Pending Policies - Prescription Drugs
Human Fibrinogen Concentrate (RiaSTAP and Fibryga)
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Human fibrinogen concentrate (RiaSTAP™) may be considered medically necessary for the treatment of acute bleeding episodes in persons with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia.
Human fibrinogen concentrate (Fibryga®) may be considered medically necessary for the treatment of acute bleeding episodes when used in an individual 12 years of age or older with CFD, including afibrinogenemia and hypofibrinogenemia.
All other uses of human fibrinogen concentrate (RiaSTAP and Fibryga) are considered experimental, investigational and/or unproven, including but not limited to dysfibrinogenemia.
Fibrinogen deficiency, also known as factor I deficiency, affects approximately 150 to 300 people in the United States (U.S.) and is usually diagnosed at birth when newborns bleed from their umbilical cord site. (1) Individuals with congenital fibrinogen deficiency (CFD) are unable to make sufficient amounts of fibrinogen (also called Factor I), which is a protein that plays a key role in blood coagulation by helping to form blood clots and prevent bleeding. Fibrinogen is manufactured in the liver and circulates in the blood plasma in a normal concentration of 250-400 mg/dL. Symptoms of CFD include excessive bleeding following an injury, bruising, spontaneous bleeding, and bone, joint, and tissue hemorrhage in addition to the excessive bleeding at the umbilical cord site. (1, 2)
Human fibrinogen concentrate, pasteurized (HFCP), made from the pooled plasma of healthy human blood donors, is used for patients who have no fibrinogen (afibrinogenemia) or abnormally low levels of fibrinogen under 50mg/dL, also known as hypofibrinogenemia. (1)
Abnormal bleeding times are identified and compared to normal bleeding times via laboratory blood coagulation testing or blood clotting factor assays, which include but are not limited to the following tests (3):
• Fibrinogen level; and
• Prothrombin time (PT); and
• Partial thromboplastin time (PTT) or activated PTT (aPTT); and
• Platelet Count; and
• International Normalized Ratio (INR); and
• Thrombin clotting time (TCT, TT), and
• Reptilase time (RT).
Additional testing may be completed to evaluate all aspects of a blood clotting disorder.
The U.S. Food and Drug Administration (FDA) Orphan Drug Act (ODA), first enacted in the U.S., was set up to encourage the development of drugs for rare diseases. (4) An orphan drug is defined as "a drug intended to treat a condition affecting fewer than 200,000 persons in the U.S. or will not recover development cost, plus a reasonable profit, within seven years following FDA approval. The ODA was signed into law on January 4, 1983." Both RiaSTAP™ and Fibryna® received accelerated FDA approval under the ODA.
On January 16, 2009, the U.S. FDA approved RiaSTAP, a concentrated form of human fibrinogen (coagulation Factor I), as an orphan drug for the treatment of bleeding in patients with CFD, including afibrinogenemia and hypofibrinogenemia. HFCP is manufactured by CSL Behring, Marburg, Germany and distributed by CSL Behring LLC, Kankakee, Illinois. HFCP is not indicated for those patients having dysfibrinogenemia, in which the patient may have normal fibrinogen levels, but defective fibrinogen function. RiaSTAP should be administered intravenously under the supervision of a physician. A target fibrinogen level of 100 mg/dl should be maintained until hemostasis is obtained. (2)
Fibryga(Previously Known as Fibryna)
In June 2017, the FDA approved Fibryna (Octapharma US, Inc., Hoboken, N.J.), a concentrated form of human fibrinogen, for the treatment of acute bleeding in adults and adolescents ≥12 years of age with CFD, including afibrinogenemia and hypofibrinogenemia. Fibryna is not indicated for those patients having dysfibrinogenemia. Fibryna should be administered intravenously with the recommended target fibrinogen level 100 mg/dl for minor bleeding and 150 mg/dl for major bleeding. (5, 6) In 2017, Octapharma (the product manufacturer) updated the brand name of Fibryna to Fibryga.
This medical policy was created in January 2010 and is supported by the U.S. Food and Drug Administration (FDA) labelled indications. A current search of peer reviewed published literature was performed through February 28, 2018. Following is a summary of the key literature to date.
