72126-0007-XX TEGSEDI 284MG/1.5ML Solution Prefilled Syringe (AKCEA THERAPEUTICS)
Inotersen is an antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) protein synthesis. It is used for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Inotersen for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Inotersen for the treatment of other conditions/diseases is considered investigational.
Inotersen is considered medically appropriate if ALL of the following criteria are met:
Individual is/has ALL of the following:
18 years of age or older
Enrolled in the Tegsedi REMS program
Platelet count of ≥ 100 X 109/L
Baseline urine protein to creatinine ratio (UPCR) of ≤ 1000 mg/g
Definitive diagnosis of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis /Familial Amyloidotic Polyneuropathy (FAP) as documented by amyloid deposition on tissue biopsy OR identification of a pathogenic TTR variant using molecular genetic testing
Receiving supplementation with vitamin A at the recommended daily allowance
Must not be used in combination with other transthyretin (TTR) reducing agents (e.g., patisiran, tafamidis, etc.)
Used for the treatment of polyneuropathy as demonstrated by ANY TWO of the following:
Subjective individual symptoms are suggestive of neuropathy
Abnormal nerve conduction studies are consistent with polyneuropathy
Abnormal neurological examination is suggestive of neuropathy
Peripheral neuropathy is attributed to hATTR/FAP and other causes of neuropathy have been excluded
Baseline in strength/weakness has been documented using an objective clinical measuring tool (e.g., Medical Research Council [MRC] muscle strength, etc.)
Individual has not been the recipient of an orthotopic liver transplant (OLT)
Inotersen is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Individual has a baseline urine protein to creatinine ratio (UPCR) of ≤ 1000 mg/g
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion-related reactions, stroke and cervicocephalic arterial dissection, hypovitaminosis A, severe thrombocytopenia, glomerulonephritis, hepatotoxicity, etc.
Disease response compared to pre-treatment baseline as evidenced by stabilization or improvement in one or more of the following:
Signs and symptoms of neuropathy
MRC muscle strength
DOSAGE & ADMINISTRATION
hATTR/ FAP polyneuropathy
The recommended dose of Tegsedi is 284 mg injected subcutaneously once weekly.
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
Lexicomp Online. (2020). AHFS DI. Inotersen sodium. Retrieved October 13, 2020 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2020, August). Inotersen. Retrieved October 13, 2020 from MICROMEDEX Healthcare Series.
Sekijima, Y., Yoshida, K., Tokuda, T., Ikeda, S. (2001, November, updated 2012, January). Familial Transthyretin Amyloidosis. In: Adam, M. P., Ardinger, H. H., Pagon, R.A., et al., eds., GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2018. Retrieved November 9, 2018 from https://www.ncbi.nlm.nih.gov/books/NBK1194/.
U. S. Food and Drug Administration. (2020, July). Center for Drug Evaluation and Research. TEGSEDI™ (inotersen) injection for subcutaneous use . Retrieved October 13, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211172s008lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 12/8/2020
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.
This document has been classified as public information
Maximum billable units per dose and over time by indication as a Medical Benefit (1.5 mL prefilled syringe = 284 mg)