Subject: Tegsedi 2773-A SGM P2022a
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
Tegsedi is indicated for the treatment of the polyneuropathy of
hereditary transthyretin-mediated amyloidosis in adults.
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. Testing or analysis confirming a mutation of the TTR gene
B. Medical record documentation confirming the member
demonstrates signs and symptoms of polyneuropathy and
an improvement in these signs and symptoms since
starting therapy for continuation
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
neurologist, geneticist, or physician specializing in the
treatment of amyloidosis.
IV. CRITERIA FOR INITIAL APPROVAL
Polyneuropathy of Hereditary Transthyretin-mediated
Amyloidosis
Authorization of 12 months may be granted for treatment of
polyneuropathy of hereditary transthyretin-mediated
amyloidosis (also called transthyretin-type familial amyloid
polyneuropathy [ATTR-FAP]) when all of the following criteria
are met:
A. The diagnosis is confirmed by detection of a mutation of
the TTR gene.
B. Member exhibits clinical manifestations of ATTR-FAP (e.g.,
amyloid deposition in biopsy specimens, TTR protein
variants in serum, progressive peripheral sensory-motor
polyneuropathy).
C. The member is not a liver transplant recipient.
D. The requested medication will not be used in combination
with patisiran (Onpattro), tafamidis (Vyndaqel, Vyndamax)
or vutrisiran (Amvuttra).
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for the continued
treatment of ATTR-FAP when all of the following criteria are
met:
A. The member must have met all initial authorization criteria.
B. The member must have demonstrated a beneficial response
to treatment with Tegsedi therapy compared to baseline
(e.g., improvement of neuropathy severity and rate of
disease progression as demonstrated by the modified
Neuropathy Impairment Scale+7 (mNIS+7) composite
score, the Norfolk Quality of Life-Diabetic Neuropathy (QoL-
DN) total score, polyneuropathy disability (PND) score, FAP
disease stage, manual grip strength). Documentation from
the medical record must be provided.
Place of Service:
Outpatient
The above policy is based on the following references:
- Tegsedi [package insert]. Waltham, MA: Sobi, Inc.; June 2022.
- Benson MD, et. al., Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5; 379(1):22-31.
- Ando Y, Coelho T, Berk JL, Cruz MW, Ericzon BG, Ikeda S, Lewis WD, Obici L, Planté-Bordeneuve V, Rapezzi C, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet J Rare Dis. 2013; 8:31.
- Sekijima Y. Hereditary Transthyretin Amyloidosis. 2001 Nov 5 [Updated 2021 June 17]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1194/. Accessed April 1, 2022.
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.
September 20, 2022
