Currentmedical mutual - ohioPolicy N/A

Andembry (garadacimab) — prophylaxis for hereditary angioedema (HAE)

Defines prior authorization, coverage criteria, dosing, approval durations, and conditions not recommended for Andembry (garadacimab) for prophylaxis of hereditary angioedema (HAE) for patients aged ≥12 and prescriber requirements. Affects providers seeking medical- or pharmacy-benefit coverage through Medical Mutual - Ohio.

Policy Summary

Payermedical mutual - ohio

PolicyAndembry (garadacimab) — prophylaxis for hereditary angioedema (HAE)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateJul 17, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for medical-benefit claims when billing HCPCS J3490, J3590, or J9999 and include documentation of HAE type I/II diagnosis and baseline labs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for approved indication

1 yearinitial approval duration

200 mg/momaintenance dosing

J3490,J3590,J9999codes requiring prior approval

Coverage Criteria for Andembry (garadacimab)

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Initial Therapy (Prophylaxis for HAE due to C1-INH deficiency)

Approve Andembry for 1 year if the patient meets ONE of the following (A or B).

Initial therapy requirements (A): i. Patient is ≥ 12 years of age; AND ii. Patient has HAE type I or type II confirmed by: (a) low functional C1-INH protein (<50% of normal) at baseline and (b) low serum C4 at baseline; AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.see lab thresholds in text

A diagnosis of HAE with normal C1-INH (type III) does NOT satisfy this requirement.

Current therapy alternative (B): Patient is currently receiving Andembry; approve if the patient meets ALL continuation criteria (see Continuation / Current Therapy).

Continuation / Current Therapy

Approve Andembry for 1 year for patients currently receiving Andembry if ALL of the following are met:

Continuation requirements: i. Patient has a diagnosis of HAE type I or type II; AND ii. According to the prescriber, the patient has had a favorable clinical response since initiating Andembry prophylactic therapy compared with baseline (examples: decreased attack frequency, decreased attack severity, or decreased duration); AND iii. Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.

If patient is currently receiving therapy but has not previously received approval for Andembry through the Coverage Review Department, evaluate under Initial Therapy criteria.

Concomitant long-term use of Andembry with other hereditary angioedema (HAE) prophylactic therapies is not recommended. Andembry has not been studied in combination with other prophylactic therapies for HAE, and combination therapy for long‑term prophylactic use is not supported. Short-term or procedural prophylaxis and on‑demand treatment for acute attacks with other agents (for example, C1 esterase inhibitors) remain allowable per clinical judgment. Coverage is not recommended for circumstances that fall outside the policy’s Recommended Authorization Criteria.

The use of Andembry in combination with other HAE prophylactic therapies for long‑term prophylaxis is not recommended because the drug has not been studied in combination and efficacy/safety in that setting is not established. Providers may continue to use other HAE medications for on‑demand treatment of acute attacks or for short‑term (procedural) prophylaxis, but long‑term combination prophylactic regimens with Andembry are not supported by current evidence and therefore are not recommended for coverage.

Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical-benefit coverage when Andembry is billed under HCPCS J3490, J3590, or J9999. Requests that meet the criteria in this policy will be approved; requests that do not meet criteria will be referred to a physician reviewer. Participating providers may be required to write off charges denied as not medically necessary.

HCPCS: J3490, J3590, J9999
Prior approval required for medical-benefit coverage
Requests meeting policy criteria will be authorized by a nurse reviewer; others will be forwarded to a physician reviewer

Documentation Required

Concomitant Prophylactic Therapy Restriction

Concomitant long‑term use of Andembry with other HAE prophylactic therapies is not recommended because combination therapy has not been studied. On‑demand treatments for acute HAE attacks and short‑term (procedural) prophylaxis with other agents (for example, C1 esterase inhibitors such as Cinryze or Haegarda, berotralstat, or lanadelumab) may be used as clinically indicated.

Concomitant long‑term prophylactic combination therapy not recommended
Short‑term (procedural) prophylaxis or on‑demand treatment with other HAE agents may be allowed
Examples of other HAE prophylactic therapies: Cinryze, Haegarda, Orladeyo (berotralstat), Takhzyro (lanadelumab)

Denial Risk

Documentation That May Be Requested & Denial Risks

The Company may request additional documentation to support medical necessity. Documentation that may be requested includes patient records, laboratory test results, and provider credentials. The Company may deny reimbursement if services or drugs were not medically necessary, were investigational/experimental, not within the member's benefits, or if required documentation is not provided.

Examples of documentation that may be requested: patient medical records, baseline and follow‑up lab results, and prescriber credentials
Potential denial reasons: lack of medical necessity, investigational/experimental therapy, out‑of‑scope services, or missing documentation

Documentation Required

Clinical Documentation Required

Clinical documentation required to support a request for Andembry includes documentation of a diagnosis of HAE type I or II, baseline laboratory values showing functional C1‑INH <50% of normal and low serum C4 per laboratory reference values, and that the medication is prescribed by (or in consultation with) an allergist/immunologist or a physician who specializes in HAE or related disorders. For continuation requests, documentation of a favorable clinical response (for example, decreased attack frequency, severity, or duration) compared with baseline is required.

Diagnosis: HAE type I or II (HAE with normal C1‑INH / type III does NOT meet criteria)
Baseline labs: functional C1‑INH <50% of normal AND low serum C4 per lab reference values
Prescriber: allergist/immunologist or HAE‑specialty physician (or consultation documented)
Continuation: documentation of favorable clinical response since initiating Andembry (decreased attack frequency, severity, or duration)

Definitions

HAE type I or II — Definition and diagnostic thresholds

DefinitionHereditary angioedema (HAE) type I or II due to C1‑inhibitor (C1‑INH) deficiency: HAE caused by low functional C1‑INH protein and low serum C4 at baseline.

Diagnostic laboratory thresholdsFunctional C1‑INH protein < 50% of normal (baseline), as defined by laboratory reference values.

Supporting lab criterionSerum C4 lower than the laboratory reference (low serum C4) at baseline.

Exclusion (type III)HAE with normal C1‑INH (HAE type III) does NOT satisfy the criteria for Andembry coverage.

Age requirementPatients must be ≥ 12 years of age for initiation of prophylactic therapy with Andembry.

Prescriber requirementMedication must be prescribed by or in consultation with an allergist/immunologist or a physician who specializes in HAE or related disorders.

OpenPayer

Andembry (garadacimab) — prophylaxis for hereditary angioedema (HAE)

Coverage Criteria for Andembry (garadacimab)

Coding and Billing Codes

Provider Actions, Documentation, and Billing Guidance

Background

Definitions

J3490	Unclassified drugs
J3590	Unclassified biologics
J9999	Unclassified antineoplastics