CurrentUnitedHealthcarePolicy 1 = 2025 P 1263-8

Takhzyro (lanadelumab-flyo) prior authorization

UnitedHealthcare prior authorization policy for Takhzyro (lanadelumab-flyo) for prophylaxis of hereditary angioedema (HAE) in insured members; defines initial and reauthorization criteria and program operational notes.

Policy Summary

PayerUnitedHealthcare

PolicyTakhzyro (lanadelumab-flyo) prior authorization

Policy CodePolicy 1 = 2025 P 1263-8

Change TypeNo material change

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting a diagnosis of hereditary angioedema and that Takhzyro is prescribed for prophylaxis and not combined with other prophylactic HAE products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=2 yrsminimum age

1program number

Prior Authprogram type

Coverage Criteria for Takhzyro (lanadelumab-flyo)

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

Initial Authorization: Takhzyro is prescribed for prophylaxis against HAE attacks.

Initial Authorization: Takhzyro is not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo).

Authorization issued for 12 months.

Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization: Documentation of positive clinical response while on Takhzyro therapy.

Reauthorization: Continued use for prophylaxis against HAE attacks.

Reauthorization: Takhzyro is not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo).

Reauthorization issued for 12 months.

Use of Takhzyro in combination with other products indicated for prophylaxis against hereditary angioedema (HAE) attacks is not permitted. Specifically, Takhzyro must not be used together with Cinryze, Haegarda, Orladeyo, or other HAE prophylactic therapies; requests that indicate combination use are subject to denial. Authorization is only issued when Takhzyro is prescribed as the sole prophylactic agent for HAE and, when approved, is issued for 12 months.

Initial Therapy Criteria

Initial Therapy

Initial approval criteria

Initial therapy: Diagnosis of hereditary angioedema (HAE).

Initial therapy: Use for prophylaxis against HAE attacks.

Initial therapy: Not combined with other HAE prophylactic products (e.g., Cinryze, Haegarda, Orladeyo).

12-month authorization.

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirements

Continuation: Documentation of positive clinical response while on Takhzyro therapy.

Continuation: Continued prophylactic indication (for prophylaxis against HAE attacks).

Continuation: Not used in combination with other prophylactic HAE products (e.g., Cinryze, Haegarda, Orladeyo).

12-month authorization.

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Initial prior authorization is required. Providers must document a diagnosis of hereditary angioedema (HAE) and that Takhzyro is being prescribed for prophylaxis against HAE attacks. Therapy will be authorized for up to 12 months on initial approval.

Diagnosis: Hereditary angioedema (HAE)
Intended use: For prophylaxis against HAE attacks
Authorization duration: Up to 12 months

Documentation Required

Reauthorization Documentation Required

Reauthorization requires documentation of a positive clinical response to Takhzyro and that the medication continues to be used for prophylaxis against HAE attacks. Reauthorizations are issued for up to 12 months.

Documented positive clinical response while on Takhzyro
Ongoing use: For prophylaxis against HAE attacks
Authorization duration: Up to 12 months

Documentation Required

Reauthorization Documentation — Renewal Specifics

Renewal requests must include specific clinical documentation demonstrating improvement or stabilization on therapy and confirmation that Takhzyro is not being used in combination with other prophylactic HAE products (e.g., Cinryze, Haegarda, Orladeyo).

Evidence of positive clinical response (improvement or stabilization)
Confirmation: Not used in combination with other prophylactic HAE therapies (Cinryze, Haegarda, Orladeyo)

Denial Risk

Triggers for Denial

Requests may be denied if required criteria are not met. Common triggers for denial include absence of an HAE diagnosis, use for non-prophylactic indications, lack of documentation of prior benefit or clinical response, or concurrent use with other prophylactic HAE products.

No documented diagnosis of hereditary angioedema (HAE)
Medication prescribed for a non-prophylactic indication
Insufficient clinical documentation of response or need
Concurrent use with other products indicated for HAE prophylaxis (e.g., Cinryze, Haegarda, Orladeyo)

Note

Program Automation and Supply Limits

UnitedHealthcare programs may use automated approval and re-approval based on prior claim and medication history, diagnosis codes (ICD-10), and internal claim logic. Supply or quantity limits may apply depending on program rules.

Automated approval/re-approval may be granted from prior claim/medication history and ICD-10 diagnosis codes
Use of automation varies by program and therapeutic class
Supply/quantity limits may be enforced

Key Definitions

Prophylaxis against HAE attacks - key facts

Intended useProphylaxis to prevent hereditary angioedema (HAE) attacks (not for treatment of acute HAE attacks)

Combination useTakhzyro must not be used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo)

Authorization durationAuthorization of therapy is issued for 12 months

Supported populationIndicated for adults and pediatric patients 2 years and older

Background

Takhzyro (lanadelumab-flyo) is a monoclonal antibody that inhibits plasma kallikrein and is indicated for prophylaxis to prevent hereditary angioedema (HAE) attacks in patients aged 2 years and older. The policy aligns coverage with this prophylactic indication and requires that Takhzyro be used as monotherapy for HAE prophylaxis; it is not intended for treatment of acute HAE attacks. When authorization criteria are met, coverage is provided for 12 months.

Step-Therapy and Program Automation

Program Action	Automation / Logic	Supply Limits
Initial approval	May be approved automatically based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic when program rules are met	Supply limits may be applied per program or therapeutic class
Re-authorization	May be re-approved automatically using prior claim/medication history, diagnosis codes, and/or claim logic depending on program	Supply limits may be applied; specifics vary by program