CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Andembry (garadacimab-gxii) for prophylaxis of hereditary angioedema — Coverage Criteria

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Covers criteria, dosing, quantity limits, and authorization requirements for Andembry (garadacimab-gxii) when used for prevention of hereditary angioedema (HAE) in members aged 12 and older.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAndembry (garadacimab-gxii) for prophylaxis of hereditary angioedema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥12, specialist involvement, confirmed HAE diagnosis, step-therapy history, and required dosing for a 6-month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for coverage

6 moauthorization period

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Andembry (garadacimab-gxii) for prophylaxis of hereditary angioedema — Coverage Criteria

Customize your policy alerts

Sign up for all Neighborhood Health Plan of Rhode Island policy alerts

Know when Neighborhood Health Plan of Rhode Island releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Covers criteria, dosing, quantity limits, and authorization requirements for Andembry (garadacimab-gxii) when used for prevention of hereditary angioedema (HAE) in members aged 12 and older.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAndembry (garadacimab-gxii) for prophylaxis of hereditary angioedema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥12, specialist involvement, confirmed HAE diagnosis, step-therapy history, and required dosing for a 6-month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for coverage

6 moauthorization period

400→200 mgrecommended dosing

200 mg/30dquantity limit

≥50% ↓continuation response

Coverage and Medical Necessity Criteria

Initial Approval

Covered when ALL of the following are met

Member is ≥ 12 years of age.
Medication is prescribed by, or in consultation with, an allergist/immunologist or a physician who specializes in the management of HAE.
ALL of the following
- ONE of: Documentation of C1 inhibitor deficiency or dysfunction confirmed by laboratory testing; and either (i) C1‑INH antigenic level below the lower limit of normal as defined by the performing laboratory, OR (ii) normal C1‑INH antigenic level with low C1‑INH functional level (functional C1‑INH < 50% or below the laboratory lower limit of normal).
- ONE of: Documentation of normal C1 inhibitor on laboratory testing AND either (i) a pathogenic variant confirmed by genetic testing in F12, ANGPT1, PLG, KNG1, HS3ST6, or MYOF, OR (ii) a documented family history of angioedema with angioedema refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent) for at least one month.
Member requires long‑term prophylactic treatment based on provider assessment of disease activity, quality of life, healthcare resources, and/or inadequate control with appropriate on‑demand therapy.
Other causes of angioedema have been ruled out (e.g., ACE‑inhibitor induced angioedema, estrogen‑related angioedema, allergic angioedema).
Member will not use Andembry (garadacimab‑gxii) concomitantly with Cinryze, Dawnzera, Haegarda, Orladeyo, or Takhzyro.
Documentation that the member has had an inadequate response, intolerance, or contraindication to one of: Orladeyo (berotralstat), Takhzyro (lanadelumab‑flyo), or Haegarda (C1‑esterase inhibitor), when applicable.

Continuation Approval

Covered when ALL of the following are met

Documentation that the member continues to meet all criteria for initial approval.
Documentation that the member has experienced a significant reduction in frequency of attacks (e.g., ≥ 50%) since starting prophylactic treatment.
Documentation that the member has reduced use of medications to treat acute attacks since starting prophylactic treatment.

All uses of Andembry outside the FDA‑approved indication are treated as experimental/investigational. Specifically, Andembry is only indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged ≥ 12 years; any request for use in other disease states or indications does not meet medical necessity criteria and may be denied.

Use of Andembry for purposes other than the FDA‑approved prophylaxis of HAE in patients aged ≥ 12 years is not medically necessary. Prior authorization for such off‑label indications is not supported by this policy and may be declined.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required; 6‑month approvals, dosing and quantity limits

Prior authorization is required for Andembry (garadacimab‑gxii). Approvals (initial and continuation) may be granted for 6 months. Dosing and quantity limits: a 400 mg subcutaneous loading dose on day 1 followed by 200 mg SC monthly; standard quantity limit is 200 mg/1.2 mL per 30 days with a one-time post‑limit exception of 2.4 mL (two 200 mg pens) for the initial loading month.

Authorization period: 6 months for initial and continuation approvals.
Loading dose: 400 mg SC on day 1; maintenance dose: 200 mg SC monthly.
Quantity limit: 200 mg/1.2 mL per 30 days; one-time 2‑pen (2.4 mL) loading exception in the initial month.

Step Therapy

Step therapy: trial/failure of specified alternatives required

Prior to approval, document an inadequate response, intolerance, or contraindication to at least one of the specified alternative prophylactic agents: Orladeyo (berotralstat), Takhzyro (lanadelumab‑flyo), or Haegarda (C1‑esterase inhibitor).

Key Definitions

HAE indication — Andembry (key facts)

IndicationAndembry (garadacimab-gxii) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged ≥ 12 years.

PopulationAdult and pediatric patients aged 12 years and older with a diagnosis of HAE.

Use ContextFor long-term prophylactic treatment to reduce frequency of HAE attacks when clinically indicated by provider assessment.

C1-INH deficiency/dysfunction diagnostic criteria

C1-INH antigenic levelC1-INH antigenic level below the lower limit of normal as defined by the laboratory performing the test.

C1-INH functional level (low antigenic)If antigenic level is normal, functional C1-INH less than 50% (or below the laboratory lower limit of normal).

Clinical Background

Hereditary angioedema (HAE) is a condition characterized by recurrent, potentially disabling episodes of angioedema. Andembry (garadacimab‑gxii) is approved to reduce the frequency of HAE attacks by providing long‑term prophylaxis in eligible patients. The policy aligns coverage with the FDA indication: prophylaxis to prevent HAE attacks in patients aged ≥ 12 years, and limits use to that setting.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAndembry (garadacimab-gxii) for prophylaxis of hereditary angioedema

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥12, specialist involvement, confirmed HAE diagnosis, step-therapy history, and required dosing for a 6-month approval.

SourceLink

On This Page

Step requirement specifically applies to Orladeyo, Takhzyro, or Haegarda.

Documentation Required

Required clinical documentation at initiation

Submit documentation that supports eligibility for Andembry, including patient age, prescribing provider specialty, confirmed diagnosis, baseline laboratory confirmation of C1‑INH status, and attack history.

Member age ≥ 12 years.
Medication prescribed by or in consultation with an allergist/immunologist or HAE specialist.
Documented diagnosis of HAE type I or II with laboratory confirmation of C1‑INH deficiency/dysfunction OR documentation of normal C1‑INH with a relevant pathogenic genetic variant or documented family history plus antihistamine‑refractory angioedema.
Other causes of angioedema ruled out (e.g., ACE‑I induced, estrogen‑related, allergic angioedema).
Documentation of inadequate response, intolerance, or contraindication to Orladeyo, Takhzyro, or Haegarda when applicable.

Documentation Required

Continuation documentation: show maintained criteria and clinical benefit

For continuation requests, provide evidence that the member still meets initial approval criteria and has derived clinical benefit from therapy.

Documentation that all initial approval criteria remain met.
Evidence of a significant reduction in attack frequency (e.g., ≥ 50%) since starting prophylaxis.
Documentation of reduced use of medications to treat acute attacks since starting prophylaxis.

Denial Risk

Indication limits — non‑FDA uses are investigational

Use of Andembry for indications other than the FDA‑approved prophylaxis of HAE in patients aged 12 years and older is considered experimental/investigational and not medically necessary and may be denied.

Coverage is limited to prophylaxis to prevent HAE attacks in patients ≥ 12 years old.

Denial Risk

Concomitant therapy exclusion: prohibited concurrent agents

Andembry must not be used concomitantly with specified C1‑esterase inhibitors or other named agents; concurrent use may result in denial.

Prohibited concurrent agents: Cinryze (C1‑esterase inhibitor), Dawnzera (donidalorsen), Haegarda (C1‑esterase inhibitor), Orladeyo (berotralstat), and Takhzyro (lanadelumab‑flyo).

Alternate diagnostic pathwayNormal C1-INH antigenic level plus pathogenic genetic variant (e.g., F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF) or family history with antihistamine-refractory angioedema supports diagnosis.