CurrentColorado Rocky Mountain Health PlansPolicy N/A

Takhzyro (lanadelumab‑flyo) prior authorization for hereditary angioedema prophylaxis

Defines medical necessity and prior authorization criteria for approval and reauthorization of Takhzyro for prophylaxis of hereditary angioedema (HAE) for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTakhzyro (lanadelumab‑flyo) prior authorization for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit documentation confirming HAE diagnosis, baseline attack rate (≥1 per 4 weeks), prescriber specialty, and absence of concurrent HAE prophylactic agents for initial prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 2+FDA-indicated age for Takhzyro

>=1/4wBaseline attack rate required

8 moInitial authorization duration

300 mg q4wReauth dosing option for zero attacks

Takhzyro (lanadelumab‑flyo) Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Diagnosis of hereditary angioedema (HAE) confirmed by ONE of the following: (1) C1 inhibitor (C1‑INH) deficiency or dysfunction (Type I or II HAE) documented by either a C1‑INH antigenic level below the lower limit of normal OR a C1‑INH functional level below the lower limit of normal; OR (2) HAE with normal C1‑INH and ONE of: confirmed pathogenic variant(s) in relevant genes (e.g., factor XII, angiopoietin‑1, plasminogen‑1, kininogen‑1, myoferlin, HS3ST6), recurring angioedema refractory to high‑dose antihistamines with confirmed family history, OR recurring angioedema refractory to high‑dose antihistamines with de‑novo/unknown mutation (HAEunknown).

Initial Authorization continued: Indication for prophylaxis against HAE attacks; AND not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo); AND prescriber attests patient has experienced attacks of severity and/or frequency such that they would clinically benefit from prophylactic therapy; AND documentation of baseline HAE attack rate >= 1 attack per 4 weeks; AND prescribed by an immunologist or allergist.baseline >=1 per 4 weeks

Age‑specific initial dosing and authorization durations apply: adults and pediatrics >=12 years — 300 mg q2w for 8 months; pediatric 6 to <12 years — 150 mg q2w for 8 months; pediatric <6 years — 150 mg q4w for 12 months.

Reauthorization / Continuation Therapy

Reauthorization approved when ALL of the following are met:

Reauthorization: Documentation of positive clinical response while on Takhzyro; AND reduction in utilization of on‑demand therapies used for acute attacks (e.g., Berinert, Ruconest, Firazyr, Kalbitor) as determined by claims information; AND prescribed by an immunologist or allergist; AND used for prophylaxis and not in combination with other prophylactic HAE products (e.g., Cinryze, Haegarda, Orladeyo).

Dosing / Authorization length based on age and attack count

Pediatric <6 years: Continue Takhzyro 150 mg every 4 weeks for 12 months.
Attack count in prior 6 months (while on therapy)
- Zero attacks: If patient experienced zero acute HAE attacks in the previous 6 months: authorize extended q4w dosing for 12 months — adults and pediatrics >=12 years: 300 mg every 4 weeks for 12 months; pediatric 6 to <12 years: 150 mg every 4 weeks for 12 months.

The policy prohibits concurrent prophylactic therapy with other HAE prophylaxis products. Takhzyro must not be used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo). Requests that include simultaneous use of Takhzyro with any of these prophylactic agents will not meet coverage criteria.

Initial authorization requires documented diagnostic evidence of hereditary angioedema and a quantified baseline attack rate. Specifically, the policy requires documentation of HAE per laboratory or genetic criteria (for example, C1‑INH antigenic or functional level below the lower limit of normal for Type I/II) and a prescriber attestation that the patient’s attack frequency/severity warrants prophylaxis. In addition, the provider must document a baseline HAE attack rate ≥ 1 attack per 4 weeks. Absent the required diagnostic documentation or the specified baseline attack rate, the request does not meet medical necessity and may be denied.

Coding and Clinical Thresholds

No explicit billing or ICD-10 codes providedmixed

No codes listed

Baseline HAE attack rate threshold used for initial authorization

Baseline HAE attack rate>= 1 attack per 4 weeks

Context for initial approvalRequired for prophylaxis indication and prescriber attestation of clinical benefit

Prescriber specialties requiredImmunologist or Allergist

Reauthorization attack-count guidance

Reauthorization: 0 attacks in prior 6 monthsAdults & pediatrics >=12: 300 mg every 4 weeks for 12 months; Pediatrics 6 to <12: 150 mg every 4 weeks for 12 months

Reauthorization: >=1 attack in prior 6 monthsAdults & pediatrics >=12: 300 mg every 2 weeks for 6 months; Pediatrics 6 to <12: 150 mg every 2 weeks for 6 months

Breakthrough guidanceIf breakthrough attacks occur after switch to q4w dosing, review to allow return to q2w dosing

Prescriber Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior authorization and reauthorization requirements

Initial prior authorization: provider must document a confirmed diagnosis of HAE per policy (either C1‑INH antigenic or functional level below the lower limit of normal for Type I/II, or criteria for HAE with normal C1‑INH), attest that the patient’s attack severity/frequency warrants prophylaxis, document a baseline HAE attack rate ≥ 1 attack per 4 weeks, ensure Takhzyro is prescribed by an immunologist or allergist, and confirm Takhzyro is not being used concurrently with other prophylactic HAE products. Approvals are issued with age‑specific dosing and authorization durations as specified in the policy.

