ModifiedmhnPolicy CP.PHAR.526

Fibrinogen Concentrate [Human] (Fibryga, RiaSTAP), Fibrinogen, Human-chmt (Fesilty)

Defines medical necessity criteria, dosing, and prior authorization requirements for human fibrinogen concentrates (Fibryga, RiaSTAP, Fesilty) for commercial and Medicaid members; applies to providers requesting coverage for acute bleeding in congenital or acquired fibrinogen deficiency.

Policy Summary

Payermhn

PolicyFibrinogen Concentrate [Human] (Fibryga, RiaSTAP), Fibrinogen, Human-chmt (Fesilty)

Policy CodePolicy CP.PHAR.526

Change TypeAdded Fesiltyupdated Fibryga indicationclarified lab documentation

Effective DateJun 1, 2021

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation (office notes and lab results) verifying diagnosis and required fibrinogen levels and coagulation studies for new starts.

SourceLink

POLICY UPDATE CHANGES

Added newly approved Fesilty product to the policy.

Updated Fibryga with new FDA indication for acquired fibrinogen deficiency.

Clarified that documentation of fibrinogen level and prolonged PT/aPTT applies only to new starts on Fibryga/RiaSTAP therapy.

3 monthsInitial approval duration

<150 mg/dLCongenital threshold

<200 mg/dLAcquired threshold

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.

Coverage and Medical Necessity Criteria

Initial Therapy - Congenital Fibrinogen Deficiency

Covered when ALL of the following are met for congenital fibrinogen deficiency (Initial Approval):

Congenital Initial: 1. Diagnosis of congenital fibrinogen deficiency, including afibrinogenemia or hypofibrinogenemia; 2. Confirmation that the member does not have dysfibrinogenemia; 3. Prescribed by or in consultation with a hematologist; 4. Request is for treatment of acute bleeding episodes; 5. For members who have not previously used fibrinogen concentrate (samples do not count), documentation of BOTH of the following: (a) plasma functional and immunoreactive fibrinogen levels < 150 mg/dL; (b) prolonged prothrombin time (PT) and activated partial thromboplastin time (aPTT) per laboratory-specific reference values; 6. Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.see node text

Approval duration: 3 months

Initial Therapy - Acquired Fibrinogen Deficiency

Covered when ALL of the following are met for acquired fibrinogen deficiency (Initial Approval):

Acquired Initial: 1. Diagnosis of acquired fibrinogen deficiency; 2. Request is for Fibryga; 3. Prescribed by or in consultation with a hematologist; 4. Request is for fibrinogen supplementation for bleeding; 5. Member meets ONE of the following: (a) plasma fibrinogen level < 200 mg/dL; (b) thromboelastometry FIBTEM A10 ≤ 10 mm; 6. Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.see node text

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Continued Therapy: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or member has previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.

Applies to all indications in Section I

This policy does not address non–FDA approved indications unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health insurance marketplace/ICHRA), and CP.PMN.53 (Medicaid). Requests for uses outside the FDA‑labeled indications will be evaluated only when supporting clinical evidence and documentation consistent with those off‑label policies are provided.

Coverage and payment for fibrinogen concentrate are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). State and federal laws and Health Plan administrative policies also apply; for Medicaid members, applicable state Medicaid provisions take precedence where they conflict with this policy. The Health Plan retains the right to change, amend, or withdraw this policy consistent with legal and regulatory requirements.

Use of fibrinogen concentrate for dysfibrinogenemia is explicitly not authorized under this policy and is considered not medically necessary.

Billing and Code References

Referenced HCPCS CodesHCPCS

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

Covered HCPCS CodesHCPCSCovered

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

Laboratory thresholds for treatment — congenital vs acquired fibrinogen deficiency

Congenital deficiency thresholdPlasma functional and immunoreactive fibrinogen <150 mg/dL plus prolonged PT and aPTT per lab reference

Acquired deficiency threshold (plasma)Plasma fibrinogen <200 mg/dL

Acquired deficiency threshold (viscoelastic)Thromboelastometry FIBTEM A10 ≤10 mm

Approval duration for congenital initial therapyInitial approval: 3 months

Dose constraintDose must not exceed the FDA‑approved maximum for the indication

J7177 — code definition for Fibryga 1 mg

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Fesilty, Fibryga, and RiaSTAP. Providers must submit supporting clinical documentation (see Documentation callout) with the PA request. Approvals are subject to member benefit document terms, exclusions, and limitations.

Applies to fibrinogen concentrate products: Fesilty, Fibryga, and RiaSTAP.
PA applies when billed under HCPCS J7177 and J7178 (see billing callout).

Documentation Required

Required Documentation

When submitting a PA request, include relevant clinical documentation to demonstrate the member meets all approval criteria. Acceptable supporting documentation includes office chart notes, hospitalization records, procedure notes, and laboratory results that substantiate the diagnosis and need for therapy.

Office/provider chart notes documenting diagnosis, symptoms, bleeding event, and treatment plan.

