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Hemophilia Products - Factor IX: Alphanine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine, Rebinyn, and Rixubis

Policy Number: PH-0339

Intravenous

​Last Review Date: 06/04/2024

Date of Origin: 12/16/2014

Dates Reviewed: 12/2014, 04/2015, 05/2015, 09/2015, 12/2015, 03/2016, 06/2016, 12/2016, 06/2017, 09/2017, 11/2017, 11/2018, 03/2019, 02/2020, 08/2020, 04/2021, 06/2021, 07/2021, 06/2022, 09/2022, 06/2023, 04/2024, 06/2024

  1. Length of Authorization

Coverage is provided for 3 months and may be renewed thereafter, unless otherwise specified*.

Note: The cumulative amount of medication the patient has on-hand will be taken into account for authorizations. Up to 5 ‘on-hand’ doses for the treatment of acute bleeding episodes will be permitted at the time of the authorization request.

* Initial and renewal authorization periods may vary by specific covered indication

  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • N/A

B. Max Units (per dose and over time) [HCPCS Unit]:

Alprolix

34,500 billable units per 30-day supply

Idelvion, Rebinyn

18,400 billable units per 28-day supply

Ixinity

64,000 billable units per 28-day supply

AlphaNine SD, Profilnine, Mononine

36,800 billable units per 28-day supply

BeneFIX

46,000 billable units per 28-day supply

Rixubis

55,200 billable units per 28-day supply

  1. Initial Approval Criteria1-11,15,18

Hemophilia Management Program

Requirements for half-life study and inhibitor tests are a part of the hemophilia management program. This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide.

Coverage is provided in the following conditions:

Universal Criteria 1-5,7-9

  • Therapy NOT used for induction of immune tolerance in patients with Hemophilia B [ONLY the following products]:
        • Alprolix
        • Rixubis
        • Ixinity
        • Idelvion
        • Rebinyn
        • AlphaNine SD
        • Mononine
        • BeneFIX; AND

Hemophilia B (congenital factor IX deficiency aka Christmas disease) † Ф 1-9

  • Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing; AND
  • Used as treatment in at least one of the following:
  • On-demand treatment and control bleeding episodes; OR
  • Perioperative management (*Authorizations valid for 1 month); OR
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
        • Used as primary prophylaxis in patients with severe factor IX deficiency (factor IX level of <1%); OR
        • Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints

Hemophilia Management Program
  • If the request is for prophylaxis and the requested dose exceeds dosing limits under part II, a half-life study should be performed to determine the appropriate dose and dosing interval.
  • If the request is for Alprolix, Idelvion, or Rebinyn, a half-life study should be performed to determine the appropriate dose and dosing interval.
    • For Alprolix, 50 IU/kg every 7 days is the preferred dosing regimen. To obtain 100 IU every 10 days, a half-life study must be submitted showing a significant clinical benefit over 50 IU/kg every 7 days.
    • Prior to switching to Alprolix, Idelvion, or Rebinyn, a half-life study should also be performed on current non- EHL factor IX product to ensure that a clinical benefit will be achieved.
  • For members with a BMI ≥ 30, a half-life study should be performed to determine the appropriate dose and dosing interval.
  • For minimally treated patients (< 50 exposure days to factor products) previously receiving a different factor product, inhibitor testing is required at baseline, then at every comprehensive care visit (yearly for the mild and moderate patients, semi-annually for the severe patients)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug (NOTE: Ф Only applies to Alphanine SD, Alprolix, BeneFIX, Idelvion, Mononine, Rixubis and Rebinyn)

  1. Dispensing Requirements for Rendering Providers (Hemophilia Management Program)
  • Prescriptions cannot be filled without an expressed need from the patient, caregiver or prescribing practitioner. Auto-filling is not allowed.
  • Monthly, rendering provider must submit for authorization of dispensing quantity before delivering factor product. Information submitted must include:
      • Original prescription information, requested amount to be dispensed, vial sizes available to be ordered from the manufacturer, and patient clinical history (including patient product inventory and bleed history)
      • Factor dose should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose. If unable to provide factor dosing within the required threshold, below the required threshold, the lowest possible dose able to be achieved above +1% should be dispensed. Prescribed dose should not be increased to meet assay management requirements.
  • The cumulative amount of medication(s) the patient has on-hand should be taken into account when dispensing factor product. Patients should not have more than 5 extra doses on-hand for the treatment of acute bleeding episodes.
  • Dispensing requirements for renderings providers are a part of the hemophilia management program. This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide.
  1. Renewal Criteria 1-11,15

