Proposal relating to funded access to infliximab, etanercept, secukinumab and rituximab
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What we’re proposing
We are proposing to make changes to the access criteria (Special Authority and Hospital Restrictions) for infliximab, etanercept, secukinumab, and rituximab. These changes aim to simplify and align the criteria where possible. Most of the changes would be to the wording of the criteria, the intent of the criteria would remain the same. However, in some instances, we are proposing to make more substantive changes by:
- increasing approval durations,
- widening the number of prescribers who can make funding applications and,
- allowing lifetime approvals in some cases.
We are not proposing to make any criteria more restrictive, and we are not considering widening access to other indications as part of this proposal.
Implementation date
At this stage we have not proposed an implementation date. Your feedback will help set the timeframes needed to implement these changes.
Consultation closes at 5pm Thursday 27 November and feedback can be emailed to consult@pharmac.govt.nz
What would the effect be?
This proposal would result in changes to the access criteria for infliximab, etanercept, secukinumab, and rituximab. The intent of these changes is to streamline these criteria and align them in a similar way to the access criteria changes made to adalimumab (Amgevita) in 2022.
The proposed changes can be broadly grouped into the following themes:
- extending Special Authority approval periods
- changing prescriber type to allow more prescribers to apply for funded access
- simplifying criteria and removing redundancies.
What we’d like to know
Along with general feedback on our proposal, we would like specific feedback on the following questions
Implementation
- Would specific support be needed to implement any of the proposed changes? For example, for some, would phased implementations be useful? If so, what timeframes would be useful? If we use phased approaches, which changes should be prioritised?
What we’d like to know – etanercept
- We have proposed to remove the requirement for the patient to have a confirmed diagnosis for at least 6 months before etanercept treatment for ankylosing spondylitis. Would this result in any change in the numbers of people using etanercept? Would we see clinical benefit in this change?
- Still disease - adult-onset – we have proposed that the patient has tried and not experienced a response to at least 6 months of corticosteroids at a daily dose of at least 0.5 mg/kg prednisone-equivalence, non-steroidal anti-inflammatory drugs (NSAIDs) and methotrexate, unless contraindicated. We are seeking feedback on the use of this terminology. Does this terminology reflect current practice? Would we see any clinical benefit with this change?
What we’d like to know - secukinumab
- Psoriatic arthritis – we have proposed to remove the requirement for the patient to have a confirmed diagnosis for at least 6 months before commencing secukinumab treatment. We are seeking specific feedback on this proposal. Would this result in any change in the numbers using secukinumab? Would we see any clinical benefit with this change?
What we’d like to know - rituximab
- Rheumatoid arthritis – we have proposed the removal of the requirement for the patient to have a confirmed diagnosis for at least 6 months before commencing Mabthera treatment. We are seeking specific feedback on this proposal. Would this result in any change in the numbers using Mabthera? Would we see any clinical benefit with this change?
Who we think will be interested
- People currently using infliximab, etanercept, secukinumab, and rituximab and their family, whānau, and caregivers
- Consumer support groups for people living with conditions that are treated with infliximab, etanercept, secukinumab, and rituximab
- Clinicians and multidisciplinary teams who treat people with conditions that are treated with infliximab, etanercept, secukinumab, and rituximab. This includes:
- dermatologists,
- gastroenterologists,
- haematologists,
- nephrologists/renal physicians,
- neurologists,
- nurse specialists
- ophthalmologists,
- rheumatologists,
- specialist general practitioners,
- nurse specialists
- Health New Zealand | Te Whatu Ora
- Community and Hospital pharmacies.
Why we’re proposing this
Infliximab, etanercept, secukinumab, and rituximab are currently listed with complex and numerous Special Authority and Hospital Indication Restrictions criteria.
In August 2021, Pharmac consulted on a range of changes to the adalimumab Special Authority and Hospital Indication Restriction criteria, including streamlining criteria, extending renewal periods from 6 months to 2 years, enabling any relevant practitioner to apply for a renewal, and, for some indications, removing the requirement for a renewal application altogether.
We received feedback supporting these changes, indicating that the increased renewal durations would reduce the workload and administrative burden associated with completing Special Authority applications and that the proposed changes would free up significant time for patient directed activities. As part of this feedback, there were requests that we consider similar changes for other biologic treatments.
Decision to widen access to adalimumab and award Principal Supply
Infliximab, etanercept, secukinumab, and rituximab all have indications with similar Special Authority criteria and are subject to similar access restrictions. As part of our notification for the adalimumab changes, we are looking to change the criteria for these other biological treatments given their substantive similarities to adalimumab.
We have now worked through this process and are seeking feedback on proposed changes.
Details about our proposal
Infliximab, etanercept, secukinumab, and rituximab are biological medicines and are used to treat a number of different conditions including autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
Please follow the following links to the proposed changes categorised by therapeutic area:
Details of the proposed changes for each medicine are as follows:
Etanercept
Where applicable, clinical references and notes would be removed from etanercept funding criteria and language aligned. In summary, we are proposing the following changes to the etanercept criteria:
Ankylosing spondylitis – ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – polyarticular course juvenile idiopathic – ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – oligoarticular course juvenile idiopathic - ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – psoriatic - ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – rheumatoid – ‘Any relevant practitioner’ would be able to apply for funding.
