CurrentNeighborhood Health Plan of Rhode IslandPolicy 2668-A

Lanadelumab (Takhzyro) — prophylaxis of hereditary angioedema (HAE)

Covers prior authorization, clinical eligibility, documentation, and continuation criteria for lanadelumab (Takhzyro) when used for prevention of hereditary angioedema (HAE) attacks in members age 2 years and older. Applies to benefit administration and prescribers managing HAE prophylaxis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLanadelumab (Takhzyro) — prophylaxis of hereditary angioedema (HAE)

Policy CodePolicy 2668-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (up to 12 months) and submit C1‑INH functional and antigenic levels; ensure prescriber is a specialist in HAE management.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=2minimum approved age

12 moauth duration

>=50%expected reduction

<50%C1‑INH functional threshold

Coverage Criteria for Lanadelumab (Takhzyro)

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Initial Therapy

Covered when ALL of the following are met

Age and indication: Patient is age 2 years or older AND request is for prophylaxis to prevent hereditary angioedema (HAE) attacks (FDA-approved indication)age >= 2 years

from FDA indication; other uses not covered

Diagnostic confirmation

C1-INH deficiency path: C1-INH antigenic level below the laboratory lower limit of normal OR normal antigenic level with C1-INH functional level <50% (or below lab lower limit)
Normal C1-INH path: Either pathogenic mutation confirmed by genetic testing in F12, ANGPT1, PLG, KNG1, HS3ST6, or MYOF OR documented family history of angioedema with angioedema refractory to a trial of high-dose antihistamine therapy (e.g., cetirizine 40 mg/day for >=1 month)

Other causes excluded: Other causes of angioedema (e.g., ACE inhibitor-induced, estrogen-related, allergic angioedema) have been ruled out

Monotherapy for prophylaxis: Requested medication will not be used in combination with any other medication used for prophylaxis of HAE attacks

Continuation Therapy

Covered when ALL of the following are met

Baseline coverage maintained: Member continues to meet all requirements in the coverage criteria section (Initial Therapy)

Clinical response: Member has experienced a significant reduction in frequency of attacks (e.g., >= 50%) since starting treatment

Reduced acute medication use: Member has reduced use of medications to treat acute attacks since starting treatment

Dosing interval: Requested drug is being dosed every 4 weeks OR dosing every 4 weeks has been considered if member is well-controlled on therapy for >6 months

Coverage is limited to the FDA-approved indication: prophylaxis to prevent attacks of hereditary angioedema (HAE). Therapy with lanadelumab (Takhzyro) is approved for use in patients age 2 years and older. Prior authorization is required and approval is contingent on meeting the clinical criteria for HAE prophylaxis.

Use of lanadelumab for any indication other than prophylaxis to prevent HAE attacks in patients age 2 years and older is considered experimental/investigational and not medically necessary and will not be covered.

Provider Requirements and Documentation

Prior Authorization

Prior Authorization and Prescriber Specialty

Prior authorization is required and may be granted for up to 12 months. The medication must be prescribed by, or in consultation with, a prescriber who specializes in the management of hereditary angioedema (HAE).

Authorization duration: up to 12 months
Prescriber specialty: specialist in HAE management

Documentation Required

Genetic Testing or Antihistamine Trial Requirement

When C1‑INH antigenic level is normal, one of the following must be documented: a pathogenic F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, or MYOF gene mutation confirmed by genetic testing; OR a documented family history of angioedema plus documentation that the angioedema was refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent for at least 1 month). Other causes of angioedema should be excluded.

Genetic testing: F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, MYOF — if applicable
Antihistamine trial: high‑dose (e.g., cetirizine 40 mg/day or equivalent) for ≥1 month when applicable

Documentation Required

Required Documentation for Authorization

For initial authorization, submit C1 inhibitor functional and antigenic protein levels. If applicable, include genetic testing results for F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, or MYOF. If applicable, provide chart notes confirming family history of angioedema and documentation that angioedema was refractory to a trial of high‑dose antihistamine therapy. For continuation requests, provide chart notes demonstrating a reduction in frequency of attacks (for example, ≥50%) and reduced use of medications for acute attacks.

Initial: C1‑INH functional and antigenic protein levels
Initial (if applicable): genetic testing results for F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF
Initial (if applicable): chart notes confirming family history and antihistamine trial failure
Continuation: chart notes showing ≥50% reduction in attack frequency and decreased acute medication use

Denial Risk

Indication Restriction

Takhzyro is indicated only for prophylaxis to prevent HAE attacks. Use for non‑prophylaxis indications is considered experimental/investigational and not medically necessary.

Covered indication: prophylaxis to prevent HAE attacks in patients ≥2 years
Not covered: all other indications

Definitions and Laboratory Criteria

C1 inhibitor deficiency or dysfunction — antigenic or functional definitions

Antigenic deficiencyC1‑INH antigenic level below the laboratory lower limit of normal (per performing lab)

Functional deficiency with normal antigenic levelNormal C1‑INH antigenic level with low C1‑INH functional level (<50% or below lab lower limit)

Clinical implicationEither antigenic low level OR low functional level (with normal antigenic) confirms C1‑INH deficiency/dysfunction for diagnosis of HAE

HAE with normal C1‑INH — genetic mutation confirmation or family history

Genetic mutation confirmationPathogenic mutation in F12, ANGPT1, PLG, KNG1, HS3ST6, or MYOF confirmed by genetic testing

Family history pathwayDocumented family history of angioedema plus angioedema refractory to high‑dose antihistamine (e.g., cetirizine 40 mg/day for ≥1 month)

ApplicabilityThis path applies when C1‑INH antigenic level is normal (HAE with normal C1‑INH)