This CPB is revised to state that recombinant coagulation factor XIII A-subunit (Tretten) is considered medically necessary for routine prophylaxis of bleeding in persons with congenital factor XIII A-subunit deficiency.

This CPB is revised to state that recombinant factor IX fc fusion protein (rFIXFc) (Alprolix) is considered medically necessary for persons diagnosed with hemophilia B for the following indications: 1) control and prevention of bleeding episodes, 2) perioperative management, and 3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. This CPB is revised to state that recombinant factor VIIa (rFVIIa, NovoSeven RT) is considered medically necessary for the prevention of bleeding in surgical interventions or invasive procedures when criteria are met. This CPB is revised to state that factor XIII concentrate [Human] (Corifact) is considered medically necessary for the peri-operative management of surgical bleeding in persons with congenital factor XIII deficiency. This CPB is revised to state that factor eight inhibitor bypassing activity (FEIBA) anti-inhibitor coagulant complex (Febia NF) is considered medically necessary for the control and prevention of bleeding episodes, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in persons with hemophilia A and B. This CPB is revised to state that FEIBA is considered experimental and investigational for the prevention and treatment of bleeding in non-hemophilic persons with acquired inhibitors.

 

This CPB is revised to state that recombinant factor VIIa (rFVIIa, NovoSeven RT) is considered medically necessary for the prevention of bleeding in surgical interventions or invasive procedures in congenital FVII deficiency and hemophilia A or B with inhibitors and in acquired hemophilia. This CPB is revised to state that factor XIII concentrate [Human] (Corifact) is considered medically necessary for the perioperative management of surgical bleeding in persons with congenital factor XIII deficiency. This CPB is revised to state that factor eight inhibitor bypassing activity (FEIBA) (Febia NF) anti-inhibitor coagulant complex is considered medically in persons with hemophilia A and B with inhibitors for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. (The previous version of the CPB stated that FEIBA is considered medically necessary for the treatment of spontaneous bleeding episodes or for use during surgery in persons with hemophilia A and B with inhibitors.) This CPB is revised to state that FEIBA is considered experimental and investigational for use in non-hemophiliac persons with acquired inhibitors to factors VIII, XI, and XII.