Subject: Takhzyro 2668-A SGM P2023
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TAKHZYRO
(lanadelumab-flyo)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indication
Takhzyro is indicated for prophylaxis to prevent attacks of
hereditary angioedema (HAE) in adult and pediatric patients
aged 2 years and older.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. For initial authorization, the following should be documented:
1. C1 inhibitor functional and antigenic protein levels
2. F12, angiopoietin-1, plasminogen, kininogen-1 (KNG1),
heparan sulfate-glucosamine 3-O-sulfotransferase 6
(HS3ST6), or myoferlin (MYOF) gene mutation testing, if
applicable
3. Chart notes confirming family history of angioedema and
the angioedema was refractory to a trial of high-dose
antihistamine therapy, if applicable
B. For continuation of therapy, chart notes demonstrating a
reduction in frequency of attacks
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
prescriber who specializes in the management of HAE.
IV. CRITERIA FOR INITIAL APPROVAL
Hereditary angioedema (HAE)
Authorization of 6 months may be granted for prevention of HAE
attacks when the requested medication will not be used in
combination with any other medication used for the prophylaxis
of HAE attacks and either of the following criteria is met at the
time of diagnosis:
A. Member has C1 inhibitor deficiency or dysfunction as
confirmed by laboratory testing and meets one of the
following criteria:
1. C1 inhibitor (C1-INH) antigenic level below the lower limit
of normal as defined by the laboratory performing the
test, or
2. Normal C1-INH antigenic level and a low C1-INH
functional level (functional C1-INH less than 50% or C1-
INH functional level below the lower limit of normal as
defined by the laboratory performing the test).
B. Member has normal C1 inhibitor as confirmed by laboratory
testing and meets one of the following criteria:
1. Member has an F12, angiopoietin-1, plasminogen,
kininogen-1 (KNG1), heparan sulfate-glucosamine 3-O-
sulfotransferase 6 (HS3ST6), or myoferlin (MYOF) gene
mutation as confirmed by genetic testing, or
2. Member has a documented family history of angioedema
and the angioedema was refractory to a trial of high-dose
antihistamine therapy (i.e., cetirizine at 40 mg per day or
the equivalent) for at least one month.
V. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continuation of
therapy when all of the following criteria are met:
A. Member meets the criteria for initial approval.
B. Member has experienced a significant reduction in frequency
of attacks (e.g., ≥ 50%) since starting treatment.
C. Member has reduced the use of medications to treat acute
attacks since starting treatment.
D. The requested drug is being dosed every 4 weeks or dosing
every 4 weeks has been considered if the member is well-
controlled on therapy for more than 6 months.
Place of Service:
Outpatient
The above policy is based on the following references:
- Takhzyro [package insert]. Lexington, MA: Dyax Corp., a Takeda company; February 2023.
- Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema – the 2021 revision and update. Allergy. 2022 Jan 10. doi: 10.1111/all. 15214. Online ahead of print.
- Henao MP, Kraschnewski J, Kelbel T, Craig T. Diagnosis and screening of patients with hereditary angioedema in primary care. Therapeutics and Clin Risk Management. 2016; 12: 701-711.
- Bernstein, J. Severity of Hereditary Angioedema, Prevalence, and Diagnostic Considerations. Am J Med. 2018:24;292-298.
- Busse PJ, Christiansen, SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol: In Practice. 2021 Jan;9(1):132-150.e3.
- Sharma J, Jindal AK, Banday AZ, et al. Pathophysiology of Hereditary Angioedema (HAE) Beyond the SERPING1 Gene [published online ahead of print, 2021 Jan 14] [published correction appears in Clin Rev Allergy Immunol. 2021 Feb 17]. Clin Rev Allergy Immunol. 2021;10.1007/s12016-021-08835-8. Doi:10.1007/s12016-021-08835-8.
- Kanani, A., Schellenberg, R. & Warrington, R. Urticaria and angioedema. All Asth Clin Immun 7, S9 (2011), Table 2.
- Veronez CL, Csuka D, Sheik FR, et al. The expanding spectrum of mutations in hereditary angioedema. J Allergy Clin Immunol Pract. 2021;S2213-2198(21)00312-3.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
October 22, 2023
