Proposal on access criteria for tixagevimab with cilgavimab (Evusheld) and sotrovimab (Xevudy)
What we’re proposing
We are seeking feedback on proposed access criteria for:
- tixagevimab with cilgavimab (Evusheld) for the pre-exposure prophylaxis of COVID-19 in severely immunocompromised people at risk of COVID-19 infection
- sotrovimab (Xevudy) for the treatment of mild to moderate COVID-19 infection in people at high risk of progression to severe disease
- treatment of persistent SARS-CoV-2 infection with any relevant currently funded treatment for COVID-19.
We are also interested in feedback on
- how to equitably distribute and administer tixagevimab with cilgavimab and sotrovimab
- the possible role of serology testing in the identification of eligible patients for tixagevimab with cilgavimab and sotrovimab and the practicalities of implementing this.
Changes are proposed to be made to the Pharmaceutical Schedule from 1 July 2022 in preparation of these treatments being available in July 2022. Access criteria would become effective if approved by Medsafe and stock is available in the country.
Stock of tixagevimab with cilgavimab and sotrovimab have been secured through advanced purchase agreements with AstraZeneca Limited and GlaxoSmithKline NZ Ltd respectively. Further detail on New Zealand’s COVID-19 Treatments Portfolio is available on our website
Consultation closes at 5 pm on Wednesday 29 June 2022 and feedback can be emailed to consult@pharmac.govt.nz.
What would the effect be?
Tixagevimab with cilgavimab (Evusheld)
Access criteria
Tixagevimab with cilgavimab would be funded for pre-exposure prophylaxis of COVID-19 for severely immunocompromised people who meet the access criteria. Prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria.
Indication – Pre-exposure prophylaxis
Access criteria - Any relevant practitioner.
Approvals are valid for patients where the prescribing clinician confirms the patient meets the following criteria and has endorsed the prescription accordingly:
All of the following:
- Patient does not currently have SARS-CoV-2 infection
AND - Either
- Patient is severely immunocompromised and considered to be at risk of inadequate immune response to SARS-CoV-2 vaccination or infection due to one of the following clinical situations:
- B-cell or T-cell depleting therapy (eg rituximab, obinutuzumab, ocrelizumab) within the previous 12 months or planned to receive within two weeks of tixagevimab and cilgavimab administration
- Receiving Bruton tyrosine kinase inhibitors
- Chimeric antigen receptor T cell recipient
- Haematopoietic stem cell transplant recipient within last 12 months, or who has chronic graft versus host disease or who requires significant ongoing immunosuppression for another reasons
- Haematologic malignancy and is on active therapy
- Lung transplant recipient (any time frame)
- Solid-organ transplant recipient within last 12 months
- Combined primary immunodeficiency syndromes (including Severe combined immunodeficiency (SCID))
- Common variable immunodeficiency (CVID) with additional T-cell defects, past opportunistic infection or requiring immunosuppressive therapy
- Newly diagnosed humoral immunodeficiency with baseline IgG < 3g/L
- HIV with a CD4 T lymphocyte cell count <200 cells/mm3
- Sphingosine 1- phosphate receptor modulator therapy (eg fingolimod) within previous 12 months
- High dose cyclophosphamide (>1g/m2) within previous 6 months.
OR
- Patient is not able to be vaccinated against COVID-19 due to a medical reason (for example a history of severe adverse reaction to a COVID-19 vaccine or components) and is considered at high risk of severe illness from COVID-19 infection.
- Patient is severely immunocompromised and considered to be at risk of inadequate immune response to SARS-CoV-2 vaccination or infection due to one of the following clinical situations:
About tixagevimab with cilgavimab
Tixagevimab with cilgavimab is currently undergoing regulatory review by Medsafe. For more information refer to the Medsafe website for the approval status of COVID-19 treatments(external link). It is anticipated that tixagevimab with cilgavimab would be available in New Zealand from July 2022, subject to approval by Medsafe.
Tixagevimab with cilgavimab is a combination of two monoclonal antibody treatments that can be used to treat immunocompromised people who are unable to mount an immune response to COVID-19 vaccination or infection.
Tixagevimab with cilgavimab for pre-exposure prophylaxis of COVID-19 was considered by our COVID-19 Treatments Advisory Group at its December 2021 and April 2022 meetings. Details of the advice we have received will be published on our website once records of these meetings are finalised. We continue to seek updated advice as evidence emerges.
Tixagevimab with cilgavimab is given as two separate and sequential intramuscular injections of tixagevimab and cilgavimab. For pre-exposure prophylaxis of COVID-19 the recommended dose is 150 mg of tixagevimab and 150 mg of cilgavimab injected into the gluteal muscle (one medicine injected into each buttock).
Emerging evidence is suggesting that tixagevimab with cilgavimab is successful in preventing COVID-19 infection in those with the BA.2 subvariant of the Omicron variant of COVID-19 that is currently dominant in New Zealand, and it may be effective preventing infections with the emerging BA.4 and BA.5 subvariants of Omicron. We continue to seek updated advice on the efficacy of treatments for different virus variants as evidence emerges.