The FDA orphan product designation was based upon a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 milligrams/kilograms of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness, a surrogate marker likely to predict clinical benefit. (2)
The approval of RiaSTAP is based on a phase II multinational, multicenter (ten centers in the U.S. and Italy), prospective, open-label, and uncontrolled design clinical trial, conducted in subjects with congenital fibrinogen deficiency (CFD) manifested as afibrinogenemia, in a non-bleeding state. Of the 15 subjects, 10 were males, with 11 in an age range of 16 to <65 years with a balance between 8 and 14 years. Plasma fibrinogen activity and antigen screening had to be undetectable (<20 mg/dl). Human fibrinogen concentrate, pasteurized (HFCP) was administered as a single intravenous infusion of 70 milligram/kilogram body weight. Blood samples were drawn at pre-dose and at 0.5, 1, 2, 4, 8, 24, 96, 144, 216, and 312 hours post-dosing. Fourteen patients’ laboratory results were evaluated (one subject’s plasma samples thawed during transport). The pharmacokinetics of HFCP, in terms of plasma fibrinogen activity and antigen screening, indicate that HFCP has a long half-life and is a slow clearance drug. The results indicated no difference between females and males. In children younger than 16 years, the half-life and clearance of HFCP were 11% shorter and 32% faster than in adults. However, due to the small study size of children younger than 16 years, it is difficult to make any outright conclusion. (7, 8)
In 2009, Beven (9) stated dysfibrinogenemia is characterized by functional abnormalities of fibrinogen, which may be asymptomatic (in 50% of cases), or cause bleeding (25%) or thrombosis (25%). Replacement of the deficient or abnormal fibrinogen with frozen plasma, cryoprecipitate, or fibrinogen concentrate has been found to be effective in practice in treating hemostatic complications related to congenital fibrinogen disorders. Although cryoprecipitate is the most commonly used replacement material, pathogen-reduced fibrinogen concentrates have several advantages, most importantly a lower potential risk of viral transmission and standardized fibrinogen content allowing accurate dosing. They also avoid transfusing unwanted clotting factors, platelet micro particles and immunoglobulins, and can be administered rapidly without thawing. The use of fibrinogen concentrate to treat congenital fibrinogen disorders is strongly supported in principle and increasingly by practical experience and evidence.
Off Label Indications
Fibrinogen is suggested to play a significant role in managing major bleeding. However, clinical evidence regarding the effect of fibrinogen concentrate (derived from human plasma) on transfusion is limited.
In 2013, Rahe-Meyer et al. (10) assessed whether fibrinogen concentrate can reduce the need for blood transfusion when given as an intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. A randomized, single-center, prospective, placebo-controlled, double-blind study in patients 18 years of age or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass was assessed. Patients were randomized to fibrinogen concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed. Twenty-nine patients in the fibrinogen concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 hours after the administration of study medication, patients in the fibrinogen concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P <0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the fibrinogen concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P <0.001). There was no observed safety concern with using fibrinogen concentrate during aortic surgery. Hemostatic therapy with fibrinogen concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. The study concluded that larger multicenter studies are necessary to confirm the role of fibrinogen concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.
In 2014, Tanaka and colleagues (11) published a study comparing hematologic and transfusion profiles between first-line acquired fibrinogen (FIB) replacement and platelet (PLT) transfusion in post-cardiac surgical bleeding in a prospective, randomized, open-label study. Twenty adult patients who underwent valve replacement or repair and fulfilled a preset visual bleeding scale were randomized to 4 g of FIB or 1 unit of apheresis platelets. Primary endpoints included hemostatic condition in the surgical field and 24-hour hemostatic product usage. Hematologic data, clinical outcome, and safety data were collected up to the 28th day postoperative visit. In patients who received the first-line FIB concentrate (n = 10), the visual bleeding scale improved after intervention, and the incidence of PLT transfusion and total plasma donor exposure were lower compared to the PLT group (n = 10). Post intervention FIB level was statistically higher (209 mg/dl vs. 165 mg/dL) in the FIB group than in the PLT group, but PLT count and prothrombin were lower. There were no statistical differences in the postoperative blood loss and red blood cell transfusion between two groups. The preliminary data concluded that primary FIB replacement may potentially reduce the incidence of Platelet transfusion and the number of donor exposures. Plasma FIB level of 200 mg/dl is attainable with a single dose of 4 g, and this level seems to mitigate bleeding despite moderately decreased thrombin generation. It concluded, a large prospective randomized study is warranted to examine the efficacy and safety of FIB therapy in high-risk cardiac surgical patients.
A 2013 Cochrane review (12) of bleeding patients concluded that while fibrinogen concentrate may reduce the number of transfusions required, the studies are low quality and underpowered to determine mortality, benefit or harm.
