Decision on access criteria for tixagevimab with cilgavimab (Evusheld) for 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: 

1. Either
   1. Patient does not currently have COVID-19 infection and requires pre-exposure prophylaxis; OR
   2. Patient has confirmed (or probable) symptomatic COVID-19 and has not had tixagevimab with cilgavimab in the last 6 months; 
      
      AND
      
      
2. Either:
   1. Patient is severely immunocompromised and considered to be at risk of inadequate immune response to SARS-CoV-2 vaccination or infection due to ANY of the following clinical situations: 
      1. heart or lung transplant recipient (any time frame)
      2. other solid-organ transplant recipient with any of the following:
         1. transplant received within the last 12 months
         2. receiving induction immunosuppressant treatment (any timeframe)
         3. receiving maintenance immunosuppressant treatment that includes mycophenolate mofetil (any timeframe)
         4. treated for graft rejection within the past 12 months
      3. allogenic haematopoietic stem cell transplant recipient with any of the following:
         1. transplant received within last 12 months
         2. has chronic graft versus host disease
         3. requires significant ongoing immunosuppression for another reason
      4. autologous haematopoietic stem cell transplant received within the last 12 months
      5. multiple myeloma on active and/or maintenance treatment
      6. combined primary immunodeficiency syndromes (including Severe Combined Immunodeficiency (SCID))
      7. common variable immunodeficiency (CVID) with additional T-cell defects, past opportunistic infection or requiring immunosuppressive therapy
      8. diagnosed humoral immunodeficiency with baseline IgG < 3g/L
      9. HIV with a CD4 T lymphocyte cell count <200 cells/mm3
      10. person who is receiving:
          1. potent B-cell or T-cell depleting therapy within the previous 12 months or planned to receive within two weeks of tixagevimab and cilgavimab administration*
          2. a B-cell inhibitor (e.g. venetoclax or a Bruton tyrosine kinase inhibitor)
          3. ruxolitinib
          4. regular 3-4-weekly intravenous or subcutaneous immunoglobulin
          5. sphingosine 1- phosphate receptor modulator therapy (eg fingolimod) within previous 12 months
          6. high dose cyclophosphamide (>1g/m2) within previous 6 months.
      11. History of previous persistent SARS-CoV-2 infection (defined as a laboratory confirmed diagnosis of persistent SARS-CoV-2 infection persisting ≥20 days) that has since resolved
          
          OR
          
          
   2. Person is both
      1. not able to be vaccinated against COVID-19 due to medical contraindication (for example a history of severe adverse reaction to a COVID-19 vaccine or its components) AND
      2. is considered at high risk of severe illness from COVID-19 infection. 

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.