CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemophilia Products - Factor X: Coagadex (Intravenous)

Policy governs authorization, dosing limits, dispensing, and renewal criteria for Coagadex (plasma-derived factor X) for Neighborhood Health Plan of Rhode Island members across Medicaid, Commercial, and Medicare-Medicaid Plan populations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products - Factor X: Coagadex (Intravenous)

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective DateOct 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization and document laboratory confirmation of congenital Factor X deficiency before dispensing Coagadex.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthstypical initial authorization period

23,000max billable units per 28 days (Medical Benefit)

J7175J-code for Coagadex

Up to 5allowed on-hand extra doses

1covered ICD-10 codes

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 Criteria for Coagadex (Factor X)

Initial Approval — Covered when ALL of the following are met

Covered when ALL of the following are met

Diagnosis confirmed: Diagnosis of congenital factor X deficiency has been confirmed by blood coagulation testing

Indication

Prophylaxis specifics: Primary prophylaxis for patients with severe factor X deficiency (factor X level <1%) OR second prophylaxis for patients with at least TWO documented spontaneous joint bleeds

Dosing constraints and testing: For prophylaxis requests exceeding dosing limits or for members with BMI ≥30 a half-life study should be performed; minimally treated patients (<50 exposure days) switching products require inhibitor testing at initiation and at subsequent comprehensive care visits as specifiedDo not exceed a peak level of 120 IU/dL; do not administer more than 60 IU/kg daily

Renewal Criteria — Renewal permitted when ALL of the following are met

Renewal permitted when ALL of the following are met

Continued eligibility: Patient continues to meet the initial approval criteria

Safety: Absence of unacceptable toxicity from the drug (examples include allergic/anaphylactic reactions, thromboembolic events, development of neutralizing antibodies/inhibitors)

Dose changes: Any increases in dose must be supported by an acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding with adherence)

Renewal periods by indication: On-demand treatment and routine prophylaxis renewals: approved for a 6 month authorization period; Perioperative management: NOT eligible for renewal

Coverage for Coagadex — Covered when ALL of the following are met per plan criteria and FDA labeling

Covered when ALL of the following are met per plan criteria and FDA labeling

Main: Member has a diagnosis consistent with hereditary factor X deficiency (ICD-10 D68.2) and the prescriber submits clinical documentation supporting use of Coagadex consistent with FDA labeling and Neighborhood clinical criteria; for Medicare members, applicable NCD/LCD determinations supersede the plan's non-Medicare criteria when present

Neighborhood will give individual consideration to requests and aligns criteria with FDA labeling and clinical literature

Perioperative use of Coagadex for surgical bleeding is eligible for initial authorization when clinically indicated per the plan’s criteria and prescriber documentation; however, coverage for perioperative management may NOT be renewed beyond the initial perioperative period.

Where applicable, Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence over the plan’s non‑Medicare coverage criteria. Providers should consult CMS resources and the referenced contractor documents when evaluating Medicare members; the plan may apply additional indications at its discretion when permitted by Medicare rules.

Auto‑filling prescriptions or dispensing without an expressed need from the patient, caregiver, or prescribing practitioner is not permitted. Rendering providers must obtain authorization for each dispensing and submit required documentation (original prescription, requested amount, vial sizes, patient clinical history and product inventory, bleed history) before delivering product; failure to comply with these dispensing requirements may lead to denial.

The intent of these criteria is to ensure use of Coagadex for medically accepted indications consistent with FDA labeling and relevant clinical literature, to minimize the risk of adverse effects, and to promote cost‑effective therapy selection when appropriate. Uses that fall outside FDA labeling or the plan’s clinical criteria may be considered not medically necessary, and each request will receive individual consideration based on the prescriber’s submitted information.

Coding, Dose Limits, and Related Standards

Jcode & NDCmixed

J7175	Coagadex, 1 IU = 1 billable unit
64208-7752	Coagadex NDC (250 IU vial)
64208-7753	Coagadex NDC (500 IU vial)

Covered ICD-10 Diagnosis CodesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

Referenced CMS Local Coverage Articles / Documentsmixed

A56065	Local Coverage Article: Billing and Coding: Guidance for Anti-Inhibitor Coagulant Complex (AICC)
A56433	Local Coverage Article: Billing and Coding: Hemophilia Factor Products (Novitas Solutions)
A56482	Local Coverage Article: Billing and Coding: Hemophilia Factor Products (First Coast Service Options)