In 2014, Levy et al. (13) believed that fibrinogen supplementation could be attained using plasma or cryoprecipitate; however, there are a number of safety concerns associated with allogeneic blood products and there is a lack of high-quality evidence to support their use. Additionally, there is sometimes a long delay associated with the preparation of frozen products for infusion. Fibrinogen concentrate provides a promising alternative to allogeneic blood products and has a number of advantages: it allows a standardized dose of fibrinogen to be rapidly administered in a small volume, has a very good safety profile, and is virally inactivated as standard. Administration of fibrinogen concentrate, often guided by point-of-care viscoelastic testing to allow individualized dosing, has been successfully used as hemostatic therapy in a range of clinical settings, including cardiovascular surgery, post-partum hemorrhage, and trauma. Some outcomes revealed that fibrinogen concentrate is associated with a reduction or even total avoidance of allogeneic blood product transfusion. Fibrinogen concentrate represents an important option for the treatment of coagulopathic bleeding; further studies are needed to determine precise dosing strategies and thresholds for fibrinogen supplementation.
In 2015, Wikkelso and colleagues (14) completed a multi-center, double-blinded, parallel RCT that theorized that pre-emptive treatment with fibrinogen concentrate (FC) reduces the need for red blood cell (RBC) transfusion in patients with postpartum hemorrhage (PPH). These investigators assigned subjects with severe PPH to a single dose of FC or placebo (saline). A dose of 2 g or equivalent was given to all subjects independent of body weight and the FC at inclusion. The primary outcome was RBC transfusion up to 6 weeks post-partum; secondary outcomes were total blood loss, total amount of blood transfused, occurrence of re-bleeding, hemoglobin of less than 58 g/L, RBC transfusion within 4 hours, 24 hours, and 7 days, and as a composite outcome of “severe PPH”, defined as a decrease in hemoglobin of greater than 40 g/L, transfusion of at least 4 units of RBCs, hemostatic intervention (angiographic embolization, surgical arterial ligation, or hysterectomy), or maternal death. Of the 249 randomized subjects, 123 of 124 in the fibrinogen group and 121 of 125 in the placebo group were included in the intention-to-treat analysis. At inclusion the subjects had severe PPH, with a mean blood loss of 1,459 (S.D. of 476) ml and a mean FC of 4.5 (S.D. of 1.2) g/L. The intervention group received a mean dose of 26 mg/kg FC, thereby significantly increasing FC compared with placebo by 0.40 g/L (95 % CI: 0.15 to 0.65; p= 0.002). Post-partum blood transfusion occurred in 25 (20 %) of the fibrinogen group and 26 (22 %) of the placebo group (relative risk [RR], 0.95; 95 % CI: 0.58 to 1.54; p = 0.88). These researchers found no difference in any pre-defined secondary outcomes, per-protocol analyses, or adjusted analyses. No thromboembolic events were detected. The authors concluded that there is no evidence to support the use of FC as pre-emptive treatment for severe PPH in patients with normo-fibrinogenemia.
In 2016 Hanna et al. (15) researched the use of HFC during proximal aortic reconstruction with deep hypothermic circulatory arrest. The researchers sought to determine if the approved dose of 70 mg/kg of HFC increases fibrinogen levels in the setting of high-risk bleeding associated with aortic reconstruction and deep hypothermic circulatory arrest (DHCA). This prospective pilot, off-label study evaluated 22 patients undergoing elective proximal aortic reconstruction with DHCA and each patient was administered 70 mg/kg HFC upon separation from cardiopulmonary bypass (CPB). Fibrinogen levels were measured at baseline, prior to surgery, and 10 minutes after HFC administration, on skin closure, and the day after surgery. The primary study outcome was the difference in fibrinogen level immediately after separation from CPB, when HFC was administered, and the fibrinogen level 10 minutes following HFC administration. Additionally, postoperative thromboembolic events were assessed as a safety analysis. The mean baseline fibrinogen level was 317 ± 49 mg/dL and fell to 235 ± 39 mg/dL just before separation from CPB. After HFC administration, the fibrinogen level rose to 331 ± 41 mg/dL (P < .001) and averaged 372 ± 45 mg/dL the next day. No postoperative thromboembolic complications occurred. The authors concluded that the administration of 70 mg/kg HFC upon separation from CPB raises fibrinogen levels by approximately 100 mg/dL without an apparent increase in thrombotic complications during proximal aortic reconstruction with DHCA. Further prospective studies in a larger cohort of patients will be needed to determine the safety and evaluate the efficacy of HFC as a hemostatic adjunct during these procedures.
