PBAC's latest decision on Tixagevimab and cilgavimab: Recommended with restriction (2022). Considered for Pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents aged 12 years and older who are severely immunocompromised or in whom vaccination with all currently authorised COVID-19 vaccines is contraindicated.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2022
Submissions
1
2022 → 2022
Eligible population
Unvaccinated, medically stable adults aged 12 years and older who are severely immunocompromised (including those with haematologic neoplasms, post-transplant status, primary immunodeficiency, advanced HIV, those on long-term dialysis, high-dose corticosteroids, or those who have received immunocompromising treatments such as chemotherapy, anti-CD20 antibodies, or selected csDMARDs in the last 3–12 months) or in whom vaccination with all currently authorised COVID-19 vaccines is contraindicated.
Therapy area
Infectious disease
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Proportion of patients developing PCR-confirmed symptomatic SARS-CoV-2 illness
Pivotal trial size
5,254 patients
Key trials
PROVENT
Comparator
placebo (representative of a no PrEP scenario)
Economic model
Not modelled
ICER note
No ICER stated in the document. The PSD does not present a numeric incremental cost-effectiveness ratio.