Currentmedical mutual - ohioPolicy N/A

Takhzyro (lanadelumab‑flyo) for hereditary angioedema prophylaxis

Defines prior authorization, site-of-care restrictions, dosing, criteria for initiation and continuation of Takhzyro for prophylaxis of hereditary angioedema (HAE) in patients ≥2 years, and conditions not recommended for approval. Applies to coverage decisions under the payer's medical and pharmacy benefits.

Policy Summary

Payermedical mutual - ohio

PolicyTakhzyro (lanadelumab‑flyo) for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateOct 20, 2018

Next Review DateN/A

Key ActionObtain prior approval for Takhzyro (HCPCS J0593) when billed under the medical benefit; requests meeting policy criteria may be authorized by a nurse reviewer or escalated to a physician reviewer.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yrsminimum age for indication

J0593prior auth code

365dapproval duration

300 mg q2wstandard dosing

attack‑free 6 mointerval extension

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Takhzyro (lanadelumab-flyo)

Initial therapy - HAE Type I or II prophylaxis

Covered when ALL of the following are met:

Initial HAE prophylaxis criteria: a) Patient is 2 years of age or older; AND b) HAE confirmed by (i) low functional C1-INH protein (<50% of normal) at baseline AND (ii) low serum C4 (<14 mg/dL) and low C1-INH levels (<19.9 mg/dL) at baseline, as defined by laboratory reference values; AND c) medication is prescribed by or in consultation with an allergist, immunologist, hematologist, or physician who specializes in HAE; AND d) site of care medical necessity is met.Functional C1-INH <50% of normal; Serum C4 <14 mg/dL; C1-INH <19.9 mg/dL

Laboratory reference values as defined by the reporting laboratory.

Continuation/Established therapy

Covered when ALL of the following are met:

Established patient criteria: a) HAE confirmed by the same laboratory criteria as initial therapy (functional C1-INH <50% of normal and serum C4 <14 mg/dL with C1-INH <19.9 mg/dL at baseline); AND b) medication is prescribed by or in consultation with an allergist, immunologist, hematologist, or physician who specializes in HAE; AND c) prescriber documents a favorable clinical response since initiating Takhzyro (e.g., decreased attack frequency, severity, or duration); AND d) if dosing every 2 weeks and patient has been attack-free for 6 months, dosing interval may be reduced to every 4 weeks; AND e) site of care medical necessity is met.see nodes

Examples of favorable response include decreased attack frequency, severity, or duration.

Dosing - medical benefit

Dosing must meet the following:

Adult and pediatric ≥12 years: 300 mg subcutaneously every 2 weeks; a dosing interval of 300 mg every 4 weeks may be considered if the patient is well-controlled (e.g., attack-free >6 months).300 mg q2w (or q4w if well-controlled)

Pediatric 6 to <12 years: 150 mg subcutaneously every 2 weeks; a dosing interval of 150 mg every 4 weeks may be considered if the patient is well-controlled (e.g., attack-free >6 months).150 mg q2w (or q4w if well-controlled)

Pediatric 2 to <6 years: 150 mg subcutaneously every 4 weeks.150 mg q4w

Concomitant long-term use of Takhzyro with other hereditary angioedema (HAE) prophylactic therapies is not recommended. The policy notes that Takhzyro has not been studied in combination with other prophylactic HAE therapies and specifically states that combination therapy for long-term prophylactic use is not recommended. Examples of other HAE prophylactic therapies include Cinryze, Haegarda, and Orladeyo. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Use of Takhzyro in combination with other HAE prophylactic therapies for long-term prophylactic use is not supported by this policy. The source indicates that Takhzyro has not been studied in combination with other prophylactic therapies for HAE and therefore combination therapy for ongoing prophylaxis is not recommended. Short-term uses — for example, on-demand treatment of acute HAE attacks or short-term procedural prophylaxis with other agents — are permitted, but chronic combination prophylaxis is not recommended.

Coding and Laboratory Criteria

Prior approval HCPCS CodesHCPCSCovered

J0593

Injection, lanadelumab-flyo, 1 mg

inv-07: Functional C1-INH — < 50% of normal

ThresholdFunctional C1-INH protein below 50% of normal (baseline), as defined by laboratory reference values

ContextRequired laboratory criterion for confirming HAE (Type I or II) for Takhzyro coverage

Measurement timingMust be documented at baseline prior to initiation of prophylactic therapy

inv-08: Serum C4 — < 14 mg/dL

ThresholdSerum C4 less than 14 mg/dL at baseline, as defined by laboratory reference values

ContextRequired laboratory criterion (with low functional C1-INH and low C1-INH level) to confirm HAE for coverage

Provider Actions, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior approval is required for Takhzyro when billed under the medical benefit (HCPCS J0593). Initial and renewal requests for Takhzyro are subject to site-of-care management; when billed under the medical benefit, administration is restricted to a non-hospital facility-based location (for example, home infusion provider, provider's office, free-standing ambulatory infusion center) unless the member meets site-of-care exception criteria. Requests meeting policy criteria may be authorized by a nurse reviewer; requests that do not meet criteria will be forwarded to a physician reviewer.

HCPCS J0593 — Injection, lanadelumab-flyo, 1 mg
Site-of-care restriction — non-hospital facility-based locations preferred

Documentation Required

Documentation Requirements

The Company reserves the right to request additional documentation to support coverage determinations. Providers must make available, upon request, documentation supporting medical necessity for the services provided. Documentation that may be requested includes patient medical records, test results, and credentials of the provider ordering or performing the service. The Company may modify or interpret this policy at its discretion.

Background

Takhzyro (lanadelumab-flyo) is addressed in this policy with respect to its role in preventing hereditary angioedema (HAE) attacks. The document clarifies that Takhzyro has not been evaluated in combination with other HAE prophylactic therapies and therefore combination regimens for long-term prophylaxis are not recommended. Providers should note that while other agents (for example, C1 esterase inhibitor preparations) may be used for on‑demand treatment of acute HAE attacks or for short-term procedural prophylaxis, long-term concomitant prophylactic use with Takhzyro is not supported by the evidence cited in the policy.

Policy Summary

Payermedical mutual - ohio

PolicyTakhzyro (lanadelumab‑flyo) for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateOct 20, 2018

Next Review DateN/A

SourceLink

On This Page

Administration: Patients ≥12 years may self-administer or have administration by a caregiver after training by a healthcare professional; pediatric patients 2 to <12 years should be administered by a healthcare provider or caregiver.age-based administration guidance

Measurement timingMust be documented at baseline prior to initiation of prophylactic therapy

inv-09: C1-INH levels — < 19.9 mg/dL

ThresholdC1‑INH antigenic levels less than 19.9 mg/dL at baseline, as defined by laboratory reference values

ContextUsed together with low functional C1‑INH and low serum C4 to confirm HAE (Type I or II) for coverage

Measurement timingMust be documented at baseline prior to initiation of prophylactic therapy

inv-15: Confirmatory laboratory criteria for HAE — low functional C1-INH AND low serum C4 and low C1-INH levels at baseline

Confirmatory criteriaLow functional C1‑INH protein (below 50% of normal) AND low serum C4 (<14 mg/dL) AND low C1‑INH levels (<19.9 mg/dL) at baseline

PurposeThese laboratory findings are required to confirm HAE (Type I or II) for coverage of Takhzyro prophylaxis

DocumentationResults must be documented using laboratory reference values and obtained at baseline prior to treatment initiation

Examples: patient records, diagnostic test results, provider credentials

Note

Concomitant Prophylactic Therapy Restriction

Concomitant long-term prophylactic use of Takhzyro with other HAE prophylactic therapies is not recommended. Takhzyro has not been studied in combination with other prophylactic HAE therapies for long-term use. Patients may use other HAE medications for on‑demand treatment of acute attacks or for short‑term procedural prophylaxis.

Examples of other HAE prophylactic therapies: Cinryze (C1 esterase inhibitor [human] IV), Haegarda (C1 esterase inhibitor [human] SC), Orladeyo (berotralstat capsules)

Denial Risk

Denial Triggers and Claims Handling

The Company may deny reimbursement when the drug or services are determined to be not medically necessary, investigational or experimental, not within the member's benefit scope, or when documentation is insufficient. Claims for HCPCS J0593 will pend with Remark Code M3M or M4M and will be adjudicated per the Corporate Medical Policy. Participating providers may be required to write off charges denied as not medically necessary.

Denial triggers: not medically necessary, investigational/experimental, outside benefit scope, insufficient documentation
Claims handling: HCPCS J0593 may pend with Remark Code M3M or M4M
Liability: providers required to write off non-covered charges