Hemophilia Therapies

POLICY NUMBER

L.5.01.433

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Hemophilia is a rare bleeding disorder in which the blood does not clot normally. Hemophilia is usually inherited and caused by a defect in one of the genes that determine how the body makes blood clotting factor VIII or IX. Rarely, hemophilia can be acquired. This can happen if the body forms antibodies that attack the clotting factors in the bloodstream, preventing the clotting factors from working. People born with hemophilia have little or no clotting factor, which is a protein needed for normal blood clotting. These proteins work with platelets, which are small blood cell fragments that form in the bone marrow, to help the blood clot. When blood vessels are injured, clotting factors help platelets stick together to plug cuts and breaks on the vessels and stop bleeding.

The two main types of hemophilia are A and B. People with hemophilia A, also called Classic hemophilia or Factor VIII deficiency, are missing or have low levels of clotting factor VIII. About 8 out of 10 people with hemophilia have type A. People with hemophilia B, also called Christmas disease or Factor IX deficiency, are missing or have low levels of clotting factor IX.

Factor X (ten) deficiency, also known as Stuart-Prower Factor Deficiency, is a disorder caused by a lack of protein called factor X in the blood. The factor X protein plays an important role in activating the enzymes that help to form a clot. Deficiency of this protein leads to problems with coagulation. The incidence of Factor X deficiency is estimated at 1 in 500,000 to 1 in a million.

Hemophilia can be mild, moderate, or severe, depending on how much clotting factor is in the blood. About 7 out of 10 people who have hemophilia A have the severe form of the disorder. People who do not have hemophilia have a factor VIII activity of 100 percent. People who have severe hemophilia A have a factor VIII activity of less than 1 percent. Hemophilia usually occurs in males. About 1 in 5,000 males are born with hemophilia each year.

The main treatment for hemophilia is called replacement therapy. Concentrates of clotting factor are slowly dripped or injected into a vein. Clotting factor concentrates can be made from human blood or recombinant clotting factors. Replacement therapy can be preventive/prophylactic or used on an as-needed basis called demand therapy. 

POLICY

Priorauthorization is required.

The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review.

Initial evaluation of Factor VIII is considered medically necessary for the following Classic Hemophilia/Hemophilia A/Factor VIII Deficiency/ Von Willebrand disease when all of the following are met:

1. ONE of the following:

   1. There is documentation that the patient is currently being treated with the requested agent (starting on samples is not approvable) OR

   2. The prescriber states the patient is using the requested agent (starting on samples is not approvable) AND is at risk if therapy is changed OR

   3. The patient has a diagnosis of hemophilia A, is currently bleeding, AND is out of medication (need immediate use) OR

   4. The patient has a diagnosis of hemophilia A and ALL of the following:

      1. If the patient has mild hemophilia A (i.e., factor VIII activity level between 5%-40%), then ONE of the following:

         1. The patient has tried and failed to be adequately controlled with Desmopressin acetate (DDAVP) OR

         2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to therapy with Desmopressin acetate (DDAVP)

            AND

      2. The requested agent is prescribed for ONE of the following:

         1. Prophylactic

         2. *On-demand bleeding

         3. Peri-operative dosing

             *Please note: Corifact is not approvable for on-demand dosing for bleeds

            AND

      3. If the request is for a long-acting product (e.g., Adynovate, Afstyla, Eloctate), then ONE of the following:

         1. The patient has tried and failed to be adequately controlled on a regular clotting factor after at least 50 exposure days OR

         2. The prescriber has documented clinical reasoning as to why a regular clotting factor cannot be utilized (convenience not acceptable)

            AND

      4. If the request is for Helixate then ONE of the following:

         1. The patient has tried and failed Kogenate and Kovaltry

            OR

         2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to therapy with Kogenate and Kovaltry

            AND

2. The prescriber has discussed with the patient that a treatment log must be maintained and a copy will be submitted (via prescriber or pharmacy) for renewal purposes.