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: anaphylaxis and hypersensitivity reactions (e.g., angioedema, chest tightness, hypotension, urticaria, wheezing, dyspnea, etc.), thromboembolic events (pulmonary embolism, venous thrombosis, and arterial thrombosis), development of neutralizing antibodies (inhibitors), nephrotic syndrome, etc.; AND
  • Any increases in dose must be supported by an acceptable clinical rationale (i.e. weight gain, half-life study results, increase in breakthrough bleeding when patient is fully adherent to therapy, etc.); AND
  • The cumulative amount of medication(s) the patient has on-hand will be taken into account when authorizing. The authorization will allow up to 5 doses on-hand for the treatment of acute bleeding episodes as needed for the duration of the authorization; AND

On-demand treatment of bleeding episodes and control bleeding episodes

  • Renewals will be approved for a 6 month authorization period

Perioperative management of bleeding

  • Coverage may NOT be renewed

Routine prophylaxis to reduce the frequency of bleeding episodes

  • Renewals will be approved for a 12 month authorization period; AND
  • Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline)
  1. Dosage/Administration1-9

Alprolix

Indication

Dose

On-demand treatment and control of bleeding episodes Hemophilia B

One unit per kilogram body weight increases the circulating Factor IX level by 1% (IU/dL) in adults and children ≥6 years of age and by 0.6% (IU/dL) in children under 6 years of age. Estimate the required dose or the expected in vivo peak increase in Factor IX level expressed as IU/dL (or % of normal) using the following: IU/dL (or % of normal) = [Total Dose (IU)/Body Weight (kg)] x Recovery (IU/dL per IU/kg)

Minor and Moderate

Circulating Factor IX required (% of normal) = 30-60 IU/dL - Repeat every 48 hours as needed

Major

Circulating Factor IX required (% of normal) = 80-100 IU/dL - Consider repeat dose after 6-10 hours, then every 24 hours for 3 days, then every 48 hours until healing achieved.

Perioperative management Hemophilia B

One unit per kilogram body weight increases the circulating Factor IX level by 1% (IU/dL) in adults and children ≥6 years of age and by 0.6% (IU/dL) in children under 6 years of age. Estimate the required dose or the expected in vivo peak increase in Factor IX level expressed as IU/dL (or % of normal) using the following: IU/dL (or % of normal) = [Total Dose (IU)/Body Weight (kg)] x Recovery (IU/dL per IU/kg)

Minor

Circulating Factor IX required (% of normal) = 50-80 IU/dL - Repeat every 24-48 hours as needed, until bleeding stops and healing is achieved.

Major

Circulating Factor IX required (% of normal) = 60-100 IU/dL (initial level) - Consider repeat dose after 6-10 hours, then every 24 hours for 3 days, then every 48 hours until bleeding stops and healing achieved.

Routine prophylaxis Hemophilia B

Adults and adolescents ≥12 years of age

50 IU/kg once weekly or 100 IU/kg once every 10 days. Adjust dosing regimen based on individual response.

Children <12 years of age

Start with 60 IU/kg once weekly. Adjust dosing regimen based on individual response. More frequent or higher doses may be needed in children <12 years of age, especially in children <6 years of age.

AlphaNine SD

Indication

Dose

On-demand treatment and control of bleeding episodes

Hemophilia B

One unit per kilogram body weight increases the circulating Factor IX level by 1% (IU/dL).   Number of Factor IX IU required = body wt (kg) x Desired increase in Plasma Factor IX (percent) x 1.0 IU/kg

Minor

Circulating Factor IX required (20 – 30 % of normal) = 20-30 IU/kg - Repeat every 12 hours as needed for 1-2 days

Moderate

Circulating Factor IX required (25 - 50% of normal) = 25-50 IU/kg - Repeat every 12 hours as needed for 2-7 days

Major

Circulating Factor IX required (50% of normal) = 30-50 IU/kg - Repeat dose every 12 hours as needed for 3-5 days. Following this treatment period, FIX levels should be maintained at 20% (20 IU FIX/kg/twice daily) until healing has been achieved. Major hemorrhages may require treatment for up to 10 days

Routine prophylaxis Hemophilia B §

25-40 IU/kg two times weekly or 15-30 IU/kg two times weekly. Adjust dosing regimen based on individual response.

