CurrentCignaPolicy N/A

Hereditary Angioedema - Takhzyro Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Takhzyro (lanadelumab) for prophylaxis of hereditary angioedema due to C1-INH deficiency, and who may prescribe it.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Takhzyro Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria clarifications and continuation handling

Effective DateN/A

Next Review DateOct 15, 2025

Key ActionSubmit prior authorization with documentation of diagnosis and baseline labs; approvals are granted for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

A patient who previously met initial therapy criteria for Takhzyro under the Coverage Review Department and is currently receiving Takhzyro is only required to meet continuation therapy criteria.

Deleted '[Type I or Type II]' from the indication heading for Hereditary Angioedema (HAE) Due to C1-INH Deficiency - Prophylaxis.

If a patient currently receiving Takhzyro did not previously receive initial therapy approval through the Coverage Review Department, they must meet initial therapy criteria.

age ≥ 2FDA minimum age

1 yearInitial approval period

specialistPrescriber requirement

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C1-INH functional threshold

Coverage Criteria for Takhzyro (lanadelumab)

Initial and Continuation Therapy

Covered when ONE of the following is met:

Overall options: Approve Takhzyro for 1 year if the patient meets ONE of the following: A) Initial therapy OR B) Currently receiving Takhzyro

A) Initial therapy: Patient has HAE type I or II confirmed AND medication is prescribed by or in consultation with an allergist/immunologist or HAE specialist

Diagnosis requires: (a) functional C1-INH < 50% of normal at baseline and (b) low serum C4 at baseline — documentation required.

B) Currently receiving Takhzyro: Patient has a diagnosis of HAE type I or II; patient has had a favorable clinical response since initiating Takhzyro compared with baseline; and medication is prescribed by or in consultation with an allergist/immunologist or HAE specialist

If patient is currently receiving Takhzyro but did not previously receive initial therapy approval through the Coverage Review Department, they must meet initial therapy criteria.

Concomitant long-term prophylactic use of Takhzyro with other hereditary angioedema (HAE) prophylactic therapies is not covered. The policy notes that Takhzyro has not been studied in combination with other prophylactic therapies for HAE, and therefore combination therapy for long‑term prophylactic use is not recommended. Short-term (procedural) prophylaxis or on‑demand treatment of acute HAE attacks with other agents is allowed and explicitly distinguished from long‑term combination prophylaxis.

Use of Takhzyro together with other HAE prophylactic agents for the purpose of long‑term prophylaxis is considered not medically necessary. The policy specifically states that because combination regimens including Takhzyro have not been evaluated in studies, such concurrent long‑term prophylactic therapy is not recommended and will not meet medical necessity criteria.

Key Clinical Thresholds and Approval Duration

C1-INH functional level — diagnostic threshold value for coverage

Diagnostic thresholdC1-INH functional level < 50% of normal (baseline), as defined by the laboratory reference values; documentation required

Supporting lab requirementLow serum C4 at baseline, as defined by the laboratory reference values; documentation required

Exclusion noteHAE with normal C1-INH (also known as HAE type III) does NOT satisfy this diagnostic requirement

Approval duration — standard authorization period when criteria met

Standard approval periodApprove Takhzyro for 1 year when the patient meets coverage criteria

Initial vs continuationIf patient is currently receiving Takhzyro but did not previously receive approval through the Coverage Review Department, review under initial therapy criteria

Prescriber and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required and approvals are issued for the duration noted in the policy. Because of the specialized skills required for evaluation, Takhzyro must be prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders.

Approval period: up to 1 year
Prescriber specialty: allergist/immunologist or physician who specializes in HAE or related disorders

Denial Risk

Combination Prophylaxis Restriction — Not Medically Necessary

Combination long-term prophylactic therapy with Takhzyro and other HAE prophylactic agents is considered not medically necessary. Concomitant use for long-term prophylaxis is not recommended; other HAE therapies may be used for on-demand treatment of acute attacks or for short-term (procedural) prophylaxis only.

Definitions and Diagnostic Criteria

HAE type I/II — diagnostic definition

Definition (HAE type I/II)Hereditary angioedema due to C1‑INH deficiency diagnosed by low C1‑INH functional level and low serum C4 levels (consistent with HAE types I/II)

Testing recommendedWhen HAE is suspected, measure serum C4, C1‑INH antigenic level, and C1‑INH functional level

HAE with normal C1‑INHHAE with normal C1‑INH (also known as HAE type III) does NOT meet criteria for Takhzyro prophylaxis under this policy

Background on Takhzyro (lanadelumab)

Takhzyro (lanadelumab‑flyo) is a monoclonal antibody indicated for prevention of hereditary angioedema (HAE) attacks. Its mechanism involves inhibition of plasma kallikrein, which reduces bradykinin generation and the frequency of HAE attacks. The policy references the FDA‑approved prophylaxis indication and clarifies that Takhzyro is intended for prevention rather than acute treatment; other HAE agents may be used for on‑demand or short‑term procedural prophylaxis as needed.

Policy Summary

PayerCigna

PolicyHereditary Angioedema - Takhzyro Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria clarifications and continuation handling

Effective DateN/A

Next Review DateOct 15, 2025

Key ActionSubmit prior authorization with documentation of diagnosis and baseline labs; approvals are granted for 1 year when criteria are met.

SourceLink

On This Page

Renewal documentationDocumentation of ongoing clinical benefit (for continuation approvals) is required as part of the review

Examples of other HAE prophylactic therapies: Cinryze, Haegarda, Orladeyo

Concomitant short-term or on-demand use (e.g., procedural prophylaxis, acute attack treatment) is acceptable

Documentation Required

Required Documentation

Documentation is required where noted in the criteria to support diagnosis, baseline labs, and treatment response. Acceptable documentation includes chart notes, laboratory records, and prescription claims records. All documentation must include patient-identifying information.

Diagnostic documentation required: documentation confirming HAE type I or II (lab reports)
Baseline labs required: functional C1-INH level (<50% of normal) and serum C4 level (report reference ranges) — include laboratory reference values
Treatment response documentation for continuation: prescriber statement or records showing favorable clinical response (decrease in attack frequency, severity, or duration)
If patient currently receiving therapy but prior approval not obtained, initial therapy documentation criteria must be met

Denial Risk

Triggers for Denial

Requests may be denied if required documentation or specialty-prescriber information is missing, or if the requested use is concomitant long-term prophylaxis with other HAE prophylactic therapies. Denial risk is increased when: initial diagnostic criteria, baseline laboratory values, or evidence of clinical response for continuation are not provided.

Missing baseline labs: absent functional C1-INH and serum C4 results with reference ranges
Missing prescriber specialty: no evidence that prescriber is an allergist/immunologist or HAE specialist or consulted one
Concomitant long-term prophylactic use with other HAE prophylactic agents (e.g., Cinryze, Haegarda, Orladeyo)
Patient diagnosed with HAE type III (HAE with normal C1-INH) — does NOT meet criteria