Plaque psoriasis – severe chronic – ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
Pyoderma gangrenosum – ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 4 months).
Still disease – adult onset (AOSD) – ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 6 months).
Undifferentiated spondyloarthritis – ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 2-year period (currently 6 months).
These changes would be made to both Section B and Section H of the Pharmaceutical Schedule.
Details of the proposal – etanercept
For details of how the restriction criteria for etanercept would be amended in the Pharmaceutical Schedule, please see:
Infliximab
Where applicable, clinical references and notes would be removed from infliximab funding criteria and language aligned. In summary, we are proposing the following changes to the infliximab criteria:
Ankylosing spondylitis – ‘Any relevant practitioner’ would be able to apply for funding. Initial applications would be valid for a 6-month period (currently 3 months). Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – psoriatic – ‘Any relevant practitioner’ would be able to apply for funding. Initial applications would be valid for a 6-month period (currently 4 months). Renewal applications would be valid for a 2-year period (currently 6 months).
Arthritis – rheumatoid – ‘Any relevant practitioner’ would be able to apply for funding. Initial applications would be valid for a 6-month period (currently 4 months). Renewal applications would be valid for a 2-year period (currently 6 months).
Behçet’s disease – Applications would be valid without further renewal unless notified (currently 6 months).
Ocular inflammation – severe – Renewal applications would be valid for a 2-year period (currently 12 months).
Ocular inflammation – chronic – Renewal applications would be valid for a 2-year period (currently 12 months).
Plaque psoriasis – ‘Any relevant practitioner’ would be able to apply for funding. Initial applications would be valid for a 4-month period (currently 3 months). Renewal applications would be valid for a 2-year period (currently 6 months).
Pyoderma gangrenosum – ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 4 months).
These changes would be made to both Section B and Section H of the Pharmaceutical Schedule.
Details of the proposal – infliximab
For details of how the restriction criteria for infliximab would be amended in the Pharmaceutical Schedule, please see:
Rituximab
The proposal as it relates to rituximab
Where applicable, clinical references and notes would be removed from rituximab funding criteria and language aligned. In summary, we are proposing the following:
Riximyo changes
Anti-NMDA receptor autoimmune encephalitis - ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 6 months).
Membranous nephropathy - ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 6 weeks).
Neuromyelitis optica spectrum disorder (NMOSD) - ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 6 months).
Severe refractory myasthenia gravis - ‘Any relevant practitioner’ would be able to apply for funding.
Steroid dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS) - ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 8 weeks).
Steroid resistant nephrotic syndrome (SRNS) - ‘Any relevant practitioner’ would be able to apply for funding. Applications would be valid without further renewal unless notified (currently 8 weeks).
Thrombotic thrombocytopenic purpura (TTP) - Applications would be valid without further renewal unless notified (currently 8 weeks).
Treatment refractory systemic lupus erythematosus (SLE) - Applications would be valid without further renewal unless notified (currently 7 months).
Severe antisynthetase syndrome - Applications would be valid without further renewal unless notified (currently 12 months).
Severe chronic inflammatory demyelinating polyneuropathy (CIPD) - Applications would be valid without further renewal unless notified (currently 6 months).
Mabthera changes
Arthritis - rheumatoid - TNF inhibitors contraindicated - ‘Any relevant practitioner’ would be able to apply for funding.
Arthritis - rheumatoid – prior TNF inhibitor use - ‘Any relevant practitioner’ would be able to apply for funding.
Arthritis - rheumatoid - Renewal - retreatment for people who experienced a partial response to rituximab - ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 12-month period (currently 4 months).
Arthritis - rheumatoid - Renewal - re-treatment for people whose condition responds to rituximab - ‘Any relevant practitioner’ would be able to apply for funding. Renewal applications would be valid for a 12-month period (currently 4 months).
These changes would be made to both Section B and Section H of the Pharmaceutical Schedule.
Details of the proposal – rituximab
For details of how the restriction criteria for rituximab would be amended in the Pharmaceutical Schedule, please see both:
Secukinumab
The proposal as it relates to secukinumab
Where applicable, clinical references and notes would be removed from secukinumab funding criteria and language aligned. In summary, we are proposing the following:
Ankylosing spondylitis - second line - ‘Any relevant practitioner’ would be able to apply for funding.
Arthritis - psoriatic - ‘Any relevant practitioner’ would be able to apply for funding.
Plaque psoriasis - severe chronic - both first line and second line - ‘Any relevant practitioner’ could apply for funding.
Currently the eligibility criteria for plaque psoriasis for secukinumab exists as two separate criteria – one for access as a first line treatment and one for access as a second line treatment. We are proposing that these are simplified and replaced by one set of overarching secukinumab for plaque psoriasis criteria that will allow access for both first line and second line treatment.
These changes would be made to both Section B and Section H of the Pharmaceutical Schedule.
Details of the proposal – secukinumab
For details of how the restriction criteria for secukinumab would be amended in the Pharmaceutical Schedule, please see:
To provide feedback
Send us an email: consult@pharmac.govt.nz by 5pm Thursday 27 November.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
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