Adalimumab changes: What patients need to know

From 1 March 2022, Amgevita, a citrate-free biosimilar adalimumab, was funded. There were also changes made so more New Zealanders can benefit from adalimumab.

What does this mean for you

The introduction of Amgevita means it is likely that you need to change adalimumab brands to continue your adalimumab treatment using Amgevita. This means moving from Humira to Amgevita with support from healthcare professionals involved in your care. There are some exceptions to this for people with Crohn’s disease and inflammation of the eye (sometimes called uveitis). If you are prescribed adalimumab for the first time you will be started on Amgevita.

The person prescribing your adalimumab will work with you to make sure the change has no effect on your treatment. If there is a change for the worse in managing your disease after changing to Amgevita, they will see if changing back to Humira is the right thing to do.  

You should talk about these changes with your doctor, specialist, pharmacist or other health professional you trust, before 1 October. They can discuss what this change will mean for you.

Important dates 

From 1 October 2022

• All current Humira Special Authority numbers expired, and the funding criteria for Humira changed.
• Amgevita will be the main funded brand of adalimumab.
• All people receiving funded adalimumab will have been changed to Amgevita with help from their prescriber.
• If you are one of the few people who Amgevita isn’t right for, your prescriber can apply for a Special Authority so you can return to, or remain on, Humira.  

If you are still using Humira

If you have not yet changed from Humira to Amgevita, you need to talk to the person who prescribes your medicine as soon as possible. Your prescriber will either change you to Amgevita, or apply for a new Special Authority for you to remain on Humira if you are eligible to. 

Your Humira Special Authority approval for funding expired on 1 October. However, repeat dispensings from your pharmacy with an expired Special Authority will still be funded if the first dispensing on that prescription was before 1 October, even if you collect your repeats after this date. 

If you’ve already trialled Amgevita and had to change back to Humira, you may need a new Special Authority, or your doctor may have arranged a waiver for you. Check with your pharmacist or prescriber on the status of your approval. 

What support is available for people using Amgevita

You told us that you value the support currently available for people using adalimumab. We’re working closely with the supplier of Amgevita to make sure everyone is comfortable and confident to use their adalimumab treatment. 

The Amgevita website is the main hub of information about Amgevita. It provides support to help you confidently use the Amgevita device. 

A free Patient Support Programme is available to assist with questions you might have about using Amgevita.

Who to contact for support – Amgevita website(external link)

When you first receive Amgevita, you will have access to: 

• A welcome pack with information about how to use Amgevita and a patient alert card.
• Information on how to access to support from registered nurses via telephone and video calling to guide you through using the Amgevita device and answer any questions you might have about Amgevita.
• A sharps bin for the safe disposal of used sharps. Sharps bins are available to order for home delivery via the Amgevita website.
• Alcohol wipes are also available for ordering on Amgevita's website.
• Ongoing support and electronic resources through the Amgevita website. 

Find supporting information on Amgevita's website(external link)

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 cells. 

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. 

Read more about biological and biosimilar medicines

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 received feedback on the use and feel of the Amgevita device. This feedback told us that Amgevita looks and functions similarly to Humira. 

Amgevita is safe and effective 

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 (original medicine). As Amgevita is Medsafe approved, it has gone through this review to check it is as effective and safe as Humira.  

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 the clinical data shows Amgevita is as effective and as safe as 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. 

Why we made this change 

By funding Amgevita, we have been able 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. 

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

Who to contact

If you have questions or concerns about your condition or your treatment, we recommend you talk with your doctor, nurse or pharmacist in the first instance. They know you and your circumstances best.

If you have questions about the Amgevita device, Amgevita support services, or the Amgevita website, we recommend that you contact Amgen:

Free phone: 0800 264 384 (0800 AMGEVITA)

Email: amgevita.nz@greencrosshealth.co.nz

For questions about the funding of Amgevita or Humira, including any questions about Special Authority criteria, you can contact Pharmac at enquiry@pharmac.govt.nz