   1. The treatment log for bleeds will include the following:

      1. Date and time of bleed

      2. Location and severity of the bleed

      3. How quickly the bleed was treated

      4. The treatment used (include the brand name, expiration date, lot number, and number of units administered)

   2. The treatment log for an infusion that is not in response to a bleed will include the following:

      1. Date and time of the infusion

      2. The treatment used (include the brand name, expiration date, lot number, and the number of units administered)

      3. The reason for the infusion (e.g., scheduled prophylaxis, pre-surgery)

         AND

3. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent AND

4. ALL of the following:

   1. The prescriber must provide the actual prescribed dose with ALL of the following supporting documentation

      1. Patient’s age

      2. Patient’s weight

      3. Severity of the factor deficiency (i.e., severe= <1% factor activity, moderate=≥1 to ≤5% factor activity, mild= >5 to 40% factor activity)

      4. Activity level

      5. Bleed history

      6. Current and desired trough level

      7. Inhibitor status

      8. Intended use/regimen: prophylaxis, on-demand, peri-operative

         AND

   2. The quantity (number of doses) requested is appropriate based on submitted supportive documentation AND

   3. ONE of the following:

      1. The dose is within the FDA labeled dosing

         OR

      2. The prescriber has provided clinical reasoning with supportive documentation (see 4.A.i-viii) for the higher dosing

Length of Approval:

• Immediate Use: Based upon request

• On-demand: 6 months

• Prophylaxis: 6 months

Renewal evaluation for requested medication will be renewed when the following are met:

1. The prescriber has provided a copy of the patient’s treatment logs. 

   1. The treatment log for bleeds includes the following:

      1. Date and time of bleed

      2. Location and severity of the bleed

      3. How quickly the bleed was treated

      4. The treatment used (include the brand name, expiration date, lot number, and number of units administered)

   2. The treatment log for an infusion that is not in response to a bleed will include the following:

      1. Date and time of the infusion

      2. The treatment used (include the brand name, expiration date, lot number, and the number of units administered)

      3. The reason for the infusion (e.g., scheduled prophylaxis, pre-surgery)

         AND

2. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent AND

3. ALL of the following:

   1. The prescriber must provide the actual prescribed dose with ALL of the following supporting documentation

      1. Patient’s age

      2. Patient’s weight

      3. Severity of the factor deficiency (i.e., severe= <1% factor activity, moderate=≥1 to ≤5% factor activity, mild= >5 to 40% factor activity)

      4. Activity level

      5. Bleed history

      6. Current and desired trough level

      7. Inhibitor status

      8. Intended use/regimen: prophylaxis, on-demand, peri-operative

         AND

   2. ONE of the following:

      1. The prescriber communicated with the patient (via any means) regarding the frequency and severity of the patient’s bleeds and has verified that the patient does not have >5 on-demand doses on hand OR

      2. The prescriber has provided information in support of the patient having more than 5 on-demand doses on hand AND

   3. The quantity (number of doses) requested is appropriate based on submitted supportive documentation AND

   4. ONE of the following:

      1. The dose is within the FDA labeled dosing

         OR

      2. The prescriber has provided clinical reasoning with supportive documentation (see 4.A.i-viii) for the higher dosing

Length of Approval:

• On-demand: 6 months

• Prophylaxis: 12 months

Initial evaluation of Factor IX is considered medically necessary for Hemophilia B/Factor IX Deficiency when ALL of the following are met:

1. ONE of the following:

2. 1. There is documentation that the patient is currently being treated with the requested agent (starting on samples is not approvable) OR

   2. The prescriber states the patient is using the requested agent (starting on samples is not approvable) AND is at risk if therapy is changed OR

   3. The patient has a diagnosis of hemophilia B, is currently bleeding, AND is out of medication (need immediate use) OR

   4. The patient has a diagnosis of hemophilia B and ALL of the following:

   5. 1. The requested agent is prescribed for ONE of the following:

      2. 1. Prophylactic

         2. On-demand bleeding

         3. Peri-operative dosing

            AND

      3. If the request is for a long-acting product (e.g., Alprolix), then ONE of the following:

         1. The patient has tried and failed to be adequately controlled on a regular clotting factor after at least 50 exposure days OR

         2. The prescriber has documented clinical reasoning as to why a regular clotting factor cannot be utilized (convenience not acceptable)AND

3. The prescriber has discussed with the patient that a treatment log must be maintained and a copy will be sent in (via prescriber or pharmacy) for renewal purposes.

