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Hemophilia Products – Factor VIIa: NovoSeven RT ®; Sevenfact ®

Policy Number: PH-90343

 

 

Intravenous

 

Last Review Date: 06/01/2023

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, 05/2020, 01/2021, 06/2021, 06/2022, 06/2023

  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]:

  • NovoSeven RT 1000 mcg vial = 12 vials per 30 days
  • NovoSeven RT 2000 mcg vial = 12 vials per 30 days
  • NovoSeven RT 5000 mcg vial = 24 vials per 30 days
  • NovoSeven RT 8000 mcg vial = 15 vials per 30 days
  • Sevenfact 1 mg vial = 48 vials per 30 days
  • Sevenfact 5 mg vial = 24 vials per 30 days

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

  • 120,000 billable units per 30-day supply
  1. Initial Approval Criteria 1-4,9

Coverage is provided in the following conditions:

NovoSeven RT ONLY 1

Hemophilia A (congenital factor VIII deficiency) † Ф

  • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND
  • Confirmation patient has acquired inhibitors to Factor VIII; AND
  • Used as treatment in at least one of the following:
  • Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
  • Perioperative management (*Authorizations valid for 1 month) ; OR
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes when the following criteria are also met:
    • Patient has at least two documented episodes of spontaneous bleeding into joints; OR
    • Patient has documented trial and failure of Immune Tolerance Induction (ITI); AND
      • Patient has documented trial and failure or contraindication to Hemlibra

Acquired Hemophilia †

  • Diagnosis of acquired hemophilia has been confirmed by blood coagulation testing; AND
  • Used as treatment for one of the following:
    • Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
    • Perioperative management (*Authorizations valid for 1 month) 

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

  • Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing; AND
  • Confirmation patient has acquired inhibitors to Factor IX; AND
  • Used as treatment for one of the following:
  • Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
  • Perioperative management (*Authorizations valid for 1 month); OR
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes when the following criteria are also met:
      • Patient has at least two documented episodes of spontaneous bleeding into joints; OR
      • Patient has documented trial and failure of Immune Tolerance Induction (ITI)

Congenital Factor VII Deficiency † Ф

  • Diagnosis of congenital factor VII deficiency has been confirmed by blood coagulation testing; AND
  • Used as treatment for one of the following:
  • Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
  • Perioperative management(*Authorizations valid for 1 month)

Glanzmann’s Thrombasthenia † Ф

  • Diagnosis of Glanzmann Thrombasthenia has been confirmed by blood coagulation testing; AND
  • Used as treatment for one of the following:
  • Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); OR
  • Perioperative management (*Authorizations valid for 1 month); AND
  • The use of platelet transfusions is known or suspected to be ineffective or contraindicated

Sevenfact ONLY 2

Hemophilia A (Congenital Factor VIII Deficiency)/Hemophilia B (Congenital Factor IX Deficiency) † Ф

  • Patient is at least 12 years of age; AND
  • Diagnosis of congenital factor VIII or IX deficiency has been confirmed by blood coagulation testing; AND
  • Confirmation patient has Hemophilia A (Factor VIII) inhibitors or Hemophilia B (Factor IX) inhibitors; AND
  • Used as treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage); AND
  • Will not be used for the treatment of Congenital Factor VII Deficiency

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  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 1-4,9-10

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the 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:  hypersensitivity reactions including anaphylaxis (e.g., hives, itching, rash, difficulty breathing, swelling around the mouth/throat, chest tightness, wheezing, dizziness/fainting, low blood pressure, etc.), serious arterial and venous thrombotic events, development of neutralizing antibodies (inhibitors), 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

Treatment and control of acute bleeding episodes (NovoSeven RT/Sevenfact)

  • Renewals will be approved for a 6-month authorization period

Perioperative management of bleeding (NovoSeven RT Only)

  • Coverage may NOT be renewed

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes (NovoSeven RT Only)

  • 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/Administration 1-4

Indication

Dose

NovoSeven RT

Control and prevention of bleeding:

Congenital Hemophilia A or B with inhibitors

Hemostatic

Administer 90 mcg/kg intravenously every 2 hours, adjustable based on severity of bleeding until hemostasis is achieved, or until the treatment has been judged to be inadequate.

