CurrentCignaPolicy IP0357

Hematology - Fibrinogen Products (Fibryga, RiaSTAP) Coverage Policy

Cigna coverage policy governing prior authorization, indications, dosing limits, and exclusions for human fibrinogen concentrates (Fibryga and RiaSTAP) for members covered under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHematology - Fibrinogen Products (Fibryga, RiaSTAP) Coverage Policy

Policy CodePolicy IP0357

Change TypeAdded Fibryga indication for acquired fibrinogen deficiencyremoved lab-confirmation requirement

Effective DateIn force until updated or retired.

Next Review Date

Key ActionPrior authorization is required and medication must be prescribed by or in consultation with a hematologist.

SourceLink

POLICY UPDATE CHANGES

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

Criteria requiring laboratory confirmation (prolonged aPTT, baseline PT and low plasma functional and antigenic fibrinogen) for congenital fibrinogen deficiency were removed.

Updated coverage policy title, review date, disclaimer, background, and references.

IP0357Policy Number

J7177, J7178Covered HCPCS

700 mg/kg/28dMax congenital dose

40 g/28d

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Coverage Criteria for Fibrinogen Products

inv-01: FDA-Approved Indication: Congenital Fibrinogen Deficiency

Covered when ALL of the following are met

Congenital Fibrinogen Deficiency (Fibryga or RiaSTAP): Diagnosis of congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia)

Approve for 1 year if prescribed by or in consultation with a hematologist; dosing up to 700 mg/kg per 28 days

inv-02: Fibryga - Acquired Fibrinogen Deficiency

Covered for Fibryga when ALL of the following are met

Acquired Fibrinogen Deficiency (Fibryga only): Diagnosis of acquired fibrinogen deficiency

Approve for 1 year if prescribed by or in consultation with a hematologist; dosing limited by age per policy: adults ≥18 years: up to 40 g per 28 days; patients 12-17 years: up to 500 mg/kg per 28 days; children <12 years: up to 700 mg/kg per 28 days

Coverage for the concomitant use of different fibrinogen concentrate products is excluded. Specifically, concomitant use of Fibryga and RiaSTAP is not covered because there are no data to support combined use of these products.

Any use of fibrinogen products that is not listed as medically necessary in this policy is considered not medically necessary. Examples include concomitant use of Fibryga and RiaSTAP and use for dysfibrinogenemia, a qualitative fibrinogen disorder in which fibrinogen levels may be adequate but function is impaired; fibrinogen concentrates are not indicated for dysfibrinogenemia.

Coding and Dosing Limits

Considered Medically Necessary when criteria metHCPCSCovered

J7177	Injection, human fibrinogen concentrate (Fibryga), 1 mg
J7178	Injection, human fibrinogen concentrate, not otherwise specified, 1 mg

inv-06: Maximum dosing limits — congenital and Fibryga-specific adult/pediatric limits

Congenital fibrinogen deficiency (all ages)Maximum dosing: up to 700 mg/kg intravenously per 28 days.

Fibryga — adults (≥18 years) with acquired fibrinogen deficiencyMaximum dosing: up to 40 g per 28 days intravenously.

Fibryga — adolescents (12–17 years) with acquired fibrinogen deficiencyMaximum dosing: up to 500 mg/kg per 28 days intravenously.

Fibryga — children (<12 years) with acquired fibrinogen deficiencyMaximum dosing: up to 700 mg/kg per 28 days intravenously.

Dosing rationaleLimits account for prophylactic dosing plus up to three days of acute or perioperative management per 28 days; doses exceeding these quantities reviewed case-by-case.

Prior Authorization, Prescribing, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of fibrinogen products (Fibryga, RiaSTAP). Approvals are issued for the durations and dosing limits specified in the policy and will be considered case-by-case for requests outside these limits by a clinician (Medical Director or Pharmacist).

All approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., hematologist).
Approve congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia) for up to 1 year when prescribed by or in consultation with a hematologist; dosing: up to 700 mg/kg IV per 28 days.
Approve acquired fibrinogen deficiency (Fibryga) for up to 1 year when prescribed by or in consultation with a hematologist; dosing options — (A) patients ≥18 years: up to 40 g per 28 days IV; (B) patients 12 to <18 years: up to 500 mg/kg per 28 days IV; (C) children <12 years: up to 700 mg/kg per 28 days IV.

Note

Guideline Context — No Enforced Step Therapy

Guidelines note that fibrinogen concentrate (e.g., RiaSTAP) may be required to treat or prevent bleeding and that cryoprecipitate is similarly effective but may have higher risk of transfusion reactions or volume overload. This policy does not enforce step therapy requiring cryoprecipitate prior to fibrinogen concentrate.

Definitions of Fibrinogen Disorders

inv-13: Afibrinogenemia / Hypofibrinogenemia — quantitative congenital fibrinogen deficiencies

DefinitionQuantitative congenital fibrinogen deficiencies characterized by absent (afibrinogenemia) or low (hypofibrinogenemia) circulating fibrinogen.

Clinical presentationVariable; patients may present with bleeding or thromboembolic events; treatment is generally on-demand for acute bleeding though prophylaxis may be used in high-risk patients.

Indicated productsFibryga and RiaSTAP are indicated for treatment of acute bleeding in congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia).

Authorization noteApprove for 1 year if medication is prescribed by or in consultation with a hematologist; dosing up to 700 mg/kg per 28 days for congenital deficiency.

inv-14: Dysfibrinogenemia — qualitative fibrinogen disorder where function is impaired; concentrates not indicated

Background

Congenital fibrinogen deficiencies are quantitative disorders of fibrinogen (Factor I) and include afibrinogenemia (absent circulating fibrinogen) and hypofibrinogenemia (low circulating fibrinogen). These conditions can present with bleeding diatheses and, in some cases, thrombotic complications. Fibrinogen concentrates such as Fibryga and RiaSTAP are used to treat acute bleeding episodes and, in selected high‑risk patients, for prophylaxis.

By contrast, dysfibrinogenemia is a qualitative defect in which fibrinogen function is impaired despite adequate antigenic levels; fibrinogen concentrates are not indicated for this disorder and use for dysfibrinogenemia is listed as not covered in this policy.