50242-0150-XX - Ocrevus 300 MG/10 ML SOLN (GENENTECH)
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.
Ocrelizumab for the treatment of multiple sclerosis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ocrelizumab for the treatment of other conditions/diseases is considered investigational.
Ocrelizumab for the treatment of multiple sclerosis is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age and older (unless otherwise specified)
Individual has been screened for the presence of Hepatitis B virus (HBV) prior to initiating treatment AND does not have active disease (i.e., positive HBsAg and anti-HBV tests)
Individual will not receive live vaccines concurrently with ocrelizumab
Individual does not have an active infection
Confirmed diagnosis of multiple sclerosis (MS) as documented by laboratory report (i.e., MRI, unless contraindicated )
Must be used as single agent therapy and diagnosed with ANY ONE of the following:
Definitive diagnosis of Multiple Sclerosis with a relapsing-remitting course [e.g., relapsing-remitting disease (RRMS) or secondary progressive MS (SPMS) with relapses] based upon ALL of the following:
Dissemination in time (Development/appearance of new CNS lesions over time) and ANY ONE of the following:
> 2 clinical attacks
1 clinical attack and ANY ONE of the following:
MRI indicating simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2- hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan
CSF-specific oligoclonal bands
Dissemination in space (Development of lesions in distinct anatomical locations within the CNS; multifocal) and ANY ONE of the following:
> 2 lesions
1 lesion and ANY ONE of the following:
Clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location
MRI indicating > 1 T2-hyperintense lesions characteristic of MS in > 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord)
Definitive diagnosis of Multiple Sclerosis with a primary progressive course [i.e., primary progressive MS (PPMS)] and ALL of the following:
1 year of disability progression independent of clinical relapse
Individual has ANY TWO of the following:
> 1 T2-hyperintense lesion characteristic of MS in one or more of the following regions of the CNS (periventricular, cortical or juxtacortical, or infratentorial)
> 2 T2-hyperintense lesions in the spinal cord
Presence of CSF-specific oligoclonal bands
Individual is less than 65 years of age
Individual has an expanded disability status scale (EDSS) score of ≤ 6.5
Ocrelizumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Individual has not received a dose of ocrelizumab within the past 5 months
Absence of unacceptable toxicity from the agent, examples of unacceptable toxicity include the following: severe infusion reactions, severe infections, malignancy, etc.
Continuous monitoring of response to therapy [manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate (ARR), development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale (EDSS), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT)]
Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as >1 relapse, >2 unequivocally new MRI-detected lesions, or increased disability on examination over a one-year period
Note: patients with primary progressive MS generally do not have clinical relapses and do not typically develop new lesions on MRI
Disease is Primary Progressive MS (PPMS) and individual continues to be ambulatory, defined as an EDSS score of <7.5
|INDICATION(S)||DOSAGE & ADMINISTRATION|
300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
600 mg intravenous infusion every 6 months
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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 mg = 1 billable unit (effective 1/1/2018)