CurrentCareSourcePolicy N/A

Fibrinogen concentrates (Fibryga, RiaSTAP) utilization and prior authorization

Defines prior authorization criteria, dosing limits, and coverage stance for human fibrinogen concentrates (Fibryga and RiaSTAP) for congenital and acquired fibrinogen deficiencies for CareSource members; applies to prescribers and facilities requesting coverage.

Policy Summary

PayerCareSource

PolicyFibrinogen concentrates (Fibryga, RiaSTAP) utilization and prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 21, 2024

Key ActionObtain prior authorization with specialist prescribing or consultation and request approval for dosing and duration per policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

700 mg/kgmax dose congenital /28d

500 mg/kgmax dose acquired (Fibryga) /28d

1 yearauthorization duration

10 dosesdosing frequency cap

Recommended Authorization Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA-Approved Indication — Congenital Fibrinogen Deficiency

Covered when ALL of the following are met

Congenital fibrinogen deficiency (RiaSTAP and Fibryga): Diagnosis of congenital fibrinogen deficiency (including afibrinogenemia or hypofibrinogenemia) and medication prescribed by or in consultation with a hematologist.Approve for 1 year; dosing up to 700 mg/kg IV per 28 days

Dosing individualized based on patient characteristics, bleeding severity, and laboratory values; maximum allows for prophylactic dosing plus acute management as described in policy.

FDA-Approved Indication — Acquired Fibrinogen Deficiency

Covered when ALL of the following are met

Acquired fibrinogen deficiency (Fibryga only): Bleeding patient with acquired fibrinogen deficiency and medication prescribed by or in consultation with a hematologist; dosing guided by plasma fibrinogen levels or thromboelastometry and clinical condition.Approve for 1 year; dosing up to 500 mg/kg IV per 28 days; dosing guidance allows up to 10 doses per 28 days

Additional doses may be required after initial administration based on laboratory monitoring and clinical response; dosing individualized to body weight and bleeding severity.

Coverage of fibrinogen concentrates for dysfibrinogenemia is not recommended. The policy follows product labeling that states these agents are not indicated for dysfibrinogenemia, a qualitative defect in which fibrinogen function is impaired despite adequate antigen levels; therefore fibrinogen concentrate use for this condition is not covered.

Use of fibrinogen concentrates for dysfibrinogenemia or for other indications not explicitly listed in the Authorization Criteria is considered not medically necessary and is not recommended for approval. Product labeling and the policy both indicate these agents are not indicated for dysfibrinogenemia, supporting a non‑coverage stance for such requests.

Dosing Limits and Coding Notes

Maximum dosing per 28 days — policy limits

Maximum dosing — congenital fibrinogen deficiency700 mg/kg IV per 28 days (approve for 1 year)

Maximum dosing — acquired fibrinogen deficiency (Fibryga)500 mg/kg IV per 28 days (approve for 1 year); dosing guidance allows up to 10 doses per 28 days

Dosing frequency rationalePolicy allows dosing to cover prophylaxis plus acute episodes and perioperative management; doses exceeding these limits reviewed case-by-case

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are provided for the durations and dosing limits specified in the policy. Requests for doses outside the dosing documented in this policy will be reviewed on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the policy.

Approvals limited to durations and dosing in policy; exceptions reviewed case‑by‑case.
Automation: None.

Note

Alternative Blood Product

Cryoprecipitate is an alternative blood product that may be similarly effective to fibrinogen concentrate (e.g., RiaSTAP or Fibryga) for treating or preventing bleeding. However, cryoprecipitate may be associated with transfusion reactions or volume overload. Guidance on alternatives should be considered; there is no explicit step‑therapy requirement mandating use of cryoprecipitate before fibrinogen concentrate.

Documentation Required

Specialist Prescribing / Consultation Required

Because of the specialized skills required for evaluation, diagnosis, monitoring of adverse events, and long‑term management of patients treated with fibrinogen products, the medication must be prescribed by or in consultation with a relevant specialist (for example, a hematologist). Where noted in the criteria, approvals are contingent on prescription by or documented consultation with the specialist.

Examples: hematologist or other physician who specializes in the condition being treated.
Approval duration (e.g., 1 year) applies when prescribed by or in consultation with a hematologist (per FDA‑approved indications).

Denial Risk

Concomitant Product Use — Not Recommended

Requests for concomitant use of Fibryga and RiaSTAP are not recommended and may be denied; there are no data to support concomitant use of these products.

Denial Risk

Non‑listed Indications — Not Recommended

Requests for indications not listed in the Recommended Authorization Criteria are not recommended and may be denied. Criteria will be updated as new published data become available.

Key Clinical Definitions

Afibrinogenemia / Hypofibrinogenemia — definitions

AfibrinogenemiaQuantitative congenital fibrinogen deficiency characterized by absence of circulating fibrinogen

HypofibrinogenemiaQuantitative congenital fibrinogen deficiency characterized by low levels of circulating fibrinogen

Clinical contextThese quantitative disorders present variably (bleeding or thromboembolism) and treatment is generally on-demand for acute bleeding episodes; prophylaxis used in select high-risk patients

Dysfibrinogenemia — qualitative defect and coverage

Dysfibrinogenemia — definitionQualitative fibrinogen defect in which circulating fibrinogen levels may be adequate but function is impaired

Coverage stanceFibrinogen concentrates (Fibryga, RiaSTAP) are not indicated for dysfibrinogenemia and coverage is not recommended

Policy consequenceRequests for fibrinogen concentrates for dysfibrinogenemia are considered not recommended for approval (not medically necessary)

Clinical Background

Congenital fibrinogen disorders include quantitative deficiencies—afibrinogenemia (absent circulating fibrinogen) and hypofibrinogenemia (reduced fibrinogen levels)—as well as qualitative defects known as dysfibrinogenemia. Clinical presentation varies from bleeding to thrombotic events. Human fibrinogen concentrates (RiaSTAP and Fibryga) are approved for treatment of acute bleeding in congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia); Fibryga is additionally FDA‑approved for bleeding due to acquired fibrinogen deficiency. Both product labels note these agents are not indicated for dysfibrinogenemia.