Decision to widen access to adalimumab and award Principal Supply

Adalimumab (Amgevita)

Inj 20 mg per 0.4 ml prefilled syringe

Amgevita

1

$190.00

Adalimumab (Amgevita)

Inj 40 mg per 0.8 ml prefilled syringe

Amgevita

2

$375.00

Adalimumab (Amgevita)

Inj 40 mg per 0.8 ml prefilled pen

Amgevita

2

$375.00

Adalimumab (Humira)

Inj 20 mg per 0.4 ml prefilled syringe

Humira

2

$1,599.96

Adalimumab (Humira)

Inj 40 mg per 0.8 ml prefilled syringe

Humira

2

$1,599.96

Adalimumab (Humira)

Inj 40 mg per 0.8 ml prefilled pen

HumiraPen

2

$1,599.96

Adalimumab (Humira – alternative brand)

Inj 20 mg per 0.4 ml prefilled syringe

Humira

2

$1,599.96

Adalimumab (Humira – alternative brand)

Inj 40 mg per 0.8 ml prefilled syringe

Humira

2

$1,599.96

Adalimumab (Humira – alternative brand)

Inj 40 mg per 0.8 ml prefilled pen

HumiraPen

2

$1,599.96

Support for the proposal

Welcome the widening of access to adalimumab noting this will increase the number of people eligible to receive and benefit from adalimumab treatment. Highlighted the significant benefit of lower costs and increased access for patients and the health system.

We are encouraged that the widened access changes to the funding of adalimumab are supported by the majority of respondents. 

Supportive of the continued availability of Humira for patients who need it.  

We acknowledge the alternative brand Special Authority criteria will support ongoing availability of Humira for people who experience clinical difficulties following a trial of Amgevita.

Starting all new patients on Amgevita is reasonable.

We are pleased to receive this feedback and note that this aligns with the clinical advice we received.

The change is unlikely to have any impact on clinical outcomes. 

Highlighted extensive literature regarding the safety and efficacy of biosimilars around the world and the safety in switching from reference to biosimilar anti-TNF medications.

This feedback is aligned with the clinical advice we have received regarding the equivalent efficacy and safety of Amgevita and Humira.

November 2020 PTAC Record [PDF, 672 KB]

Supportive of funding an effective dose of adalimumab in a form that patients can administer at home. 

Many patients prefer prefilled syringes and ease of use of the biosimilar injection device is important for many patients.

Amgevita is available in the same presentations (prefilled pen and prefilled syringe) as Humira, which enables effective treatment at home for patients who are trained in subcutaneous injection. This will offer a suitable alternative treatment option for patients such as those with ulcerative colitis who will be able to access funded treatment with Amgevita.  

We know that the device is an important aspect of the use of adalimumab. Amgevita prefilled syringes are considered to be similar to the current Humira prefilled syringes.

Supportive of the changes, reducing the workload and administrative burden associated with completing Special Authority applications noting this would free up significant clinician time for patient directed activities.

We are encouraged that the changes to the Special Authority criteria for adalimumab are, in general, supported by majority of respondents to this consultation.

Comments regarding Amgevita and Principal Supply Status

The benefit of a citrate free formulation for the paediatric population will be significant. Injection site tenderness is the most common side effect patients experience and a citrate-free formulation would be well-received, noting Amgevita may still sting.

We are pleased to be listing a citrate-free adalimumab. 

Clinical advice indicated that the absence of citrate may reduce the pain of injecting adalimumab which will be a benefit for some patients. We acknowledge that injection pain can be caused by a range of factors and so some patients may find Amgevita is less painful to inject, while others may not.

November 2016 PTAC record [PDF, 687 KB]

There are currently no biosimilars in New Zealand being used for inflammatory bowel disease (IBD) with comments that this will change over time.

We acknowledge this is the first biosimilar introduced for IBD in New Zealand. Biosimilars are increasingly being used internationally and are likely to become more common in New Zealand. 

Pharmac remains supportive of, and will continue to consider, funding other biosimilar medicines in the future where they would help us improve the health outcomes of New Zealanders.

