Garadacimab-gxii (Andembry) — prophylaxis for hereditary angioedema
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Policy governing medical necessity and prior authorization criteria for Andembry (garadacimab-gxii) as prophylaxis to prevent hereditary angioedema (HAE) attacks across applicable QualChoice lines of business.
Criteria updated to align with FDA labeling for Andembry and approval durations revised for Medicaid/HIM from 6 months to 12 months.
Step therapy redirection to Haegarda, Takhzyro, or Orladeyo was added.
RT4: drug is now FDA approved - criteria updated per FDA labeling; revised initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.
Coverage Criteria
inv-01: Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Follow listed specialist, diagnostic, step therapy, combination therapy, and dosing rules.
inv-02: Continuation Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Continuation requires clinical response and adherence to dosing limits.
Requests for use of Garadacimab‑gxii (Andembry) for indications that are not FDA‑approved under this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), or CP.PMN.53 (Medicaid), or unless there is other supporting evidence of coverage as outlined in plan documents.
When there is a conflict between this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage rules that apply to this policy.
Use of Andembry for non‑FDA‑approved indications without adequate supporting clinical evidence or without the required off‑label documentation is considered not authorized and may be denied. Providers requesting coverage for off‑label uses must follow the plan’s off‑label documentation requirements and reference the relevant off‑label use policies noted in the policy.
Initial Therapy (Hereditary Angioedema)
inv-21: Initial Therapy (HAE) — Initial approval for HAE requires all criteria below
Initial approval for HAE requires all criteria below.
IL HIM exception for step therapy as of 1/1/2026 per IL HB 5395.
inv-22: Initial therapy labeling update — Policy updates reflect FDA approval and labeling changes
Policy updates reflect FDA approval and labeling changes.
Policy revisions also include operational changes described in the policy history (e.g., redirecting step therapy to Haegarda, Takhzyro, Orladeyo).
Continuation / Renewal Criteria
inv-23: Renewal requirements — Renewal requires evidence of clinical response and continuation conditions
Renewal requires evidence of clinical response and continuation conditions.
Approval durations vary by line of business; clinical response is required for renewal.
inv-24: Approval duration — Initial approval duration updated in recent revision
Initial approval duration updated in recent revision.
Per RT4 revision noted in policy history.
Step Therapy Requirements
| Step | Requirement | Exceptions / Notes |
|---|---|---|
| 1 | Prior failure of at least one preferred alternative required before approving Andembry: Haegarda, Takhzyro, or Orladeyo. | Exceptions: clinically significant adverse effects or contraindications to listed agents; Illinois HIM requests exempt from step therapy as of 1/1/2026 per IL HB 5395. |
| Change | Detail | Effective / Source |
|---|---|---|
| Redirection to alternative therapies | Per August SDC, policy was updated to redirect to one of the following preferred alternatives when applicable: Haegarda, Takhzyro, or Orladeyo. | Documented in policy revisions and coding implications notes; see August SDC entry. |
Coding and Billing
Prior authorization required; HCPCS C9399/J3590 may be used
Prior authorization is required for garadacimab-gxii (Andembry); requests will be reviewed against the policy’s documented criteria including confirmed HAE diagnosis, specialist involvement, age, step‑therapy failure, dosing limits, and prohibition of concurrent long‑term prophylaxis agents. Use of unclassified drug/biologic HCPCS codes C9399 or J3590 may be referenced when submitting a PA, and prior authorization requirements apply per the health plan’s procedures.
- PA decision requires documentation that member meets all approval criteria (diagnosis, labs, specialist consult/prescriber, age ≥12, clinical need for long‑term prophylaxis).
- Do not combine Andembry with other FDA‑approved long‑term prophylaxis agents (e.g., Cinryze, Haegarda, Takhzyro, Orladeyo).
- Dose limits enforced: loading dose 400 mg; maintenance 200 mg monthly.
Submit supporting clinical documentation and confirm coding guidance before claims
Providers must include supporting clinical documentation with PA and claims submissions — e.g., office notes, relevant laboratory results (C4 and C1‑INH antigenic/functional levels), and other clinical information demonstrating the member meets all approval criteria. Also reference the most up‑to‑date professional coding guidance prior to claim submission; inclusion or exclusion of codes in this policy does not guarantee coverage.
