Decision on access criteria for tixagevimab with cilgavimab (Evusheld) for COVID-19

Support

Support for treatments being made available for immunocompromised patients at risk of severe COVID-19 infection.  

We are pleased to secure these treatments and to confirm Access Criteria which would make treatments available to people who are severely immunocompromised at risk of severe illness from COVID-19 infection and at risk of inadequate immune response to SARS-CoV-2 vaccination or infection.

Querying access for individual patients 

Individuals requested access to tixagevimab with cilgavimab and for specific circumstances including solid organ transplant (3.5 years ago), chronic kidney disease, myasthenia gravis, psoriatic arthritis in combination with immunosuppression.

We appreciate the time that people have taken to provide us with feedback and share their personal stories with us. Depending on the immunosuppressive treatments being received, people with these conditions may be eligible for treatment with tixagevimab with cilgavimab. Anyone who considers they may be eligible for treatment with tixagevimab with cilgavimab should seek advice from their specialist clinician. 

We acknowledge that not everyone who might benefit from treatment with tixagevimab with cilgavimab would be able to access it. The access criteria have been designed to target available treatment courses to people most at risk of an inadequate immune response and severe illness following COVID-19 infection.

Tixagevimab with cilgavimab Access Criteria

A respondent noted that criteria 2.1.1, 2.1.2, 2.1.3, 2.1.5, and 2.1.10, as proposed/numbered in the June consultation letter, could be amended to more specifically target profoundly immunocompromised people and reflect the current treatments available in New Zealand.

We have proposed changes to criteria 2.1 to clarify the targeted patient groups, including people that have received potent B-cell or T-cell depleting therapy using a range of treatments.

Changes to the criteria to include people receiving venetoclax (currently funded by Pharmac) and Bruton tyrosine kinase inhibitors, which are not currently funded but are available in New Zealand.

In responses to concerns that the criteria may be too broad, the criteria have been amended to clarify the groups of people with blood cancers who would be eligible for treatment with tixagevimab with cilgavimab.

Respondents requested the timeframes for those who have received B-cell or T-cell depleting therapy or those who have been transplanted for access to tixagevimab with cilgavimab should be extended beyond 12 months or removed.

Respondents also requested that access to tixagevimab with cilgavimab for lung transplant recipients (any time period) should also include heart transplant recipients. 

Respondents requested time-unlimited access be extended to all solid organ transplant recipients, particularly for induction (not maintenance) immunosuppression or mycophenolate maintenance or treated for rejection within the last 12 months. 

Considering the feedback received and the availability of stock following proposed increases to the recommended dosing for tixagevimab with cilgavimab, we have not removed the timeframes in the criteria.  

Access Criteria have been amended to reflect the risk that may be faced by individuals receiving transplant induction immunosuppressant treatment and those receiving maintenance immunosuppressant treatment. This includes mycophenolate mofetil, or those being treated for graft rejection within the past 12 months. Change reflects that the risk of severe COVID-19 for transplant recipients is related to the treatments being received rather than the time period since receiving an organ transplant. Heart transplant patients are also included.

Tixagevimab-cilgavimab should be made available to people who have not received COVID-19 vaccination and who are at high risk of progression to severe COVID-19. 

Respondents noted that this may offer benefits for Māori and Pacific patients who may be over-represented in the unvaccinated high-risk population.

As a result of the limited courses available we have not expanded access to include unvaccinated people who have not received vaccination against COVID-19. We consider there are other treatment options including vaccination and antiviral treatments that may be more appropriate in the first instance. 

The access criteria for tixagevimab with cilgavimab allows access for people who are considered at high risk of severe illness as a result of COVID-19 infection and are unable to be vaccinated against COVID-19 due to medical contraindication.

Access to tixagevimab with cilgavimab be available for early treatment for high-risk groups with confirmed (or highly suspected) SARS-CoV-2 infection, who are unable to receive nirmatrelvir with ritonavir.

We have not extended use of tixagevimab with cilgavimab for the treatment of individuals with COVID-19 infection at this time. We understand that a submission regarding this is expected to be made to Medsafe by AstraZeneca shortly. Available data for this indication will be reviewed at the August 2022 meeting of Pharmac’s COVID-19 Treatments Advisory Group. 

Requested that access to tixagevimab with cilgavimab pre-exposure prophylaxis also include people with a history of persistent SARS-CoV-2 infection.

We have amended the criteria to include individuals with a history of persistent COVID-19. This change reflects the risk faced by these people from future COVID-19 infection.

Access to tixagevimab with cilgavimab to include immunocompromised patients with no spike antibodies.

Noting the lack of equitable availability of serology testing in New Zealand and challenges associated with is interpretation, we have not specifically included in the criteria patients with no spike antibodies measured, rather we have identified conditions and treatments that may cause an individual to be profoundly immunocompromised.

Some rheumatology patients with life-threatening autoimmune conditions (such as systemic lupus erythematosus, dermatomyositis) will be on similar medications to patients with recent solid organ transplants.

We acknowledge that there may be a range of people, not explicitly identified in the criteria who are immunocompromised and at risk from COVID-19 infection.

Noting the limited courses available, the access criteria have been designed to target access to the most profoundly immunocompromised people. Based on the advice and feedback we received, this includes transplant patients who have received immunosuppression with a combination of agents.

We continue to welcome feedback and review the criteria as tixagevimab with imedivimab is implemented in New Zealand.

