CurrentCareSourcePolicy N/A

Berinert (C1 esterase inhibitor [human]) medical coverage

Defines medical-benefit coverage, prior authorization, quantity limits, sites of service, and clinical criteria for Berinert for treatment of hereditary angioedema (HAE) for CareSource members in Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyBerinert (C1 esterase inhibitor [human]) medical coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization before dispensing Berinert under the medical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PA requiredauthorization requirement

8 vialsquantity limit

Home/Officesite of service

6 moinitial approval

12 morenewal approval

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization for HAE: Member has a clinical diagnosis of hereditary angioedema (HAE).

Indication: Medication is being prescribed for the treatment of acute HAE attacks.

No combination therapy: Medication is not being used in combination with another on‑demand therapy (e.g.: Kalbitor; Firazyr; Ruconest).

Dose: Dosage: 20 International Units (IU) per kg body weight by IV injection.20 IU/kg

Policy Summary

PayerCareSource

PolicyBerinert (C1 esterase inhibitor [human]) medical coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization before dispensing Berinert under the medical benefit.

SourceLink

On This Page

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Initial approval duration: 6 months.

Continuation/Reauthorization

Covered for reauthorization when the following is documented:

Reauthorization: Chart notes document improvement such as faster time to symptom relief or resolution of attack.

If met, approved for an additional 12 months.

CareSource considers treatments for conditions not specifically listed in this policy to be not medically necessary. Requests for Berinert (C1 esterase inhibitor [human]) for diagnoses outside the documented indication of hereditary angioedema (HAE) will be denied as not medically necessary.

Berinert (C1 esterase inhibitor [human]) is not medically necessary when prescribed for conditions other than the listed indication of hereditary angioedema (HAE). Requests for use of Berinert to treat diseases not described in this policy will be considered not medically necessary and are not covered.

Initial Therapy

Initial authorization for acute HAE attacks

Initial: Prescribed for treatment of acute HAE attacks, not used with other on‑demand therapies, dosing 20 IU/kg IV.20 IU/kg

Initial approval duration: 6 months.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirement

Reauthorization requirement: Chart notes must document improvement (e.g., faster time to symptom relief or resolution of attack).

Approval duration on reauthorization: 12 months.

Coding

Covered HCPCSHCPCSCovered

J0597

C1 esterase inhibitor (human)

inv-06: Dosage per administration

Dosage per administration20 IU/kg

RouteIntravenous (IV) injection

Indication contextFor treatment of acute hereditary angioedema (HAE) attacks

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Berinert (medical benefit).

Benefit type: Medical
Billing code: J0597
Site of service allowed: Home/Office
Quantity limit: 8 vials per fill

Denial Risk

Do not combine with other on‑demand HAE therapies

Medication must not be used in combination with another on‑demand HAE therapy for treatment of acute HAE attacks (e.g., Kalbitor, Firazyr, Ruconest).

Documentation Required

Documentation required for reauthorization

For reauthorization, chart notes must document clinical improvement such as faster time to symptom relief or resolution of attacks.

Reauthorization approval duration: 12 months

Denial Risk

Not medically necessary for unlisted indications

Berinert is considered not medically necessary for treatment of diseases not listed in this document.

Background

Hereditary angioedema (HAE) is a genetic disorder characterized by recurrent angioedema attacks. C1 esterase inhibitor (human) concentrate (Berinert) is indicated in this policy for treatment of acute HAE attacks by intravenous administration at weight‑based dosing. Prior authorization is required for Berinert and coverage is limited to the clinical scenarios and criteria specified in this document. For reauthorization, chart notes must document clinical improvement such as faster time to symptom relief or resolution of the attack; when reauthorization criteria are met the medication may be approved for an additional 12 months. Treatments or indications not listed in this policy are considered not medically necessary.

Definitions

inv-12: Berinert dosing

Allowed dose20 International Units (IU) per kg body weight by IV injection for acute HAE attacks

Billing HCPCSJ0597 (C1 esterase inhibitor [human])

Approval duration (initial)If criteria met, approved for 6 months

Step Therapy / Combination Use

Step	Requirement
1
Medication must not be used in combination with another on-demand HAE therapy for treatment of acute attacks (e.g., Kalbitor; Firazyr; Ruconest).

Quantity Limits

inv-16: Berinert

Quantity limit8 vials per fill

Benefit typeMedical benefit

Site of serviceHome or Office

Site of Care

Note

Allowed site: Home

Site of service allowed: Home.

Home infusion is an approved setting for administration.

Note

Allowed site: Office

Site of service allowed: Office.

Office administration is an approved setting for Berinert.