Definitions and Key Terms

Congenital fibrinogen deficiency / dysfibrinogenemia

DefinitionCongenital fibrinogen deficiency includes afibrinogenemia and hypofibrinogenemia

Dysfibrinogenemia exclusionDysfibrinogenemia is not an indicated use and is specifically excluded

Indication contextFesilty, Fibryga, and RiaSTAP are indicated for acute bleeding in congenital fibrinogen deficiency

Clinical requirementConfirmation that the member does not have dysfibrinogenemia is required for congenital indication

Clinical Background

Congenital and acquired fibrinogen deficiencies increase bleeding risk because fibrinogen (coagulation factor I) is essential for clot formation. Congenital fibrinogen deficiency includes afibrinogenemia and hypofibrinogenemia, conditions in which endogenous fibrinogen is absent or markedly reduced, leading to spontaneous or trauma‑related bleeding. Acquired fibrinogen deficiency may occur in settings such as massive hemorrhage, liver disease, or consumptive coagulopathy and can similarly result in clinically significant bleeding.

Human fibrinogen concentrates (for example, Fesilty, Fibryga, and RiaSTAP) are indicated for treatment of acute bleeding in patients with congenital fibrinogen deficiency; Fibryga also has an FDA indication for acquired fibrinogen deficiency. These products provide a plasma‑derived source of fibrinogen to restore hemostasis when laboratory thresholds and clinical context indicate supplementation is required.

Policy Revision History

2026-01-05addedLatest

Policy modified to add newly approved Fesilty product (fibrinogen, human‑chmt) to the covered product list and availability section.

2024-08-14revised

Fibryga entry updated to reflect new FDA indication for acquired fibrinogen deficiency.

2022-03-04clarified

Policy Summary

Payermhn

PolicyFibrinogen Concentrate [Human] (Fibryga, RiaSTAP), Fibrinogen, Human-chmt (Fesilty)

Policy CodePolicy CP.PHAR.526

Change TypeAdded Fesiltyupdated Fibryga indicationclarified lab documentation

Effective DateJun 1, 2021

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation (office notes and lab results) verifying diagnosis and required fibrinogen levels and coagulation studies for new starts.

SourceLink

On This Page

HCPCS codeJ7177

DescriptionInjection, human fibrinogen concentrate (Fibryga), 1 mg

Used forBilling Fibryga fibrinogen concentrate (per coding list)

J7178 — code definition for human fibrinogen concentrate, NOS, 1 mg

HCPCS codeJ7178

DescriptionInjection, human fibrinogen concentrate, not otherwise specified, 1 mg

Used forBilling human fibrinogen concentrate when not otherwise specified

Laboratory results (see lab callout) such as plasma fibrinogen level and coagulation studies.

Consultation notes or documentation that the drug was prescribed by or in consultation with a hematologist, when required by criteria.

Medication history documenting prior fibrinogen concentrate use (samples do not count).

Dose justification showing requested dose does not exceed FDA-approved maximum for the indication.

Documentation Required

Lab Documentation for New Starts

For new starts on Fibryga or RiaSTAP, documentation must include baseline fibrinogen and coagulation testing. This requirement specifically applies to members initiating fibrinogen concentrate therapy and is used to confirm eligibility under the congenital fibrinogen deficiency criteria.

Baseline plasma functional and immunoreactive fibrinogen level (< 150 mg/dL for congenital deficiency criterion).
Documentation of prolonged prothrombin time (PT) and activated partial thromboplastin time (aPTT) per laboratory-specific reference ranges.
For acquired deficiency (Fibryga), documentation of plasma fibrinogen level < 200 mg/dL or thromboelastometry FIBTEM A10 ≤ 10 mm, as applicable.

Note

Formulary / Referral Guidance for Label Changes

If a recent label change (new indication, age expansion, or dosing regimen) is not yet reflected in this policy, follow formulary and referral guidance for coverage determination and PA processing.

For drugs on formulary/PDL, see the no coverage criteria policy for the applicable line of business: CP.CPA.190 (commercial), HIM.PA.33 (health insurance marketplace/ICHRA), CP.PMN.255 (Medicaid).
For drugs NOT on formulary/PDL, see the non-formulary policy: CP.CPA.190 (commercial), HIM.PA.103 (health insurance marketplace/ICHRA), CP.PMN.16 (Medicaid).
For requests not specifically listed in indications and not covered above, refer to off-label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace/ICHRA), CP.PMN.53 (Medicaid).

Billing Rule

HCPCS-based Prior Authorization

Prior authorization applies when fibrinogen concentrate is billed under HCPCS codes J7177 or J7178. Ensure claims and PA requests reference the appropriate HCPCS code.

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

Note

Benefit Document and Policy Conformity

Coverage decisions are subject to all terms, conditions, exclusions, and limitations in the member's benefit documents. This clinical policy is a medical necessity guide and does not guarantee payment; state/federal requirements and Health Plan administrative policies also apply.

Verify the member's evidence of coverage, certificate of coverage, or policy prior to submission.
If there is a conflict between this clinical policy effective date and legal/regulatory requirements, the law governs.

Clarified that documentation of fibrinogen level and prolonged PT/aPTT applies only to new starts on Fibryga/RiaSTAP therapy and updated RiaSTAP pediatric language.