There might be advantages for Pharmac to have more than one biosimilar supplier to ensure continuity of supply and financial competition.

If there were multiple suppliers, there would need to be a mechanism to support this where practitioners and patients know the “brand” being dispensed. 

For many essential medicines in New Zealand, only one brand is funded. Having multiple brands of a product in a market does not necessarily improve security of supply. When there is one supplier, forecasting is often more accurate which helps prevent out-of-stock situations. Multiple brands being available in the market can result in patients inadvertently being dispensed different brands. 

Pharmac ensures that in our supply contracts suppliers agree to conditions to prevent and manage potential out-of-stocks. This includes significant stockholding, frequent stock reporting to Pharmac and a commitment to source a suitable alternative to prevent a potential out-of-stock occurring.

Amgevita is also supplied and used in Australia with similar labelling. This means stock could be shared from Australia  if required and sourced quickly in the event of any unforeseen stock shortages.

Recommended close patient monitoring for patients transitioning to Amgevita to observe for loss of efficacy and/or adverse reactions.

We acknowledge that this may be a complex change for some patients who require close management. The available clinical evidence and international data indicates the majority of patients will receive the same level of benefit from Amgevita, without adverse events. 

Primary and secondary care will need to continue to work together to manage the appropriate care and monitoring of people using adalimumab. 

Medsafe is responsible for pharmacovigilance and post-marketing surveillance of medicines across New Zealand. We will continue to work closely with Medsafe to monitor any reports of adverse events as a result of biosimilar (specifically Amgevita) use in New Zealand.

Implementation and support activities to support a change

Strong feedback was received across all therapeutic areas highlighting the importance of good support for patients managed on adalimumab treatment and healthcare professionals involved in their care. 

This feedback indicated that an easily accessible and effective support and service package had a range of benefits for patients and their whānau, and prescribers. This included the benefits of support on patient adherence to adalimumab treatment and general  healthcare experiences for patients and their whānau.

We understand that good support for patients, whānau and the health system is needed for this change to be successful.

Pharmac has developed a comprehensive support plan to ensure that adequate information and education will be provided to healthcare professionals and patients. This will be delivered alongside material developed by the supplier, Amgen.

Resources will be available to support patients changing to Amgevita treatment and initiating Amgevita treatment.  This includes nursing support, written and electronic information and availability of demonstration pens and sharps bins. 

We plan to develop a range of different education materials for different patient groups and languages and will continue to assess what additional support is helpful for patients and prescribers throughout the change.   

Please note these will be updated through transition to provide updated information as Amgevita is introduced.

Consumer information developed should be easy to follow and understand and be age-appropriate.

We agree that it is important to have easily accessible information available about biosimilars. A range of different education materials will be developed suitable for different patient groups and audiences.

Changing to a biosimilar

Feedback was provided regarding the use of biosimilars: 

• biosimilars are considered to be as safe and as effective as the reference drugs, but, unlike generic medications, cannot be considered identical.
• the importance of ensuring the new brand provides equivalent efficacy.
• patients who either reduce or temporarily stop current treatment may not achieve the same level of benefit
• biosimilars don't require comparative clinical trials
• biosimilars have only recently been developed 

We acknowledge that continuing adalimumab treatment with a biosimilar may raise questions or concerns for some people, especially for people who have been on treatment for a long time. We also recognise the impact on people’s lives of the conditions that adalimumab is used to treat. 

Biosimilar medicines undergo extensive quality and clinical testing to show they are as safe and effective as the reference biologic. As part of its regulatory review, Medsafe determines comparability of a biosimilar to its reference biologic with respect to efficacy and safety. To meet Medsafe requirements (and other international agencies) for approval, a biosimilar must demonstrate that it is sufficiently similar to the reference biologic and any differences have no clinically meaningful effect on quality, safety, or efficacy. Extrapolation of approved indications is considered as part of this process based on clinical evidence showing pharmacokinetic comparability. 

Amgevita is Medsafe approved, for the same indications as Humira and is used extensively internationally. It has been available in Europe since 2017 based on the available evidence of Amgevita’s biosimilarity to Humira. 

