Human Fibrinogen Concentrate - NC Standard

Restricted Product(s)

• Fibryga® (fibrinogen concentrate (human)) 
• RiaSTAP® (fibrinogen concentrate (human))

FDA Approved Use

• Fibryga and RiaSTAP are approved for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
• Fibryga is indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.
• Limitation of Use: Fibryga and RiaSTAP are not indicated for dysfibrinogenemia.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of fibrinogen deficiency (factor I deficiency); AND
   1. The patient is currently bleeding, AND is out of medication (need immediate use); OR 
   2. ALL of the following:
      1. The patient has a fibrinogen level of < 150 mg/dL; AND 
      2. The patient does NOT have dysfibrinogenemia; AND 
      3. The requested agent will be used as on-demand treatment to control acute bleeding episodes; AND 
      4. 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; OR
2. The patient has diagnosis of acquired fibrinogen deficiency and fibrinogen supplementation is needed for bleeding; AND
   1. The request is for Fibryga; AND
   2. ONE of the following:
      1. The patient has a plasma fibrinogen level ≤200 mg/dL; OR
      2. Thromboelastometry FIBTEM A10 is ≤10 mm (or equivalent values generated by other viscoelastic testing methods); AND
   3. The patient does NOT have dysfibrinogenemia; AND
   4. The prescriber has communicated with the patient (via any means) and has verified that the patient does NOT have more than 5 ondemand doses on hand; AND
3. Treatment dosing details have been provided for review, as highlighted below:
   1. Patient age and weight; AND
4. 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
5. The patient does NOT have any FDA labeled contraindications to the requested agent; AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval:
Immediate use: 1 time (30 days)
On-demand treatment: 3 months

References

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

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

August 2024: Criteria change: Added expanded indication for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency in patients 12 years and older. Added Limitation of Use section.
September 2023: Criteria update: Criteria review and formatting changes.
October 2021: Original utilization management policy issued