- Submit office notes and labs that confirm diagnosis (history of recurrent angioedema plus low C4 and low C1‑INH antigenic or functional level).
- Provide documentation of prior failure/intolerance/contraindication to a preferred alternative when step therapy is applicable (Haegarda, Takhzyro, Orladeyo).
- Verify coding using current professional guidance; codes listed (C9399, J3590) are informational only and do not ensure payment.
Provider Actions and Requirements
Prior authorization required; approval follows documented criteria
Prior authorization is required for Andembry; approval is granted only when the member meets the documented clinical criteria (diagnosis confirmation, specialist prescribing/consultation, age ≥ 12 years, required clinical need for long‑term prophylaxis, step‑therapy failure when applicable, dosing limits, and not used in combination with other FDA‑approved long‑term prophylaxis agents).
- Criteria include confirmation of HAE by history and lab (low C4 and low C1‑INH antigenic or functional level).
- Prescriber must be or consult with a hematologist, allergist, or immunologist.
- Dose limits: loading dose ≤ 400 mg; maintenance ≤ 200 mg monthly.
Step‑therapy: failure of one preferred HAE therapy required
Member must have failed, been intolerant to, or have a contraindication to at least one of the following prior therapies—Haegarda, Takhzyro, or Orladeyo—before Andembry will be approved, unless an exception applies (e.g., IL HIM requests exempt per IL HB 5395).
- Prior failure/intolerance/contraindication to one preferred alternative is required.
- Illinois HIM requests are exempt from step therapy requirements as of 1/1/2026 per IL HB 5395.
Policy redirects to Haegarda, Takhzyro, or Orladeyo as alternatives
Per the August SDC revision, the policy includes redirection to one of the preferred alternatives (Haegarda, Takhzyro, or Orladeyo) as the required prior alternative therapies before Andembry.
- August SDC added redirection to Haegarda, Takhzyro, or Orladeyo.
Provide supporting clinical documentation with PA request
Submit documentation such as office chart notes, laboratory results, or other clinical information to demonstrate the member meets all approval criteria.
- Examples include office notes and lab results documenting recurrent angioedema and low C4/C1‑INH levels.
- Documentation should support specialist involvement, age, attack frequency/severity, and prior therapy history.
Non‑FDA indications require sufficient off‑label documentation
Requests for indications not FDA‑approved and not addressed in this policy require sufficient off‑label documentation per the applicable off‑label use policies; otherwise such requests are not authorized and may be denied.
- Off‑label requests must meet documentation standards in CP.CPA.09 (Commercial) or CP.PMN.53 (Medicaid).
- Non‑FDA indications without sufficient evidence are considered not authorized.
Coding list is informational; coverage not guaranteed by codes shown
Inclusion or exclusion of any billing codes in this policy does not guarantee payment or coverage; providers must reference current professional coding guidance before submitting claims.
- Codes referenced are informational only; coverage is determined by benefit and coding submission.
- Providers should confirm coding and billing rules with the payer prior to claim submission.
Background
Hereditary angioedema (HAE) includes subtypes with C1‑INH deficiency (Type I and II) and HAE with normal C1‑INH. In Types I and II, patients typically have a history of recurrent angioedema with low C4 and either low C1‑INH antigenic (Type I) or low functional C1‑INH levels (Type II). Garadacimab‑gxii (Andembry) is a factor XIIa‑inhibitory monoclonal antibody indicated as prophylaxis to prevent HAE attacks in patients aged 12 years and older. Clinical use under this policy requires confirmation of diagnosis, specialist prescribing or consultation, adherence to step‑therapy and dosing limits, and avoidance of combination with other long‑term prophylactic agents unless otherwise specified.
Definitions
Quantity Limits
Site of Care
Product available as 200 mg prefilled syringe or autoinjector; site of care not restricted
Product is supplied as a 200 mg single‑dose prefilled syringe or 200 mg single‑dose autoinjector; site of administration is not restricted in this section and home administration is noted as available.
- Single‑dose prefilled syringe: 200 mg/1.2 mL.
- Single‑dose prefilled autoinjector: 200 mg/1.2 mL.
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