More information on biological and biosimilar medicines is available on the following patient information leaflet [PDF, 67 KB]. 

We have received extensive advice from our clinical expert advisors regarding the evidence and international experience supporting the use of biosimilars and Amgevita. The advice from our Pharmacology and Therapeutics Advisory Committee  (PTAC) and our Specialist Advisory Committees indicates that, based on the available evidence, there is no reason to suggest there would be a change in the expected effectiveness or safety associated with adalimumab treatment with Amgevita.

November 2020 PTAC record [PDF, 672 KB]

This review included evaluation of the evidence of the efficacy and safety of patients who change more than once between biologic and biosimilar medicines and showed no difference in long term efficacy, safety and immunogenicity. 

Based on the available evidence and international experience we expect it would be rare for people to experience clinical difficulty with Amgevita but appreciate that there may be some patients who need to return to treatment with Humira or are unable to trial Amgevita. We have provided a pathway for funded access to Humira for these people, if required, following a discussion between the patient and their prescriber.

Questions regarding how to access Humira for people who experience difficulty following a trial of Amgevita:

• how long patients need to trial Amgevita before can change back to Humira (if required for a clinical reason)
• how long access to Humira will be retained for people 
• how difficult the process to return to Humira (if required) will be.

The Special Authority criteria for access to Humira mean that patients will be able to return to Humira after a trial of at least 4-weeks (2 doses), but no longer than 6-months of Amgevita use. This is irrespective of the transition period and would be based on the first date of dispensing Amgevita for the individual. 

A return to Humira would be via Special Authority criteria. People currently require a Special Authority for ongoing treatment with Humira and so access is aligned with the current process. 

There may be exceptional circumstances where a patient is unable to complete a trial of Amgevita. In the event that the clinician considers it appropriate for a patient to return to Humira treatment and the patient does not meet the Humira criteria, an application for funding could be assessed through Pharmac’s exceptions process (as a Special Authority waiver).

Some respondents noted a risk of the nocebo effect for patients. Considered that educating Health Care Providers (HCP) may help but would not be the sole solution for managing or preventing this.

BPAC article about nocebo effect(external link)

We are aware that following any change, there may be people who experience adverse events that would occur irrespective of a change, but that these may be attributed to the change. Many factors can contribute to this. 

This change will need to be carefully managed and will require discussions with treating clinicians, working closely the patient, their family, whānau, and caregivers. We anticipate that people currently using Humira will be able to continue their treatment with adalimumab using Amgevita without any clinical issue.  

We will add resources to this page to support the introduction of Amgevita to New Zealand for patients and clinicians.

The introduction of a biosimilar should be a decision shared between the healthcare provider (physicians and nurses) and patient/whānau.

We agree and expect this change will be led by prescribers and supported by healthcare professionals involved in the care of people using adalimumab. The decision to change from Humira to Amgevita should follow a discussion between clinician and patient. 

We recommend that prescribers and patients start discussing use of Amgevita at their next opportunity. This will ensure people currently using Humira are well informed before transitioning to Amgevita.

One respondent noted concerns regarding a general lack of faith and trust in generic brands.

Biologic and biosimilar medicines are different to other medicines and generics as they tend to be large, complex molecules made from living organisms. 

Read more about biologic and biosimilar medicines

A generic medicine has the same active ingredient and works the same way as the original brand. Pharmac makes sure to carefully consider whether brand changes for specific medicines are appropriate, taking into account clinical risks and making sure to seek clinical advice from clinicians and pharmacists. 

Pharmac also only seeks to implement medicine changes if the new brand is approved by Medsafe. Medsafe makes sure all medicines available in New Zealand meet the standards of quality, efficacy and safety. Whether a medicine is the original brand or a generic, Medsafe ensures they all meet the appropriate standard.

Read more about how Medsafe ensures the quality of generic medicines(external link)

Special Authority changes 

Would the changes to the Special Authority criteria for Amgevita (e.g., removing dosing restrictions) apply to the new uses such as ulcerative colitis?