Fibryga®(Previously Known as Fibryna)
The safety and efficacy of Fibryna is based on 2 clinical trials: FORMA 01 and FORMA 02. (6) The FORMA 01 trial was a randomized, phase 2 crossover study in which 22 subjects (ranging in age 12 to 53 years; 6 adolescents and 16 adults) with CFD compared the pharmacokinetics (PK) and pharmacodynamics (PD) of Fibryna to the comparable fibrinogen concentrate product, RiaSTAP. Each subject received a single intravenous 70 mg/kg dose of Fibryna and RiaSTAP. Blood samples were drawn from the subjects to determine the fibrinogen activity at baseline and up to 14 days after the infusion. The incremental in vivo recovery (IVR) was determined from levels obtained up to 4 hours post-infusion. The median incremental IVR was a 1.8 mg/dL (range 1.1 – 2.6 mg/dL) increase per mg/kg. The median IVR indicated that a dose of 70 mg/kg will increase patients’ fibrinogen plasma concentration by approximately 125 mg/dL. No difference in fibrinogen activity was observed between males and females. There was no difference in the PK of Fibryna between adults and adolescents (12-17 years of age).
An interim analysis of the FORMA 02 was used for the FDA-approved indications of Fibryna. The FORMA 02 is an ongoing prospective, uncontrolled phase 3, open-label, multicenter clinical study involving 13 patients (ranging in age 13 to 53 years; 2 adolescents and 11 adults) with CFD (afibrinogenemia and hypofibrinogenemia). Of the 22 bleeding events, 21 (95%) were rated as having a good or excellent efficacy. For 1 bleeding event, the investigator’s assessment was missing. The median number of infusions for the bleeding events was 1. Two (9%) bleeding events required 2 infusions. None of the bleeding events required more than 2 infusions. The most common adverse reactions observed in more than one subject in the clinical study (> 5%) included vomiting, weakness and pyrexia (6).
Off Label Indications
No studies were identified for the off-label use of Fibryna.
Professional Guidelines and Position Statements
The World Federation for Hemophilia (16) specifies three treatment options for the management of factor I deficiency. All are made from human plasma. Available treatment options include fibrinogen concentrate, cryoprecipitate or fresh frozen plasma (FFP). Treatment may also be given to prevent the formation of blood clots, as this complication can occur after fibrinogen replacement therapy. Many people who have hypofibrinogenemia or dysfibrinogenemia do not need treatment. Excessive menstrual bleeding in women with factor I deficiency may be controlled with hormonal contraceptives (birth control pills), intra-uterine devices (IUDs), or antifibrinolytic drugs.
Summary of Evidence
The evidence is sufficient to support the use of human fibrinogen concentrate (RiaSTAP) for the treatment of acute bleeding episodes in persons with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia. Human fibrinogen concentrate (RiaSTAP) is supported by the U.S. Food and Drug Administration (FDA) approved labelled indications, which is based on clinical trial outcomes documented in the published labeling.
The evidence is sufficient to support the use of human fibrinogen concentrate (Fibryna) for the treatment of acute bleeding episodes when used in individuals 12 years of age or older with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia. Human fibrinogen concentrate (Fibryna) is supported by the FDA approved labelled indications, which is based on clinical trial outcomes documented in the published labeling.
The evidence is insufficient to support the use of human fibrinogen concentrate (RiaSTAP and Fibryna) beyond the FDA approved indications therefore, off label use is considered experimental, investigational and/or unproven including but not limited to dysfibrinogenemia.
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1. Barclay L. FDA Approves Human Fibrinogen Concentrate for Treatment of Bleeding in Congenital Fibrinogen Deficiency. Medscape. (2009 January). Available at <https://www.medscape.com> (accessed 2018 March 21).
2. FDA–RiaSTAP (human fibrinogen concentrate, pasteurized): Product Label. Food and Drug Administration. (2009 January 16). Available at: <https://www.fda.gov> (accessed 2018 March 21).
3. Pietrangelo, A. Coagulation Tests. Healthline. (2017 May 5). Available at <https://www.healthline.com> (accessed 2018 March 22).