Diagnosis of HAE confirmed by: C1‑INH antigenic level below LLN OR C1‑INH functional level below LLN, OR HAE with normal C1‑INH meeting listed genetic/clinical criteria (see policy).
Prescriber attestation that patient’s attack severity/frequency justifies prophylaxis and documentation of baseline attack rate ≥ 1 per 4 weeks.
Prescriber must be an immunologist or allergist.
Takhzyro must not be used in combination with other prophylactic HAE products.
Age‑specific initial dosing and authorization durations apply (see policy for 300 mg q2w or 150 mg dosing and lengths).

Step Therapy

Concurrent prophylaxis restriction

Do not prescribe Takhzyro together with other products indicated for prophylaxis against HAE attacks; concurrent use with agents such as Cinryze, Haegarda, or Orladeyo is prohibited by the policy.

Policy explicitly states Takhzyro must not be used in combination with other prophylactic HAE products (examples listed: Cinryze, Haegarda, Orladeyo).
This restriction applies to both initial authorization and reauthorization.

Documentation Required

Required documentation

Providers must submit diagnostic laboratory or genetic evidence and attack history: either C1‑INH antigenic level below the lower limit of normal or C1‑INH functional level below the lower limit of normal for Type I/II HAE, or documented genetic variant or clinical criteria for HAE with normal C1‑INH; plus prescriber attestation of attack severity/frequency and documentation of baseline HAE attack rate (≥1 per 4 weeks).

C1‑INH antigenic level below LLN OR C1‑INH functional level below LLN (Type I/II HAE).
OR confirmed pathogenic variant(s) in listed genes or refractory recurrent angioedema meeting policy criteria for HAE with normal C1‑INH.
Prescriber attestation of clinical benefit from prophylaxis and documentation of baseline attack rate ≥ 1 per 4 weeks.

Denial Risk

Triggers for denial

The policy lists specific grounds for denial: missing documented diagnostic criteria for HAE, failure to document a baseline attack rate ≥ 1 per 4 weeks for initial authorization, or concurrent use with other prophylactic HAE therapies — any of these will not meet medical necessity.

No laboratory or genetic evidence meeting the policy’s diagnostic definitions for HAE (C1‑INH lab results or required genetic/clinical criteria).
Baseline HAE attack rate not documented as ≥ 1 attack per 4 weeks for initial requests.
Concurrent use of Takhzyro with other prophylactic HAE products (e.g., Cinryze, Haegarda, Orladeyo).

Key Clinical Definitions

Definition — HAE Type I/II (C1‑INH deficiency/dysfunction)

DefinitionHAE Type I/II = C1‑INH deficiency or dysfunction documented by C1‑INH antigenic level below the lower limit of normal OR C1‑INH functional level below the lower limit of normal

Diagnostic evidence sourcePer laboratory standard (antigenic or functional testing)

Implication for coverageRequired to meet initial authorization criteria for prophylaxis with Takhzyro

Definition — HAE with normal C1‑INH

DefinitionHAE with normal C1‑INH = HAE with normal C1 inhibitor levels plus one of: confirmed pathogenic variant in specified genes (factor XII, angiopoietin‑1, plasminogen‑1, kininogen‑1, myoferlin, HS3ST6) OR recurring angioedema refractory to high‑dose antihistamines with family history OR recurring refractory angioedema with de‑novo mutation

Genetic confirmationPresence of variant(s) in listed genes supports diagnosis

Clinical criteriaRecurrent antihistamine‑refractory angioedema with family history or de‑novo presentation qualifies

Revision History

2018-11policy_created

Program created as a prior authorization/medical necessity policy for Takhzyro (lanadelumab‑flyo).

2019-11annual_update

Program updated (new program entry recorded).

2020-06annual_review_update

Annual review with updated references; aligned criteria with acute and prophylactic therapies.

2021-03criteria_update

Criteria aligned with acute and prophylactic therapies and other adjustments made to program criteria.

2022-03criteria_update

Added diagnosis criteria and aligned combination-use language with prophylactic therapies; updated references.

2023-03annual_review

Annual review performed (no clinical changes recorded in this entry).

2024-03annual_review_update

Annual review with updated background to reflect expanded FDA indication for patients aged 2 years and older and updated pediatric dosing recommendations.

2025-03annual_review_update

Annual review with updates to diagnostic criteria for HAE with normal C1 inhibitor levels and simplified reauthorization criteria.

2025-06-01effective_dateLatest

Policy effective date set to 2025-06-01 for the current program version.

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