Yes, the changes to existing Special Authority criteria (such as removal of dosing restrictions) will apply to all conditions and people using Amgevita, including the new uses such as ulcerative colitis.

Therapeutic drug monitoring (TDM) can be used to tailor the dose and frequency of adalimumab to ensure the best effect from funding. The use of TDM has been shown to be a cost-effective strategy which can improve a patient’s quality of life, and productiveness to society.

We understand that TDM is becoming standard practise for many conditions and are supportive of this. We consider that use of TDM is a clinical decision best made by the treating prescriber. 

Removal of dosing restrictions for Amgevita will enable effective application of TDM and provide clinicians the option to consider whether TDM is appropriate for their patient before making any dosing changes.

Many respondents were supportive of the changes to the Special Authority criteria relating to renewals. Some comments included:

• requests for safeguards for changes to ensure a specialist evaluates their patient at regular intervals to ensure the continued effectiveness and safety of therapy 
• recommendation that there be appropriate plans to train medical practitioners to evaluate patients managed on biologics effectively for the purpose of applying for renewal.

We acknowledge that the decision to continue a patient on biologic treatment is an important one. 

It is anticipated that primary and secondary care will continue to work together to manage the appropriate care of people using adalimumab, including ensuring regular review as required for patients managed on adalimumab treatment. 

These changes are intended to relieve pressure on prescribers by reducing the administrative burden associated with continued access to adalimumab treatment for patients. This will improve access, particularly for patients who are stable on treatment.

The Crohn’s disease activity index (CDAI) is an outdated method of assessing for disease in Crohn’s patients, and many patients can have an elevated CDAI without having active disease. 

Based on the feedback received we have included the Harvey-Bradshaw Index (HBI) as a disease measurement score, as an alternative to CDAI. 

We sought additional advice on the suitable measures of disease severity in Crohn's disease which is supportive of this change.

The severity descriptions for Crohn’s disease and ulcerative colitis for funded access to infliximab and adalimumab do not necessarily match the disease activity scores. 

We have removed the qualitative disease descriptions (moderate and/or severe) from the adalimumab Special Authority criteria, enabling assessment of disease severity based on the disease activity score only.  

Similar changes will be considered for infliximab.

The requirement to trial conventional disease modifying anti-rheumatic drugs before accessing adalimumab (and other biologics) doesn’t allow for  patients who are contraindicated to these due to allergy or other co-morbid conditions. This makes access to biologic treatment difficult.

These criteria currently require patients to trial a ‘maximum tolerated dose’ which may be reasonably interpreted to be zero mg in certain clinical circumstances. 

To improve clarity of these access criteria, the phrase ‘unless contraindicated’ has been included in relevant Special Authority criteria.

Theme

Pharmac Comment

Sector considerations

One respondent provided feedback noting a request to avoid sending consultation documents in Level 4

We appreciate the additional workloads that are taken on by essential workers throughout the COVID-19 pandemic and provided an extended consultation period. We also delayed consultations on other proposals to reduce the burden on the health sector. 

The length of the consultation period was informed by the need to enable public consultation and consideration of responses prior to a 1 March 2022 listing date.

Prescribing by brand (Amgevita instead of generic adalimumab) may be a change for some healthcare providers. 

Some concern regarding the risk of patients changing treatment without the prescriber’s knowledge (inadvertent changing) and noted the importance of both prescribers and patients being aware of the change to ensure there is opportunity for patients to discuss the use of Amgevita. Feedback noted biosimilars are not currently considered interchangeable in New Zealand.

From 1 March 2022 prescribers will need to ensure that all prescriptions for adalimumab specify brand (Amgevita or Humira), and pharmacists will need to ensure the correct brand of adalimumab is supplied to patients. This is to ensure people have the opportunity to discuss any changes to their treatment with their prescriber before they receive Amgevita for the first time. 

We will take steps to ensure that prescribers and pharmacists are supported in making sure that patients receive the right treatment at the right time. We expect that this change will be led by prescribers and that prescribers, pharmacists and patients work together to support individual patients with their transition to Amgevita. 

