ph-0342
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Hemophilia Products - Factor XIII: Corifact

Policy Number: PH-0342

(Intravenous)

Last Review Date: 02/04/2020

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

  1. Length of Authorization

Unless otherwise specified*, the initial authorization will be provided for 3 months and may be renewed for a period of 12 month thereafter.

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]:
  • Corifact 1000-1600 IU vial: 5 vials per 28-day supply
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 4,600 billable units per 28 day supply
  1. Initial Approval Criteria 1,2,3,8

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

Congenital Factor XIII deficiency †

  • Diagnosis of congenital factor XIII deficiency has been confirmed by blood coagulation testing; AND
  • Used for routine prophylactic treatment; OR
  • Used for perioperative management of surgical bleeding (*Authorizations valid for 1 month)

Hemophilia Management Program

  • If the request is for routine 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.
  • 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)

  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 1,2,3,8

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 the following:  symptoms of allergic-anaphylactic reactions (anaphylaxis, dyspnea, rash); thromboembolic events (thromboembolism, pulmonary embolism); and development of neutralizing antibodies (inhibitors); 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

Prevention of acute bleeding episodes/Routine prophylaxis to prevent or reduce the frequency of bleeding episode

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

Indication

Dose

Routine prophylaxis for bleeding  Congenital factor XIII deficiency

40 International Units (IU) per kg body weight at a rate not to exceed 4 mL per minute, given every 28 days.  Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity.

Perioperative management Congenital factor XIII deficiency

40 International Units (IU) per kg body weight at a rate not to exceed 4 mL per minute.

Dosing should be individualized based on the patient’s FXIII activity level, type of surgery, and clinical response.  Monitor patient’s FXIII activity levels during and after surgery. Dose adjustment will need to be made depending on when last prophylactic dose was given.

  • Within 7 days – Additional dose may not be needed
  • 8-21 days - Additional partial or full dose may be needed based on FXIII activity level
  • 21-28 days - Full prophylactic dose
  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

J-Code

1 Billable Unit Equiv.

Vial Size

NDC

Corifact

CSL Behring LLC

J7180

1 IU

1000-1600 units

63833-0518

  1. References
  1. Corifact [package insert]. Kankakee, IL; CSL Behring LLC; September 2017. Accessed January 2020.
  2. 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.
  3. 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.
  4. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated April 2016. Access January 2019.
  5. Graham A1, Jaworski K. Pharmacokinetic analysis of anti-hemophilic factor in the obese patient. Haemophilia. 2014 Mar;20(2):226-9.
  6. Croteau SE1, Neufeld EJ. Transition considerations for extended half-life factor products. Haemophilia. 2015 May;21(3):285-8.
  7. 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).
  8. MASAC RECOMMENDATION CONCERNING PROPHYLAXIS. 2016 National Hemophilia Foundation.  MASAC Document #241; February 2016.  Available at: http://www.hemophilia.org.   Accessed January 2019.
  9. 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.
  10. 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.
  11. 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

D68.2

Hereditary deficiency of other clotting factors

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