Perioperative management Hemophilia B

Prior to surgery, FIX should be brought to 50-100% of normal (50-100 IU/kg repeat every 12 hours). For the next 7 to 10 days, or until healing has been achieved, the patient should be maintained at 50-100% FIX levels (50-100 IU/kg every 12 hours).

BeneFIX

Indication

Dose

On-demand treatment and control of bleeding episodes and Perioperative management Hemophilia B

One IU per kilogram body weight increases the circulating Factor IX level by 0.8 ± 0.2 IU/dL in adolescents/adults (≥12 years) and 0.7 ± 0.3 IU/dL in children (< 12 years). 

Initial dose: Number of Factor IX IU required (IU) = body weight (kg) x desired factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)

  • Minor hemorrhage: Circulating Factor IX activity required [% of normal or (IU/dL)]: 20-30, dosed every 12 to 24 hours for 1 to 2 days.
  • Moderate hemorrhage: Circulating Factor IX activity required [% of normal or (IU/dL)]: 25-50, dosed every 12 to 24 hours for 2 to 7 days until bleeding stops and healing begins.
  • Major hemorrhage: Circulating Factor IX activity required [% of normal or (IU/dL)]: 50-100, dosed every 12 to 24 hours for 7 to 10 days.

Dosage and duration of treatment with BeneFIX depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

Routine prophylaxis Hemophilia B
  • 100 IU/kg once weekly
  • Adjust the dosing regimen (dose or frequency) based on the patient’s clinical response.

Idelvion

Indication

Dose

On-demand treatment and control of bleeding episodes 

Hemophilia B
  • One IU of IDELVION per kg body weight is expected to increase the circulating activity of Factor IX as follows:
    • Adolescents and adults: 1.3 IU/dL per IU/kg
    • Pediatrics (<12 years): 1 IU/dL per IU/kg
  • Dosage and duration of treatment with IDELVION depends on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of Factor IX.
  • Determine the initial dose using the following formula:
    • Required Dose (IU) = Body Weight (kg) x Desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery (IU/kg per IU/dL))
  • Adjust dose based on the patient’s clinical condition and response.

Minor/Moderate

Desired peak Factor IX Level (% of normal or IU/dL): 30-60, dosed every 48-72 hours for at least 1 day until healing is achieved

Major

Desired peak Factor IX Level (% of normal or IU/dL): 60-100, dosed every 48-72 hours for 7-14 days until healing is achieved. Maintenance dose is weekly.

Perioperative management

Hemophilia B
  • One IU of IDELVION per kg body weight is expected to increase the circulating activity of Factor IX as follows:
    • Adolescents and adults: 1.3 IU/dL per IU/kg
    • Pediatrics (<12 years): 1 IU/dL per IU/kg
  • Dosage and duration of treatment with IDELVION depends on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of Factor IX.
  • Determine the initial dose using the following formula:
    • Required Dose (IU) = Body Weight (kg) x Desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery (IU/kg per IU/dL))
  • Adjust dose based on the patient’s clinical condition and response.

Minor

Desired peak Factor IX Level (% of normal or IU/dL): 50-80, dosed every 48-72 hours for at least 1 day until healing is achieved

Major

Desired peak Factor IX Level (% of normal or IU/dL): 60-100, dosed every 48-72 hours for 7-14 days until healing is achieved. Repeat dose every 48-72 hours for the first week or until healing is achieved. Maintenance dose is once or twice weekly.

Routine prophylaxis Hemophilia B

Patients ≥12 years of age:

25-40 IU/kg body weight every 7 days. Patients who are well-controlled on this regimen may be switched to a 14-day interval at 50-75 IU/kg body weight.

Patients <12 years of age:

40-55 IU/kg body weight every 7 days.

Ixinity

Indication

Dose

On-demand treatment and control of bleeding episodes Hemophilia B

One IU per kilogram body weight increases the circulating activity of Factor IX by 0.79 IU/dL for patients <12 years of age and 0.98 IU/dL for patients ≥ 12 years of age.

  • Initial dose:  Required factor IX units (IU) = body weight (kg) x desired factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)
  • Maintenance dose: Depends upon the type of bleed or surgery, clinical response, and the severity of the underlying factor IX deficiency
  • Minor bleeding episode: Desired peak Factor IX Level (% of normal or IU/dL): 30-60, dosed every 24 hours for 1-3 days until healing is achieved
  • Moderate bleeding episode: Desired peak Factor IX Level (% of normal or IU/dL): 40-60, dosed every 24 hours for 2-7 days until healing is achieved
  • Major or life threatening bleeding episode: Desired peak Factor IX Level (% of normal or IU/dL): 60-100, dosed every 12-24 hours for 2-14 days until healing is achieved

Perioperative management

Hemophilia B

One IU per kilogram body weight increases the circulating activity of Factor IX by 0.79 IU/dL for patients <12 years of age and 0.98 IU/dL for patients ≥ 12 years of age.

Initial dose:  Required factor IX units (IU) = body weight (kg) x desired factor IX increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)

Maintenance dose: Depends upon the type of bleed or surgery, clinical response, and the severity of the underlying factor IX deficiency

Minor surgery:

  • Pre-op: Desired peak Factor IX Level (% of normal or IU/dL) 50-80
  • Post-op: Desired peak Factor IX Level (% of normal or IU/dL) 30-80, dosed every 24 hours for 1-5 days, depending on type of procedure

Major surgery:

  • Pre-op: Desired peak Factor IX Level (% of normal or IU/dL) 60-80
  • Post-op: Desired peak Factor IX Level (% of normal or IU/dL) 40-60, dosed every 8-24 hours for 1-3 days, then 30-50 dosed every 8-24 hours for 4-6 days, and then 20-40 dosed every 8-24 hours for 7-14 days

Routine prophylaxis

Hemophilia B

Patients ≥ 12 years of age:

  • 40 to 70 IU/kg twice weekly

Patients < 12 years of age:

  • 35 to 75 IU/kg twice weekly

NOTE: Adjust the dosing regimen (dose or frequency) based on the patient's clinical response. Adjust the dose based on the individual patient’s age, bleeding pattern, and physical activity.

Mononine

Indication

Dose

On-demand treatment and control of bleeding episodes and Perioperative management Hemophilia B

One unit per kilogram body weight increases the circulating Factor IX level by 1% (IU/dL). Estimate the required dose with the following formula: Number of Factor IX IU required (IU) = Body Weight (in kg) x desired Factor IX increase (% or IU/dL normal) x 1.0 IU/kg [per IU/dL]

Minor Spontaneous Hemorrhage Prophylaxis

Circulating Factor IX required (% of normal)(15-25%) = up to 20-30 IU/kg for one dose. Repeat in 24 hours if necessary.

Major Trauma or Surgery

Circulating Factor IX required (% of normal)(25-50%) = up to 75 IU/kg dosed every 18-30 hours depending on T1/2 and measured Factor IX levels. Continue for up to 10 days depending upon nature of insult.

Profilnine

Indication

Dose

On-demand treatment and control of bleeding episodes

Hemophilia B

Patients ≥ 18 years of age:

One unit per kilogram body weight increases the circulating Factor IX level by 1% (IU/dL). Number of Factor IX IU required = body wt (kg) x Desired increase in Plasma Factor IX (percent) x 1.0 IU/kg

Minor to Moderate

Single dose of product sufficient to raise plasma Factor IX levels to 20-30% of normal. 20-30 IU/kg every 16-24 hours until hemorrhage stops and healing is achieved. For minor, may repeat for 1-2 days, for moderate, may repeat for 2-7 days.

Major

Single dose of product sufficient to raise plasma Factor IX levels to 30-50% of normal. 30-50 IU/kg every 16-24 hours for up to 3-10 days. Following this treatment period, maintain Factor IX levels at 20% of normal until healing has been achieved.

Routine prophylaxis Hemophilia B §

Patients ≥ 18 years of age:

25-40 IU/kg two times weekly or 15-30 IU/kg two times weekly. Adjust dosing regimen based on individual response.

Perioperative management Hemophilia B

Patients ≥ 18 years of age:

Surgery associated with bleeding in Factor IX deficient patients require Factor IX levels of 30-50% of normal. For dental extractions, the Factor IX level should be raised to 50% of normal immediately prior to procedure. 30-50 IU/kg every 16-24 hours for 7-10 days until healing is achieved. Maintain Factor IX levels at 30-50% of normal until healing has been achieved.

Rebinyn

Indication

Dose

On-demand treatment and control of bleeding episodes Hemophilia B

Minor and Moderate

40 IU/kg of actual body weight. A single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.

Major

80 IU/kg of actual body weight. Additional doses of 40 IU/kg can be given.

Perioperative management

Hemophilia B

Minor

Pre-op: 40 IU/kg of actual body weight (single pre-op dose should be sufficient)

Post-op: Additional doses can be given if required

Major

Pre-op: 80 IU/kg of actual body weight

Peri/Post-op:  40 IU/kg of actual body weight. As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after major surgery may be administered. Due to the long half-life, the frequency of dosing in the post-surgical setting may be extended to once weekly after the first week until bleeding stops and healing is achieved.

Routine prophylaxis Hemophilia B

40 IU/kg once weekly. Adjust the dose based on the individual patient’s bleeding pattern and physical activity.

Rixubis

Indication

Dose

On-demand treatment and control of bleeding episodes

Hemophilia B

One IU per kilogram body weight increases the circulating activity of Factor IX by 0.7 IU/dL for patients <12 years of age and 0.9 IU/dL for patients ≥ 12 years of age. 

Initial dose = body wt (kg) x desired factor IX increase (percent of normal or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)

Minor

Circulating Factor IX level required (% or IU/dL) = 20-30 every 12 - 24 hours for at least 1 day, until healing is achieved

Moderate

Circulating Factor IX level required (% or IU/dL) = 25-50 every 12 - 24 hours for 2-7 days, until bleeding stops and healing is achieved

Major

Circulating Factor IX level required (% or IU/dL) = 50-100 every 12 - 24 hours for 7-10 days, until bleeding stops and healing is achieved

Routine prophylaxis Hemophilia B

Dosing for previously treated patients (PTPs):

Patients <12 years of age

60 – 80 IU/kg twice weekly

Patients ≥ 12 years of age

40 – 60 IU/kg twice weekly

Adjust the dose based on the individual patient’s age, bleeding pattern, and physical activity.

Perioperative management

Hemophilia B

One IU per kilogram body weight increases the circulating activity of Factor IX by 0.7 IU/dL for patients <12 years of age and 0.9 IU/dL for patients ≥ 12 years of age. 
Minor

Circulating Factor IX level required (% or IU/dL) = 30-60 every 24 hours for at least 1 day, until healing is achieved

Major

Circulating Factor IX level required (% or IU/dL) = 80-100 every 8 - 24 hours for 7-10 days, until bleeding stops and healing is achieved

§ Utrecht and/or Malmö protocols used as basis for dosing

  1. Billing Code/Availability Information

Hemophilia products are covered under the prescription drug benefits of a member’s plan.  Claims for hemophilia products submitted for payment under any benefit section of the member’s plan (other than prescription drug benefits) will be denied as non-covered benefits.    The only exceptions to this are claims for hemophilia products used in an inpatient facility or for emergency use, accidents or surgery (Type Services A, S, or 2) in the following settings:

  • Outpatient Facility
  • Physician office

If home health nursing assistance is needed for drug administration, the hemophilia product should be accessed and paid through the member’s prescription benefit coverage. Nursing services should be billed only for the administration of the hemophilia product under the member’s home health benefits.

HCPCS Code(s) & NDC(s):

Drug

Manufacturer

HCPCS Code

1 Billable Unit Equiv.

Vial Size

NDC

AlphaNine SD

Grifols Biologicals Inc.

J7193

1 IU

500 units

68516-3610

68516-3607

1000 units

68516-3611

68516-3608

1500 units

68516-3612

68516-3609

Mononine

CSL Behring LLC

J7193

1 IU

1000 units

00053-6233

Alprolix

Bioverativ Therapeutics Inc.

J7201

1 IU

250 units

71104-0966

500 units

71104-0911

1000 units

71104-0922

2000 units

71104-0933

3000 units

71104-0944

4000 units

71104-0977

Profilnine

Grifols Biologicals LLC

J7194

1 IU

500 units

68516-3210

68516-3207

1000 units

68516-3211

68516-3208

1500 units

68516-3212

68516-3209

BeneFIX

Wyeth Pharmaceuticals LLC

J7195

1 IU

250 units

58394-0633

500 units

58394-0634

1000 units

58394-0635

2000 units

58394-0636

3000 units

58394-0637

Ixinity

Medexus Pharma, Inc.

J7213

1 IU

250 units

59137-0287

500 units

59137-0282

1000 units

59137-0283

1500 units

59137-0284

2000 units

59137-0288

3000 units

59137-0289

Rixubis

Takeda Pharmaceuticals U.S.A., Inc.

J7200

1 IU

250 units

00944-3026

500 units

00944-3028

1000 units

00944-3030

2000 units

00944-3032

3000 units

00944-3034

Idelvion

CSL Behring LLC

J7202

1 IU

250 units

69911-0864

500 units

69911-0865

1000 units

69911-0866

2000 units

69911-0867

3500 units

69911-0869

Rebinyn

Novo Nordisk Inc.

J7203

1 IU

500 units

00169-7905

1000 units

00169-7901

2000 units

00169-7902

3000 units

00169-7903
  1. References
  1. AlphaNine SD [package insert]. Los Angeles, CA; Grifols Biologicals Inc.; November 2022.  Accessed May 2024.
  2. Alprolix [package insert]. Waltham, MA; Bioverativ Therapeutics Inc.; May 2023.  Accessed May 2024.
  3. BeneFIX [package insert]. Philadelphia, PA; Wyeth Pharmaceuticals LLC; November 2022. Accessed May 2024.
  4. Ixinity [package insert]. Chicago, IL. Medexus Pharma, Inc.; March 2024. Accessed May 2024.
  5. Mononine [package insert]. Kankakee, IL; CSL Behring LLC; December 2018. Accessed May 2024.
  6. Profilnine [package insert]. Los Angeles, CA; Grifols Biologicals LLC; June 2023.  Accessed May 2024.
  7. Rebinyn [package insert]. Plainsboro, NJ; Novo Nordisk Inc.; August 2022. Accessed May 2024.
  8. Rixubis [package insert]. Lexington, MA; Takeda Pharmaceuticals U.S.A., Inc.; March 2023; Accessed May 2024.
  9. Idelvion [package insert]. Kankakee, IL; CSL Behring LLC; June 2023. Accessed May 2024.
  10. MASAC Recommendations Concerning Products Licensed For The Treatment Of Hemophilia And Selected Disorders of the Coagulation System. Revised April 11, 2024. National Hemophilia Foundation. MASAC Document #284; April 2024. Available at: https://www.bleeding.org.  Accessed May 2024.
  11. Guidelines for the Management of Hemophilia. 3rd Edition. World Federation of Hemophilia 2020. Available at: https://www1.wfh.org/publications/files/pdf-1863.pdf. Accessed May 2024.
  12. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated Dec 2020. Accessed May 2024.
  13. Graham A1, Jaworski K. Pharmacokinetic analysis of anti-hemophilic factor in the obese patient. Haemophilia. 2014 Mar;20(2):226-9.
  14. Croteau SE1, Neufeld EJ. Transition considerations for extended half-life factor products. Haemophilia. 2015 May;21(3):285-8.
  15. Mingot-Castellano, et al. Application of Pharmacokinetics Programs in Optimization of Haemostatic Treatment in Severe Hemophilia a Patients: Changes in Consumption, Clinical Outcomes and Quality of Life. Blood. 2014 December; 124 (21).
  16. MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. Revised April 27, 2022. National Hemophilia Foundation. MASAC Document #267; April 2022. Available at: https://www.bleeding.org. Accessed May 2024.
  17. Rayment R, Chalmers E, Forsyth K, et al. Guidelines on the use of prophylactic factor replacement for children and adults with Haemophilia A and B. B J Haem:190;5, Sep 2020. https://doi.org/10.1111/bjh.16704. Accessed May 2024.
  18. Hoots, WK. (2024). Hemophilia A and B: Routine management including prophylaxis. In Leung LLK, Tirnauer JS (Eds.), UptoDate. Last updated: April 16, 2024. Accessed May 13, 2024. Available from https://www.uptodate.com/contents/hemophilia-a-and-b-routine-management-including-prophylaxis?search=hemophilia%20a&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H978189854
  19. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56482). Centers for Medicare & Medicaid Services Inc. Updated on 09/29/2023 with effective date 10/01/2023. Accessed May 2024.
  20. Palmetto GBA. Local Coverage Article: Billing and Coding: Guidance for Anti-Inhibitor Coagulant Complex (AICC) National Coverage Determination (NCD) 110.3 (A56065). Centers for Medicare & Medicaid Services Inc. Updated on 11/14/2022 with effective date 11/24/2022. Accessed May 2024.
  21. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56433). Centers for Medicare & Medicaid Services Inc. Updated on 09/29/2023 with effective date 10/01/2023. Accessed May 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

D67

Hereditary factor IX deficiency

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes

Jurisdiction

NCD/LCA/LCD Document (s)

Contractor

H,L

A56433

Novitas Solutions, Inc.

J, M

A56065

Palmetto GBA

N

A56482

First Coast Service Options, Inc. Insurance Corp (WPS)

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

 

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