CurrentCignaPolicy IP0554

Hematology - Coagadex

Defines medical necessity criteria, dosing, authorization durations, and coding for coverage of Coagadex for hereditary Factor X deficiency under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyHematology - Coagadex

Policy CodePolicy IP0554

Change TypeNo material change

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting hereditary Factor X deficiency and that use is for prophylaxis, treatment of bleeding, or perioperative management; approvals up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 12 monthsInitial & reauthorization approval duration

J7175Billing code

Up to 600 IU/kgMax dosing/infusion

Hereditary FX deficiencyCovered indication

Coverage Criteria

Initial Therapy

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.

Hereditary Factor X Deficiency criteria: 1. Individual has Hereditary Factor X Deficiency AND documentation of ONE of: (i) routine prophylaxis to reduce the frequency of bleeding episodes; (ii) treatment of bleeding episodes; (iii) perioperative management of bleeding in individuals with mild, moderate, and severe hereditary Factor X deficiency. 2. Medication is prescribed by, or in consultation with, a hematologist.N/A

Dosing up to 600 IU/kg IV no more frequently than once every 28 days

Continuation Therapy

Reauthorization (Continuation Therapy)

Reauthorization: Continuation is medically necessary when the initial medical necessity criteria are still met AND there is documentation of beneficial response to therapy.N/A

Reauthorization approval duration: up to 12 months

Initial Therapy and Dosing

Initial therapy and dosing

Initial coverage criteria and dosing guidance

Initial therapy: Medication is indicated for hereditary Factor X deficiency for on-demand treatment of bleeding episodes, perioperative management, or routine prophylaxis; must be prescribed by or in consultation with a hematologist.Up to 600 IU/kg per infusion; dosing frequency no more often than every 28 days

Allows for prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days; doses exceeding this quantity will be reviewed case-by-case by a clinician.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization rules

Continuation of therapy: Continuation is allowed when original criteria are still met and there is documented beneficial response; reauthorization approvals up to 12 months.N/A

Documentation of beneficial response required for reauthorization.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Coagadex (see medical necessity criteria). Documentation supporting the request must be submitted prior to initiation of therapy. Requests should include clinical indication, dosing plan, prescriber specialty, and previous treatment history as applicable.

Prior authorization required for initial and reauthorization requests
Include prescriber specialty (hematologist or consultation with hematology)
Authorization durations: initial up to 12 months; reauthorization up to 12 months

Step Therapy

No step therapy is required before initiating Coagadex. However, the medication should be prescribed by, or in consultation with, a hematologist and requests are expected to document hematology involvement.

No prerequisite trials of other agents required
Hematology prescriber or documented hematology consultation expected

Documentation Required

Required Documentation

Provide complete documentation to support medical necessity. Include indication, reason for use (prophylaxis, treatment of bleeding episodes, or perioperative management), relevant laboratory or diagnostic data, dosing regimen, and evidence of beneficial response for reauthorization.

Indication: routine prophylaxis, treatment of bleeding episodes, or perioperative management
Documentation of ONE qualifying indication item (prophylaxis, treatment, or perioperative use)
Prescriber: hematologist or documentation of hematology consultation
Dosing plan (up to 600 IU/kg IV no more frequently than once every 28 days) and site of care
For reauthorization: documentation of beneficial clinical response
Note: receipt of sample product does not satisfy documentation requirements

Denial Risk

Not Covered / Denial Risk

Uses other than hereditary Factor X deficiency are considered experimental, investigational, or unproven and may be denied.

Coverage limited to Hereditary Factor X Deficiency per medical necessity criteria
Any other indication is at high risk for denial as experimental/investigational

Coding and Monitoring

Considered Medically Necessary when criteria metHCPCSCovered

J7175

Injection, Factor X, (human), 1 IU

inv-07: Recommended trough level

Recommended trough levelAround 20% to 30% (target trough levels recommended in management)

Source guidance contextMASAC guidance and disease overview note maintaining troughs ~20–30%

Clinical implicationTrough goals inform prophylaxis dosing and supply planning (prophylactic plus days for breakthrough bleeding)

Step Therapy / Prior Treatment Requirements

Step	Requirement	Prescriber
No step therapy specified	No prior trials or step requirements are listed in the policy; therapy may be initiated without documented failure of other agents.
Hematology involvement required	Medication must be prescribed by, or in consultation with, a hematologist as a condition of medical necessity.	Prescribed by, or in consultation with, a hematologist

Quantity Limits and Dosing Caps

inv-17: Coagadex — quantity limits

Per-infusion maximumUp to 600 IU/kg per intravenous infusion

28-day allowancePolicy allows prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days

Frequency limitNo more frequently than once every 28 days for standard dosing interval

Excess dosing reviewDoses exceeding these quantities will be reviewed case-by-case by a clinician

Site of Care Considerations

Note

Choose clinically appropriate site of care (home, infusion center, or hospital outpatient)

Site of care (home, infusion center, or hospital outpatient) should be reasonable and clinically appropriate for the patient; dosing, frequency, duration, and site of care must be supported by evidence-based literature and adjusted based on severity, alternative treatments, and prior response to therapy.

Dosing up to 600 IU/kg IV no more frequently than once every 28 days; site selection should align with clinical needs and evidence.
Maximum dosing allowance considers prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days; doses above this will be reviewed case-by-case.

Definitions

inv-13: Hereditary Factor X deficiency — definition

DefinitionA rare autosomal recessive inherited bleeding disorder caused by deficiency of coagulation Factor X leading to impaired clot formation and variable bleeding severity.

Prevalence noteAffects approximately 1 in 500,000 to 1,000,000 patients worldwide.

Clinical featuresManifests with easy bruising, mucocutaneous bleeding, bleeding after trauma or surgery, and serious spontaneous bleeds in severe cases.

Background

Hereditary Factor X deficiency is a rare bleeding disorder caused by deficiency of coagulation Factor X leading to impaired clot formation and variable bleeding severity. Management recommendations in this policy apply specifically to that inherited condition; therapies for other indications are considered experimental, investigational, or unproven and are not covered under this policy.