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.
Adalimumab biosimilar improves access
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Adalimumab biosimilar improves access
Adalimumab is used to treat a range of dermatological, rheumatological, gastrointestinal and ophthalmologic conditions.1
Currently in New Zealand, Humira, an adalimumab reference biological, is routinely self-injected by about 6400 patients.2 However, this number is set to increase with the adalimumab biosimilar Amgevita being funded from 1 March under Special Authority.1
Funding of Amgevita widens access to adalimumab, treating more conditions compared with Humira, and improving access to treatment for conditions previously funded. This will enable over 700 more Kiwis to access adalimumab within the first funding year.1
Indications newly eligible to be treated with funded Amgevita are undifferentiated spondyloarthritis, inflammatory bowel disease-associated arthritis, and ulcerative colitis (first-line treatment).
Some conditions currently funded have access to treatment widened. These include 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 level to be >15mg/L); Behçet disease and ocular inflammation (Amgevita funded as a first-line biologic for both).3
Changes to Special Authority criteria improve access to treatment for all indications. Changes include the removal of dosage restrictions; extension of Special Authority renewal periods to two years; allowance for any relevant practitioner to apply for renewals; and removal of renewals for some conditions.1 These changes will lessen administrative burden, and allow better continuity of care and flexibility in patient management.
Amgevita appears and functions similarly to Humira and is citrate-free, which some patients may find less painful to inject.4 It has a longer shelf life, which translates to cheaper holding costs for community pharmacy and less liability from expired stock.5
Now is a good time for prescribers and patients to discuss Amgevita use. Free phone and video-based advice is available from the supplier.
For more information visit www.akohiringa.co.nz/tags/biological-medicines.
Adalimumab biosimilar funded
Amgevita, an adalimumab biosimilar, is funded under Special Authority from 1 March. From this date, patients starting treatment with the TNF-α inhibitor adalimumab will receive Amgevita rather than the reference product, Humira.
Funding of the biosimilar allows for increased use of adalimumab, with the Amgevita access criteria expanded for both existing and new indications.1
Patients already stable on Humira can be transitioned to Amgevita in primary care over seven months, while both brands are funded.
From 1 October, Amgevita becomes the primary funded option for adalimumab for all uses. Exceptions are available for continued funded use of Humira.
References
1. Pharmac. Decision to widen access to adalimumab and award Principal Supply. 17 November 2021. Available online at https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2021-11-17-decision-to-widen-access-to-adalimumab-and-award-principal-supply Accessed February 2022.
2. Pharmac. Proposal to widen access to adalimumab and award Principal Supply. 26 August 2021. Available online at https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2021-08-26-proposal-to-widen-access-to-adalimumab-and-award-principal-supply Accessed February 2022.
3. Pharmac. Amgevita access criteria. https://pharmac.govt.nz/assets/2021-11-Amgevita-Special-Authority.pdf Accessed February 2022.
4. Amgen (New Zealand) Limited. Launch mailer (PDF): What's behind Amgevita makes the difference. 20 January 2022. https://pharmac.govt.nz/assets/AM10660-Amgevita-Launch-Mailer-1-v3.pdf Accessed February 2022.
5. Medsafe. New Zealand data sheet. Amgevita. Available online at www.medsafe.govt.nz/profs/Datasheet/a/amgevitainj.pdf Accessed February 2022.