Original Title: Avis - Évaluation d’HyQviaMC (immunoglobulines humaines normales à 10 % et hyaluronidase) – déficit immunitaire primaire et secondaire

Authors' objectives: At the request of the manufacturer, Takeda Canada Inc., the Institut national d’excellence en santé et en services sociaux (INESSS) evaluated HyQvia™, a combination of human normal immunoglobulin 10% and hyaluronidase for subcutaneous (SC) administration. This product is indicated as a replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adults. This is the first evaluation of this immunoglobulin preparation.

Authors' results and conclusions: RESULTS: 1. (Efficacy): Pivotal, extension, and real-world studies show that the annual rate of severe acute bacterial infections was below the cut-off value of 1 in patients with PI and SI treated with HyQvia™. • The overall annual infection rate ranged from 0.88 to 2.99 across studies. • These results are comparable to those for other immunoglobulin preparations currently available in Québec. • The quality of the studies considered ranges from low to moderate, and the strength of the evidence is low. 2. (Expert perspective): • Despite the low quality of the studies, the experts consulted consider the efficacy of HyQvia™ in preventing infections and its safety profile to be comparable to those of the currently available immunoglobulin preparations. 3. (Patient perspective): • Immunoglobulin replacement therapy by IV infusion (IVIg) or SC injection (SCIg) is experienced as a burden by many patients. 4. (Organizational dimension): • The administration of HyQvia™ requires that patients be properly trained. The experts noted that the use of HyQvia™ requires a higher level of skill than that required for the administration of conventional SCIg.

Authors' recommendations: The members of the Comité scientifique de l’évaluation des médicaments aux fins d’inscription (CSEMI) s recognize that HyQvia™ addresses a health need in the target population, including some patients who have difficulty with the frequency of administration of the currently distributed SCIg preparations. The product could also help address supply issues. INESSS recommends that HyQvia™ be included on the Liste des produits du système du sang du Québec as a replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in adults. Note concerning the recommendation From a distributive justice perspective, coverage of HyQvia™ for the requested indication would be a responsible, fair and equitable decision, provided the cost of using it does not exceed the cost of using the other immunoglobulin preparations currently distributed in Québec, in the next call for tenders.

Authors' methods: Published trials and manufacturer data were reviewed to assess the efficacy, safety and cost-effectiveness of HyQvia™. Contextual and experiential data from expert consultations are presented as well.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-dhyqviamc-immunoglobulines-humaines-normales-a-10-et-hyaluronidase-deficit-immunitaire-primaire-et-secondaire.html

Year Published: 2022

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-dhyqviamc-immunoglobulines-humaines-normales-a-10-et-hyaluronidase-deficit-immunitaire-primaire-et-secondaire.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec