CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Takhzyro (lanadelumab-flyo) for hereditary angioedema prophylaxis

This specialty guideline describes coverage criteria, dosing limits, and authorization requirements for lanadelumab (Takhzyro) used for prevention of hereditary angioedema (HAE) attacks in members age 2 years and older under the Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTakhzyro (lanadelumab-flyo) for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization for initial and continuation therapy (approvals up to 6 months) and document diagnosis, laboratory or genetic confirmation, and treatment response as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age ≥ 2minimum age for covered indication

6 monthsinitial/continuation approval

2/28 daysquantity limit

q2w or q4wdosing interval options

FDA-approved onlyuses excluded

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Coverage Criteria for Takhzyro (lanadelumab)

Initial Therapy

Authorization for 6 months may be granted when ALL of the following are met:

Initial Approval - All criteria

Laboratory/genetic confirmation: Either low C1‑INH antigenic level (below laboratory lower limit of normal) OR low C1‑INH functional level (functional C1‑INH <50% or below the laboratory lower limit of normal) OR documented pathogenic mutation in F12, angiopoietin‑1, HS3ST6, or MYOF OR family history of angioedema with angioedema refractory to a trial of high‑dose antihistamine for at least one month.functional C1‑INH <50%
Laboratory reference ranges per performing laboratory; genetic testing per report.

Continuation Therapy

Authorization for 6 months may be granted for continuation when ALL of the following are met:

Continuation Approval - All criteria: Member meets all criteria for initial approval; documentation of a favorable clinical response since initiating Takhzyro (decrease in attack frequency, severity, or duration); documentation of the number of acute HAE attacks in the previous 6 months while on therapy; dosing regimen requested aligns with attack frequency.6 month response assessment

Approve for 6 months with dosing interval determined by attack frequency: if 0 attacks in prior 6 months → every 4 weeks for 6 months; if ≥1 attack in prior 6 months → every 2 weeks for 6 months.

All indications for Takhzyro (lanadelumab) other than prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged ≥ 2 years are considered experimental/investigational and are excluded from coverage.

Use of Takhzyro for non‑HAE indications that are not FDA‑approved is considered not medically necessary under this policy and is treated as experimental/investigational; such uses are not covered.

Product Strengths, Dosing, and Related Coding

Product strengths (no billing codes provided)mixed

NDC/Codes not listed

Document lists product strengths (150 mg/mL or 300 mg/2 mL) but does not provide specific CPT/HCPCS/NDC codes.

Attack count in previous 6 months

0 attacks in prior 6 monthsEligible for dosing every 4 weeks (approval granted for 6 months)

≥1 attack in prior 6 monthsEligible for dosing every 2 weeks (approval granted for 6 months)

Documentation requiredProvider must document number of acute HAE attacks in previous 6 months while on therapy

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial and continuation approvals may be granted for up to 6 months when criteria are met. Quantity limits apply as specified in the policy.

Authorization period: up to 6 months for initial and continuation approvals
Quantity limit: per policy (see quantity limit section)

Note

On‑demand Therapy Failure or Access Limitation

Documented inadequate control with or limited access to on‑demand (rescue) therapies (for example, icatibant, ecallantide, or C1‑INH replacement) may support the medical need for prophylactic therapy.

Documentation Required

Clinical Background

Hereditary angioedema (HAE) is a disorder characterized by recurrent, potentially severe swelling attacks. Prophylactic therapy with agents such as lanadelumab (Takhzyro) is indicated to prevent HAE attacks in patients with C1‑inhibitor deficiency or dysfunction, and this policy addresses coverage for that preventive (prophylactic) use in patients aged ≥ 2 years.

Laboratory and Genetic Definitions

Laboratory confirmation of C1‑INH deficiency/dysfunction

Functional C1‑INH thresholdC1‑INH functional level less than 50% or below the laboratory lower limit of normal

Antigenic C1‑INHC1‑INH antigenic level below the lower limit of normal as defined by the performing laboratory

Laboratory definition noteReference ranges and lower limits are those reported by the performing laboratory

Genetic confirmation

Genetic mutations includedMutations in F12, angiopoietin‑1, HS3ST6, or MYOF associated with angioedema

Use of genetic confirmationGenetic testing confirming one of the listed mutations supports diagnosis when C1‑INH is normal

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTakhzyro (lanadelumab-flyo) for hereditary angioedema prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization for initial and continuation therapy (approvals up to 6 months) and document diagnosis, laboratory or genetic confirmation, and treatment response as specified.

SourceLink

On This Page

Diagnostic Documentation Required

Provider must document the diagnosis of hereditary angioedema (HAE) type I or II. Laboratory confirmation of C1‑INH deficiency or dysfunction is required, such as low C1‑INH antigenic level or low C1‑INH functional level (functional C1‑INH <50% or below the laboratory lower limit of normal). If C1‑INH antigenic level is normal with low functional level, include the functional assay result. Genetic testing (e.g., F12, ANGPT1, HS3ST6, MYOF) and family history may be included where applicable. Other causes of angioedema (e.g., ACE inhibitor–induced angioedema, allergic angioedema) must be ruled out.

Documentation Required

Response Documentation for Continuation

For continuation of therapy, the provider must document a favorable clinical response since initiating prophylactic therapy compared with baseline. Evidence may include a decreased frequency of acute HAE attacks, decreased severity of attacks (e.g., fewer airway or debilitating cutaneous/gastrointestinal episodes), or decreased duration of attacks. If the member had zero acute HAE attacks in the prior 6 months, the regimen and dosing requested should be documented (e.g., 300 mg every 4 weeks). If the member experienced one or more attacks in the prior 6 months, document attacks and support for a 300 mg every 2 weeks regimen as applicable.

Documentation Required

Prescriber Requirement

Medication must be prescribed by, or in consultation with, an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders. Include documentation of the consulting specialist when applicable.

Associated requirementOther causes of angioedema should be ruled out when using genetic confirmation