Proposal to widen access to adalimumab and award Principal Supply
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What we’re proposing
We want to hear from people on a proposal that would give more New Zealanders funded access to adalimumab.
We are seeking feedback on a proposal to make changes to the funded brand of adalimumab, from Humira to a citrate-free biosimilar adalimumab called Amgevita from 1 February 2022 through a provisional agreement with Amgen (New Zealand) Limited. Adalimumab is a biologic medicine used to treat a range of rheumatology, gastrointestinal, dermatological and other autoimmune conditions.
If the proposal is approved, the following changes would occur:
- A biosimilar adalimumab (Amgevita, supplied by Amgen) would be funded from 1 February 2022.
- All people who start on adalimumab treatment after 1 February 2022 would receive Amgevita.
- People who are receiving treatment with the currently listed brand of adalimumab (Humira) before 1 February 2022 would need to move to Amgevita before 31 August 2022.
- We understand there may be some exceptions to this for people who need to move back to, or remain on, Humira. Humira would remain listed for these circumstances, subject to funding criteria.
- Amgevita would become the Principal brand of adalimumab for all funded uses from 1 September 2022 until 30 June 2026. This means it would be the main funded brand of adalimumab available in New Zealand.
- From 1 February 2022, funded access to Amgevita would be widened to include the following uses (links to Application Tracker included):
- Ulcerative colitis first line(external link)
- Amending existing funding criteria to enable Crohn's disease dose escalation(external link)
- Undifferentiated spondyloarthritis(external link)
- Inflammatory bowel disease-associated arthritis(external link)
- Rheumatoid arthritis; reduction in the number of swollen joints required for access to treatment(external link), and removal of the requirement for CRP to be greater than 15 mg/L(external link)
- Behçet’s disease; access to funded treatment with Amgevita as a first line biologic(external link)
- Ocular inflammation; access to funded treatment with Amgevita as a first line biologic
- This proposal would also result in a number of changes to the funding criteria (Special Authority criteria) for currently funded uses to improve access to treatment. From 1 February 2022, the Special Authority (Amgevita brand only) criteria would be widened to include the following changes:
- Removal of dosing restrictions for people using Amgevita
- Special Authority renewal periods would be extended from 6 months to 2 years
- Special Authority renewals could be applied for by any relevant practitioner and in some uses, renewals would not be required
This proposal results from a competitive process for the Principal Supply of funded adalimumab. It would release significant funds for Pharmac to invest in other medicines for the benefit of New Zealanders.
Feedback on this consultation will help us to understand if any changes should be made to this proposal. Consultation closes at 5 pm on Wednesday, 22 September 2021. Feedback can be emailed to firstname.lastname@example.org, or
What would the effect be?
From 1 February 2022, two brands of adalimumab would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, each with access criteria for funding.
Pharmac and the supplier of Amgevita (Amgen) would provide information and resources about biosimilar’s and biosimilar adalimumab to support this change. It is anticipated that this change would be prescriber led; however, prescribers, pharmacists and patients would need to work together to manage the transition of individual patients from Humira to Amgevita.
Each brand of adalimumab would have separate Special Authority funding criteria.
Proposed funding of adalimumab
From 1 February 2022 until 31 August 2022:
- Existing patients and uses
- Amgevita would be listed for all currently funded uses(external link).
- Either the Humira brand or the Amgevita brand of adalimumab could be funded.
- New patients and uses
- Only the Amgevita brand could be prescribed for new uses and new patients.
From 1 September 2022:
- Prescribed for all funded uses (current and new) with access criteria (eg Special Authority or Hospital Restrictions).
- Prescribed for people with conditions previously controlled on Humira who, after a move to Amgevita, experience clinical difficulties and, following discussion with their doctor, need to return to funded treatment with Humira.
Approximately 6,400 people received adalimumab treatment in 2020. From 1 February 2022, these people receiving treatment with Humira would need to move to Amgevita. This change would be carefully managed by treating clinicians, working closely with primary care, the patient, their family, whānau, and caregivers.
Patients receiving funded Humira prior to 1 February 2022 would be automatically issued a new Special Authority number to enable dispensing of Amgevita.
Based on clinical advice received (see below), we anticipate that most existing patients who take adalimumab would be able to change to the Amgevita brand of adalimumab. However, if Amgevita is unable to be tolerated by a current patient, after a trial, their clinician can apply via a Special Authority to return to Humira (where it is safe to consider further treatment with adalimumab).
Pharmac has identified that there may be some people with ocular inflammation (uveitis) or Crohn’s disease who are at higher risk of experiencing severe adverse clinical outcomes associated with loss of disease control. Where a clinician considers that changing to Amgevita would put their patient at risk of severe disease destabilisation, the clinician can apply via a Special Authority to continue treatment with Humira without the need to trial Amgevita.
From 1 February 2022, all people starting treatment with adalimumab for any funded indication would receive Amgevita.
This would include patients who receive adalimumab treatment for newly funded uses and as a result of widened access. Pharmac is proposing to widen funded access to adalimumab (Amgevita) for a range of uses. We estimate that approximately 720 people would benefit in the first year from these changes in access.
More information on these proposed changes is available below.
For prescribers and pharmacists
From 1 February 2022:
- Either the Amgevita or Humira brand could be prescribed for existing patients and uses
- Only the Amgevita brand could be prescribed for new patients and uses
From 1 September 2022:
- Only the Amgevita brand could be prescribed for all funded uses (current and new)
- The Humira brand would be available subject to Special Authority criteria for people who, for clinical reasons, need to change back to Humira. A new Special Authority application would need to be made for these patients following discussion with their doctor.
To dispense and claim a subsidy, the correct brand would need to be prescribed for each patient. Special Authority approvals would not be interchangeable.
Pharmac would work with Primary Care Professionals to provide resources and support (for example, a Brand Switch Fee and learning material) to assist with the transition of patients from Humira to Amgevita.
Who we think will be interested
- People currently using adalimumab and their family, whānau, and caregivers
- Consumer support groups for people living with conditions that are treated with adalimumab
- Clinicians who treat people with conditions that are treated with adalimumab. This includes rheumatologists, gastroenterologists, ophthalmologists, dermatologists, general practitioners, and nurse specialists
- Hospital and community pharmacists
- Wholesalers and suppliers of adalimumab and biologic medicines
Why we’re proposing this
Several biosimilar adalimumab products are now approved by Medsafe for use in New Zealand. A biosimilar is a very similar version of a biological medicine and is comparable in all essential aspects of an approved biologic medicine including safety, efficacy and mode of action. Amgevita is a Medsafe approved biosimilar adalimumab treatment which is used in more than 40 countries around the world.
The availability of biosimilar’s provides Pharmac with the opportunity to promote competition and reduce the cost of adalimumab. This allows Pharmac to propose wider access to adalimumab for more New Zealanders.