BlueCross BlueShield of Tennessee Medical Policy Manual

Ocrelizumab

NDC CODE(S)

50242-0150-XX Ocrevus 300 mg/10 mL vial (GENENTECH)

DESCRIPTION

Ocrelizumab is a recombinant humanized monoclonal antibody that is directed against CD20-directed B-cells.  It is a glycosylated immunoglobulin G1 (IgG1) and the exact mechanism by which it exerts its therapeutic effect in multiple sclerosis is unknown.  It is presumed to involve binding to the cell surface antigen CD20 present on pre-B and mature B lymphocytes resulting in antibody-dependent cellular cytolysis and complement-mediated lysis.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Relapsing or Primary Progressive forms of Multiple Sclerosis
  • Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial (Must be diluted prior to administration)

    • Initial dosage: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion

    • Subsequent doses: 600 mg intravenous infusion every 6 months

  • Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion

  • Monitor patients closely during and for at least one hour after infusion

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. (2017, March). Center for Drug Evaluation and Research. Ocrevus™ (ocrelizumab) injection, for intravenous use. Retrieved March 30, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf.

ORIGINAL EFFECTIVE DATE:  4/28/2017

MOST RECENT REVIEW DATE:  4/28/2017

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

Ocrelizumab (Ocrevus)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 18 years of age or older with a negative screen for the Hepatitis B virus (HBV)?

If yes, go to question #3

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

  1. Does the individual have a diagnosis of multiple sclerosis further diagnosed as ANY ONE of the following?

If yes, go to question #4

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

  1. Is the request for 2 single dose vials (300 mg/10 mL in a single-dose vial, for a total request of 600 mg) for a 300 mg IV infusion followed 2 weeks later by a second 300 mg infusion, both with premedication with a methylprednisolone and an antihistamine with close monitoring during and for at least an hour after infusion for an initial authorization period of 6 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

  1. Is there absence of unacceptable toxicity from the agent, e.g., severe upper respiratory tract infections, lower respiratory tract infections, skin infections, herpes-related infections, bronchospasm, pharyngeal or laryngeal edema, hypotension, headache, dyspnea, pyrexia, tachycardia?

If yes, go to question #6

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

  1. Is there absence of active infection?

If yes, go to question #7

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

  1. Does the individual show evidence of ANY ONE of the following?

If yes, go to question #8

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

  1. Is the request for 2 single dose vials (300 mg/10 mL in a single-dose vial, for a total request of 600 mg) with premedication with a methylprednisolone and an antihistamine with close monitoring during and for at least an hour after infusion for an authorization period of six months?

If yes, this satisfies medical necessity and medical appropriateness criteria for the initial dosage

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

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