Factor VIIa (Recombinant)
DESCRIPTION
Recombinant Factor VIIa (rFVIIa) is a vitamin K-dependent glycoprotein that is structurally similar to human plasma-derived factor VIIa (FVIIa) or activated factor VII. Factor VIIa promotes hemostasis by activating the extrinsic pathway of the coagulation cascade. Simply put, when complexed with tissue factor, FVIIa activates coagulation factor X to factor Xa. Factor Xa complexes with other factors to covert prothrombin to thrombin leading to the conversion of fibrinogen to fibrin forming a hemostatic plug and inducing local hemostasis.
Since factor VIIa bypasses factors VII, VIII and IX in the clotting cascade, it is useful in treating conditions with abnormalities in those clotting factors. Individuals with hemophilia A and B may develop inhibitors or alloantibodies to anticoagulation factors VIII and/or IX from factor replacement therapy. Rarely, acquired hemophilia occurs with the spontaneous development of autoantibodies to factor VIII in individuals who previously had normal factor VIII levels. Additionally, individuals may have congenital factor VII deficiency, the most common of the nonhemophilic coagulation deficiencies.
Examples of preparations of factor VIIa (recombinant) are: NovoSeven® and NovoSeven® RT (room temperature stable).
REFER TO DECISION SUPPORT TREE
POLICY
Factor VIIa (recombinant) for the treatment of hemorrhagic episodes is considered medically necessary if the medical appropriateness criteria are met.
Factor VIIa (recombinant) for the prevention of any of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Hemorrhagic episodes
Bleeding in surgical/invasive procedures
Factor VIIa (recombinant) for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Factor VIIa (recombinant) for the treatment of hemorrhagic episodes is considered medically appropriate if the individual has ANY ONE of the following:
Inhibitors (alloantibodies) to factor VIII or factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital factor VII deficiency
Factor VIIa (recombinant) for the prevention of ANY ONE of the following is considered medically appropriate if the criteria are met:
Hemorrhagic episodes if the individual has ANY ONE of the following:
Inhibitors (alloantibodies) to factor VIII or factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital factor VII deficiency
Bleeding in surgical/invasive procedures if the individual has ANY ONE of the following:
Inhibitors (alloantibodies) to factor VIII or factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital factor VII deficiency
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of Factor VIIa (recombinant) for the treatment or prevention of any other conditions/diseases.
SOURCES
Gailani, D., Neff, A. T. (2008). Rare coagulation factor deficiencies: Factor VII deficiency. In R. Hoffman, E. J. Benz, Jr., S. J. Shattil, B. Furie, L. E. Silberstein, P. McGlave, et al (Eds.), Hematology: Basic principles and practice (5th ed., ch. 127). Philadelphia: Churchill Livingstone.
Lexi-Comp Online. (2009). AHFS DI. Factor VIIa (recombinant). Retrieved November 17, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Coagulation factor VIIa. Retrieved November 17, 2009 from MICROMEDEX.
U. S. Food and Drug Administration. (2006, October). Center for Biologics Evaluation and Research. NovoSeven® Coagulation factor VIIa (recombinant). Retrieved November 17, 2009 from http://www.fda.gov/cber/products/novoseven.htm.
U. S. Food and Drug Administration. (2008, May). Center for Biologics Evaluation and Research. NovoSeven® RT Coagulation factor VIIa (recombinant) room temperature stable, lyophilized powder. Retrieved November 17, 2009 from http://www.fda.gov/cber/label/novosevenrtLB.pdf.
ORIGINAL EFFECTIVE DATE: 2/1/2005
MOST RECENT REVIEW DATE: 3/24/2010
ID_BT
If no, this does not meet medical necessity and/or medical appropriateness criteriaPolicies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Factor VIIa (NovoSeven® and NovoSeven® RT)
Is the requested medication being used to treat hemorrhagic episodes due to ANY ONE of the following?
Inhibitors (alloantibodies) to factor VIII or Factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital factor VII deficiency
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Is the requested medication being used to prevent hemorrhagic episodes due to ANY ONE of the following?
Inhibitors (alloantibodies) to factor VIII or factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital factor VII deficiency
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Is the requested medication being used to prevent bleeding in surgical/invasive procedures due to ANY ONE of the following?
Inhibitors (alloantibodies) to factor VIII or factor IX with a diagnosis of ANY ONE of the following:
Hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency, classic hemophilia)
Hemophilia B (i.e., factor IX deficiency, Christmas disease)
Acquired hemophilia
Congenital Factor VII deficiency
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.