CurrentCareSourcePolicy N/A

Hematology - Fibrinogen Products Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing limits, and exclusions for human fibrinogen concentrates (Fibryga and RiaSTAP) for congenital and acquired fibrinogen deficiency for CareSource members; applies to prescribers and payers involved in authorization decisions.

Policy Summary

PayerCareSource

PolicyHematology - Fibrinogen Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and dosing updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document hematology involvement; approve for up to 1 year when coverage criteria and dosing limits are met.

SourceLink

POLICY UPDATE CHANGES

Requirement that diagnosis be confirmed by laboratory testing (prolonged aPTT and PT and low plasma functional and antigenic fibrinogen levels) was removed for congenital fibrinogen deficiency criteria.

Acquired fibrinogen deficiency was added as a new approval indication for Fibryga only.

Dosing limits for Fibryga and RiaSTAP established (e.g., up to 700 mg/kg per 28 days for congenital deficiency; Fibryga specific per-age limits for acquired deficiency).

700 mg/kgmax dosing per 28 days (congenital)

40 gFibryga max (adults, acquired)

10max doses/28 days (acquired guidance)

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Coverage Criteria for Fibrinogen Concentrates

Recommended Authorization Criteria

Coverage is recommended when ALL of the following are met for the indicated condition

Congenital Fibrinogen Deficiency

Agent: Either Fibryga or RiaSTAP may be used for congenital deficiency.

Acquired Fibrinogen Deficiency (Fibryga only): Patient has acquired fibrinogen deficiency and Fibryga is prescribed by or in consultation with a hematologist.Approve dosing per age group: (A) patients ≥18 years: up to 40 g per 28 days given intravenously; OR (B) patients 12–17 years: up to 500 mg/kg per 28 days given intravenously; OR (C) children <12 years: up to 700 mg/kg per 28 days given intravenously.

Approve for 1 year when criteria met

Coverage of Fibryga and RiaSTAP is not recommended in certain situations. Concomitant use of Fibryga and RiaSTAP is discouraged because there are no data to support combined administration and such requests may be denied. Additionally, use of these fibrinogen concentrates for dysfibrinogenemia is not recommended for approval, as patients with dysfibrinogenemia have adequate fibrinogen levels but dysfunctional fibrin clotting. Finally, coverage is not recommended for circumstances that fall outside the conditions explicitly listed in the Recommended Authorization Criteria.

Fibryga and RiaSTAP are not indicated for the treatment of dysfibrinogenemia; the prescribing information for both products states they are not indicated for this qualitative fibrinogen disorder. Requests for fibrinogen concentrate to treat dysfibrinogenemia are therefore not recommended for approval under this policy.

Coding and Dosing Limits

Covered CPT Codesmixed

No codes listed

Maximum dosing per 28 days — congenital and Fibryga age-stratified maximums and operational dosing caps

Congenital fibrinogen deficiency (per 28 days)Approve up to 700 mg/kg intravenously per 28 days (applies to Fibryga or RiaSTAP)

Fibryga — Acquired deficiency (adults ≥18 yrs)Approve up to 40 g intravenously per 28 days

Fibryga — Acquired deficiency (ages 12–17 yrs)Approve up to 500 mg/kg intravenously per 28 days

Fibryga — Acquired deficiency (children <12 yrs)Approve up to 700 mg/kg intravenously per 28 days

Operational dosing cap rationaleMaximums allow for prophylactic dosing plus three days of acute episodes or perioperative management per 28 days; doses beyond caps reviewed case-by-case

Prescriber Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for fibrinogen products (Fibryga, RiaSTAP). Approvals are recommended when the Coverage Criteria and Dosing limits in this policy are met. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician (Medical Director or Pharmacist). Automation: None.

Prior authorization recommended for Fibryga and RiaSTAP
Requests for doses outside policy dosing reviewed case-by-case by clinician

Note

Alternative Product Context

Cryoprecipitate may be similarly effective to fibrinogen concentrate (e.g., RiaSTAP) but can be associated with transfusion reactions or volume overload. Guidelines from the British Committee for Standards in Haematology (2014) discuss these alternatives; note the guideline predates approval of Fibryga.

Cryoprecipitate is an alternative to fibrinogen concentrate but has comparative risk of transfusion reactions and volume overload

Key Definitions

Congenital fibrinogen deficiency (afibrinogenemia, hypofibrinogenemia) description

DefinitionCongenital fibrinogen deficiency (Factor I deficiency) includes afibrinogenemia (absent circulating fibrinogen) and hypofibrinogenemia (low circulating fibrinogen) and is a quantitative disorder that increases bleeding and thromboembolic risk

Typical presentationClinical presentation is variable; patients may present with bleeding and thromboembolism; treatment is generally on‑demand for acute bleeding with prophylaxis used in select high‑risk situations

Authorized productsFibryga and RiaSTAP are indicated for treatment of acute bleeding in congenital fibrinogen deficiency

Dysfibrinogenemia: qualitative disorder; concentrates not indicated

DefinitionDysfibrinogenemia is a qualitative fibrinogen disorder in which fibrinogen levels may be adequate but function is impaired

Background and Clinical Context

Congenital fibrinogen deficiencies (including afibrinogenemia and hypofibrinogenemia) are quantitative disorders characterized by low or absent circulating fibrinogen and an increased bleeding risk. Human fibrinogen concentrates such as Fibryga and RiaSTAP are indicated for treatment of acute bleeding episodes in patients with these congenital deficiencies and may be used on-demand or for prophylaxis in high‑risk situations.