Factor VIIa (Recombinant)
DESCRIPTION
Factor VIIa (recombinant) is a vitamin K-dependent glycoprotein made up of 406 amino acid residues, and is structurally similar to human plasma-derived factor VIIa. It is intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. Factor VIIa is used for the prevention and control of hemorrhagic episodes in certain individuals with hemophilia.
Type A hemophilia is five times more prevalent than type B. Factor VIII inhibitors develop in approximately 20% of multiple transfused hemophilia A individuals and they inhibit factor VIII coagulant activity. In very rare instances, factor VIII inhibitors can also arise spontaneously as autoantibodies in individuals who do not have a hereditary deficiency of factor VIII. This condition is known as acquired hemophilia and may be associated with rheumatoid arthritis, pregnancy, malignancy, systemic lupus erythematosus, and in some cases of allergic drug reaction or autoimmune disease; in 50% of cases no cause is found.
The U. S. Food and Drug Administration (FDA) requires that factor VIIa be administered to individuals only under the direct supervision of a physician experienced in the treatment of hemophilia.
Examples of preparations of factor VIIa are: NovoSeven® and NovoSeven® RT.
REFER TO DECISION SUPPORT TREE
POLICY
Factor VIIa for the treatment and prevention of hemorrhagic episodes is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Factor VIIa for the prevention of bleeding in surgical interventions or invasive procedures is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Factor VIIa for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Factor VIIa for the treatment and prevention of hemorrhagic episodes is considered medically appropriate if ANY ONE of the following are met:
For hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency/classic hemophilia) or hemophilia B (i.e., factor IX deficiency/Christmas disease) in individuals that have developed inhibitors (alloantibodies) to factor VIII or factor IX
For acquired hemophilia
For congenital factor VII deficiency
Factor VIIa for the prevention of bleeding in surgical interventions or invasive procedures is considered medically appropriate if ANY ONE of the following criteria are met:
For hemophilia A or hemophilia B in individuals that have developed inhibitors (alloantibodies) to factor VIII or factor IX
For acquired hemophilia
For 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.
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).
There is insufficient evidence in support of the use of factor VIIa for the treatment of other conditions/diseases including, but not limited to non-hemophilia related bleeding episodes.
SOURCES
Lexi-Comp Online. (2008). AHFS DI. Factor VIIa (recombinant). Retrieved May 2, 2008 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Coagulation factor VIIa. Retrieved May 6, 2008 from MICROMEDEX.
NovoSeven for non-hemophilia hemostasis. (2004, April). The Medical Letter On Drugs and Therapeutics, 46 (Issue 1181), 33-34.
Rakel, R. E., & Bope, E. T. (Eds.). (2008). Conn's Current Therapy 2004 (60th ed.). St. Louis: W. B. Saunders Company.
U. S. Food and Drug Administration. (2006, October). Center for Biologics Evaluation and Research. Product Approval Information. Retrieved May 2, 2008 from http://www.fda.gov/cber/products/novoseven.htm.
U. S. Food and Drug Administration. (2008, May). Center for Biologics Evaluation and Research. Product Approval Information. Coagulation factor VIIa (recombinant). http://www.fda.gov/cber/label/novosevenrtLB.pdf.
University of Cincinnati. (2004, March/April). Acquired hemophilia. Lab Lines, 10 (2), 1-2. Retrieved June 2, 2004 from http://pathology.uc.edu/LABLINES/V10I2.pdf.
ORIGINAL EFFECTIVE DATE: 2/1/2005
MOST RECENT REVIEW DATE: 9/9/2008
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 agent being used for the treatment and prevention of hemorrhagic episodes for ANY ONE of the following?
For hemophilia A (i.e., antihemophilic factor [factor VIII] deficiency/classic hemophilia) or hemophilia B (i.e., factor IX deficiency/Christmas disease) in individuals that have developed inhibitors (alloantibodies) to factor VIII or factor IX
For acquired hemophilia
For congenital factor VII deficiency
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Is the agent being used for the prevention of bleeding in surgical interventions or invasive procedures for ANY ONE of the following?
For hemophilia A or hemophilia B in individuals that have developed inhibitors (alloantibodies) to factor VIII or factor IX
For acquired hemophilia
For 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.