Post-Hemostatic

Administer 90 mcg/kg intravenously every 3-6 hours after hemostasis is achieved for severe bleeds

Control and prevention of bleeding:

Acquired Hemophilia

Administer 70-90 mcg/kg intravenously every 2-3 hours until hemostasis is achieved

Control and prevention of bleeding:

Congenital Factor VII deficiency

Administer 15-30 mcg/kg intravenously every 4-6 hours until hemostasis is achieved

Control and prevention of bleeding: Glanzmann’s Thrombasthenia

Administer 90 mcg/kg intravenously every 2-6 hours in severe bleeding episodes requiring systemic hemostatic therapy until hemostasis is achieved

Perioperative management Congenital Hemophilia A or B with inhibitors

Minor

  • Initial: Administer 90 mcg/kg intravenously immediately before surgery, repeat every 2 hours during surgery.
  • Post-Op: Administer 90 mcg/kg intravenously every 2 hours after surgery for 48 hours, then every 2-6 hours until healing has occurred.

Major

  • Initial: Administer 90 mcg/kg intravenously immediately before surgery, repeat every 2 hours during surgery. 
  • Post-Op: Administer 90 mcg/kg intravenously every 2 hours after surgery for 5 days, then every 4 hours or by continuous infusion, via pump, at 50 mcg/kg/hr until healing occurs.

Perioperative management Acquired Hemophilia

Administer 70-90 mcg/kg intravenously immediately before surgery and every 2-3 hours for the duration of surgery and until hemostasis is achieved

Perioperative management

Congenital Factor VII deficiency

Administer 15-30 mcg/kg intravenously immediately before surgery and every 4-6 hours for the duration of surgery and until hemostasis is achieved

Perioperative management Glanzmann’s Thrombasthenia

Initial: Administer 90 mcg/kg intravenously immediately before surgery and repeat every 2 hours for the duration of the procedure. 

Post-Op: Administer 90 mcg/kg intravenously every 2-6 hours to prevent post-operative bleeding

Sevenfact

Control and treatment of bleeding:

Congenital Hemophilia A or B with inhibitors

For Mild or Moderate Bleeds:

    • Administer 75 mcg/kg intravenously repeated every 3 hours until hemostasis is achieved

or

      • Initial dose of 225 mcg/kg. If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis

For Severe Bleeds:

    • Administer 225 mcg/kg intravenously initially, followed if necessary 6 hours later with 75 mcg/kg every 2 hours until hemostasis is achieved.
  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 & NDC:

Drug

Manufacturer

HCPCS Code

1 Billable Unit Equiv.

Vial Size

NDC

NovoSeven RT

Novo Nordisk

J7189

1 mcg

1 mg

00169-7010-xx

2 mg

00169-7020-xx

5 mg

00169-7050-xx

8 mg

00169-7040-xx

NovoSeven RT with MixPro package

1 mg

00169-7201-xx

2 mg

00169-7202-xx

5 mg

00169-7205-xx

8 mg

00169-7208-xx

Sevenfact

LFB S.A.

J7212

1 mcg

1 mg

71127-1000-xx

5 mg

71127-5000-xx

  1. References
  1. NovoSeven RT [package insert]. Bagsvaerd, Denmark; Novo Nordisk; July 2020. Accessed May 2023.
  2. Sevenfact [package insert]. Puteaux, France; LFB S.A., November 2022. Accessed May 2023.
  3. MASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS. Revised August 2020 National Hemophilia Foundation. MASAC Document #263; August 2020. Available at: https://www.hemophilia.org/. Accessed May 2023.
  4. 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 April 2022.
  5. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated April 2016. Accessed April 2022.
  6. Graham A1, Jaworski K. Pharmacokinetic analysis of anti-hemophilic factor in the obese patient. Haemophilia. 2014 Mar;20(2):226-9.
  7. Croteau SE1, Neufeld EJ. Transition considerations for extended half-life factor products. Haemophilia. 2015 May;21(3):285-8.
  8. 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).
  9. MASAC RECOMMENDATION CONCERNING PROPHYLAXIS. 2016 National Hemophilia Foundation. MASAC Document #241; February 2016. Available at: http://www.hemophilia.org/. Accessed May 2023.
  10. 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, Sep2020. https://onlinelibrary.wiley.com/doi/10.1111/bjh.16704. Accessed April 2022.
  11. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Hemophilia Clotting Factors (A56482). Centers for Medicare & Medicaid Services Inc. Updated on 10/28/2022 with effective date 10/01/2022. Accessed May 2023.
  12. 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 2023.
  13. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56433). Centers for Medicare & Medicaid Services Inc. Updated on 10/14/2022 with effective date 10/01/2022. Accessed May 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

D66

Hereditary factor VIII deficiency

D67

Hereditary factor IX deficiency

D68.0

Von Willebrand's disease

D68.2

Hereditary deficiency of other clotting factors

D68.311

Acquired hemophilia

D69.1

Qualitative platelet defects

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx . Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): N

NCD/LCD Document (s): A56482

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56482&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): J,M

NCD/LCD Document (s): A56065

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56065&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): H,L

NCD/LCD Document (s): A56433

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56433&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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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