Coagulation Factor X – NC Standard

Restricted Product(s)

• Coagadex® (coagulation Factor X (human))

FDA Approved Use

• For prophylaxis and treatment of bleeding episodes in children and adults with hereditary factor X deficiency and perioperative management of bleeding episodes in children and adults with mild and moderate hereditary factor X deficiency.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of hereditary Factor X deficiency; AND 
   1. The patient is currently bleeding, AND is out of medicine (need immediate use); OR 
   2. The patient has a diagnosis of hereditary Factor X deficiency; AND 
      1. The requested agent will be used for prophylaxis treatment; AND 
         1. The patient has severe or moderate Factor X deficiency (Factor X level ≤ 5%); OR 
         2. The patient has mild Factor X deficiency (Factor X level 6-10%) AND the prescriber has provided information supporting prophylaxis use of the requested agent (medical record documentation required); OR 
      2. The requested agent will be used as on-demand treatment to control bleeding episodes; AND 
         1. The prescriber has communicated with the patient (via any means) and has verified that the patient does NOT have more than 5 on-demand doses on hand; AND 
         2. ONE of the following: 
            1. The patient has tried and had an inadequate response to aminocaproic acid or tranexamic acid; OR 
            2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH aminocaproic acid and tranexamic acid; OR 
      3. The requested agent will be used as perioperative management of bleeding; AND 
         1. The patient has mild hereditary Factor X deficiency (Factor X level 6-10%); AND 
         2. ONE of the following: 
            1. The patient has tried and had an inadequate response to aminocaproic acid or tranexamic acid; OR 
            2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH aminocaproic acid and tranexamic acid; AND 
2. Treatment dosing details have been provided for review, as noted below: a. Patient age and weight b. Mode of treatment (i.e. prophylaxis vs on-demand bleeding vs peri-operative dosing) c. Current Factor X level and target Factor X level; AND
3. The prescriber is a specialist (e.g. hematologist) in the area of the patient’s diagnosis or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
4. The patient does NOT have liver disease; AND 
5. The patient does NOT have vitamin K deficiency; AND 
6. The patient will NOT be using the requested agent in combination with an indirect or direct Factor Xa inhibitor [e.g., apixaban (Eliquis), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto) or warfarin (Coumadin)]; AND 
7. The patient does NOT have any FDA labeled contraindications to the requested agent; AND 
8. The requested dose is within FDA labeled dosing for the requested use; AND 
9. The quantity (number of doses) requested is appropriate based on intended use (e.g., on-demand, perioperative management of bleeding, prophylaxis); AND 
10. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval:
    Immediate use: 1 time (30 days)
    Perioperative management of bleeding: 1 time (30 days)
    On-demand treatment: 3 months
    Prophylaxis treatment: 12 months

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

October 2021: Original utilization management policy issued.