Original Title: Avis: Cutaquig (préparation d’immunoglobulines humaines) Avis d’introduction à la Liste des produits du système du sang du Québec

Authors' objectives: The Institut national d'excellence en santé et en services sociaux (INESSS) carried out an evaluation of Cutaquig, a preparation of immunoglobulins administered by subcutaneous injection for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) who require immune globulin replacement therapy.

Authors' results and conclusions: EFFICACY: • No severe infections during Ig replacement therapy with Cutaquig; • Number of non-severe infections: 3.43 per patient/year; • Results comparable to those for the other immunoglobulin preparations that are currently available. Very low quality of evidence SAFETY: • No serious adverse events associated with replacement therapy with Cutaquig; • Results comparable to those for the other immunoglobulin preparations that are currently available. Very low quality of evidence QUALITY OF LIFE: • Little or no change in the quality-of-life scores following replacement therapy with Cutaquig; Very low quality of evidence ASSESSMENT OF THERAPEUTIC VALUE: • The efficacy of subcutaneously administered immunoglobulin concentrates is equivalent to that of those administered intravenously; • The subcutaneous route is generally associated with a better quality of life than the intravenous route; • The experts consulted recognize the therapeutic value of Cutaquig as replacement therapy in cases of PID or SID. Ig preparations are considered interchangeable; • However, according to the members of the expert group on blood system products, guidance on the use of Ig preparations is an issue. They stress that, regardless of the product chosen for distribution, a patient education program should be put in place. EFFICIENCY: • Based on a comparison of prices per gram of protein, Cutaquig is more efficient than its comparators.

Authors' recommendations: Deliberation concerning Cutaquig: The members of the Comité scientifique permanent de l'évaluation des médicaments aux fins d'inscription unanimously recognized the therapeutic value of Cutaquig for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) who require immune globulin replacement therapy. Consequently, the members are unanimously of the opinion that the blood system product Cutaquig should be added to the Liste des produits du système du sang du Québec. Reasons for the unanimous position • Two other subcutaneous Ig preparations are presently on the Liste des produits du système du sang du Québec. • The therapeutic value of Cutaquig was considered comparable to that of the currently available products, based mainly on the efficacy, safety and quality-of-life data examined. • Based on a comparison of prices per gram of protein, Cutaquig is more efficient than its comparators. • Cutaquig could lead to cost reductions of $1 to $14 million during each of the next three years, depending on the market shares captured.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/thematiques/sante/produits-du-systeme-du-sang/produits-du-systeme-du-sang/avis-au-ministre.html#c4361

Year Published: 2019

URL for published report: https://www.inesss.qc.ca/thematiques/sante/produits-du-systeme-du-sang/produits-du-systeme-du-sang/avis-au-ministre.html#c4361

Requestor: Minister of Health

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