EVUSHELD (tixagévimab/cilgavimab) - COVID-19

Key points

Approval of reimbursement subject to susceptibility of the SARS-CoV-2 strain to EVUSHELD (tixagevimab/cilgavimab) and where alternatives cannot be used due to contraindications for the following indication: “treatment of COVID-19 for adults and adolescents (aged 12 years and over and weighing at least 40 kg), who do not require oxygen supplementation, and who are at an increased risk of progression to a severe form of COVID-19”. Indeed, despite the loss of activity on the Omicron sublineage BA.5, predominant in France at the time of the assessment, which will render its use very marginal or even useless, considering the unpredictability of the epidemic situation and the emergence of more susceptible variants, it is vital to retain access to as many treatment options, including the tixagevimab/cilgavimab association, as possible, even if they may not be deemed to be relevant at the time of assessment.

Therapeutic improvement?

Therapeutic improvement in the care pathway for treatment-susceptible strains of SARS-CoV-2 and where alternatives cannot be used due to contraindications.

Role in therapeutic strategy?

Given the current predominant circulation of the BA.5 sublineage in France (93% of screened tests), the early curative treatment strategy aimed at preventing progression to a severe form in at-risk patients is based on:

• PAXLOVID (nirmatelvir/ritonavir), as a first-line approach, regardless of the SARS-CoV-2 variant or sublineage causing the infection;
• In the event of contraindication:
  • VEKLURY (remdesivir), as an alternative to PAXLOVID (nirmatrelvir/ritonavir) and given the limited activity of EVUSHELD against the Omicron BA.4 and BA.5 sublineages;
  • EVUSHELD (tixagevimab/cilgavimab) for patients for whom PAXLOVID (nirmatelvir/ritonavir) is strictly contraindicated and in cases of renal contraindication or failure access to VEKLURY (remdesivir)Erreur ! Signet non défini. or once again in the context of infection with a documented subvariant for which EVUSHELD retains significant neutralising activity in vitro.

Role of the medicinal product

The Committee deems that EVUSHELD (tixagevimab/cilgavimab) is a potential treatment option, subject to susceptibility of the SARS-CoV-2 strain to EVUSHELD (tixagevimab/cilgavimab) and where alternatives cannot be used due to contraindications, for the treatment of COVID-19 for adults and adolescents (aged 12 years and over and weighing at least 40 kg), who do not require oxygen supplementation, and who are at an increased risk of progression to a severe form of COVID-19.

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

The proprietary medicinal product EVUSHELD (tixagevimab/cilgavimab) must be administered at the earliest possible opportunity no later than 7 days following symptom onset (see SPC, “Posology and method of administration” section).

The summary of product characteristics (SPC) and the Risk Management Plan (RMP) must be adhered to.

For pregnant or breastfeeding women, or women of reproductive age not using contraception, this medicinal product must be used in accordance with the SPC.

Special recommendations

The Committee points out that use of anti-COVID-19 treatments does not exempt patients from adhering to control and social distancing measures within the framework of COVID-19 prevention, and that EVUSHELD (tixagevimab/cilgavimab) is not intended to be used as a substitute for SARS-CoV-2 vaccination.

The Committee relays the request from patient associations around the need to facilitate access to COVID-19 treatment in community settings.

Due to the rapidly evolving epidemiological context, the Committee would like to see regular updates of the national guidelines in order to adapt the COVID-19 care strategy according to data on the susceptibility of the variants in circulation to the treatments available.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 14 mars 2023. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir le traitement de la COVID-19 chez les adultes et les adolescents qui ne nécessitent pas de supplémentation en oxygène et qui présentent un risque accru d’évolution vers une forme sévère de la COVID-19.

La CEESP n’a été en mesure de conclure sur le niveau d’efficience du produit en raison d’une incertitude globale majeure retenue.

Compte-tenu de la forte incertitude relative à l’évolution du contexte épidémiologique et du fait que le produit n’est plus recommandé à ce jour, les résultats de l’analyse d’impact budgétaire ne sont pas retenus.

EVUSHELD - Avis économique (pdf)