between different batches of the same biologic.
Amgevita is Medsafe approved 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.
Amgevita is a citrate-free formulation of adalimumab. Citrate is a chemical buffer that is included in some medicines to keep them stable. Some people find that the inclusion of citrate in medicines that are injected can cause ‘stinging’. As Amgevita is citrate-free, some people may find Amgevita less painful to inject.
We have also sought feedback on the use and feel of the Amgevita device. This feedback told us that Amgevita looks and functions similarly to Humira.
Amgevita is used in many other countries
Although Amgevita is new to New Zealand, Amgevita is used in Australia, Canada, Europe and in the UK safely and effectively.
Before 28 February 2022
- No changes to adalimumab.
- Take this time to talk with your prescriber about Amgevita.
1 March 2022 until 30 September 2022
- If you haven’t already, discuss your ongoing treatment plan and transition to Amgevita with your prescriber.
- Both Amgevita and Humira will be available if you are using adalimumab.
- If you are prescribed adalimumab for the first time you will be started on Amgevita.
From 1 October 2022
- All people receiving funded adalimumab treatment will have transitioned to Amgevita with help from their prescriber.
- If you qualify, your prescriber can apply for a Special Authority so you can return to, or remain on, Humira.
Why are we making this change
By funding Amgevita, we have made savings that have enabled us to widen the access to adalimumab to help more people access adalimumab treatment.
Over 700 New Zealanders will have more access to adalimumab within the first year of Amgevita being funded. Our job is to improve health outcomes for New Zealanders through medicines, within the budget the Government sets. Making changes like this helps us free up our fixed budget to achieve this.
What support is available for using Amgevita
You told us that you value the support currently available for people using adalimumab. We are working closely with the supplier of Amgevita (Amgen) to make sure everyone is comfortable and confident to use their adalimumab treatment.
We will add resources to this page to support the introduction of Amgevita to New Zealand.
When you are first dispensed Amgevita, you will receive:
- A welcome pack with information about how to use Amgevita and a patient alert card. This information will also be provided electronically and in multiple languages.
- Ongoing access to support from registered nurses via telephone and video calling to guide you through using the device and answer any questions you might have about Amgevita.
- A sharps bin for the safe disposal of used sharps. Amgen will ensure that replacement sharps bins are available when required.
- Ongoing access to support and resources through the Amgevita website.
New Zealand clinical experts are supportive of this change
Before we made this decision, we sought advice from experts who treat people with adalimumab and experts who carefully evaluate the strength and quality of evidence associated with new treatments.
Our clinical advisors looked at the evidence for biosimilar adalimumab, and Amgevita specifically, and supported the use of Amgevita. They told us that, based the clinical data shows Amgevita is as effective and as safe as Humira. You can find more details of what was discussed by clinical experts in the full records of those meetings:
- Pharmacology and Therapeutics Advisory Committee [PDF, 672 KB]
- Dermatology and Ophthalmology Subcommittees record [PDF, 27 KB]
- Gastrointestinal Subcommittee record [PDF, 20 KB]
- Rheumatology Subcommittee record [PDF, 22 KB]
We received more advice about what funding restrictions we should apply and how to make sure people know about the changes to adalimumab. You can find more details of what was discussed by our clinical experts in the full records of those meetings:
- Dermatology and Ophthalmology Subcommittees record [PDF, 87 KB]
- Gastrointestinal Subcommittee record [PDF, 95 KB]
- Rheumatology Subcommittee record [PDF, 83 KB]
- Primary Care Advisors meeting record [PDF, 88 KB]
Who to contact
We recommend you talk with your doctor, nurse or pharmacist if you have any questions or concerns about using Amgevita. They know you and your circumstances best.
You can also contact Pharmac at email@example.com