BlueCross BlueShield of Tennessee Medical Policy Manual

Blinatumomab

NDC CODE(S)

55513-0160-XX Blincyto 35 MCG SOLR (AMGEN)  

DESCRIPTION

Blinatumomab is the first immunotherapy approved by the FDA to activate the body’s own T-cells to fight disease. T-cells are types of white blood cells or lymphocytes Blinatumomab is the first immunotherapy approved by the FDA to activate the body’s own T-cells to fight disease. T-cells are types of white blood cells or lymphocytes which are natural parts of the immune system.  Functionally, blinatumomab is a bispecific CD19-directed CD3 T- cell engager.

The B-lymphocyte antigen CD19 is found on the surface of B-cells throughout all stages of their development.  CD19 is present on both benign and malignant B-cells and has been found to be an effective target for antineoplastic agents.

The CD3 antigen or T-cell co-receptor is a protein complex is found on the surface of T-cells.  It is comprised of four distinct immunoglobulin chains and a single immunoreceptor tyrosine-based activation motif (ITAM). The transmembrane region of the chains is negatively charged and associates with the positively-charged T-cell receptor (TCR) molecule forming the TCR complex.  This complex generates the signal for T-cell proliferation and activation.

Blinatumomab selectively binds to CD19 molecules on the surface of CD19+ B-cell lymphoblasts and to the CD3 on T-cells causing proliferation of T-cells through the action of the TCR complex.  The outcome is upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines and proliferation of T-cells leading to destruction of malignant B-cells such as those of leukemia.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION

ALL

(wt ≥ 45 kg)

Cycle 1:

9 mcg daily x 7 days, then 28 mcg daily x 21 days in a 42 day cycle

Cycles 2-5:

28 mcg daily x 28 days in a 42 day cycle.

Cycles 6-9:

28 mcg daily x 28 days in an 84 day cycle.

*May repeat for up to 9 total cycles of therapy.

ALL

(wt < 45 kg)

Cycle 1:

5 mcg/m2/day (not to exceed 9 mcg/day) x 7 days, then 15 mcg/m2/day (not to exceed 28 mcg/day) x 21 days in a 42 day cycle

Cycles 2-5:

15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in a 42 day cycle.

Cycles 6-9:

15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in an 84 day cycle.

*May repeat for up to 9 total cycles of therapy

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).

No controlled studies were found in the published literature that validate the use of blinatumomab for the treatment or prevention of other conditions or diseases.

SOURCES

Lexicomp Online. (2017). AHFS DI. Blinatumomab. Retrieved August 30,2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, July). Blinatumomab. Retrieved August 30, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Blinatumomab. Retrieved August 30, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, July). Center for Drug Evaluation and Research. Blincyto™ (blinatumomab) for injection, for intravenous use. Retrieved August 30, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/22/2015

MOST RECENT REVIEW DATE:  10/10/2017

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

Pharmaceutical Decision Support Tree

Blinatumomab (Blincyto®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 1 month of age or older with a diagnosis of B –cell precursor acute lymphoblastic leukemia (ALL) that is relapsed or refractory?

If yes, go to question #3

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

  1. Will treatment be as a single agent?

If yes, go to question #4

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

  1. Is the request for ANY ONE of the following Initial coverage will be provided for 30 weeks for a total of five cycles (2 cycles of induction followed by 3 cycles of consolidation) (continued coverage will be provided every 24 weeks for a maximum of two additional authorizations (4 cycles of continued therapy)?

INDICATION(S) DOSAGE & ADMINISTRATION

ALL

(wt ≥ 45 kg)

Cycle 1:

9 mcg daily x 7 days, then 28 mcg daily x 21 days in a 42 day cycle

Cycles 2-5:

28 mcg daily x 28 days in a 42 day cycle.

Cycles 6-9:

28 mcg daily x 28 days in an 84 day cycle.

*May repeat for up to 9 total cycles of therapy.

ALL

(wt < 45 kg)

Cycle 1:

5 mcg/m2/day (not to exceed 9 mcg/day) x 7 days, then 15 mcg/m2/day (not to exceed 28 mcg/day) x 21 days in a 42 day cycle

Cycles 2-5:

15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in a 42 day cycle.

Cycles 6-9:

15 mcg/m2/day (not to exceed 28 mcg/day) x 28 days in an 84 day cycle.

*May repeat for up to 9 total cycles of therapy

If yes, this satisfies medical necessity and 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 criteria in questions 2 through 4?

If yes, go to question #6

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

  1. Is there absence of unacceptable toxicity e.g., Cytokine Release Syndrome (CRS), neurological toxicities, serious infections, pancreatitis; etc.?

If yes, go to question #7

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

  1. Response to treatment or stabilization of disease is indicated by CBC, bone marrow cytogenic analysis, QPCR, or FISH?

If yes, go to question #8

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

  1. Has the Individual NOT exceeded a total of 4 cycles of continued therapy or 9 total cycles of blinatumomab?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

This document has been classified as public information.