Tixagevimab And Cilgavimab
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.
Decisions on record
- Meeting Dec 2022 Not recommended Pre-exposure prophylaxis (PrEP) against COVID-19 infection in severely immunocompromised individuals aged 12 years or older no PSD
- Meeting Sep 2022 Not recommended Pre-exposure prophylaxis of COVID-19 in severely immunocompromised individuals aged 12 years or older
From the public summary
The PBAC did not recommend PBS listing of tixagevimab and cilgavimab for use as pre- exposure prophylaxis against COVID-19 infection because of uncertainty about the clinical place in prevention and appropriate PBS eligibility criteria; uncertainty about the dose and duration of protection against the Omicron variants of the SARS-CoV-2 virus; a lack of information on the safety and effectiveness of the proposed repeat dosing regimen; a high and highly …PSD · Sep 2022
The PBAC acknowledged concerns regarding the negative effects of shielding behaviour in severely immunocompromised individuals, which may include withdrawal from social contact, as well as detrimental impacts on employment, mental health and quality of life. The PBAC considered these concerns important and relevant, however there were no data presented to demonstrate tixagevimab and cilgavimab would lead to changes in shielding behaviour.PSD · Sep 2022
A modelled cost-utility analysis was conducted to inform consideration of the performance of tixagevimab and cilgavimab for PrEP against COVID-19, relative to placebo (as a proxy for no PrEP) from an economic perspective. The submission did not present its own model but did provide comment on the model included in the rapid HTA commissioned by the Department in late November 2021.PSD · Sep 2022
The analysis captures the following benefits of treatment with tixagevimab and cilgavimab: • Reduced risk of developing symptomatic COVID-19PSD · Sep 2022
The submission implicitly suggests that tixagevimab 300 mg and cilgavimab 300 mg administered every 6 months is superior in terms of effectiveness compared to placebo for PrEP against symptomatic COVID-19 caused by any SARS-CoV-2 variant.PSD · Sep 2022
The submission does not make any explicit claim in regard to the safety of tixagevimab 300 mg and cilgavimab 300 mg administered every 6 months.PSD · Sep 2022
The revised submission did not make any reference to a risk sharing arrangement.PSD · Sep 2022
The evaluation identified the following potential clinical and financial risks:PSD · Sep 2022
Cost-effectiveness
No ICER stated in the document. The PSD does not present a numeric incremental cost-effectiveness ratio.
Decision context
PopulationUnvaccinated, 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2022 | Not recommended | placebo (representative of a no PrEP scenario) | — | RCT · Proportion of patients developing PCR-confirmed symptomatic SARS-CoV-2 illness |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severely immunocompromised patients or those with vaccine contraindications; TGA label includes all aged 12+ years.