CurrentCignaPolicy IP0554

Hematology - Coagadex

Defines medical necessity and authorization requirements for Coagadex (plasma‑derived human Factor X) for treatment, perioperative management, and routine prophylaxis of hereditary Factor X deficiency for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHematology - Coagadex

Policy CodePolicy IP0554

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization; initial and reauthorization approvals are for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J7175HCPCS code for Coagadex (per IU)

up to 600 IU/kgMax dosing per infusion

12 monthsAuthorization duration

Adults & childrenLabeled indications

Coverage Criteria for Coagadex (Factor X [human])

Initial therapy - Hereditary Factor X Deficiency

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Hereditary Factor X Deficiency criteria: Member has hereditary Factor X deficiency

Clinical use: Documentation of ONE of the following: routine prophylaxis to reduce the frequency of bleeding episodes; treatment of bleeding episodes; perioperative management of bleeding in individuals with mild, moderate, or severe hereditary Factor X deficiency.

Prescriber requirement: Medication is prescribed by, or in consultation with, a hematologist.

Coding and Dosing Information

Considered Medically Necessary HCPCS CodesHCPCSCovered

J7175

Injection, Factor X, (human), 1 IU

mixed

No codes listed

Dosing frequency and quantity

Maximum dose per infusionUp to 600 IU/kg by intravenous infusion

Minimum interval between infusionsNo more frequently than once every 28 days

Monthly allowance rationalePolicy allows prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days

Excess dosing reviewDoses exceeding the allowed quantity will be reviewed case-by-case by a clinician

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Coagadex. Initial and reauthorization approvals are for up to 12 months.

Initial approval: up to 12 months
Reauthorization approval: up to 12 months

Documentation Required

Documentation Requirements

Documentation must clearly show a diagnosis of hereditary Factor X deficiency and include ONE of the following treatment intents: routine prophylaxis to reduce bleeding frequency, treatment of bleeding episodes, or perioperative management of bleeding. Medication should be prescribed by or in consultation with a hematologist. Receipt of sample product does not satisfy documentation requirements.

Note

Dosing Operational Note

Dosing should account for prophylactic dosing plus up to three days of acute bleeding or perioperative management per 28 days; policy allows up to 600 IU/kg by IV no more frequently than once every 28 days. Doses exceeding the quantity that covers prophylaxis plus three days of acute/perioperative use will be reviewed case-by-case by a clinician.

Denial Risk

Requests for any use other than hereditary Factor X deficiency (the specified indications above) are considered experimental, investigational, or unproven and are subject to denial.

Background

Factor X deficiency is a rare autosomal recessive bleeding disorder caused by reduced or absent Factor X activity, which leads to impaired clot formation and bleeding manifestations ranging from easy bruising and mucosal bleeding to post‑traumatic or surgical bleeding and, in severe cases, spontaneous life‑threatening hemorrhage.

Definitions

Hereditary Factor X Deficiency

DefinitionA rare autosomal recessive inherited bleeding disorder characterized by reduced or absent Factor X activity leading to impaired clot formation

Clinical manifestationsEasy bruising, mucosal bleeding (nose or mouth), bleeding after trauma or surgery, and in severe cases spontaneous intracranial or gastrointestinal hemorrhage

Special considerationsWomen may experience heavy menstrual bleeding; umbilical cord bleeding can be an early sign in severe cases; recommended trough levels ~20%–30%

Initial Therapy

Initial approval criteria

Prescriber and indication: Prescribed by or in consultation with a hematologist for treatment, prophylaxis, or perioperative management of hereditary Factor X deficiency.

Up to 12 months initial approval.

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization requirements

Beneficial response required: Documentation of beneficial response is required for continuation of therapy.

Reauthorization duration up to 12 months.

Quantity and Dosing Limits

Coagadex — Dosing and quantity limits

Indication summaryCoagadex (coagulation Factor X [human]) is indicated for on‑demand treatment of bleeding, perioperative management, and routine prophylaxis in adults and children with hereditary Factor X deficiency

Dosing per infusionUp to 600 IU/kg by intravenous infusion

Frequency and monthly allowanceNo more frequently than once every 28 days; policy allows prophylactic dosing plus three days of acute bleeding or perioperative management per 28 days

Excess dose policyDoses exceeding the allowed quantity will be reviewed on a case-by-case basis by a clinician

Site of Care Considerations