   1. The treatment log for bleeds will include the following:

      1. Date and time of bleed

      2. Location and severity of the bleed

      3. How quickly the bleed was treated

      4. The treatment used (include the brand name, expiration date, lot number, and number of units administered)

   2. The treatment log for an infusion that is not in response to a bleed will include the following:

      1. Date and time of the infusion

      2. The treatment used (include the brand name, expiration date, lot number, and the number of units administered)

      3. The reason for the infusion (e.g., scheduled prophylaxis, pre-surgery)AND

4. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent AND

5. ALL of the following:

   1. The prescriber must provide the actual prescribed dose with ALL of the following supporting documentation:

      1. Patient’s age

      2. Patient’s weight

      3. Severity of the factor deficiency (i.e., severe= <1% factor activity, moderate=≥1 to ≤5% factor activity, mild= >5 to 40% factor activity)

      4. Activity level

      5. Bleed history

      6. Current and desired trough level

      7. Inhibitor status

      8. Intended use/regimen: prophylaxis, on-demand, peri-operativeAND

   2. The quantity (number of doses) requested is appropriate based on submitted supportive documentation AND

   3. ONE of the following:

      1. The dose is within the FDA labeled dosingOR

      2. The prescriber has provided clinical reasoning with supportive documentation (see 4.a.i-viii) for the higher dosing

Length of Approval:

• Immediate Use: Based upon request

• On-demand: 6 months

• Prophylaxis: 6 months

Renewal evaluation for requested medication will be renewed when the following are met:

1. The prescriber has provided a copy of the patient’s treatment logs AND the treatment log for bleeds includes ALL of the following:

   1. Date and time of bleed

   2. Location and severity of the bleed

   3. How quickly the bleed was treated

   4. The treatment used (include the brand name, expiration date, lot number, and number of units administered)

2. The treatment log for an infusion that is not in response to a bleed will include the following:

   1. Date and time of the infusion

   2. The treatment used (include the brand name, expiration date, lot number, and the number of units administered)

   3. The reason for the infusion (e.g., scheduled prophylaxis, pre-surgery)

      AND

3. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent AND

4. ALL of the following:

   1. The prescriber must provide the actual prescribed dose with ALL of the following supporting documentation:

      1. Patient’s age

      2. Patient’s weight

      3. Severity of the factor deficiency (i.e., severe= <1% factor activity, moderate=≥1 to ≤5% factor activity, mild= >5 to 40% factor activity)

      4. Activity level

      5. Bleed history

      6. Current and desired trough level

      7. Inhibitor status

      8. Intended use/regimen: prophylaxis, on-demand, peri-operative

         AND

   2. ONE of the following:

      1. The prescriber communicated with the patient (via any means) regarding the frequency and severity of the patient’s bleeds and has verified that the patient does not have >5 on-demand doses on hand

         OR

      2. The prescriber has provided information in support of the patient having more than 5 on-demand doses on hand

         AND

   3. The quantity (number of doses) requested is appropriate based on submitted supportive documentation AND

   4. ONE of the following:

      1. The dose is within the FDA labeled dosing

         OR

      2. The prescriber has provided clinical reasoning with supportive documentation (see 4.a.i-viii) for the higher dosing

Length of Approval:

• On-demand: 6 months

• Prophylaxis: 12 months

 Factor X is considered medically necessary for the following disease states:

• Factor X Deficiency/Stuart-Prower Factor Deficiency

 Von Willebrand factor is considered medically necessary for the following disease states:

• Von Willebrand disease

Esperoct,Hemlibra, Hympavzi, Jivi, Qfitlia, and Roctavian are considered not medically necessary as there are other alternatives covered by the plan for the treatment of Hemophilia A and Hemophilia B.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors.  In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

4/1999: 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.

04/01/2014: Policy title changed from "Hemophilia Factor VIII (Human, Recombinant, Porcine) and Factor IX (Human, Complex, Recombinant)" to "Hemophilia Factor VIII Factor IX." Policy description and FDA Approved Indications for Factors VIII and IX were updated. Policy statement updated to include "Factor VIII Deficiency" and "Hemophilia B" in medically necessary statements. Removed deleted HCPCS code Q2023 from the Code Reference section.

