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

Medicines COVID-19 Decision

What we’re doing

We have made the decision to widen the access criteria for tixagevimab with cilgavimab (Evusheld) to include the treatment of COVID-19 infection. 

This will mean that the same groups of people who are currently able to access tixagevimab with cilgavimab for the preexposure prophylaxis of COVID-19 will be eligible to receive tixagevimab with cilgavimab for the treatment of COVID-19 if they become infected with COVID-19. 

Much of the tixagevimab with cilgavimab stock that has been secured by Pharmac expires on 31 December 2022 (approximately 8,000 300mg courses). A further 6500 300mg courses expire later in 2023. We know that many of the eligible population for tixagevimab with cilgavimab have not received pre-exposure prophylaxis to date. As COVID-19 infection case numbers in New Zealand are predicted to continue to rise in the next two weeks, prior to the summer holiday period, we want to ensure that severely immunocompromised people at risk of severe illness from COVID-19 infection have the option to access treatment with tixagevimab with cilgavimab if treatment is appropriate. 

Pharmac is aware that cases of Omicron subvariants of COVID-19 that may not be susceptible to tixagevimab with cilgavimab are increasing in New Zealand. While tixagevimab with cilgavimab retains efficacy against some circulating variants supply will remain available for distribution. Pharmac continues to monitor the ongoing efficacy against new variants. 

Medsafe has previously granted provisional approval(external link) to tixagevimab with cilgavimab for use in New Zealand for the preexposure prophylaxis of COVID-19. We understand that the supplier of tixagevimab with cilgavimab (AstraZeneca) has submitted an application to Medsafe for tixagevimab with cilgavimab in the treatment of COVID-19 in August 2022, which is currently under review. Any use of tixagevimab with cilgavimab for the treatment of COVID-19 prior to any Medsafe approval would be an unapproved indication. 

Tixagevimab with cilgavimab will continue to be available through Te Whatu Ora – Health New Zealand hospitals and primary care providers.

Detail about this decision

From tomorrow (15 December 2022) the following access criteria will apply to tixagevimab with cilgavimab. The current criteria have been updated to include both preexposure prophylaxis and treatment of COVID-19

Indication – Pre-exposure prophylaxis or treatment of COVID-19

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: 

Notes:

* potent B-cell or T-cell depleting therapy such as rituximab, obinutuzumab, ocrelizumab, bendamustine, fludarabine, cladribine, alemtuzumab, anti-thymocyte globulin, CamPath antibody treatment, anti-B-cell bispecific antibody, CAR T-cells or BiTE antibody treatment 

Funded dosing:

  1. Medsafe has provisionally approved Evusheld for pre-exposure prophylaxis at a dose of 300mg IM (150mg tixagevimab and 150mg cilgavimab).
  2. Maximum funded single dose of 600mg IM (300mg tixagevimab and 300 mg cilgavimab) permitted for pre. This dose is unapproved and under consideration by Medsafe.
  3. Repeat dosing not currently funded, this remains under consideration.
  4. Evusheld for use in treatment of COVID-19 infection is unapproved and under consideration by Medsafe. 

Accessing supply of tixagevimab with cilgavimab

There have been no changes to the way in which tixagevimab with cilgavimab is accessed. Further information regardingthe administration process for tixagevimab with cilgavimab is available on the Te Whatu Ora website.(external link)

Information is also available on the 25 August Decision on access criteria for tixagevimab with cilgavimab page on the Pharmac website

Where to get more information

Most up to date information regarding all COVID-19 treatments

Additional information about Evusheld is available on Health Navigator(external link)