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HYQVIA (normal human immunoglobulin), multi-purpose immunoglobulin combined with recombinant human hyaluronidase
Reason for request
Insufficient clinical benefit to justify its reimbursement for children and adolescents (< 18 years) for replacement therapy for primary immunodeficiency
High clinical benefit but no proven clinical added value in adults for hypogammaglobulinaemia before or after allogeneic haematopoietic stem cell transplantation.
Insufficient clinical benefit to justify reimbursement for this indication in children (< 18 years)
- HYQVIA has been granted a marketing authorisation for children and adolescents (aged from 0 to 18 years) for replacement therapy for primary immunodeficiency.
- It differs from other immunoglobulins by its lower administration frequency: a single injection every 3 to 4 weeks, whereas other subcutaneous immunoglobulins have a weekly administration schedule.
- Its observed efficacy is similar to that of other immunoglobulins, but not demonstrated failing a comparative study versus other normal human immunoglobulins.
- In children, uncertainties concerning the impact of recombinant human hyaluronidase on fertility and the lack of follow-up on safety (not more than 3.3 years of exposure), although the treatment would be prescribed on a long-term basis, mean that HYQVIA cannot be assigned a role in the therapeutic strategy, while therapeutic alternatives that are equally effective and do not involve this uncertainty are available.
- HYQVIA has been granted an indication extension for children and adults for the treatment of hypogammaglobulinaemia before or after allogeneic haematopoietic stem cell transplantation.
- It differs from other immunoglobulins by its lower administration frequency: a single injection every 3 to 4 weeks, whereas other subcutaneous immunoglobulins have a weekly administration schedule.
- Its observed efficacy is similar to that of other immunoglobulins, but not demonstrated failing a comparative study versus other normal human immunoglobulins.
- In children, uncertainties on the impact of recombinant human hyaluronidase on fertility and the lack of follow-up on safety (not more than 3.3 years of exposure), although the treatment would be prescribed on a long-term basis, mean that HYQVIA cannot be assigned a role in the therapeutic strategy, while therapeutic alternatives that are equally effective and do not involve this uncertainty are available.
Clinical Benefit
| Substantial |
Le service médical rendu par HYQVIA est important chez l’adulte dans le « traitement substitutif de l’hypogammaglobulinémie chez des patients avant ou après une transplantation de cellules souches hématopoïétiques allogènes », et aux posologies de l’AMM. |
| Insufficient |
Le service médical rendu par HYQVIA 100 mg/ml est insuffisant pour justifier d’une prise en charge pas la solidarité nationale :
|
Clinical Added Value
| no clinical added value |
Bien qu’il n’y ait aucune données spécifiques dans cette indication mais au regard des données disponibles pour les autres Ig, la Commission considère que HYQVIA n’apporte pas d’amélioration du service médical rendu (ASMR V) dans la stratégie thérapeutique de prise en charge du traitement substitutif de l’hypogammaglobulinémie avant ou après une transplantation de cellules souches hématopoïétiques allogènes, de l’adulte uniquement. La stratégie thérapeutique comprend les comparateurs cliniquement pertinents cités au chapitre 06. |