Supply and listing
Pharmac has secured supply of 20,000 courses of tixagevimab with cilgavimab, with an option to purchase an additional 20,000 courses. Supply is expected to be delivered to New Zealand across a number of shipments. The proposed access criteria are designed to prioritise use of the initial supply of tixagevimab with cilgavimab in the most severely immunocompromised New Zealanders who are at the highest risk of poor outcomes from COVID-19.
We expect the identification of eligible people for preventive treatment with tixagevimab with cilgavimab would be mainly led by secondary care clinicians who are likely to be closely involved in their medical treatment. Administration of tixagevimab with cilgavimab to eligible people may also be supported by primary care.
As further stock becomes available, we would expect to consider widening access to include the next most at risk group of people, such as moderately immunocompromised New Zealanders. Any decision to widen access to tixagevimab with cilgavimab would be subject to a separate consultation process.
Tixagevimab with cilgavimab would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, subject to access criteria. Prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria, if approved by Medsafe, as follows.
| Chemical | Formulation | Brand | Pack size | Price |
|---|---|---|---|---|
| tixagevimab with cilgavimab | Inj 150 mg per 1.5 ml tixagevimab and Inj 150 mg per 1.5 ml cilgavimab | Evusheld |
1 |
$0 |
The Xpharm restriction would apply, meaning that community pharmacies cannot claim subsidy because Pharmac has made alternative funding arrangements.
The price and subsidy would be listed as $0 as stock has been purchased directly by Pharmac. COVID-19 treatments are funded from a dedicated budget allocated by the Government. That means COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). DHBs would need to order stock from a pharmaceutical wholesaler as required, but would not be invoiced for supply.
Sotrovimab (Xevudy)
Access criteria
Sotrovimab would be funded for the treatment of high-risk immunocompromised patients with COVID-19 infection who meet the access criteria.
All of the following:
- Patient has confirmed (or probable) symptomatic COVID-19 or has symptoms consistent with COVID-19 and is a household contact of a positive case; and
- COVID-19 is confirmed or very likely due to a sotrovimab-susceptible SARS-CoV-2 variant; and
- Patient’s symptoms started within the last 7 days; and
- Patient does not require supplemental oxygen#; and
- Treatment with a funded COVID-19 antiviral is not clinically appropriate; and
- Patient is immunocompromised* AND is not expected to mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection, regardless of vaccination status
Notes:
* As per Ministry of Health criteria(external link) of ‘severe immunocompromise’ for third primary dose
# Supplemental oxygen to maintain oxygen saturation >93% or at or above baseline for patients with chronic resting hypoxia
About sotrovimab
Sotrovimab is a monoclonal antibody treatment that could be used to treat high risk immunocompromised people who become infected with COVID-19. Sotrovimab is currently undergoing regulatory review by Medsafe. For more information refer to the Medsafe website for the approval status of COVID-19 treatments(external link). It is anticipated that sotrovimab could be available in New Zealand in July 2022, subject to approval by Medsafe.
Sotrovimab is supplied as a single dose vial for infusion after dilution. The recommended dose is 500 mg of sotrovimab administered as an intravenous infusion over 30 minutes.
Sotrovimab for the treatment of COVID-19 was considered by our COVID-19 Treatments Advisory Group at its April 2022 meeting. Details of the advice we received will be published on our website once the record of this meeting is finalised. We continue to seek updated advice as evidence emerges.
Evidence suggests that the recommended dose of sotrovimab may not successfully treat people with the BA.2 subvariant of the Omicron variant of COVID-19 that is currently dominant in New Zealand. We understand that the supplier is investigating whether a higher dose may be effective against the BA.2 subvariant of the Omicron variant of COVID-19, however results are yet to be published. Pharmac is continuing to work as quickly as possible to assess the latest information as it becomes available.
Pharmac’s portfolio approach to securing COVID-19 treatments means that not all the treatments we have secured are expected to be effective against all variants of COVID-19. As COVID-19 continues to evolve and new variants emerge, treatments such as sotrovimab that may not be effective in treating currently circulating variants may though eventuate to be effective in treating future variants. We consider it is important that sotrovimab is retained as part of New Zealand’s portfolio of COVID-19 treatments.
Supply and listing
Pharmac has secured supply of a limited volume of approximately 2,304 courses of sotrovimab, which is expected to be delivered to New Zealand in a single shipment. The proposed access criteria are designed to prioritise treatment with sotrovimab to those people most likely to benefit and who do not have other suitable treatments available.
Sotrovimab is administered via intravenous infusion. We expect the majority of sotrovimab use would occur in DHB Hospitals with the required resources and appropriate facilities. Any use of sotrovimab in outpatient settings would be led by DHBs.
