EVUSHELD (tixagévimab/cilgavimab) - COVID-19

Key points

Favourable opinion for reimbursement in the event of a susceptible SARS-CoV-2 strain, for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg with immune deficiency related to a disease or treatments and demonstrating no or low response to a complete vaccination regimen in accordance with current guidelines OR not eligible for vaccination and at increased risk for severe COVID-19.

What therapeutic improvement?

Therapeutic improvement in the management of the disease, in the event of a SARS-CoV-2 strain susceptible to the treatment.

Role in the care pathway?

Currently, vaccination combined with protective measures are the main pillars in the management of COVID-19, in order to prevent infection with SARS-CoV-2 and the development of symptomatic COVID-19 that may potentially progress towards a severe form of the disease.

However, recent studies have shown that approximately 50% of immunocompromised individuals (depending on the type of immunosuppression) having received a complete vaccination regimen were seronegative after the third dose of vaccine. Furthermore, in view of the emergence of new variants of concern (which may be less susceptible to currently available vaccines), other preventive and curative antiviral treatments that can help reduce the risk of developing severe forms of the disease, hospitalisations and deaths, constitute an additional weapon to that of vaccination in order to effectively fight the pandemic, particularly in individuals demonstrating no or low response to vaccination.

Role of the medicinal product in the care pathway

Based on available data from the PROVENT clinical trial, having demonstrated:

• a beneficial effect in terms of an approximately 80% reduction in the incidence of virologically confirmed (positive nasopharyngeal RT-qPCR test) symptomatic SARS-CoV-2 infection, occurring after injection and prior to day 183 following injection of the investigational treatment;
• in vitro data suggesting a maintained activity of EVUSHELD (tixagevimab/cilgavimab) against Omicron subvariant BA.2 (currently the dominant subvariant in France, 98.6% of screened tests);

the Committee considers that EVUSHELD (tixagevimab/cilgavimab) could be a therapeutic option, providing that the SARS-CoV-2 strain is susceptible to the tixagevimab/cilgavimab combination, for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg with immune deficiency related to a disease or treatments and demonstrating no or low response to a complete vaccination regimen in accordance with current guidelines OR not eligible for vaccination and at increased risk for severe COVID-19.

Refer to the national guidelines in terms of the strategy for the use of prophylactic and curative treatments for COVID-19.

It should be noted that guidelines on the conditions for use of anti-COVID-19 treatments will soon be issued by the ANRS-MIE or the DGS (Ministry of Health).

The Summary of Product Characteristics (SPC) and the Risk Management Plan (RMP) must be complied with.

The use of this medicinal product in pregnant or breast-feeding women, or in women of childbearing potential not using contraception must comply with the SPC.

Special recommendations

The Committee highlights the fact that the use of anti-COVID-19 treatments does not dispense with the need for patients to comply with protective and physical distancing measures in the context of control of COVID-19 and that EVUSHELD (tixagevimab/cilgavimab) is not intended to be used as a substitute for vaccination against SARS-CoV-2.

The Committee endorses the requests of patient associations relative to the need to facilitate access to COVID-19 treatment in the non-hospital setting.

Due to the rapidly evolving epidemic context, the Committee would like to see regular updating of national guidelines in order to adapt the management strategy for COVID-19 based on data on the susceptibility of circulating variants to available treatments.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 30 août 2022.  

L’évaluation porte sur une indication plus restreinte que l’AMM, mais superposable à la demande de remboursement à savoir : en prophylaxie pré-exposition de la COVID-19 chez les adultes et les adolescents (âgés de 12 ans et plus pesant au moins 40 kg) : 

• ayant un déficit de l’immunité lié à une pathologie ou à des traitements et insuffisamment ou non répondeurs après un schéma vaccinal complet conformément aux recommandations en vigueur ; 
• ou non éligibles à la vaccination et qui sont à haut risque de forme sévère de COVID-19.  

 La CEESP conclut que l’évaluation économique déposée par l’industriel ne permet pas de démontrer l’efficience de tixagevimab/cilgavimab associé aux soins standards dans l’indication pour laquelle l’industriel demande le remboursement en raison d’une incertitude globale majeure. 

Au prix public du tixagevimab/cilgavimab, et selon les parts de marchés prévisionnelles envisagées par l’industriel, la mise à disposition du tixagevimab/cilgavimab représente une augmentation des dépenses de l’assurance maladie de 270% dans cette indication, pour une population cible estimée à 350 000 patients à 1 an.

EVUSHELD - Avis économique (pdf)