CurrentAetnaPolicy N/A

Takhzyro (lanadelumab‑flyo) Medication Precertification Request (HAE)

This document is Aetna's precertification request form and required clinical checklist for Takhzyro (lanadelumab-flyo) used for prevention of hereditary angioedema (HAE); it governs prior authorization submissions by providers for Aetna members.

Policy Summary

PayerAetna

PolicyTakhzyro (lanadelumab‑flyo) precertification request form for prevention of hereditary angioedema (HAE)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed two‑page precertification form with required clinical documentation, signatures, ICD codes, and product dosing information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

multiplerequired clinical items

phone/faxcontact lines

Coverage Criteria

Medical necessity data elements

Coverage consideration requires documented diagnosis and supporting clinical information; form collects items used to determine medical necessity.

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Initial therapy criteria

Requested medication is being used for the prevention of hereditary angioedema (HAE) attacks (Yes required).
Indicate whether medication will be used in combination with other HAE prophylactic medications (Yes/No).
Prescriber is the specialist in HAE management or has consulted with a prescriber who specializes in HAE (Yes required).
Number of hereditary angioedema (HAE) attacks per month is documented.
Diagnostic confirmation (ONE of)
- HAE with C1 inhibitor deficiency or dysfunction confirmed by laboratory testing (C1-INH antigenic level below lab lower limit).
- Normal C1-INH antigenic level with low C1-INH functional level (functional C1-INH <50% or below lab lower limit).
- HAE with normal C1-INH confirmed by laboratory testing (with genetic testing where applicable).
Genetic testing (if applicable)
- Documentation of F12, angiopoietin-1, plasminogen, KNG1, HS3ST6, or MYOF gene mutation confirmed by genetic testing.
- If genetic testing not applicable or not performed, other supporting diagnostic information documented (select 'Other' with explanation).
Prior trial/family history (ONE of)
- Angioedema refractory to a trial of high-dose antihistamine therapy (eg, cetirizine 40 mg/day or equivalent) for at least 1 month AND family history of angioedema (both required when this option selected).
- Other documented justification for initiation (select 'Other' and provide clinical rationale).
Product requested (Takhzyro/lanadelumab-flyo), dose and frequency are specified on the form.
Relevant ICD-10 diagnosis codes (primary and any secondary/other) and supporting clinical notes are provided.

Continuation of therapy criteria

Documentation the patient experienced a significant reduction in frequency of acute attacks since starting treatment (eg, ≥ 50%).>= 50%
Documentation that use of medications to treat acute attacks has decreased since starting the requested medication (Yes/No).
Current dosing interval is documented (is the medication dosed every 4 weeks?).
Documentation that the patient has been well-controlled on therapy for more than 6 months (Yes/No).
Consideration/documentation of whether dosing every 4 weeks has been considered.

Operational note: Form fields map to these requirements; completed, legible documentation including signature/date must be submitted for precertification review.

The form explicitly flags requests that lack required diagnostic confirmation or are not for HAE prophylaxis. Providers must indicate that the medication is being used for the prevention of HAE attacks, document whether the drug will be used in combination with other prophylactic therapies, and provide laboratory or genetic confirmation of HAE subtype. The form also asks whether angioedema was refractory to a prior trial of high‑dose antihistamine therapy (cetirizine 40 mg/day or equivalent for ≥1 month), and includes checkboxes that would identify requests that do not meet these clinical prerequisites.

Coding

Administration CPT codesCPT

Administration code(s) (CPT)

Administration code(s) to be specified by provider on form

ICD-10 codesICD-10

Primary ICD Code	Primary diagnosis ICD code to be provided
Secondary ICD Code	Secondary diagnosis ICD code to be provided
Other ICD Code	Other diagnosis ICD code to be provided

inv-06: Significant reduction in acute attacks — threshold

Threshold for meaningful response>= 50% reduction in frequency of acute HAE attacks since starting treatment

Documentation checkboxForm asks: 'Has the patient experienced a significant reduction in frequency of acute attacks (e.g., >= 50%) since starting treatment?'

Use caseRequired for continuation of therapy determinations on the precertification form

Provider Actions & Submission Requirements

Prior Authorization

Precertification required

Precertification is required for Takhzyro — use Aetna precertification lines (Phone: 1-866-752-7021; Fax: 1-888-267-3277). For Medicare Advantage Part B members, submit using the Medicare Request Form.

Precertification phone: 1-866-752-7021
Precertification fax: 1-888-267-3277
Medicare Advantage Part B: use Medicare Request Form

Step Therapy

Prior medication trial

The precertification form asks whether angioedema was refractory to a trial of high‑dose antihistamine therapy (example given: cetirizine 40 mg/day or equivalent) for at least one month — document prior medication trial and duration.

Document trial of high‑dose antihistamine (e.g., cetirizine 40 mg/day) for ≥1 month
If refractory, indicate on form

Documentation Required

Required submission documents

Submit the completed two‑page precertification form with all required patient demographics, prescriber and dispensing details, product (dose/frequency) and diagnosis information, and complete clinical documentation. For continuation requests include documentation of treatment response (e.g., ≥50% reduction in attack frequency, reduced use of acute‑attack medications), dosing interval, and duration of control.

Complete both pages of the Takhzyro precertification request form
Include patient demographics and contact information
Include prescriber credentials, NPI, specialty and contact details
Provide product name, dose, frequency and ICD‑10 diagnosis code(s)
Attach clinical documentation supporting diagnosis and prior therapies
For continuation: document clinical benefit (e.g., ≥50% reduction in attacks) and treatment duration

Denial Risk

Incomplete or fraudulent requests

Incomplete, illegible, or materially false information may result in denial of the request and referral for fraud investigation. The plan may request additional information or clarification as needed to evaluate requests.

Ensure all fields are complete and legible on both pages
Material misrepresentation or concealment of information may lead to denial and criminal/civil penalties
Plan may request additional information to evaluate the request

Background

Takhzyro (lanadelumab‑flyo) is intended for the prevention of hereditary angioedema (HAE) attacks. The precertification form collects required clinical information to support medical necessity, including confirmation that the request is for prophylaxis, the number of HAE attacks per month, whether the prescriber is or consulted with an HAE specialist, and laboratory or genetic evidence of either C1‑INH deficiency/dysfunction or HAE with normal C1‑INH (with specified gene mutation testing where applicable).

Definitions

inv-12: HAE with C1-INH deficiency/dysfunction — definition

DefinitionHereditary angioedema (HAE) with C1 inhibitor deficiency or dysfunction confirmed by laboratory testing

Laboratory findings (examples)C1 inhibitor (C1-INH) antigenic level below the lower limit of normal as defined by the testing laboratory

Laboratory findings (functional)Normal C1-INH antigenic level with low C1-INH functional level (functional C1-INH <50% or below lab lower limit of normal)

inv-13: HAE with normal C1-INH — definition

DefinitionHereditary angioedema (HAE) with normal C1 inhibitor confirmed by laboratory testing

Genetic testing — possible mutationsMay include F12, angiopoietin-1, plasminogen, kininogen-1 (KNG1), HS3ST6, or MYOF gene mutations as confirmed by genetic testing

Differentiation noteUsed when C1-INH antigenic and functional testing are normal but HAE is suspected and genetic confirmation is present