CurrentCareSourcePolicy N/A

Ceprotin (protein C concentrate) Utilization Management Medical Policy

This policy governs prior authorization and medical necessity criteria for Ceprotin (protein C concentrate [human]) for treatment and prevention of complications of severe congenital protein C deficiency for neonates, pediatric, and adult patients within the payer's jurisdiction.

Policy Summary

PayerCareSource

PolicyCeprotin (protein C concentrate) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization; approval recommended when listed diagnostic criteria and dosing limits (≤4,440 IU/kg per 28 days) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100-120 IU/kginitial dose recommended for acute episodes

45-60 IU/kgmaintenance dose range

4,440 IU/kgmaximum approval quantity

1 per 4Mpredicted incidence

Recommended Authorization Criteria

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Billing and Codes

Prior authorization affected codesmixed

affected codes

policy references prior authorization requirement for specific billing codes (not enumerated in document)

Maximum monthly quantity — dosing limit

Maximum monthly quantity4,440 IU/kg per 28 days

Dosing contextApproval dosing limit applies to intravenous Ceprotin administration as stated in the FDA‑approved indication

ExceptionsRequests for doses above 4,440 IU/kg per 28 days will be reviewed case‑by‑case by a clinician

What Providers Must Do

Policy Summary

PayerCareSource

PolicyCeprotin (protein C concentrate) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization; approval recommended when listed diagnostic criteria and dosing limits (≤4,440 IU/kg per 28 days) are met.

SourceLink

On This Page

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.

Prior Authorization

Prior authorization required — approvals follow criteria and dosing limits

Prior Authorization is recommended for medical benefit coverage of Ceprotin. Approval is recommended for members who meet the Recommended Authorization Criteria and dosing limits; dosing approvals may be granted up to 4,440 IU/kg intravenously per 28 days.

Step Therapy

Dose exceptions reviewed by clinician

Requests for doses outside the established dosing documented in this policy will be considered on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist).

Documentation Required

Required diagnostic documentation

Documentation must demonstrate one of the following diagnostic confirmations: plasma protein C activity below the laboratory age‑specific lower limit of normal, plasma protein C antigen below the laboratory age‑specific lower limit of normal, or genetic testing demonstrating biallelic pathogenic PROC variants; acquired causes must be excluded and Ceprotin must be prescribed by or in consultation with a hematologist.

Exclude acquired causes (examples: recent vitamin K antagonist use within 30 days, vitamin K deficiency, chronic liver disease, recent thrombosis, recent surgery, or disseminated intravascular coagulation).

Denial Risk

Not recommended when criteria are not met

Coverage is not recommended for circumstances that are not listed in the Recommended Authorization Criteria; these conditions are listed under the policy's 'Conditions Not Recommended for Approval' section.

Clinical Background

Severe congenital protein C deficiency is an autosomal recessive disorder caused by biallelic pathogenic variants in the PROC gene that result in marked protein C deficiency and clinical presentations that commonly include neonatal purpura fulminans, disseminated intravascular coagulation in neonates, and later-life thrombotic events. Diagnosis relies on clinical features and family history, measurement of protein C activity or antigen using age-specific laboratory reference ranges, exclusion of acquired causes of deficiency, and consideration of genetic testing to identify biallelic PROC variants.

Key Terms

Severe congenital protein C deficiency — definition and key features

DefinitionAn autosomal recessive disorder with biallelic PROC pathogenic variants leading to very low or undetectable protein C levels (often ~0.01 IU/mL), presenting with early‑life purpura fulminans and thrombotic complications.

Typical presentationPurpura fulminans and disseminated intravascular coagulation within 72 hours of birth; retinal and cerebral vessel thrombosis may occur in infancy

Biochemical severityProtein C levels by definition are ~0.01 IU/mL and are often undetectable; some cases have 0.01–0.2 IU/mL

Diagnostic considerationsDiagnosis uses characteristic symptoms, family history, and measurement of protein C activity or antigen; exclude acquired causes

Predicted incidenceApproximately 1 per 4 million births