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Asset Publisher
Ocrevus™ (ocrelizumab)
Policy Number: PH-0298
Intravenous
Last Review Date: 10/03/2023
Date of Origin: 04/25/2017
Dates Reviewed: 04/2017, 9/19/2017, 12/2017, 03/2018, 06/2018, 10/2018, 09/2019, 10/2020, 10/2021, 10/2022, 10/2023
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC unit]:
- Ocrevus 300 mg single-dose vial: 2 vials in first 2 weeks, then 2 vials per 6 months
- Max Units (per dose and over time) [HCPCS Unit]:
Initial dose:
- 300 billable units (300 mg) on day 1 and day 15
Subsequent doses:
- 600 billable units (600 mg) every 6 months
- Initial Approval Criteria 1
Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information. |
Coverage is provided in the following conditions:
- Patient is at least 18 years of age (unless otherwise specified); AND
- Patient 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); AND
- Patient has had baseline serum immunoglobulins assessed; AND
Universal Criteria 1
- Patient will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation of treatment; AND
- Patient does not have an active infection; AND
- Must be used as single agent therapy; AND
- Patient has not received a dose of ocrelizumab or ublituximab within the past 5 months; AND
Multiple Sclerosis † 1,7,11
- Patient must have a confirmed diagnosis of multiple sclerosis (MS) as documented by laboratory report (i.e., MRI); AND
- Patient has a diagnosis of a relapsing form of MS [i.e., relapsing-remitting MS (RRMS)*, active secondary progressive disease (SPMS)**, or clinically isolated syndrome (CIS)***]; OR
- Patient has a diagnosis of primary progressive MS (PPMS)****; AND
-
- Patient is less than 65 years of age; AND
- Patient has an expanded disability status scale (EDSS) score of ≤ 6.5
† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug
*Definitive diagnosis of MS with a relapsing-remitting course is based upon BOTH dissemination in time and space. Unless contraindicated, MRI should be obtained (even if criteria are met). 11 |
|
Dissemination in time (Development/appearance of new CNS lesions over time) |
Dissemination in space (Development of lesions in distinct anatomical locations within the CNS; multifocal) |
|
|
**Active secondary progressive MS (SPMS) is defined as the following: 8,11-13,15 |
|
***Definitive diagnosis of CIS is based upon ALL of the following: 11 |
|
****Definitive diagnosis of MS with a primary progressive course is based upon the following: 11 |
|
- Renewal Criteria 1,6,10,14
Coverage can be renewed based on the following criteria:
- Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, severe infections, progressive multifocal leukoencephalopathy malignancy, hypogammaglobulinemia, immune-mediated colitis, etc.; AND
- Continuous monitoring of response to therapy indicates a beneficial response* [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)]
*Note:
|
Note: patients with primary progressive MS generally do not have clinical relapses and do not typically develop new lesions on MRI
PPMS
- Patient continues to be ambulatory, defined as an EDSS score of <7.5
- Dosage/Administration 1
Indication |
Dose |
Multiple Sclerosis |
Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg IV infusion Subsequent doses: 600 mg IV infusion every 6 months
|
- Billing Code/Availability Information
HCPCS:
- J2350 – Injection, ocrelizumab, 1 mg; 1 mg = 1 billable unit
NDC:
- Ocrevus 300 mg/10 mL single-dose vial: 50242-0150-xx
- References
- Ocrevus [package Insert]. South San Francisco, CA; Genentech, Inc.; August 2023. Accessed September 2023.
- Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220.
- Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234.
- Gawronski KM, Rainka MM, Patel MJ, Gengo FM. Treatment Options for Multiple Sclerosis: Current and Emerging Therapies. Pharmacotherapy. 2010; 30(9):916-927.
- Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22; 58(2):169-78.
- Freedman MS, Selchen D, Arnold DL, et al. Treatment optimization in MS: Canadian MS Working Group updated recommendations. Can J Neurol Sci. 2013 May;40(3):307-23.
- Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria. Ann Neurol. 2011 Feb; 69(2): 292–302. doi: 10.1002/ana.22366.
- Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86.
- Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. 2019 September. http://www.nationalmssociety.org/getmedia/5ca284d3-fc7c-4ba5-b005-ab537d495c3c/DMT_Consensus_MS_Coalition_color. Accessed August 2023.
- 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.
- 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.
- Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263. Epub 2018 Mar 23.
- Lorscheider J, Buzzard K, Jokubaitis V, et al, on behalf of the MSBase Study Group. Defining secondary progressive multiple sclerosis. Brain, Volume 139, Issue 9, September 2016, Pages 2395–2405, https://doi.org/10.1093/brain/aww173.
- Freedman MS, Devonshire V, Duquette P, et al; Canadian MS Working Group. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. Can J Neurol Sci. 2020 Jul;47(4):437-455. doi: 10.1017/cjn.2020.66.
- Cree BAC, Arnold DL, Chataway J, et al. Secondary Progressive Multiple Sclerosis: New Insights. Neurology. 2021 Aug 24;97(8):378-388. doi: 10.1212/WNL.0000000000012323. Epub 2021 Jun 4.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
G35 |
Multiple Sclerosis |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
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Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |