Adalimumab Q&A

Contributor
He Ako Hiringa
16 June 2022
Adalimumab Q&A

With recent funding changes to adalimumab, prescribers are being urged to change patients from Humira (the reference biological) to Amgevita (a biosimilar). We’ve collated this list of questions and answers, with links to other useful resources, to help inform your conversations with colleagues and patients.


Introduction


Access to the anti-tumour necrosis factor alpha (TNF-α inhibitor) adalimumab, has been widened with the funding of the biosimilar Amgevita. Dosage restrictions have been removed, and the Special Authority renewal period has been extended to two years. From 1 March 2022, all new patients starting adalimumab receive Amgevita.

From 1 October 2022, Amgevita becomes the primary funded option for adalimumab. Patients who are already stable on the reference product, Humira, can be transitioned to Amgevita in primary care during the period where both brands are funded (1 March to 1 October 2022).

Exemptions are in place for continued funded use of Humira for certain patients who need to remain on, or move back to, the reference medicine. However, there is no provision for patients who have never used Humira to transition from Amgevita to funded Humira.


What are the key things healthcare professionals need to do?

  • Ensure adalimumab is prescribed by brand (either Amgevita or Humira) to avoid confusion around which product is intended
  • Identify patients using adalimumab and discuss continuation their treatment, by changing to Amgevita, when their Humira Special Authority is due for renewal, or before 1 October 2022
  • Frame conversations about changing from Humira to Amgevita positively – listen to the He Ako Hiringa podcasts Initiating new medicines Part 1 and Part 2
  • Visit the Amgevita website for resources to support you and your patients with the change
  • Visit the Pharmac website for information about the changes to funding criteria
  • Be prepared for questions from patients such as “What is going to change and what will stay the same?” and “If I don’t think it’s working, what do I do?” – watch the He Ako Hiringa short video The patient voice: Moving to Amgevita.

Amgevita demonstration pens can be ordered from the Amgevita website (register and log in as a healthcare professional).

Medical information for healthcare professionals is available from Amgen, the supplier of Amgevita, at medinfo.japac@amgen.com or on 0800 443 885. You can also report a defective product, request a replacement product, or report an adverse event.

If you have questions about using the Amgevita device, or about the Amgevita support services or website, contact Amgen on 0800 264 384 (0800 AMGEVITA) or amgevita.nz@greencrosshealth.co.nz

Additional actions for pharmacists
  • Carefully assess prescriptions for adalimumab prior to dispensing, especially those written generically - 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.

General


Where can I find a summary article about changing from Humira to Amgevita?

The He Ako Hiringa article Transition to adalimumab biosimilar summarises the 2022 changes regarding adalimumab funding and access in New Zealand. It provides background and links to other resources to help foster confidence in biosimilars, and references real-world data from studies of patients changing from Humira to Amgevita.

You can also find helpful information on the Pharmac website.

Where can I find easy-to-understand information about biological and biosimilar medicines?

Find out more about reference biological medicines and their biosimilars by reading the He Ako Hiringa Introduction to biological medicines article, watching the embedded short videos and completing the quizzes.

You can also visit the He Ako Hiringa Biological medicines resource hub for links to content from multiple providers.

How does Amgevita differ from Humira?

Amgevita appears and functions similarly to Humira. The Amgevita formulation is citrate-free, which some patients may find less painful to inject than Humira. Amgevita has a longer shelf life than Humira (36 months vs 24 months), which translates to cheaper holding costs for community pharmacy and less liability from expired stock.

Find out more about reference biological medicines and their biosimilars by reading the He Ako Hiringa Introduction to biological medicines article, watching the embedded short videos and completing the quizzes.

Is Amgevita less safe or effective than Humira?

New Zealand’s Pharmacology and Therapeutics Advisory Committee (PTAC) concluded that, based on available evidence, biosimilar adalimumab appears equally effective to reference adalimumab with no evidence to indicate any specific clinical risk or harm with switching from the reference product to a biosimilar. The committee also considered that there is currently no evidence that the rate of development of immunogenicity – including the identification of treatment antibodies leading to loss of treatment effectiveness – differed between reference and biosimilar adalimumab.

