ph-0343
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Hemophilia Products – Factor VIIa: NovoSeven RT ™; Sevenfact

Policy Number: PH-0343

Hemophilia Products – Factor VIIa:

NovoSeven RT ™; Sevenfact ®

(Intravenous)

Document Number: IC-0343

Last Review Date: 01/01/2021

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

  1. Length of Authorization

Unless otherwise specified*, the initial authorization will be provided for 3 months and may be renewed.

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
  1. 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
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 120,000 billable units per 30-day supply
  1. Initial Approval Criteria 1,2,3,4,9

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:
  • Control and prevention 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:
    • Control and prevention 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:
  • Control and prevention 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:
  • Control and prevention 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:
  • Control and prevention 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 age of 12 years or older; 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);  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 1,2,3,4,9

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet indication-specific relevant criteria identified in section III ; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:  symptoms of allergic-anaphylactic reactions (anaphylaxis, dyspnea, rash); thromboembolic events (thromboembolism, pulmonary embolism); and development of neutralizing antibodies (inhibitors); AND
  • Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline); 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 of acute bleeding episodes/Treatment of Spontaneous and trauma-induced bleeding episodes/On-demand treatment of bleeding episodes (NovoSeven RT/Sevenfact)

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

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

  • Renewals will be approved for a 12-month authorization period
  1. Dosage/Administration1,2,3,4

Indication

Dose

NovoSeven RT

Control and prevention of bleeding:

Congenital Hemophilia A or B with inhibitors

Hemostatic

90 mcg/kg 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

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

Control and prevention of bleeding:

Acquired Hemophilia

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

Control and prevention of bleeding:

Congenital Factor VII deficiency

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

Control and prevention of bleeding: Glanzmann’s Thrombasthenia

90 mcg/kg 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: 90 mcg/kg immediately before surgery, repeat every 2 hours during surgery.

Post-Op: 90 mcg/kg every 2 hours after surgery for 48 hours, repeat every 2-6 hours until healing has occurred.

Major

Initial: 90 mcg/kg immediately before surgery, repeat every 2 hours during surgery. 

Post-Op: 90 mcg/kg 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

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

Perioperative management Congenital Factor VII deficiency

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

Perioperative management Glanzmann’s Thrombasthenia

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

Post-Op: 90 mcg/kg 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:

    • 75 mcg/kg repeated every 3 hours until bleeds: 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:

    • 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours
  1. Billing Code/Availability Information

HCPCS Code & NDC:

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.

Drug

Manufacturer

J-Code

1 Billable Unit Equiv.

Vial Size

NDC

Novoseven RT

Novo Nordisk

J7189

1 mcg

1 mg

00169-7010

2 mg

00169-7020

5 mg

00169-7050

8 mg

00169-7040

Novoseven RT with MixPro package

1 mg

00169-7201

2 mg

00169-7202

5 mg

00169-7205

8 mg

00169-7208

Sevenfact

LFB S.A.

J7189/J3590

J7212 (Eff. 1/1/21)

1 mcg/NA

1 mg

71127-1000

5 mg

71127-5000

  1. References
  1. NovoSeven RT [package insert]. Bagsvaerd, Denmark; Novo Nordisk; January 2019.  Accessed January 2020.
  2. Sevenfact [package insert]. Les Ulis, France; LFB S.A., April 2020. Accessed April 2020.
  3. MASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS.  2016 National Hemophilia Foundation.  MASAC Document #249; October 2016.  Available at: http://www.hemophilia.org.   Accessed January 2019.
  4. Guidelines for the Management of Hemophilia. 2nd Edition. World Federation of Hemophilia. 2013. Available at: https://www1.wfh.org/publication/files/pdf-1472.pdf.  Accessed January 2019.
  5. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated April 2016. Access January 2019.
  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 January 2019.
  10. First Coast Service Options, Inc. Local Coverage Article: Hemophilia Clotting Factors (A56482). Centers for Medicare & Medicaid Services Inc. Updated on 12/06/2019 with effective date 07/01/2019. Accessed January 2020.
  11. 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 10/24/2019 with effective date 10/31/2019. Accessed January 2020.
  12. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Hemophilia Factor Products (A56433). Centers for Medicare & Medicaid Services Inc. Updated on 11/08/2019 with effective date 11/14/2019. Accessed January 2020.

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) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-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):

Jurisdiction(s): N

NCD/LCD Document (s): A56482

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56482&bc=gAAAAAAAAAAA

Jurisdiction(s): J,M

NCD/LCD Document (s): A56065

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56065&bc=gAAAAAAAAAAA

Jurisdiction(s): H,L

NCD/LCD Document (s): A56433

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56433&bc=gAAAAAAAAAAA

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