Factor IX
DESCRIPTION
Factor IX, also known as Christmas factor or antihemophilic factor B, is a vitamin K-dependent coagulation factor synthesized in the liver. A component of plasma thromboplastin, factor IX is a proenzyme with no catalytic activity. Factor IX’s role in the coagulation cascade, simply put, is that factor IX is activated to factor IXa (active) either by factor XIa (intrinsically) or factor VIIa-tissue factor (extrinsically) in the presence of calcium. Factor IXa in the presence of factor VIIIa activates factor X (Stuart Prower factor) leading to the conversion of prothrombin to thrombin which converts fibrinogen to fibrin and a clot is formed. Insufficient factor IX disrupts the normal coagulation cascade.
Factor IX preparations are either derived from pooled human plasma that is purified to reduce the risk of viral transmission or produced through recombinant DNA technology. Purified pooled factor IX preparations are available as isolated factor IX or as a complex of factor IX and factors II, X and VII, although these factors may not exist in clinically significant quantities.
Examples of preparations of factor IX (human) are AlphaNine® SD and Mononine®.
An example of a preparation of factor IX (recombinant) is BeneFIX®.
Examples of preparations of factor IX complex (human) are Bebulin® VH and Profilnine® SD.
REFER TO DECISION SUPPORT TREE
POLICY
Factor IX for the treatment and/or prevention of hemorrhagic episodes is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Factor IX for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Factor IX for the treatment and/or prevention of hemorrhagic episodes is considered medically appropriate if ANY ONE of the following is met:
Diagnosis of hemophilia B (i.e., Christmas disease or factor IX deficiency)
Diagnosis of factor VII deficiency with treatment using a factor IX complex (human) preparation (e.g., Bebulin® VH, Profilnine® SD)
Diagnosis of anticoagulant induced hemorrhage
Diagnosis of hemophilia A with ALL of the following:
Development of inhibitor antibodies to antihemophilic factor VIII (alloantibodies)
Treatment is with factor IX complex (human) preparation (e.g., Bebulin® VH, Profilnine® SD)
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).
Production of Proplex T, a preparation of heat treated factor IX complex (human), was discontinued in December of 2006 per Baxter Healthcare Corporation, 4/6/10.
No evidence was found in the published literature that validates the use of factor IX preparations in the treatment/prevention of any other conditions/diseases.
SOURCES
Baxter Healthcare Corp. (2006, September). Bebulin® VH (factor IX complex) vapor heated. Retrieved April 2. 2010 from http://www.thereforyou.com/pdf/bebulin-vh_pi.pdf.
CSL Behring, LLC. (2007, January). Coagulation factor IX (human) Mononine®; monoclonal antibody purified. Retrieved April 2, 2010 from http://www.cslbehring.com/docs/242/35/C1821_Mononine%20PI.pdf.
Grifols Biologicals, Inc. (2004, January). Coagulation factor IX (human) Alphanine® SD; solvent detergent treated/virus filtered. Retrieved April 2, 2010 from http://www.consignadvantage.com/Product%20Inserts/Grifols/alphanine_pi.pdf.
Grifols Biologicals, Inc. (2004, January). Factor IX complex; Profilnine® SD; solvent detergent treated. Retrieved April 2, 2010 from http://www.grifolsusa.com/pdfs/pi/g_pi_profilnine.pdf.
Lexi-Comp Online. (2010). AHFS DI. Factor IX. Retrieved April 6, 2010 from Lexi-Comp Online with AHFS.
Lexi-Comp Online. (2010). AHFS DI. Factor IX (recombinant). Retrieved April 6, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Factor IX. Retrieved April 6, 2010 from MICROMEDEX Healthcare Series.
Wyeth Pharmaceuticals, Inc. (2009, December). BeneFIX® [coagulation factor IX (recombinant)] for intravenous use, lyophilized powder for reconstitution. Retrieved April 2, 2010 from http://www.wyeth.com/content/showlabeling.asp?id=492.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 7/6/2010
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 IX (AlphaNine® SD, Bebulin® VH, BeneFix®, Mononine®, Profilnine® SD)
Does the individual have a diagnosis of Hemophilia B (i.e., Christmas disease or factor IX deficiency)?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of factor VII deficiency?
If yes, go to question #3
If no, go to question #4
Is the agent requested a factor IX complex (human) preparation?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of anticoagulant induced hemorrhage?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of Hemophilia A?
If yes, go to question #6
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent requested a factor IX complex (human) preparation?
If yes, go to question #7
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual show development of inhibitor antibodies to antihemophilic factor VIII (alloantibodies)?
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.