Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    All Factor Products require prior authorization.

2)    Factor products are used to treat hemophilia A, hemophilia B, and von Willebrand disease, among other coagulation disorders.

3)    Factor products include Afstyla®, Adynovate, Alprolix®, Altuviiio, Andexxa®, Eloctate®, Esperoct®, Novoseven®, Novoeight ®, Rixubis®, Monoclate-P®, Humate-P®, Alphanate®, Corifact™, Hemofil M®, Koate-DVI®, Wilate®, Advate®, Helixate FS®, Kogenate FS®, Kovaltry®, Recombinate®, Xyntha®, Mononine®, Alphanine SD®, Profilnine®, Tretten®, Bebuline VH®, Benefix®, Rebinyn®, Hemlibra®, Jivi® and Feiba VH®.

4)    Factor products are covered under the medical benefit as a specialty drug.  

Coverage for factor products is provided for members with a diagnosis of hemophilia A (D66), hemophilia B (D67), or von Willebrand disease (D68.0) who meet any one of the following criteria:

1)     Treatment and/or management of acute bleeding in members with severe hemophilia, and maintenance therapy as needed to maintain trough factor levels at 1% or greater.

2)    Treatment and/or management of acute bleeding episodes for members with mild hemophilia (factor levels of 1% - 5%), such as bleeding episodes associated with surgery or trauma.

3)    Treatment and/or management of acute bleeding in members with von Willebrand disease, and in clinical situations in which patients with von Willebrand disease are at increased risk of bleeding (i.e. surgery or trauma).

4)    Treatment and/or management of significant menorrhagia in women with von Willebrand disease.

In addition to the above criteria, coverage for NovoSeven products (Coagulation Factor VIIa [recombinant]) for member with acquired hemophilia (D68.311) or congenital factor VII deficiency (D68.2) when either of the following criteria is met:

1)    Treatment and/or management of acute bleeding episodes for members with acquired hemophilia, and in clinical situations in which patients with acquired hemophilia are at increased risk of bleeding (i.e. surgery or trauma).

2)    Treatment and/or management of acute bleeding in member with congenital factor VII deficiency, and in clinical situations in which patients with congenital factor VII deficiency are at increased risk of bleeding (i.e. surgery or trauma).

Coverage for Factor XIII Concentrate is provided for members with a diagnosis of congenital Factor XIII (FXIII) deficiency (D68.2) when the following criterion is met:

1)    Routine prophylactic treatment of congenital FXIII deficiency in clinical situations in which patients with congenital Factor XIII deficiency are at increased risk of bleeding (i.e. surgery or trauma).

Codes Used In This BI:

C9136            Injection, factor VIII, Fc fusion protein, (recombinant), per IU

C9137            Injection, factor VIII (antihemophilic factor, recombinant) PEGylated, 1IU

C9140            Injection factor VIII (antihemophilic factor, recombinant) (Afstyla), 1 IU (new 1/1/17) J7180 Injection, factor XIII (antihemophilic factor, human), 1 IU

J7169             Injection, coagulation Factor Xa (recombinant), inactivated-zhzo, 10mg

J7181             Injection, factor XIII A-subunit, (recombinant), per IU

J7182             Injection, factor VIII, (antihemophilic factor, recombinant), per IU

J7183             Injection, von Willebrand factor complex (human), Wilate, 1 IU VWF: RCO

J7185             Injection, factor VIII (antihemophilic factor, recombinant) (Xyntha), per IU

J7186             Injection, antihemophilic factor VIII/Von Willebrand factor complex (human), per factor VIII I.U.

J7187             Injection, Von Willebrand factor complex (Humate-P), per IU, VWF: RCO

J7189             Factor VIIa (antihemophilic factor, recombinant), per 1 microgram

J7190             Factor VIII (antihemophilic factor [human]) per IU

J7192             Factor VIII (antihemophilic factor, recombinant) per IU

J7193             Factor IX (antihemophilic factor, purified, non-recombinant) per IU

J7194             Factor IX, complex, per IU

J7195             Factor IX (antihemophilic factor, recombinant) per IU

J7199             Hemophilia clotting factor, not otherwise classified

J7200             Injection, factor IX, (antihemophilic factor, recombinant), per IU