Pharmac will continue to work with healthcare professionals and health system partners to support healthcare professionals throughout the transition period.

One respondent highlighted that a price change would have a financial impact on the supply chain for DHBs which may have an impact on the supply chain for community pharmacies.

We understand the reduction in list price is likely to have a significant impact on supply chain management for DHBs. 

Pricing detail was not included in the consultation to avoid the disclosure of commercially sensitive information prior to a decision on the proposal. 

Pharmac will work with DHBs and pharmacies to develop guidance to support good management and stock levels as a result of this change. The list date of 1 March 2022, and seven-month transition, means wholesalers and pharmacies will have time to appropriately plan and manage their stock levels.

Feedback that any change would require extra considerations during the dispensing process and requests for a Brand Switch Fee to be provided for pharmacists to support the extra work associated with this.

As indicated in the consultation a Brand Switch Fee will be applied to reimburse pharmacists for the time supporting this change, including time spent providing educating and information to patients.

Consultation to widen access to adalimumab

Current guidance from BPAC on use of biosimilars includes reference to recording of batch numbers as part of the dispensing process and requested guidance on the expectations for dispensing of biosimilar medicines.

BPAC's biosimilar guidance(external link)

Recording of batch numbers is recommended as best practice for pharmacists to allow tracing of any medicine,  where possible. This information may be required for reporting of any adverse reaction reports to the Centre for Adverse Reactions Monitoring (CARM).

Concerns regarding the impact that repetitively changing between different biosimilars due to commercial contract changes could have impacts on patients.  Recommended long commercial contracts with suppliers to reduce the risk of multiple changes within a patient’s treatment lifetime to reduce this risk.

We are aware that the duration of a supply contract is an important consideration when considering the introduction of Principal Supply Status for one supplier. We also acknowledge that changing treatments can be challenging for both patients and prescribers.

In recognition of this and to reduce the risk that patients would need to change more than once whilst using adalimumab, our agreement with Amgen for the supply of Amgevita includes a Principal Supply period of approximately 4-years (ending 31 July 2026), with the option to extend to 30 June 2027.

Widened access and requests for funding of other pharmaceuticals

Dermatology

Some respondents requested Special Authority changes adalimumab including:

• enabling access for patients who have previously trialled secukinumab (as a first-line biologic agent). 
• including genital and flexural psoriasis as part of the chronic plaque psoriasis criteria.

We are in the process of considering this feedback

and assessing the impact of aligning the criteria to enable access for people who have previously trialled secukinumab and widening access to enable treatment for genital and flexural psoriasis for people. 

We will continue to assess these applications against other options for investment. This proposal to fund Amgevita and widen access would not prevent Pharmac from considering these applications in the future.

Request to fund rituximab for pemphigus variants, noting rituximab is a first-line agent for refractory disease where there is a small number of patients and access to effective treatment would have a significant impact.

We acknowledge the unmet need for effective treatment options in this patient group. We have previously received a funding application for this indication which has been ranked and is an option for funding. 

Full details of the advice we have received and the status of this applications is available through the Application Tracker

Application to fund rituximab for pemphigus variants(external link)

This proposal to fund Amgevita and widen access would not prevent Pharmac from considering this applications in the future.

Requests for funding additional biological treatments for dermatological conditions including dupilumab, risankizumab and upadacitinib. 

This feedback noted there is a disparity in the access to biologic treatment compared to what is available internationally for dermatological conditions.

Pharmac has received applications for funding for several of these treatments and these are under assessment.

Full details of the progress of these applications are available via the Application Tracker:

• No funding application has been received for dupilumab. We would welcome an application, with supporting evidence, for funding of dupilumab for the treatment of recalcitrant/severe atopic eczema 
• Risankizumab(external link)
• Upadacitinib(external link)

We will continue to assess these applications against other options for investment. This proposal to fund Amgevita and widen access would not prevent Pharmac from considering these applications in the future.

Gastroenterology

Feedback noting there are treatment inequity considerations for patients with inflammatory bowel disease (IBD) and Pharmac should consider funding changes to address these. 