Amgevita has been approved by the European Medicines Agency (EMA) for use in the EU, by the Food and Drug Administration in the US, by the Therapeutic Goods Administration in Australia, and by Medsafe in New Zealand for all the indications of the reference adalimumab product (Humira).

For detailed, referenced information about the safety and efficacy of original (‘reference’ or ‘innovator’) biological medicines and their biosimilars, read the He Ako Hiringa Transition to adalimumab biosimilar article.

How can I get Amgevita demonstration pens?

Demonstration pens and information for clinicians can be ordered from the Amgevita website (register and log in as a healthcare professional).

Why are we being asked to prescribe and dispense by brand name?

To avoid inadvertent substitution, the New Zealand Formulary advises to always use brand names when discussing, prescribing and dispensing biological medicines. They also recommend recording the batch number at dispensing, to ensure the batch of medicine is traceable.

Who can I contact for more information about Amgevita?

If you have questions about using the Amgevita device, Amgevita support services, or the Amgevita website, contact Amgen on 0800 264 384 (0800 AMGEVITA) or amgevita.nz@greencrosshealth.co.nz

If you need to report a defective product, request a replacement product, or report an adverse event, contact Amgen Medical Information on 0800 443 885 or medinfo.japac@amgen.com


Funding and Special Authority criteria


Why are the funding and access criteria changing?

Adalimumab (supplied as the reference product Humira) has been the second biggest spend for the Pharmac budget. Now that the patent for Humira has expired, various biosimilar products have become available, at a fraction of the price. At the time of writing, the cost of two 40mg pre-filled syringes/pens is $375 for Amgevita and $1,600 for Humira [Pharmaceutical Schedule, Special Authority forms – June 2022].

Approximately 6,400 patients routinely self-injected Humira in 2021. Funding of Amgevita, allows for widened access to adalimumab, treating more conditions compared with Humira, and improving access to treatment for conditions previously funded. Over 700 more patients will be able to access adalimumab within the first year of the changed funding.

Moving from Humira to Amgevita will free up a significant amount of Pharmac's fixed budget which will be used to fund other medicines.

What is the timeline for the changes?

  • From 1 March 2022 the only funded adalimumab product for new patients is Amgevita (this includes patients eligible under expanded and new access criteria)
  • On 1 March 2022, all people currently using adalimumab were automatically issued an initial Special Authority number for Amgevita. Their Humira Special Authority will remain current.
  • Humira will remain funded for existing patients until 30 September 2022
  • All existing Special Authorities for Humira expire on 30 September 2022
  • From 1 October Amgevita becomes the primary funded adalimumab option for all uses
  • Exceptions are available for continued funded use of Humira past 1 October 2022 (a new Special Authority must be obtained).

You can view a timeline of the changes in the He Ako Hiringa Transition to adalimumab biosimilar article.

What additional indications is Amgevita funded for that Humira wasn’t?

Funding of Amgevita allows improved access to treatment with adalimumab.

New indications eligible to be treated with funded Amgevita are undifferentiated spondyloarthritis, inflammatory bowel disease-associated arthritis, and first-line treatment for ulcerative colitis.

Some conditions that were funded for Humira have widened access with Amgevita, including: Crohn disease (dose escalation enabled); rheumatoid arthritis (reduction in swollen joint number required to meet Special Authority criteria, and removal of criteria for C-reactive protein to be >15mg/L); Behçet disease and ocular inflammation (Amgevita funded as a first-line biologic for both).

See a summary of the funding changes in Table 2 of the He Ako Hiringa Transition to adalimumab biosimilar article.

Go to the online Pharmaceutical Schedule and click on the SA links under the drug listings to see the full Special Authority criteria (and application forms) for Amgevita and Humira.

What other changes have been made to the Special Authority for adalimumab?

