CurrentmhnPolicy CP.PHAR.330

Protein C Concentrate, Human (Ceprotin)

Medical necessity and coverage criteria for human plasma-derived Protein C concentrate (Ceprotin) for neonate, pediatric, and adult patients, including initial and continued therapy criteria and dosing; applies to Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyProtein C Concentrate, Human (Ceprotin)

Policy CodePolicy CP.PHAR.330

Change TypeNo material changes

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit documentation (chart notes, labs) demonstrating the member meets all approval criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J2724HCPCS code referenced

500;1000 IUVial sizes available

6 moInitial approval

12 moContinued approval

45-120 IU/kgDose range

no sig changes

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Congenital Protein C Deficiency):

Initial Approval - Congenital Protein C Deficiency: 1. Diagnosis of congenital protein C deficiency;

Initial Approval - Congenital Protein C Deficiency: 2. Prescribed by or in consultation with a hematologist or physician with expertise in inherited thrombophilias;

Initial Approval - Congenital Protein C Deficiency: 3. One of the following: a. Prescribed for use in an acute setting; OR b. Laboratory result confirming low protein C activity (due to low protein C levels or function or both).

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Congenital Protein C Deficiency):

Continued Therapy - Congenital Protein C Deficiency: 1. Member meets one of the following: a. Currently receiving medication via Centene benefit or previously met initial approval criteria; OR b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations.

Continued Therapy - Congenital Protein C Deficiency: 2. Member is responding positively to therapy;

Continued Therapy - Congenital Protein C Deficiency: 3. If not previously determined, laboratory result confirming baseline low protein C activity (due to low protein C levels or function or both).

Other/Off-label Pathways

Other diagnoses/indications:

Other Indications: 1. If this drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the referenced formulary/no-coverage or non-formulary policy for the applicable line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16 as applicable).

Other Indications: 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under the policy's section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Requests for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence of coverage documents.

Coverage under this clinical policy is governed by the member's benefit documents. Decisions about coverage and administration of benefits are subject to all terms, conditions, exclusions, and limitations in the member's evidence of coverage, certificate of coverage, policy, or contract. Where state Medicaid provisions conflict with this clinical policy, state Medicaid provisions take precedence.

Non‑FDA approved uses that are not described in this policy will not be approved unless they meet the requirements of the Health Plan's off‑label use procedures. Providers should follow the referenced off‑label policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or provide alternative evidence of coverage to justify non‑label use.

Coding and Dosing

HCPCS CodesHCPCS

J2724

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

HCPCS CodesHCPCS

J2724

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

Dosing ranges — Protein C concentrate (Ceprotin)

Initial dose100-120 IU/kg IV

Subsequent doses (acute setting)60-80 IU/kg IV every 6 hours (three doses following initial)

Maintenance dose (short-term/acute follow-up)45-60 IU/kg IV every 6 or 12 hours

Long-term maintenance45-60 IU/kg IV every 12 hours

Provider Actions and Requirements

Note

General coverage limitation note

Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures. This clinical policy is a guide to medical necessity and does not guarantee payment or coverage. Providers should verify member eligibility, benefit limitations, and prior authorization requirements with the applicable Health Plan before providing services.

Coverage is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents.
This clinical policy is a guide to medical necessity and does not guarantee payment.
Providers must verify member eligibility, benefits, and prior authorization requirements with the Health Plan prior to service.

Documentation Required

Required supporting documentation

Provider must submit documentation (for example, office chart notes, laboratory results, or other relevant clinical information) supporting that the member has met all approval criteria. Lack of submitted documentation demonstrating that the member meets approval criteria may result in denial of the request. Providers are expected to exercise professional medical judgment; this policy is a guide to medical necessity but does not replace clinical judgment or constitute a guarantee of payment.

Background

Ceprotin (protein C concentrate, human) is a human plasma‑derived product indicated in neonate, pediatric, and adult patients with severe congenital Protein C deficiency for prevention and treatment of venous thrombosis and purpura fulminans. Dosing strategies include higher initial or acute dosing followed by individualized maintenance regimens.

Definitions

Congenital Protein C Deficiency — key definition

DefinitionSevere congenital Protein C deficiency: an inherited deficiency of protein C activity leading to risk of venous thrombosis and purpura fulminans.

FDA‑approved patient populationsNeonate, pediatric, and adult patients with severe congenital Protein C deficiency for prevention and treatment of venous thrombosis and purpura fulminans.

Clinical riskIncreased risk of venous thrombosis and purpura fulminans due to low protein C activity.