INESSS recommends the addition of Fibryga® to the blood product list of Québec

Octapharma Canada is pleased to announce that the Institut national d’excellence en santé et en services sociaux (INESSS) has recommended the addition of Fibryga® (Human Fibrinogen Concentrate) for use in acquired fibrinogen deficiency (AFD) to the blood product list in the province of Québec.

On June 28, 2022, INESSS issued an evaluation report on Fibryga®,  stating that “…the members of the Comité scientifique de l’évaluation des médicaments aux fins d’inscription (CSEMI) unanimously concurred that the therapeutic value of Fibryga® is recognized when used as complementary therapy during the management of severe, uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency.’’1 Furthermore, the committee also recognized that the “conclusions regarding the therapeutic value of fibrinogen concentrate also apply to the medical conditions in which acquired hypofibrinogenemia is clearly demonstrated.” 1 According to the summary of the report1, the opinion was supported by two main studies: FIBRES2 and FORMA-053. While the FIBRES study demonstrated non-inferiority of Fibryga® when compared to cryoprecipitate during cardiac surgery2, the “FORMA-05 study supports the use of fibrinogen concentrate during surgery other than cardiac surgery with extracorporeal circulation.”1

Beyond the recognition of therapeutic value, there were a few additional deliberations made recognizing the benefit of Fibryga®, such as the organizational impact in reducing operating room administration time in the event of acquired hypofibrinogenemia if distribution occurred in a decentralized manner. Finally, the cost-effectiveness and cost-savings analysis for Québec showed that Fibryga® is a more cost-effective treatment option than the cryoprecipitate currently distributed in Québec, and further concluded that distributing Fibryga® “for the management of acquired hypofibrinogenemia would result in an estimated $7.4 million in cost savings in the health-care facility budget over the next 3 years.”1

Stewardship on the appropriate use of blood and blood products is an important topic that impacts patient care and healthcare resources. The clinical evidence now available demonstrates that Fibryga® can reduce the use of allogenic blood product utilization besides being cost-effective. This will positively impact the national movement to use blood and blood products more efficiently.

You can read the entire summary by INESSS here.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centers across Europe and the US.

About Fibryga®4

Fibryga® (Fibrinogen Concentrate [Human], 1 g/vial) is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia.

Fibryga® may be used as a complementary therapy during the management of uncontrolled severe bleeding in patients with acquired fibrinogen deficiency in the course of surgical interventions.

Fibryga® is produced from large pools of human plasma and its safety is ensured through double virus inactivation steps. Fibryga® can be reconstituted within approximately 5 minutes and infused at a maximum rate of 20 mL per minute during the management of uncontrolled severe bleeding in the course of surgical interventions for patients with acquired fibrinogen deficiency. Fibryga® can be stored at room temperature and is stable after reconstitution for 24hrs.

Please consult the complete product monograph for further prescribing information.

The FIBRES trial results are available here.

The FORMA-05 trial results are available here.

References:

1. Evaluation of Fibryga (TM) (human fibrinogen concentrate) - acquired fibrinogen deficiency. INESSS. https://www.inesss.qc.ca/en/publications/publications/publication/evaluation-de-fibrygamc-concentre-de-fibrinogene-humain-deficit-acquis-en-fibrinogene.html. Published June 28, 2022. Accessed July 11, 2022.

2. Callum et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery - The FIBRES randomized clinical trial. JAMA 2019. doi:10.1001/jama.2019.17312. Published online October 21, 2019.

3. Roy A et al. Efficacy of fibrinogen concentrate in major abdominal surgery - A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. J Thromb Haemost. 2020;18(2):352-363. doi:10.1111/jth.14665. Published online November 26, 2019.

4. Fibryga® Product Monograph, approved November 25, 2021.

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