Coagadex (Factor X) prior authorization
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Defines prior authorization requirements for coverage of Coagadex for treatment of hereditary Factor X deficiency under the Curative Health Plan; applies to providers requesting this drug for plan members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Coagadex
Use of Coagadex in combination with indirect or direct Factor Xa inhibitors is not allowed. Examples of prohibited concomitant agents include apixaban (Eliquis), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and warfarin (Coumadin).
Initial Therapy Criteria and Approvals
inv-11: Initial Therapy
Initial approval is available for emergency, prophylaxis, on-demand, or perioperative uses with required documentation.
Initial approval available for emergency, prophylaxis, on-demand, or perioperative uses
Continuation Therapy Criteria
inv-12: Continued Therapy
Continued therapy coverage requires prior plan approval and recent use with clinical benefit.
From Continued Therapy Approval
Provider Actions and Documentation Requirements
Prior authorization required for Coagadex
Prior authorization is required for Coagadex; approval is granted only when the requested medication is being used for an FDA-approved indication and all coverage criteria are met.
Specialist involvement required
The prescriber must be a specialist or must have consulted a specialist in the area of the patient's diagnosis (e.g., hematology) for both initial and continued therapy requests.
Required documentation and timeframe
Provide chart documentation confirming hereditary Factor X deficiency within the required timeframe: within the past 90 days for initial requests and within the past 12 months for continued therapy. For continued therapy also include prior plan approval (unless initial evaluation is required) and evidence the patient was treated with the requested agent within the past 90 days (samples are not acceptable).
- Initial requests: chart notes documenting hereditary Factor X deficiency within past 90 days.
- Continued therapy: chart notes documenting hereditary Factor X deficiency within past 12 months.
- Continued therapy must include prior plan approval history (or meet initial criteria if prior approvals were only emergency uses) and documentation of treatment with the requested agent within past 90 days (samples not acceptable).
Triggers for denial
Denial may occur if required documentation is missing or outside the specified timeframes, or if the request documents concurrent use with an indirect or direct Factor Xa inhibitor.
- No chart documentation of hereditary Factor X deficiency within past 90 days for initial requests or within past 12 months for continued therapy.
- Documentation indicates concurrent use with indirect or direct Factor Xa inhibitors (e.g., apixaban, dalteparin, edoxaban, enoxaparin, fondaparinux, rivaroxaban, warfarin).
Factor X Levels and Coding Notes
Definitions and Perioperative Management
Background
Hereditary Factor X deficiency is an inherited bleeding disorder characterized by low factor X activity. Management options include on‑demand treatment for active bleeds, perioperative management based on Factor X activity, one‑time emergency dosing when a patient is actively bleeding and out of medication, and routine prophylaxis to prevent bleeding episodes.
Perioperative management should be guided by Factor X level: mild: 6–10%; moderate: 1–5%; severe: <1%. Prescriber documentation of the patient’s Factor X level and the intended perioperative use is required for authorization.
Revision History
Initial publication of the Coagadex (Factor X) prior authorization clinical criteria for hereditary Factor X deficiency, including initial and continued therapy requirements, documentation windows, and approval durations.
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