CurrentCentenePolicy CP PHAR.330

Protein C Concentrate, Human (Ceprotin)

Defines medical necessity criteria, approval durations, dosing, and coding implications for Ceprotin (protein C concentrate, human) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyProtein C Concentrate, Human (Ceprotin)

Policy CodePolicy CP PHAR.330

Change TypeClarified (template changes); no material clinical changes

Effective DateMar 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria, including lab confirmation of low protein C activity if available.

POLICY UPDATE CHANGES

Annual reviews from 2021-2025 noted no significant changes; latest P&T Approval Date 02.25.

1FDA-approved indication (severe congenital Protein C deficiency)

1Primary HCPCS code referenced

2Vial sizes available (IU)

Coverage Summary

Coverage stance: covered_with_criteria for Ceprotin (protein C concentrate, human) aligned with the FDA-approved indication for severe congenital Protein C deficiency. Policy number: CP PHAR.330. Effective date: 2017-03-01. Last review date: 2025-02-25. Scope: Defines medical necessity criteria, approval durations, dosing, and coding implications for Ceprotin (protein C concentrate, human) across Commercial, HIM, and Medicaid lines of business.

Surface thresholds and quick facts

Approval duration - Medicaid/HIM (initial)6 months

Approval duration - Medicaid/HIM (continued)12 months

Approval duration - Commercial (initial)6 months or to the member's renewal date, whichever is longer

Approval duration - Commercial (continued)6 months or to the member's renewal date, whichever is longer

Protein C activity (definition)Laboratory measure of protein C level or function used to confirm deficiency.

Vial sizes available (IU)500 IU per vial; 1,000 IU per vial

Primary HCPCS code referenced (count)1 (J2724: Injection, protein C concentrate, intravenous, human, 10 IU)

Initial Therapy Criteria

Documentation Required

Specialist involvement

Prescription must be by or in consultation with a hematologist or physician with expertise in inherited thrombophilias.

Prior Authorization

Documentation required for prior authorization

Submit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria; include laboratory confirmation of low protein C activity if available.

J2724

Continuation Therapy Criteria

Approval durations — Medicaid/HIM: initial approval 6 months; continued therapy 12 months.

Approval durations — Commercial: initial approval 6 months or to the member's renewal date, whichever is longer; continued therapy 6 months or to the member's renewal date, whichever is longer. Note: Commercial approvals may be tied to the member's renewal date logic as stated above.

Applicable Codes

HCPCS J-code for CeprotinHCPCSCovered

J2724

Injection, protein C concentrate, intravenous, human, 10 IU

Billing Rule

Coding implications

Codes referenced are informational; inclusion or exclusion does not guarantee coverage. Providers should reference current professional coding guidance when submitting claims.

J2724

Provider Actions

Prior Authorization

Documentation required for prior authorization

Providers must submit office chart notes, lab results, or other clinical documentation demonstrating the member meets all approval criteria as part of the prior authorization request; include lab confirmation of low protein C activity when available.

J2724

Documentation Required

Specialist involvement

Prescription must be by or in consultation with a hematologist or physician experienced in inherited thrombophilias.

Clinical Evidence & Guidance

Prescribing Information: Ceprotin Prescribing Information, Baxalta US, Inc.; March 2023 — cited as the product label supporting the FDA indication and dosing/administration details.

Clinical guidance: MASAC guidelines and ISTH communication on severe congenital protein C deficiency — cited as relevant clinical guidance informing evaluation and management and alignment with FDA-labeled use and requirements for specialist involvement and laboratory confirmation of protein C activity.

Background

Ceprotin is a plasma-derived human protein C concentrate indicated for the prevention and treatment of venous thrombosis and purpura fulminans in neonate, pediatric, and adult patients with severe congenital Protein C deficiency, consistent with the FDA-approved indication.

This policy aligns coverage with the FDA indication and requires that prescriptions be by or in consultation with a hematologist or physician with expertise in inherited thrombophilias.

Clinical criteria require laboratory confirmation of low Protein C activity (low protein C level and/or function) to support the diagnosis of severe congenital Protein C deficiency and medical necessity for Ceprotin.

Protein C activityLaboratory measure of protein C level or function used to confirm deficiency.

Revision History

2022-09-21template_change

Template changes applied previously to other diagnoses/indications and continued therapy sections (2022).

2025-02-25annual_reviewLatest