Special Authority renewal periods have been extended to two years, any relevant practitioner may apply for renewals, and renewal is no longer needed for some conditions. These changes are intended to lessen administrative burden and allow better continuity of care and flexibility in patient management.

Where can I find the access criteria for Amgevita for all the different indications?

The Special Authority forms and criteria for all community schedule medicines are listed on the Pharmaceutical Schedule.

Does the patient have to see the specialist to change from Humira to Amgevita?

No (but this does not preclude specialist input as appropriate). To allow patients to access Amgevita as early as possible, the Ministry of Health has issued a temporary new Amgevita Special Authority number to all patients receiving funded Humira. As Amgevita Special Authority renewals can be made by any relevant prescriber, this allows primary care prescribers to make a renewal application for Amgevita to continue therapy with the biosimilar.

Find out more by reading “The ins and outs of the adalimumab changes” on the Pharmac Adalimumab (Amgevita & Humira): Information for health care professionals page.

For what indications does Humira remain funded?

Humira may be funded for certain patients who need to remain on it or move back to it after transitioning to Amgevita.

Go to the online Pharmaceutical Schedule and click on the SA links under the drug listings to see the full Special Authority criteria (including indications and application forms) for Amgevita and Humira.

If you have questions about the pharmaceutical schedule or funding, contact Pharmac by email enquiry@pharmac.govt.nz or phone 0800 660 050.

Can any patients access funded Humira after 30 September 2022?

Two exemptions are in place that allows certain patients who were using Humira prior to 1 March 2022 to remain using, or change back to, Humira following discussion with their prescriber:

  1. Patients with Crohn disease or ocular inflammation who are considered at risk of disease destabilisation with a change in treatment can continue to access Humira.
  2. Patients who trial at least four weeks treatment (two doses) of Amgevita and experience clinical difficulty within six months of this trial (intolerable side effects, or loss of disease control attributed to the change) can return to funded treatment with Humira.

All existing Special Authorities for Humira will expire automatically after 30 September 2022. From 1 October 2022, the appropriate prescriber will need to complete a new initial Special Authority for patients who require ongoing funded access to Humira.

New patients started on adalimumab after 1 March 2022 will receive Amgevita, and there is no option to switch to funded Humira.

More information can be found on the Pharmac website.

Who can I contact about the funding of adalimumab?

If you have questions about the pharmaceutical schedule or funding of medicines, contact Pharmac by email enquiry@pharmac.govt.nz or phone 0800 660 050.

For questions regarding the issuing of Special Authorities, contact the Ministry of Health Sector Operations on 0800 855 066.


Information for patients


Where can I find patient information about Amgevita?

​​​​The Amgen website has the following patient information:

  • Patient booklet: explains what the medicine is used for, potential side effects, instructions for administration. Available in English, Te reo Māori, Samoan, Tongan and Chinese.
  • Reminder leaflet (adult, child): patients are advised to keep this with them – it outlines possible side effects, when to contact a healthcare professional, etc.
  • Alert card: patients are advised to always keep this with them in case of emergency
  • Written instructions for use for pre-filled pen and pre-filled syringe
  • Videos: a series of six videos about using the pre-filled pen and a single video for the pre-filled syringe
  • Sharps bin order form

Amgevita support nurse: Patients (and health providers) can contact an Amgevita support nurse if they have questions or need assistance with administration of the medicine. Email amgevita.nz@greencrosshealth.co.nz or call 0800 AMGEVITA (0800 264 384) between 9am and 5pm Monday to Friday.

Health Navigator has patient information and links to the Amgen website videos.

Te reo resources: The Māori Pharmacists’ Association, Ngā Kaitiaki o Te Puna Rongoā, has a free phone line to answer questions that whānau have about any medicines. Call 0800 664 688.

Pharmac website: Adalimumab changes: What patients need to know

How do patients access free sharps bins for disposing of the Amgevita devices?

Free sharps bins for used pens or syringes can be ordered from the Amgen website. The last four digits of the barcode from the back of the Amgevita pack will need to be entered when the order is submitted.