IDEFIRIX (imlifidase)

Key points

Favourable opinion for the reimbursement in the desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor, with use to be reserved for patients unlikely to be transplanted under the current available kidney allocation system, including prioritisation programmes for highly sensitised patients.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

In highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor, the objective of HLA desensitisation is to eliminate as many anti-HLA antibodies from the plasma as possible in order to make transplantation possible.

Desensitisation is currently based on protocols using apheresis and/or medicinal products used off-label. However, this technique is relatively little used due to its limitations:

• Desensitisation protocols are not standardised and there is no consensus relating to this subject. They are considered on a case-by-case basis depending on the management strategies specific to each transplant unit,
• The medicinal products used in the protocols have no MA in this indication (B-cell depleting agents (mainly rituximab), immunomodulatory therapies (intravenous immunoglobulins [Ig IV])),
• It requires repeated doses for several weeks or months prior to transplantation before a transplant can be considered,
• It does not always enable a sufficient reduction in antibodies to allow transplantation,
• It can cause serious adverse effects (bleeding risk, risk of infection for apheresis techniques, risk of infection for immunomodulators).

These protocols are almost exclusively used for live donor kidney transplants since they are impossible to implement urgently to achieve crossmatch conversion from positive to negative in the event of a deceased donor transplant. In some cases, a desensitisation protocol can be put in place while awaiting a deceased donor transplant for which the crossmatch is “acceptable”. However, this is very rarely done in practice given a moderate and transient efficacy.

Role of the medicinal product in the care pathway

The proprietary medicinal product IDEFIRIX (imlifidase) is a first-line treatment in the desensitisation strategy for highly sensitised adult kidney transplant patients. In accordance with its marketing authorisation, its use is reserved for patients with positive crossmatch against an available deceased donor and unlikely to be transplanted under the current available kidney allocation system, including prioritisation programmes for highly sensitised patients.

In the absence of comparative data in patients eligible for these experimental desensitisation techniques, despite the low prevalence in the event of deceased donor transplant, the role of imlifidase compared to these techniques should be determined on the basis of the patient’s profile and available efficacy and safety data.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 24 mai 2022.

L’évaluation concerne la population des patients adultes hyperimmunisés en attente d’une transplantation rénale ayant un crossmatch positif pour les antigènes d’un greffon disponible de donneur décédé, ayant déjà reçu une désimmunisation sans succès ou chez qui une désimmunisation n’est pas possible. L’évaluation porte sur une population plus restreinte que l’indication de l’AMM.

La Commission évaluation économique et de santé publique conclut que l’efficience du produit n’est pas démontrée en raison de l’incertitude globale majeure associée à l’estimation des résultats et de la réserve méthodologique majeure formulée.

> IDEFIRX - Avis économique (pdf)