Pharmacy Prior Authorization Criteria

Sevenfact [coagulation factor VIIa (recombinant)-jncw] - NF

Indications for Prior Authorization

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

• For diagnosis of Hemophilia A or B with Inhibitors
  Indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

  Limitation of Use: Sevenfact is not indicated for the treatment of patients with congenital Factor VII deficiency.

Criteria

Sevenfact

*If case is to be denied for this one criterion alone, approve for one time approval

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial of or intolerance to Novoseven RT
AND
• Submission of medical records (e.g., chart notes) confirming both of the following:
• Patient's weight
• Dosing will not exceed a cumulative dose of 900mcg/kg in any 24-hour period for more than one 24-hour interval*
AND
• Prescribed by a hematologist
AND
• Patient is being treated at or comanaged by a hemophilia treatment center

P & T Revisions

2025-12-16, 2025-06-20, 2025-02-28, 2024-06-20, 2023-05-23, 2022-06-16, 2021-12-01, 2021-06-02

References

1. Sevenfact Prescribing Information. Hema Biologics, Louisville, KY. June 2024.

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Revision History

• 2025-12-16: Update to the NF criteria for Sevenfact to ensure appropriate use in line with FDA label.
• 2025-06-20: 2025 annual review: No criteria changes. Updated GPIs and reference.
• 2025-02-28: Removal of ST criteria due to low utilization within 2024
• 2024-06-20: 2024 annual review: no changes.
• 2023-05-23: 2023 UM Annual Review. No criteria changes
• 2022-06-16: Annual review - no changes.
• 2021-12-01: Added NF section and diagnosis requirement to ST.
• 2021-06-02: New program.

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