Noted there is an unmet health need of IBD patients who require additional pharmaceutical therapy, with a disparity of funded agents available in New Zealand compared with other countries, and a lack of alternative biologic options with differing mechanisms of action. 

Requested widened access to infliximab to allow increased dosing (to align with adalimumab), and funding of a new biologic agent(s) to provide additional treatment options for IBD patients that experience ongoing disease. 

We acknowledge the high unmet need for other treatment options in this patient group. The requested changes to the Schedule (e.g., widened access to infliximab and new listings) have been ranked and remain future options for investment. 

Full details of the advice we have received and the status of individual applications relating to IBD are available on the Application Tracker:

• Infliximab dose escalation(external link)
• Ustekinumab(external link)
• Vedolizumab(external link)
• Golimumab(external link)

We continue to assess these applications against other options for investment. This proposal to fund Amgevita and widen access would not prevent Pharmac from considering these applications in the future.

Requested Special Authority changes for adalimumab including: 

• lowering the CDAI score required for patients with Crohn’s disease who have not responded to other therapies, from 300 to 220. This feedback noted the impact of waiting to reach severe disease before meeting criteria to access a biologic treatment. 
• enabling access to patients who have required a course of exclusive enteral nutrition (EEN). This feedback noted EEN is an international preferred treatment to induce remission in children with Crohn’s disease, reducing exposure to corticosteroids.  

We are in the process of considering this feedback and assessing the impact of aligning the criteria to include a lowered CDAI score, and access to adalimumab for paediatric patients who have trialled EEN. 

We will continue to assess these applications against other options for investment. This proposal to fund Amgevita and widen access would not prevent Pharmac from considering these applications in the future. 

You can follow our progress in the assessment of these requested changes through the Application Tracker:

Adalimumab: widened access to patients with a CDAI score of 220 or greater(external link)

Adalimumab: widened access to paediatric patients who have required a course of EEN(external link)

Rheumatology

Requested changes to the psoriatic arthritis (PsA) Special Authority criteria to align with the access criteria for rheumatoid arthritis (RA). Noting PsA is commonly associated with a poor quality of life and PsA may be active with either no CRP response or a very moderate CRP response. 

Current criteria encourage the use of prednisone in patients where oral steroids are of little use and/or are contra-indicated due the risk of subsequent rebound of skin psoriasis

We acknowledge there is a difference in funded access to adalimumab between rheumatoid arthritis and psoriatic arthritis. 

We have considered this feedback and are undertaking additional assessment of the impact of removing the Special Authority criteria requiring CRP measurements and/or use of three months of oral steroids prior to access to adalimumab for treatment of PsA. This would align the Special Authority criteria of PsA to those for RA. 

Follow our progress in the assessment of this requested change through the Application Tracker.(external link) 

Requested further changes to the Special Authority for access to adalimumab for rheumatoid arthritis:

• changes to diagnostic criteria to enable patients who are unable to undergo advanced imaging and are CCP negative (anti-cyclic citrullinated peptide negative) to access treatment if they are Rheumatoid Factor positive
• reduction in the number of swollen joints required to access adalimumab treatment from 15 to >6, noting 15 joints represents extremely active disease.

We have considered this feedback and are undertaking additional assessment of the impact of including Rheumatoid Factor positive as a possible diagnostic criteria for funded access to biological treatment.

We will continue to assess this application against other options for investment. This proposal to fund Amgevita and widen access would not prevent Pharmac from considering these applications in the future. 

The changes to the Special Authority criteria for Amgevita treatment for rheumatoid arthritis as a result of this decision include a reduction in joint counts from 20 to 15. 

We would welcome a funding application to enable further consideration of widened access to include fewer joint counts. This would enable us to seek clinical advice and understand the impact of this change relative to other funding priorities.

Requested access to Cimzia (certolizumab), noting it is an appropriate treatment option for people of child-bearing potential, as it doesn't cross the placenta and so is suitable for use in pregnancy.

Pharmac has previously considered Cimzia(external link) (certolizumab) for funding for the treatment of rheumatoid arthritis and PTAC recommended it for decline in 2012. Pharmac continues to consider this funding application and will seek updated clinical advice based on the information received. 