12/31/2014: Added the following new 2015 HCPCS code for Factor VIII to the Code Reference section: J7182. Added the following new 2015 HCPCS codes for Factor IX to the Code Reference section: J7200 and J7201. Revised the description of the following HCPCS code: J7195.

05/28/2015: Policy description updated to add the brand name Eloctate® for Factor VIII (recombinant) and Alprolix® for Factor IX (recombinant).

08/28/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 286.5 to the fifth digit as 286.52 - 286.59. Removed deleted HCPCS code J7184.

03/01/2016: Policy description updated to add the brand name Nuwiq® for Factor VIII (recombinant) and brand names Rixibus® and Ixinity® for Factor IX (recombinant). Policy statement unchanged. Policy guidelines updated to add medically necessary definition. Sources section updated.

04/04/2016: Policy description updated to add the brand name Alphanate® for Factor VIII/VWF.

05/26/2016: Policy number L.5.01.433 added.

06/30/2016: Policy title updated to include Factor X. Policy description updated regarding Factor X and its indications. Added brand name Adynovate® for Factor VIII (Recombinant). Added policy statement that Factor X is considered medically necessary for Factor X Deficiency/Stuart-Prower Deficiency. Sources section updated.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

12/05/2016: Policy updated to add indication for Von Willebrand disease and to add the following brand names: Kovaltry®, Afstyla®, Idelvion®, and Vonvendi®. Added policy statement that Von Willebrand factor is considered medically necessary for Von Willebrand disease. Sources updated.

12/30/2016: Code Reference section updated to add new 2017 HCPCS codes J7179, J7207, and J7209 for Factor VIII and J7202 for Factor IX. For Factor X, added new Covered Codes table, new 2017 HCPCS code J7175, and ICD-10 diagnosis code D68.2.

06/15/2017: Policy description updated to add indications for antihemophilic factor (recombinant), porcine sequence. Added brand name Obizur®. Added policy statement that antihemophilic factor (recombinant), porcine sequence is considered medically necessary for bleeding episodes in adults with acquired hemophilia A.

07/01/2017: Policy description updated to add the brand name Obizur® for Factor VIII (Recombinant), Porcine.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

12/22/2017: Code Reference section updated to add new 2018 HCPCS codes J7210 and J7211.

04/01/2018: Policy description updated to remove the FDA approved indications, as well as the generic and brand names. Policy statements revised to add criteria for initial and renewal evaluations of Factor VIII and Factor IX.

12/19/2018: Code Reference section updated to add new HCPCS code J7203, effective 01/01/2019.

09/30/2019: Code Reference section updated regarding deleted ICD-10 procedure codes.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Hemophilia Factor VIII Factor IX Factor X" to "Hemophilia Therapies." Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Added statement that Esperoct, Hemlibra, and Jivi are considered not medically necessary as there are other alternatives covered by the plan for the treatment of Hemophilia A. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and to define investigative. Sources updated. Code Reference section updated to add not medically necessary HCPCS codes J7170, J7204, and J7208.

12/27/2021: Code Reference section updated to make note of deleted ICD-10 procedure codes. Removed deleted ICD-10 procedure codes 30250V1, 30253V1, 30260V1, 30263V1, 30250W1, 30253W1, 30260W1, and 30263W1.

09/19/2022: Code Reference section updated to add new ICD-10 diagnosis codes D68.00, D68.01, D68.020, D68.021, D68.022, D68.023, D68.029, D68.03, D68.04, D68.09, effective 10/01/2022.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

02/15/2023: Policy reviewed. Medically necessary criteria for the initial evaluation of Factor IX updated to remove the following statement: *Please Note: Rebinyn is NOT FDA approved for routine prophylactic use and is not approvable for that indication. Sources updated. Removed deleted ICD-10 procedure codes 30230V1, 30240V1, 30230W1, and 30240W1.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants. Code Reference section updated to add new HCPCS code J7213.

04/01/2024: Policy updated to add Roctavian as not medically necessary as there are other alternatives covered by the plan for the treatment of Hemophilia A. Sources updated. Code Reference section updated to remove deleted ICD-10 diagnosis code D68.0. Added HCPCS code J1412 as not medically necessary.

