BlueCross BlueShield of Tennessee Medical Policy Manual

Ocrelizumab

NDC CODE(S)

50242-0150-XX - Ocrevus 300 MG/10 ML SOLN (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.      

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

Note: patients with primary progressive MS generally do not have clinical relapses and do not typically develop new lesions on MRI

INDICATION(S) DOSAGE & ADMINISTRATION

Multiple Sclerosis

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

  • Administer first subsequent dose 6 months after infusion of the initial dose

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and is eligible for renewal.

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  

Lexi-Comp Online. (2018). AHFS DI. Ocrellizumab. Retrieved November 2, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018,October). Ocrellizumab. Retrieved November 1, 2018 from MICROMEDEX Healthcare Series.

Rae-Grant, A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Report of the Guideline Development, Dissemination, and  Implementation Subcommittee of the American Academy of Neurology. Neurology® 2018;90:777-788. doi:10.1212/WNL.0000000000005347.

Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.

U. S. Food and Drug Administration. (2017, March). Center for Drug Evaluation and Research. Ocrevus™ (ocrelizumab) injection, for intravenous use. Retrieved November  1, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf.

ORIGINAL EFFECTIVE DATE: 4/28/2017

MOST RECENT REVIEW DATE:  4/2/2019

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  1 mg = 1 billable unit (effective 1/1/2018)  

DIAGNOSIS

MAXIMUM UNITS

Multiple Sclerosis

Initial dose:

300 billable units (mg) D1 and D15

Subsequent doses:

600 billable units (mg) every 6 months