People who are wishing to get pregnant whilst on immunomodulator or biologic treatment should discuss available treatment options with their clinician. Where specific treatments are contraindicated, access to biologic treatment could be considered via Pharmac's exceptional circumstances framework.

General

Consideration should be given to extending the proposed Special Authority changes to other biologics such as infliximab to improve access,  including enabling community access.

We are working to assess what changes can be made to other biologic treatments that have criteria that are substantively similar to adalimumab, to ensure these are aligned where possible.

Some biologics such as infliximab are used specifically in hospitals or DHB outpatient clinics as they are intravenous infusions. For these products access in the community is currently unable to be considered.

Requested that any savings made from the introduction of Amgevita be reinvested into their specific clinical group (gastroenterology, dermatology or rheumatology).

Moving from Humira to Amgevita will free up money within our fixed budget that Pharmac can then use to fund more medicines.

The number of new medicines that we would like to fund will always exceed the budget we have available.

Every medicine that is recommended for funding by our advisors is compared and prioritised against all other medicine funding options. We compare all the applications we get and use our options for investment list to make sure that new medicines we fund would deliver the best health outcomes possible from within our fixed funding.

More information about priority lists

Widened access should include funding for all people who may benefit, particularly those without alternative available treatment options.

As part of this proposal, Pharmac has considered what indications adalimumab could be widened to based on previous funding applications. 

Removal of all Special Authority criteria or further widened access to adalimumab to enable earlier usage has not been considered at this time or previously assessed.   

We’re pleased to be widening access to over 380 new people and improving access to existing users of adalimumab and we welcome funding applications for any additional widening of access to adalimumab.

Will patients with Crohn’s disease who currently receive extra Humira as part of a compassionate access scheme, managed by the supplier of Humira (AbbVie), continue to have this access if they remain on Humira treatment?

Pharmac is not involved in the provision of treatment through compassionate supply programmes developed by suppliers for unfunded medicines. Suppliers are able to provide products to patients under compassionate access schemes which may involve part or no payment from a patient. 

Our view is that where a Pharmaceutical Supplier  commences compassionate supply, the supplier has taken responsibility of providing treatment for as long as the patient continues to benefit. We encourage clinicians to seek assurance from suppliers about ongoing supply for patients who are benefitting from treatment being delivered via compassionate supply programmes. Pharmac is unable to guarantee that access to this scheme would continue as it is not a funded service. 

Patients who require increased dosing will be eligible for Amgevita treatment which will have no dosing restrictions.

Requested the criteria for Humira be similarly aligned with the criteria for Amgevita to enable consistent access for patients who remain on or return to Humira treatment including widened access.

These changes in access applied to Amgevita reflect funding requests that have been made to Pharmac and have previously been considered for Pharmaceutical Schedule listing. These changes were previously unable to be progressed for funding due to the price of Humira. The price reduction of adalimumab with the change to Amgevita means we are now able to progress these applications for funding.

No changes will occur to the funding for access to Humira. Access will remain as it currently is for patients who remain on Humira treatment. 

The decision to enable patients to remain on Humira, or to allow patients to return to funded treatment with Humira is based on the advice that these patients are either unable to be considered for a change in treatment due to risk of disease destabilisation or have experienced loss of disease control following a trial of Amgevita. On this basis, maintenance of funded access to Humira for these patients as per current funding arrangements (status quo) is not considered to disadvantage these patients. 

Any patients that experience disease deterioration while on treatment with Humira will be eligible to change to Amgevita at any time (and therefore able to access increased dosing).

Theme

Pharmac Comment

Transition period

The transition period needs to be sufficient to enable a smooth changeover for patients who are transitioning to Amgevita.

The transition period is seven months, from 1 March 2022 until 30 September 2022. As current Special Authority durations are six months, this transition period is designed to fit within the current Special Authority approval period, to reduce the need for patients to visit their prescriber more than once.

Patients currently using Humira are recommended to start discussing the use of Amgevita with their prescriber at their next appointment to make sure they have all the information they need before 30 September 2022.