BlueCross BlueShield of Tennessee Medical Policy Manual

Patisiran

NDC CODE(S)

71336-1000-XX Onpattro 10 MG/5ML SOLN (ALNYLAM PHARMACEUTICALS)

DESCRIPTION

Patisiran is a double-stranded small interfering ribonucleic acid (siRNA) which is formulated as a lipid complex.  This makes it deliverable to hepatocytes where it specifically binds to mutant and wild-type transthyretin (TTR) messenger RNA (mRNA). This causes degradation of TTR mRNA through RNA interference resulting in a reduction of serum TTR protein.  Mean serum TTR was reduced by approximately 80% within 10 to 14 days after a single dose.  Ultimately it leads to diminished TTR protein deposits in tissues.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Polyneuropathy of hATTR/FAP

Recommended dosage:

Weight < 100 kg -  0.3 mg/kg intravenously every 3 weeks

Weight ≥ 100 kg - 30 mg intravenously every 3 weeks

Preparing for Therapy:

Dosing is based on actual body weight

Individual should be premedicated with a corticosteroid, acetaminophen and antihistamines.

Infusion should be filtered and diluted and infused, via a pump, over at least 80 minutes.

Individual should receive vitamin A supplementation.

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 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

Lexicomp Online. (2018, September). AHFS DI. Patisiran. Retrieved October 1, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, August). Patisiran. Retrieved October 1, 2018 from MICROMEDEX Healthcare Series.

Sekijima, Y., Yoshida, K., Tokuda, T., Ikeda, S. (2001, November 1, 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 October 2, 2018 from https://www.ncbi.nlm.nih.gov/books/NBK1194/.

U. S. Food and Drug Administration. (2018, August). Center for Drug Evaluation and Research. ONPATTRO® (patisiran) lipid complex injection, for intravenous use. Retrieved October 1, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/31/2019

MOST RECENT REVIEW DATE:  1/31/2019

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; 10 mg/5 mL single-dose vial

DIAGNOSIS

MAXIMUM UNITS

Polyneuropathy of hATTR/FAP 30 mg every 3 weeks