Original Title: Validation du cadre de gestion des pénuries d’immunoglobulines humaines non spécifiques

Authors' objectives: During the public health crisis caused by coronavirus disease (COVID-19), production and supply problems might lead to a reduction in immunoglobulin reserves or an immunoglobulin shortage in Québec. In order to manage such a situation, the Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d’excellence en santé et en services sociaux 1) to validate the rules proposed by the nonspecific human immunoglobulin (Ig) shortage management framework of the emergency measures plan developed by MSSS’s Direction de la biovigilance et de la biologie médicale and 2) to determine whether an additional level of reserve availability should be created between the yellow and red levels in the current management framework to better meet the needs associated with the COVID-19 pandemic.

Authors' results and conclusions: The rules in the immunoglobulin shortage management framework of the emergency measures plan are optimal for 12 of the 30 indications. However, changes to the conditions of use of immunoglobulins are proposed for the following 18 indications: primary immune deficiencies, including severe immunodeficiency, combined immunodeficiency, combined immunodeficiency with associated or syndromic features, genetically or non-genetically characterized agammaglobulinemia, common variable immune deficiency, hyper-IgM syndrome, isolated primary IgG deficiency, LRBA or CTL4A deficiency, WHIM syndrome and Good syndrome, hypogammaglobulinemia secondary to hematologic cancer, Kawasaki disease, acute immune thrombocytopenia, chronic immune thrombocytopenia, fetal or neonatal alloimmune thrombocytopenia, immune thrombocytopenia during pregnancy, autoimmune hemolytic anemia, hemolytic disease of the newborn or fetus, autoimmune neutropenia, allogeneic hematopoietic stem cell transplant, parvovirus B19-induced red cell aplasia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, Rasmussen’s encephalitis, bullous dermatoses and Stevens-Johnson syndrome/toxic epidermal necrolysis. As well, the addition of an indication ‒ multisystem inflammatory syndrome in children temporally associated with COVID-19 ‒ is recommended under the same conditions of use as for Kawasaki disease. The creation of an additional level of reserve availability between the yellow and red levels does not appear necessary. However, the lime green and yellow levels should be adjusted according to different situations and in light of the many factors that can set the Ig shortage management plan in motion. Conclusion The purpose of this report was to provide the MSSS with guidance regarding the rules to be included in the Ig shortage management framework of the emergency measures plan. An examination of the entirety of the data led to the development of recommendations on the indications to be included in the management framework, the conditions of use for each indication, and the reserve availability levels. In addition, several ethical considerations to be taken into account when allocating limited resources were identified. In the event of a decrease in Ig reserve availability or of an Ig shortage, the recommendations in this report will promote fair and equitable use of these products in order to maximize the health and well-being of those who need them in Québec.

Authors' recommendations: To limit the impact of a reduction in Ig reserves or of an Ig shortage on patients who use these products, MSSS should put conditions in place that favour the dissemination and implementation of the Ig shortage management framework of the emergency measures plan within Québec’s system of health and social services. MSSS should also ensure institutional compliance with the rules proposed therein in order to standardize prescribing practices among prescribers and institutions, to promote optimal Ig use, and to ensure fair and equitable access for those most in need of this treatment. To promote optimal Ig use, the standardized AH-240 and AH-241 forms should be used for all IVIg prescriptions.

Authors' methods: The validation of the rules proposed by the nonspecific human immunoglobulin shortage management framework was based on the clinical recommendations in the five immunoglobulin optimal use guides developed outside of the context of the COVID-19 pandemic by INESSS, as well as on contextual information and stakeholders’ perspectives regarding the current public health crisis. The guides contain clinical recommendations on the optimal use of immunoglobulins for indications in neurology, hematology, clinical immunology, dermatology and rheumatology. The validation of the information and rules in the immunoglobulin shortage management framework was enhanced by gathering the perspectives of various experts, including clinicians and an ethicist, and took the legislative, regulatory, organizational and economic context specific to Québec into account. The advisability of creating an additional phase between the yellow and red levels was assessed in light of the perspectives of the various stakeholders and on the basis of the contextual data. In addition, as part of this work, a narrative review of the ethical issues surrounding immunoglobulin shortages was conducted.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/validation-du-cadre-de-gestion-des-penuries-dimmunoglobulines-humaines-non-specifiques.html

Year Published: 2021

URL for published report: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/INESSS_Penuries_Ig_Avis_VF.pdf

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: L'Institut national d'excellence en sante et en services sociaux (INESSS)