06/27/2024: Policy revised to update Length of Approval.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

09/15/2025: Policy updated to add Hympavzi as not medically necessary as there are other alternatives covered by the plan for the treatment of Hemophilia A and Hemophilia B. Sources updated. Code Reference section updated to add HCPCS code J7172 to the Not Medically Necessary Codes table.

11/01/2025: Policy statement updated to add Qfitlia as not medically necessary as there are other alternatives covered by the plan for the treatment of Hemophilia A and Hemophilia B. Sources updated. Code Reference section updated to add new HCPCS code J7174 to the Not Medically Necessary Codes table.

SOURCE(S)

1. Advate prescribing information. Baxalta US, Inc. January 2019. Last accessed June 2020.

2. Adynovate prescribing information. Baxalta US, Inc. March 2020. Last accessed June 2020.

3. Afstyla prescribing information. CSL Behring Lengnau AG. April 2020. Last accessed June 2020.

4. Alphanate prescribing information. Grifols USA, LLC. February 2020. Last accessed June 2020.

5. AlphaNine SD prescribing information. Grifols USA, LLC. February 2020. Last accessed June 2020.

6. Alprolix prescribing information. Bioverativ Therapeutics, Inc. November 2019. Last accessed June 2020.

7. American Hospital Formulary Services 1998

8. Bebulin VH prescribing information.

9. BeneFix prescribing information. Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. March 2020. Last accessed June 2020.

10. Coagadex prescribing information. Bio Products Laboratory Limited. November 2018. Last accessed June 2020.

11. Eloctate prescribing information. Bioverativ Therapeutics, Inc. October 2019. Last accessed June 2020.

12. Esperoct prescribing information. Novo Nordisk. October 2019. Last accessed June 2020.

13. Fact and Comparisons, November, 1998

14. Helixate prescribing information. CSL Behring, Inc. May 2016. Last accessed June 2020.

15. Hemlibra prescribing information. Genentech, Inc. October 2018. Last accessed June 2020.

16. Hemofil M prescribing information. Baxalta US, Inc. June 2018. Last accessed June 2020.

17. Hympavzi prescribing information. Pfizer Laboratories Div Pfizer Inc. February 2025. Last accessed September 2025.

18. Humate P prescribing information. CSL Behring GmbH. August 2018. Last accessed June 2020.

19. Idelvion prescribing information. CSL Behring Lengnau AG. October 2019. Last accessed June 2020.

20. Ixinity prescribing information. Aptevo BioTherapeutics, LLC. January 2019. Last accessed June 2020.

21. Koate DVI prescribing information. Kedrion Biopharma, Inc. January 2020. Last accessed June 2020.

22. Kogenate prescribing information. Bayer HealthCare, LLC. December 2019. Last accessed June 2020.

23. Kovaltry prescribing information. Bayer HealthCare, LLC. March 2016. Last accessed June 2020.

24. Micromedex, 1998, 2006

25. Monoclate P prescribing information.

26. Mononine prescribing information. CSL Behring, LLC. February 2019. Last accessed June 2020.

27. National Heart, Lung, and Blood Institute http://www.nhlbi.nih.gov/health/health-topics/topics/hemophilia/

28. Nuwiq prescribing information. Octapharma USA, Inc. July 2017. Last accessed June 2020.

29. Qfitlia prescribing information. Genzyme Corporation. September 2025. Last accessed October 2025.

30. Profilnine SD prescribing information. Grifols USA, LLC. February 2020. Last accessed June 2020.

31. Rebinyn prescribing information. Novo Nordisk. August 2022. Last accessed February 2023.

32. Recombinate prescribing information. Baxalta US, Inc. February 2019. Last accessed June 2020.

33. Rixubis prescribing information. Baxalta US, Inc. February 2020. Last accessed June 2020.

34. Roctavian prescribing information. BioMarin Pharmaceutical Inc. December 2019. Last accessed March 2024.

35. Vonvendi prescribing information. Baxalta US, Inc. February 2019. Last accessed June 2020.

36. Wilate prescribing information. Octapharma USA, Inc. September 2016. Last accessed June 2020.

37. Xyntha prescribing information. Xyntha prescribing information. Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. March 2020. Last accessed June 2020.

CODE REFERENCE

This 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

Covered Codes for Factor X

Not Medically Necessary Codes 

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.