Sotrovimab would be listed in Part II of Section H of the Pharmaceutical Schedule for use by DHB Hospitals as follows and would be subject to access criteria. Prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria.
| Chemical | Formulation | Brand | Pack size | Price |
|---|---|---|---|---|
| Sotrovimab | Inj 500 mg per 8ml | Xevudy | 1 | $0 |
We are not proposing the sotrovimab would be available for dispensing in the community.
The price and subsidy would be listed as $0 as stock has been purchased directly by Pharmac. COVID-19 treatments are funded from a dedicated budget allocated by the Government. That means COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). DHBs would need to order stock from a pharmaceutical wholesaler as required but would not be invoiced for supply.
Persistent SARS-CoV-2 Infection
The following access criteria for persistent SARS-CoV-2 Infection would be applied to all COVID-19 treatments listed in Part II of Section H of the Pharmaceutical Schedule. This would include:
- Nirmatrelvir with ritonavir (Paxlovid)
- Molnupiravir (Lageviro)
- Remdesivir (Veklury)
- Casirivimab with imdevimab (Ronapreve)
- Sotrovimab (Xevudy)
- Tixagevimab with Cilgavimab (Evusheld)
Initial Application – Treatment of persistent SARS-CoV-2 infection*
Access criteria - Any relevant practitioner
Approvals are valid for patients where the prescribing clinician confirms the patient meets the following criteria and has endorsed the prescription accordingly
All of the following:
- Patient has laboratory confirmed diagnosis of persistent SARS-CoV-2 infection (≥20 days); and
- Patient is immunocompromised; and
- A multidisciplinary team (including an infectious disease physician) considers the treatment plan to be appropriate.
Note: Indications marked with * are unapproved indications.
The treatment of persistent SARS-CoV-2 Infection was considered by our COVID-19 Treatments Advisory Group at its May 2022 meeting. Details of the advice we have received will be published on our website once records of this meeting are finalised.
The use of COVID-19 treatments for persistent SARS-CoV-2 Infection would be an unapproved indication. This means that when they are being used for the treatment of persistent SARS-CoV-2 infection, these medicines would need to be to be prescribed and used in accordance with section 25 of the Medicines Act 1981. This allows authorised prescribers to prescribe any medicine (approved or unapproved) for a particular patient in their care. You can read more about section 25 of the Medicines Act 1981, including the definition of authorised prescribers on the Medsafe website(external link).
Criteria would be available on the Pharmac website and we would reference the criteria in the Schedule listing for each treatment.
The proposed access criteria intend treatment of a small group of extremely immunocompromised people with persistent and remitting SARS-CoV-2 infection who are unable to clear the virus and who remain unwell. The proposed criteria would provide discretion for the multidisciplinary team caring for the patient to determine the appropriate combinations and duration of treatment.
Due to the complexity of the cases, it is expected that people with persistent SARS-CoV-2 Infection would be managed from within DHB Hospitals by specialist multidisciplinary teams.
Why we’re proposing this
Tixagevimab with cilgavimab and sotrovimab
Pharmac and the suppliers of tixagevimab with cilgavimab (AstraZeneca Limited) and sotrovimab (GlaxoSmithKline NZ Limited) have negotiated agreements to secure supply of fixed amounts of tixagevimab with cilgavimab and sotrovimab for the treatment of immunocompromised people at risk of poor outcomes from COVID-19. The proposed criteria reflect the supply volumes that would initially be available.
COVID-19 is an area of rapidly evolving evidence and knowledge. We understand that there may be additional groups of people that could benefit from treatment with tixagevimab with cilgavimab or sotrovimab who may fall outside the currently proposed criteria. Any future proposals for wider access criteria would be subject to a separate consultation process.
The exact distribution mechanisms that would be used to make tixagevimab with cilgavimab and sotrovimab available to patients are being developed. We are working with the Ministry of Health to confirm the best options. We are particularly interested in receiving feedback on how to achieve distribution that is equitable.
Serology testing
We have considered whether serology testing could be used to identify and target COVID-19 treatments such as tixagevimab with cilgavimab and sotrovimab to high-risk immunocompromised patients who may benefit from treatment. We are not proposing to include this in the access criteria at this stage. We are aware there are a number of challenges with accessing serology testing and interpreting the results of serology testing in the context of the ongoing Omicron outbreak and this may limit its use.
Persistent COVID-19 infection
Pharmac has received feedback from its COVID-19 Treatments Advisory Group that there is a small group of extremely immunocompromised people in New Zealand that are at risk of persistent and remitting SARS-CoV-2 infection if they become infected. The COVID-19 Treatments Advisory Group considered that it would be important that treatments are available for these patients.
We did consider if Pharmac’s Exceptional Circumstances Framework could be used to consider funding requests for individuals with persistent and remitting SARS-CoV-2 infection. We are proposing access through the Hospital Medicines List to provide timely treatment for high-risk patients and to reduce the administrative burden on clinicians involved in the care of these patients.
To provide feedback
Please send us an email: consult@pharmac.govt.nz by 5 pm on Wednesday 22 June 2022.
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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