Original Title: Avis: Évaluation de Fibryga (concentré de fibrinogène humain) - déficit acquis en fibrinogène

Authors' objectives: At the request of the manufacturer, Octapharma Canada Inc., the Institut national d’excellence en santé et en services sociaux (INESSS) evaluated Fibryga™, a human fibrinogen concentrate. This product is indicated “for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia” and “as a complementary therapy during the management of uncontrolled severe bleeding in patients with acquired fibrinogen deficiency in the course of surgical interventions”. The present evaluation concerns the indication involving acquired fibrinogen deficiency.

Authors' results and conclusions: RESULTS: (1. Sociocultural and populational dimensions): Acquired fibrinogen deficiency, also known as acquired hypofibrinogenemia, is usually caused by the consumptionof coagulation factors following major bleeding. Acquired hypofibrinogenemia can occur unpredictably in adults and children during surgical interventions, major trauma, during the postpartum period, and in certain diseases. (2. Clinical dimension Efficacy): The main efficacy and safety data on the treatment of acquired hypofibrinogenemia in the surgical context come from the Canadian study FIBRES, considered to be of good methodological quality, which compared fibrinogen concentrate and cryoprecipitate in cardiac surgery with cardiopulmonary bypass. The results showed that a dose of 4 g of fibrinogen concentrate is noninferior to 10 units of cryoprecipitate for the management of perioperative bleeding in cardiac surgery with extracorporeal circulation.(2: Safety): The safety profile of fibrinogen concentrate is considered acceptable and comparable to that of cryoprecipitate. • However, the use of cryoprecipitate is still associated with the rare risk of transfusion reactions or its contamination with an emerging pathogen. These risks are considered very low by the experts consulted and do not call into question the use of cryoprecipitate in Québec. (3: Expert perspective): The experts note that the FIBRES study’s conclusion is that a dose of 4 g of fibrinogen concentrate is noninferior to 10 units of cryoprecipitate in the context of cardiac surgery with extracorporeal circulation. However, these data do not establish that these doses are the minimum quantities needed to treat acquired hypofibrinogenemia. • The experts consulted consider Québec’s blood system to be very safe. The risks of transmission of infectious agents and of transfusion reactions do exist but are extremely rare. • According to the experts, the faster administration of fibrinogen concentrate by 0.40 h compared to cryoprecipitate in the FORMA-05 study is of the order of what is expected when fibrinogen concentrates are prepared in the operating room compared to those ordered and prepared at the blood bank. (4. Organizational dimension): Fibrinogen concentrates could reduce operating room administration times in the event of acquired hypofibrinogenemia if they are distributed in a decentralized manner, if the operating room is adequately equipped, and if the staff is adequately trained. (5. Economic dimension): Cost-effectiveness analysis • At the price submitted by the manufacturer, Fibryga™ is a more cost-effective treatment option than the cryoprecipitate currently used in Québec for the treatment of acquired fibrinogen deficiency. Budget impact analysis • At the price submitted by the manufacturer, distributing Fibryga™ for the management of acquired hypofibrinogenemia could result in an estimated reduction of $7.4 million in expenditures over the next 3 years.

Authors' recommendations: In light of the available data, INESSS recommends that the fibrinogen concentrate Fibryga™ be added to the Liste des produits du système du sang du Québec as complementary therapy during the management of severe uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency

Authors' methods: Data from the scientific literature and those provided by the manufacturer were reviewed to document the efficacy, safety and cost-effectiveness of the human fibrinogen concentrate Fibryga™. Contextual and experiential data from the expert consultations are also presented. Lastly, INESSS performed a cost-effectiveness and budget impact analysis. The members of the Comité scientifique de l’évaluation des médicaments aux fins d’inscription (CSEMI) are of the unanimously opinion that the therapeutic value of the fibrinogen concentrate Fibryga™ is recognized when used as complementary therapy during the management of severe uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/en/publications/publications/publication/evaluation-de-fibrygamc-concentre-de-fibrinogene-humain-deficit-acquis-en-fibrinogene.html

Year Published: 2022

URL for published report: https://www.inesss.qc.ca/en/publications/publications/publication/evaluation-de-fibrygamc-concentre-de-fibrinogene-humain-deficit-acquis-en-fibrinogene.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