BlueCross BlueShield of Tennessee Medical Policy Manual

Nusinersen

NDC CODE(S)

64406-0058-01 Spinraza 12 MG/5ML SOLN (Biogen Idec)

DESCRIPTION

Nusinersen (Spinraza™) is a modified antisense oligonucleotide (ASO) designed to increase exon 7 inclusion in SMN2 messenger RNA (mRNA) transcripts and increase production of full-length survival motor neuron (SMN) protein. Deficiency of full-length SMN1 protein may be caused by mutations in chromosome 5q. Nusinersen bypasses this particular 5q mutation in the treatment of SMA.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Spinal muscular atrophy,

All types

The recommended dosage is 12 mg (5 mL) per intrathecal administration:

4 loading doses - first three at 14-day intervals, 4th at 30 days after 3rd dose

Maintenance dose once every 4 months thereafter

The initial authorization period will be for 4 months for loading doses - a total of 20 billable units - 60 mg (20 mL)

Subsequent authorization periods are for 12 months - a total of 15 billable units - 36mg (15mL)

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).

SOURCE

U. S. Food and Drug Administration. (2016, December). Center for Drug Evaluation and Research. Spinraza™ (nusinersen) injection, for intrathecal use. Retrieved January 23, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/30/2017

MOST RECENT REVIEW DATE:  3/30/2017

ID_MRxEx

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.

Pharmaceutical Decision Support Tree

Nusinersen (Spinraza™)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #7

  1. Does the individual have a diagnosis of 5q spinal muscular atrophy (SMA) confirmed by ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation of baseline laboratory testing and confirmation that it will be performed prior to each administration of ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual maintain voluntary motor function with baseline documentation of ANY ONE (or more) of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will administration be by intrathecal bolus performed by a healthcare professional experienced in lumbar punctures?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 4 loading doses at 12 mg (5 mL) per intrathecal administration, the first three at 14-day intervals and the 4th to be given 30 days after 3rd dose for a total of 20 billable units in a 4 month initial authorization period? 

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 5?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation of updated laboratory testing prior to each administration including ALL of the following?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation of the absence of unacceptable toxicity from the agent, e.g., coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia and renal toxicity, including potentially fatal glomerulonephritis?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the individual responded to therapy compared to pretreatment baseline in ANY ONE (or more) of the following with improvement or slowed rate of decline in ALL measures?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for maintenance dosing once every 4 months after the previous dose, for a total of 15 billable units of 36 mg (15 mL) in a 12 month period?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.