BlueCross BlueShield of Tennessee Medical Policy Manual

Vutrisiran (Amvuttra™)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

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

Amvuttra 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.    Initial Requests:

1. Testing or analysis confirming a mutation in the TTR gene
2.  Medical record documentation confirming the member demonstrates signs and symptoms of polyneuropathy

2. Continuation requests: Chart notes or medical record documentation supporting clinical benefit of therapy compared to baseline.

       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 in 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 any other medication approved for the treatment of hereditary transthyretin-mediated amyloidosis (e.g., Onpattro, Tegsedi, Vyndamax, Vyndaqel, Wainua). 

         V.    CONTINUATION OF THERAPY   

Authorization of 12 months may be granted for the continued treatment in members requesting reauthorization for an indication listed in Section IV when all of the following criteria are met:

A.    Member must have met all initial authorization criteria.

B.    Member must have demonstrated a beneficial response to treatment with the requested medication 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).         

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Amvuttra [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; February 2023.
2. Ando Y, Coelho T, Berk JL, , et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet J Rare Dis. 2013; 8:31.
3. Sekijima Y. Hereditary Transthyretin Amyloidosis. 2001 Nov 5 [Updated 2021 June 17]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1194/.   Accessed March 4, 2024.

ORIGINAL EFFECTIVE DATE: 8/30/2022

MOST RECENT REVIEW DATE: 3/4/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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