Pharmac’s exceptional circumstances framework would remain available for people where suitable funded treatments are not available for them. 

Identification of eligible patients for tixagevimab with cilgavimab

Primary care is not appropriately resourced to identify eligible patients and administer tixagevimab with cilgavimab and this should be the responsibility of secondary care specialists.

Initially tixagevimab with cilgavimab for the pre-exposure prophylaxis of COVID-19 will be available in Te Whatu Ora hospitals only.

Pharmac is working with Te Whatu Ora’s COVID-19 Care in the Community Team to establish appropriate access for tixagevimab with cilgavimab in the community to meet the needs of eligible people who do not receive regular care from Te Whatu Ora Hospitals and need access to treatment in their community.

Pharmacists are well placed to provide equitable access to these treatments and reduce pressure on general practice and hospitals and should be appropriately reimbursed for these services.

We acknowledge that Pharmacists may be well placed to support the administration of COVID-19 treatments in community settings. 

Tixagevimab with cilgavimab has been listed in Part II Section H and Section B of the Pharmaceutical Schedule, which would allow it to be administered in the community and hospitals, including by community pharmacists if required. 

Pharmac is working closely with Te Whatu Ora’s COVID-19 Care in the Community Team to establish appropriate access for tixagevimab with cilgavimab in the community. 

Te Whatu Ora’s COVID-19 Care in the Community team is responsible for establishing the fees for providing these treatments to patients, we will share this feedback with them.

Use of serology testing to identify eligible patients

One respondent provided feedback that serology testing may be helpful for identifying eligible patients for pre-exposure prophylaxis. 

Other feedback acknowledged that serology testing may not be available nationally and that there is no standard for interpreting results and the use of serology testing may contribute to additional burden on laboratory services and may also be a further barrier to accessing treatment in the highest risk groups.

We acknowledge that serology testing may be useful for the identification of profoundly immunocompromised patients however, on balance of the feedback provided and advice from serology experts, the difficulty in interpreting results and its possible contribution to inequitable access to these treatments we have not included it in the access criteria at this time. 

We note the review of COVID-19 serology in New Zealand by McAuliffe & Blackmore NZ Med J 2020(external link).

General

Māori and Pacific peoples are over-represented in those experiencing COVID-19 and making more treatments available will contribute to approved outcomes for these groups.

We are pleased to be able to make more COVID-19 treatments available to people who need them. It will be important for clinicians at Te Whatu Ora hospitals to identify eligible Māori and Pacific peoples. 

We are working with the Te Whatu Ora’s COVID-19 Care in the Community Team to ensure these treatments are accessible in the community to eligible Māori and Pacific peoples.

Raised that tixagevimab with cilgavimab may be less effective against the BA.4 and BA.5 Omicron subvariants.

Evidence for the effectiveness of COVID-19 treatments against new variants of COVID-19, including BA.4 and BA.5 continues to emerge. As this evidence becomes available, we continue to seek regular advice from our COVID-19 Treatments Advisory Group and make changes to the access criteria as needed. 

Updated Information provided to us by the supplier (AstraZeneca) indicates that it intends to increase the recommended dose for tixagevimab with cilgavimab to 600 mg, in part due to emerging evidence of reduced efficacy against the BA.4 and BA.5 variants of COVID-19. Use at this increased dose would be unapproved as the application remains under review with Medsafe.

Queried the returns policy for tixagevimab with cilgavimab in order to avoid wastage and redistribute stock if required

Pharmac has secured supply of 20,000 (300 mg) treatment courses of tixagevimab with cilgavimab. The first deliveries have arrived in New Zealand and have an expiry of December 2022, the remainder of this stock would have an expiry date of October 2023. As this stock has been secured and paid for by Pharmac it would not be able to be returned to AstraZeneca.

We understand that the Medicines Act 1981, does not currently allow for stock of pharmaceuticals to be shared between pharmacies. Noting the limited number of treatment courses available (10,000 at 600 mg) and the intent is prophylaxis prior to infection, we expect treatment would be scheduled and supply ordered for known people in advance, rather than large volumes being held for opportunistic dispensing.

Concerns were raised about the current workload and ongoing capacity of primary care to provide currently available COVID-19 treatments.

Concerns were also raised about the ability of patients to access these treatments with COVID-19 and influenza continuing to circulate in the community

We acknowledge that workloads across the health sector remain high due to the ongoing COVID-19 pandemic. 

We expect the prescribing of tixagevimab with cilgavimab would be a collaborative effort between Secondary and Primary Care. It is expected that Secondary Care Clinicians would lead the identification of eligible patients with Primary Care could provide support to administer treatments as needed.

Tixagevimab with cilgavimab and sotrovimab are specialist medicines and training modules should be available to pharmacists.

The supplier of tixagevimab with cilgavimab has developed resources and information that would be available to support the implementation of these treatments. In addition, information will also be made available via Health Pathways and the Hospital Guidelines for COVID-19 Treatments. Given the relatively small numbers of people who would receive treatment and their similarities to other currently available treatments Pharmac has not commissioned training modules specifically for these treatments. We will continue to monitor information and training needs of the sector, working closely with Te Whatu Ora.

Persistent SARS-CoV-2 infection Access Criteria

Respondents considered the proposed Access Criteria for the treatment of Persistent SARS-CoV-2 infection were appropriate.

We are pleased that the proposed Access Criteria are supported and that treatments would be available to New Zealanders with persistent SARS-CoV-2 infection where a multidisciplinary team considers this to be appropriate.