4. Herder M. What is the purpose of the orphan drug act? Public Library of Science Medicine (2017); 14(1). PMID 28045908
5. FDA-BLA approval letter Fibrinogen (Human) Fibryna. (2017 June 7). Available at <https://www.fda.gov> (accessed 2018 March 22).
6. FDA-Fibryna (human fibrinogen): Product Label. Food and Drug Administration (2017 June 7). Available at <https://www.fda.gov> (accessed 2018 March 21).
7. Kreuz, W., Meili, E., Peter-Salonen K., et al. Efficacy and tolerability of a pasteurized human fibrinogen concentrate in patients with congenital fibrinogen deficiency. Transfusion and Apheresis Science (2005 June); 32(3):247-53. PMID 15919240
8. Negrier, C., Rothschild, C., Goudemand J., et al. Pharmacokinetics and pharmacodynamics of a new highly secured fibrinogen concentrate. Journal of Thrombosis and Haemostatis (2008 September) 6(9); 1494-9. PMID 18627444
9. Bevan DH. Cryoprecipitate: No longer the best therapeutic choice in congenital fibrinogen disorders. Thrombosis Research. (2009); 124 Suppl 2:S12-S16. PMID 20109651
10. Rahe-Meyer N., Solomon C., Hanke A., et al., Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. (2013 May); 118(5):1244. PMID 23249928
11. Tanaka KA., Egan K, Szlam F., et al. Transfusion and hematologic variables after fibrinogen or platelet transfusion in valve replacement surgery: preliminary data of purified lyophilized human fibrinogen concentrate versus conventional transfusion. Transfusion. (2014 January); 54(1):109-18. PMID 23718572
12. Wikkelso A., Lunde J., Johansen M., et al. Fibrinogen concentrate in bleeding patients. Cochrane Database system Review. (2013 August); CD008864. PMID 23986527
13. Levy JH., Welsby I., Goodnough LT., et al. Fibrinogen as a therapeutic target for bleeding: A review of critical levels and replacement therapy. Transfusion. (2014); 54(5):1389-1405. PMID 24117955
14. Wikkelso A.J., Edwards H.M., Afshari A., et al. Pre-emptive treatment with fibrogen concentrate for postpartum hemorrhage: randomized controlled trial. Br J Anaesth. (2015 April); 114(4):623-33. PMID 25586727
15. Hanna JM., Keenan JE., Wang H., et al. Use of human fibrinogen concentrate during proximal aortic reconstruction with deep hypothermic circulatory arrest. J Thorac Cardiovasc Surg. (2016); 151(2):376-382.PMID 26428473
16. World Federation of Hemophilia. About bleeding disorders: What is factor I (fibrinogen) deficiency? (May 2012). Available at <https://www.wfh.org> (accessed 2018 March 22)
|9/15/2018||Document updated with literature review. The following changes were made in Coverage: 1) Removed the following requirements from the medically necessary criteria for human fibrinogen concentrate, (RiaSTAP™) a) Confirmed CFD by prothrombin time, partial thromboplastin time, thrombin clotting time, and reptilase time; and b) failed response to substitution with a cryoprecipitate or substitution with fresh frozen plasma. 2) Added human fibrinogen concentrate (Fibryga) may be considered medically necessary for the treatment of acute bleeding episodes when used in an individual 12 years of age or older with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia. 3) Added Fibryga to the existing experimental, investigational and/or unproven statement in Coverage. Title changed from Human Fibrinogen Concentrate (RiaSTAP). Added references 1, 3, 5, 6, 16.|
|4/15/2017||Document updated with literature review. Coverage unchanged.|
|4/1/2016||Reviewed. No changes.|
|1/1/2015||Document updated with literature review. Coverage unchanged.|
|8/1/2012||Document updated with literature review. Coverage unchanged.|
|1/1/2010||New medical document. Human Fibrinogen Concentrate (RaiSTAP ™) may be considered medically necessary when criteria are met for treatment of Factor I bleeding disorder (congenital fibrinogenemia).|
|Title:||Effective Date:||End Date:|
|Human Fibrinogen Concentrate (RiaSTAP)||04-15-2017||09-14-2018|
|Human Fibrinogen Concentrate (RiaSTAP)||04-01-2016||04-14-2017|
|Human Fibrinogen Concentrate (RiaSTAP)||01-01-2015||03-31-2016|
|Human Fibrinogen Concentrate (RiaSTAP)||08-01-2012||12-31-2014|
|Human Fibrinogen Concentrate (RiaSTAP)||01-01-2010||07-31-2012|