BlueCross BlueShield of Tennessee Medical Policy Manual

Inotersen

NDC CODE(S)

71860-0007-XX Tegsedi 284 mg / 1.5 ml SYR (AKCEA THERAPEUTICS INC)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION

hATTR/ FAP polyneuropathy

The recommended dose of Tegsedi is 284 mg injected subcutaneously once weekly.

·         For consistency of dosing, patients should be instructed to give the injection on the same day every week.

·         If a dose is missed, patients should be instructed to take the missed dose as soon as possible, unless the next scheduled dose is within 2 days. In this situation, the patient should be directed to skip the missed dose and take the next scheduled dose on the scheduled day.

Patients should receive vitamin A supplementation.

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.

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, the express terms of the health plan will govern.

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).

SOURCES

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, October). Inoterson. Retrieved November 6, 2018 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. (2018 October). Center for Drug Evaluation and Research. TEGSEDI™ (inotersen) injection for subcutaneous use . Retrieved November 5, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf.    

ORIGINAL EFFECTIVE DATE:  3/2/2019

MOST RECENT REVIEW DATE:  5/31/2019

ID_MRx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

MAXIMUM UNITS

hATTR/ FAP polyneuropathy

284 mg every 7 days