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Factor VIII (Human, Recombinant, Porcine) and Factor IX (Human, Complex, Recombinant)
DESCRIPTIONHemophilia A and B are inherited (or, very rarely, autoimmune) bleeding disorders caused by deficiencies of clotting factor VIII (FVIII) and factor IX (FIX), respectively. The disorders are considered together because of their similar clinical pictures and similar patterns of inheritance. These deficiencies result in insufficient generation of thrombin by FIXa and FVIIIa complex through the intrinsic pathway of the coagulation cascade. Clinically, the disorders present with spontaneous bleeding (often into the joints, most commonly the knee) and compromised blood-clotting. When a blood vessel is injured, a scab will not form and the vessel can continue to bleed excessively for a long period of time. The bleeding can be external, if the skin is broken by a scrape, cut or abrasion, or it can be internal, into muscles, joints or hollow organs. It might therefore present visibly as skin bruises, or subtly as melena, hematuria, or bleeding in the brain.
Factor VIII, (human), an antihemophilic factor (AHF), is a protein found in normal plasma that is necessary for clot formation. Factor VIII (human) is prepared from pooled human venous plasma obtained from suitable whole-blood donors. Administration of an AHF can temporarily correct the coagulation defect of patients with classical hemophilia (hemophilia A). It is needed for transformation of prothrombin (II) to thrombin by the intrinsic pathway.
Factor VIII (recombinant) is a biosynthetic blood coagulation preparation prepared using recombinant DNA technology. Factor VIII (recombinant) is structurally similar to endogenous human Factor VIII and produces the same biologic effects. The most important difference between Factor VIII (recombinant) and Factor VIII (human) is that the biosynthetic preparation is associated with a substantially reduced risk of contamination with blood-borne human viruses.
Factor VIII (porcine) is a protein found in normal plasma that is necessary for clot formation. Factor VIII (porcine), which is prepared from porcine plasma (porcine Factor VIII:C), is structurally similar to endogenous human Factor VIII and produces the same biologic effects.
Factor IX (human) is a highly purified, sterile, lyophilized concentrate of blood coagulation Factor IX that is prepared from human plasma. It is obtained from a prothrombin complex concentrate derived by cryoprecipitation of pooled human venous plasma.
Factor IX (complex) also called prothrombin complex concentrate (PCC), is a sterile, lyophilized concentrate of blood coagulation factors II, VII, IX, and X. It is derived from fresh venous plasma obtained from healthy human donors.
Factor IX (recombinant) is a purified protein produced by recombinant DNA technology. A genetically engineered Chinese hamster ovary cell line secretes recombinant factor IX into a defined cell culture medium. This is then purified by a chromatography purification process.
FDA APPROVED INDICATIONS FOR FACTOR VIII
FDA APPROVED INDICATIONS FOR FACTOR IX
Generic Name: Factor VIII (human)
Generic Name: Factor VIII (recombinant)
Generic Name: Factor VIII/VWF
Generic Name: Factor IX (human)
Generic Name: Factor IX (complex)
Generic Name: Factor IX (recombinant)
POLICYPrior authorization is required.
Factor VIII is considered medically necessary for the following disease states:
Factor VIII (recombinant) is considered medically necessary for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children (0-16) with hemophilia A with no pre-existing joint damage.
Factor IX is considered medically necessary for the following disease states:
POLICY GUIDELINESThe coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY4/1999: Approved by Pharmacy & Therapeutics (P & T) Oncology Committee
1/30/2002: Factor VIII (Human), Factor VIII (Recombinant) and Factor VIII (Porcine) policies combined into one policy titled "Factor VIII"; Prior authorization deleted
4/24/2002: Type of Service and Place of Service deleted. Code Reference section completed
11/6/2002: Koate-DVI® added, Koate-P® and Koate-HP® deleted
8/17/2004: Code Reference section updated, ICD-9 diagnosis code 286.1, 286.4, 286.5 added, HCPCS S9345 added
9/24/2004: Code Reference section updated, CPT code 36440, 85244 deleted
10/29/2006: Factor VIII and Factor IX policies combined
9/12/2007: Added Mississippi Comprehensive Health Insurance Risk Pool Association will no longer provide benefits for antihemophilic factor, factor VIII, factor IX, factor concentrate or factorate products of any kind and services or related supplies received on an outpatient basis effective August 1, 2007, to Policy Exceptions
12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions.
01/01/2009: Accredo preferred provider information removed. BCBSMS information added.
6/30/2009: New HCPC code Q2023 added to covered table.
8/26/2009: Policy statement updated to include medically necessary indications for VIII for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children (0-16) with hemophilia A with no pre-existing joint damage.
12/15/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions
03/08/2010: Description section was updated with Humate-P®, Wilate®. Also added brand names (ReFacto®, Xyntha® and Advate®) for Factor VIII (recombinant). Policy Section updated with coverage for Von Willebrand disease for Factor VIII. Policy Exceptions Section updated to remove Risk Pool language. HCPCS code J7185 & J7187 were added to Covered Codes for Factor VIII.
02/28/2011: Added new HCPCS code J7184 for Wilate® to the Code Reference section.
SOURCE(S)Fact and Comparisons, November, 1998
American Hospital Formulary Services 1998
Micromedex, 1998, 2006
BeneFix® Prescribing Information
Helixate® Prescribing Information
Kogenate® Prescribing Information
Wilate® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Covered Codes for Factor VIII
Covered Codes for Factor IX