J7201             Injection, factor IX, Fc fusion protein (recombinant), per IU

J7203             Injection factor IX, glycopegylated, Rebinyn, per IU

J7204             Injection, Factor VIII, antihemophilic factor (recombinant), glycopegylated-exei, per IU

J7205             Injection, factor VIII Fc fusion (recombinant), per IU (Eloctate)

J7207             Injection, Factor VIII, (antihemophilic factor, recombinant), PEGylated, 1   IU  (new code eff 01/01/2017)

J7208             Injection, factor VIII (antihemophilic factor, recombinant) pegylated

J7209             Injection, factor VIII (antihemophilic, factor, recombinant)(Nuwiq)

J7210             Injection, Factor VIII, (antihemophilic factor, recombinant), (Afstyla), 1 IU (new code eff 01/01/2018)

J7211             Injection, factor VIII, (antihemophilic factor, recombinant), (Kovaltry), 1 IU

J7212            Factor VIIa (antihemophilic factor, recombinant)-jncw (Sevenfact), 1 mcg

Hemophilia is a genetic bleeding disorder that prevents the blood from clotting normally. The main symptom is uncontrolled, often spontaneous bleeding. Internal bleeding into the joints can result in pain, swelling and, if left untreated, can cause permanent damage

Hemophilia results from the deficiency of one more proteins known as blood clotting factors. There are 13 clotting proteins in the body, all of which contribute to the formation of a clot. The two main forms are hemophilia A (factor VIII deficiency) and hemophilia B (factor IX deficiency). Hemophilia occurs in 1 in 5,000 live male births, of these, 80% are hemophilia A, and 20% are hemophilia B. The worldwide incidence of hemophilia is estimated at more than 400,000 people. Approximately 70% of people around the world do not have access to treatment.

• Currently, there is no cure for hemophilia. While treatment exists, it is costly and may require lifelong infusion of replacement clotting factor that is manufactured either from human plasma or using recombinant technology. Hemophilia occurs predominately in males. Women are carriers of the defective gene and may experience mild symptoms. In about one-third of cases there is no known family history of hemophilia. Instead, the disorder results from a spontaneous genetic mutation.
• Nearly 90% of Americans with severe hemophilia became infected with HIV in the 1980s when the nation’s blood supply was contaminated by blood pooled from people infected by HIV/AIDS. More than 50% of people with hemophilia infected with HIV have died. Since 1986, there have been no reported cases of HIV transmission through factor concentrates in the U.S. Current donor screening measures and improved viral inactivation methods have been integrated into the manufacturing process to dramatically improve the safety of these plasma-derived products.

von Willebrand disease is another genetic bleeding disorder that prevents the blood from clotting normally. It is caused by a deficient or defective blood protein known as von Willebrand factor. It occurs with equal frequency in men and women. It is estimated to affect more than two million people in the U.S.  Of the three main types, type I (the mildest form of the disease) accounts for 70% of cases. Symptoms include frequent nosebleeds, a tendency to bruise easily, and excessive bleeding following surgery. In women, the disease may also cause heavy, prolonged bleeding during menstruation and excessive bleeding following childbirth. VWD is often undiagnosed or incorrectly attributed to a gynecologic condition.

1)    TUFTS Health Plan Medical Policy – Factor Products.  Reviewed June 12, 2012.

2)    Aetna Pharmacy Clinical Policy Bulletin – Blood Products coagulants.  Reviewed January 2012.

3)    Clinical Pharmacology.  Accessed online November 2012.

4)    National Hemophilia Foundation website www.hemophilia.org

Addendum:

Effective 09/01/2017: Code update

Effective 01/01/2018: Added J7211 to policy.

Effective 07/01/2018:  Added J7192 to policy and added Hemlibra (no code currently)

Effective 01/01/2019:  Added Jivi to policy (no code currently)

Effective 10/01/2019:  Updated Jivi code (J7208)

Effective 07/01/2020: Updated Andexxa code (J7169) and Esperoct code (J7204)

Effective 01/01/2021:  Added new code J7212.

Effective 10/01/2021: Added codes J7207 & J7210 to the search box as well as their descriptions in the claims statement and Codes listed in this BI.  These were replacements codes to codes listed already.

Effective 01/01/2023: Added Rebinyn (J7203) to policy.

Effective 08/01/2023: added Altuviiio to policy.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.