Peak Factor X level limit

Peak Factor X level limitDo not exceed a peak level of 120 IU/dL

Monitoring target (related)Monitor trough blood levels targeting ≥5 IU/dL for prophylaxis and adjust to clinical response

Context of limitApplies to prophylaxis dosing per product labeling

Daily maximum dose

Daily maximum doseDo not administer more than 60 IU/kg daily

Age/indication notesLimit applies to on‑demand, perioperative management, and dosing guidance per labeling

Dose calculation referenceUse weight‑based dosing formulas provided for pre‑surgery plasma Factor X targets

Prior Authorization, Documentation, and Dispensing Rules

Prior Authorization

Length of Authorization

Unless otherwise specified, initial authorization will be provided for 3 months by default and may be renewed. Initial and renewal authorization periods may vary by specific covered indication. The cumulative amount of medication the patient has on-hand will be taken into account for authorizations; up to 5 on-hand doses for the treatment of acute bleeding episodes will be permitted at the time of the authorization request.

Initial authorization period: 3 months (unless otherwise specified).
Up to 5 on‑hand doses permitted for acute bleeding episodes will be considered when authorizing.

Step Therapy

Step Therapy Exception for MMP Members

MMP (Medicare‑Medicaid Plan/INTEGRITY) members who have previously received this medication within the past 365 days are exempt from step therapy requirements and are not subject to the plan's step therapy sequencing for initiation.

MMP members with prior use within 365 days: step therapy not required.

Documentation Required

Dispensing Requirements for Rendering Providers

Prescriptions cannot be filled without an expressed need from the patient, caregiver, or prescribing practitioner; auto‑filling is not allowed. Rendering providers must, on a monthly basis, submit authorization for the dispensing quantity before delivering factor product. Submitted information must include the original prescription, requested amount to be dispensed, vial sizes available from the manufacturer, and patient clinical history including current product inventory and bleed history. Factor dose dispensed should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose. The cumulative amount of medication the patient has on-hand must be considered; patients should not have more than 5 extra doses on-hand for acute bleeding episodes. These dispensing requirements are part of the Hemophilia Management Program and are intended as guidance, not to replace clinical decision making.

Prescriptions require an expressed need; auto‑filling prohibited.
Monthly pre-dispense authorization required with: original prescription, requested amount, vial sizes, patient clinical history, inventory and bleed history.
Dispensed factor dose tolerance: +1% of prescribed dose; max 3 vials per dose.
Do not exceed 5 extra doses on-hand for acute bleeds.

Denial Risk

Clinical Review and Denial Risk

Authorization decisions will be made through individual clinical review of the prescriber‑submitted information. Requests may be denied if they do not meet the plan's clinical coverage criteria, which are aligned with FDA labeling and relevant clinical literature, or if required documentation is incomplete or absent. For Medicare members, applicable NCDs/LCDs (see CMS coverage resources) must be followed where applicable; for INTEGRITY (MMP) members these coverage criteria apply only in the absence of an applicable NCD/LCD.

Requests may be denied if they do not meet plan clinical coverage criteria aligned with FDA labeling and guidelines.
Medicare members: applicable NCDs/LCDs must be followed.
INTEGRITY (MMP) members: plan criteria apply only if no applicable NCD/LCD exists.

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with authorization requests and should include, at minimum: diagnostic confirmation (e.g., laboratory confirmation of congenital Factor X deficiency by blood coagulation testing), indication for use (on‑demand treatment, routine prophylaxis, primary prophylaxis for severe deficiency defined as Factor X level <1%, second prophylaxis with ≥2 documented spontaneous joint bleeds, or perioperative management), relevant bleed history, current product inventory, prior use of the medication (dates and quantities), and any pertinent surgical or perioperative plans. For perioperative authorizations, note that authorizations for perioperative management for mild deficiency are valid for 1 month unless otherwise specified.

Laboratory confirmation of congenital Factor X deficiency required.
Specify intended use: on‑demand, routine prophylaxis, primary prophylaxis (Factor X <1%), second prophylaxis (≥2 spontaneous joint bleeds), or perioperative management.
Include bleed history, current product inventory, prior medication use (dates/quantities), and surgical plans if applicable.
Perioperative authorizations for mild deficiency: valid for 1 month.

OpenPayer

Hemophilia Products - Factor X: Coagadex (Intravenous)

Coverage Criteria for Coagadex (Factor X)

Coding, Dose Limits, and Related Standards

Prior Authorization, Documentation, and Dispensing Rules

Background on Coagadex and Indication

Definitions Related to Coverage