Medical Drug Criteria (MDC)
Policy Num: P1.002.005
Policy Name: Ocrevus™ (ocrelizumab)
Policy ID: [P1.002.005] [Ac / Mg / M+ / P+] [0.00.00]
Last Review: December 19, 2025
Next Review: December 20, 2026
Related MDC: NONE
| Popultation Reference No. | Populations |
|---|---|
| 1 | Individuals:
|
Ocrelizumab is a humanized monoclonal antibody that is directed against CD20-expressing B-cells. CD20 is a cell surface antigen that is present on pre-B and mature B lymphocytes. Ocrelizumab binds to CD20 on B lymphocytes and causes antibody-dependent cellular cytolysis and complement-mediated lysis.
Initiation of ocrelizumab (Ocrevus) meets the definition of medical necessity when all the criteria below is met.
Authorization of 12 months may be granted for ocrelizumab (Ocrevus) when prescribed for the treatment of primary progressive multiple sclerosis (MS) in adults and relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults.
Multiple Sclerosis
Initial dose:
300 mg once IV on day 1, followed by 300mg once IV two weeks later
Subsequent doses:
600 mg IV once every 6 months (beginning 6 months after the first 300mg dose).
Before initiating OCREVUS, screen for Hepatitis B virus and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin.
Hepatitis B Virus Screening
Prior to initiating OCREVUS, perform Hepatitis B virus (HBV) screening. OCREVUS is contraindicated in patients with active HBV confirmed by positive results for HBsAg and anti-HBV tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.
Serum Immunoglobulins
Prior to initiating OCREVUS, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with OCREVUS.
Liver Function Tests
Prior to initiating OCREVUS, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels.
Recommended Dose, Infusion Rate, and Infusion Duration for RMS and PPMS
| Amount and Volume | Infusion Rate and Duration | ||
| Initial Dose | Infusion 1 | 300 mg in 250 mL | Start at 30 mL per hour Increase by 30 mL per hour every 30 minutes Maximum: 180 mL per hour Duration: 2.5 hours or longer |
| Infusion 2 (2 weeks later) | 300 mg in 250 mL | ||
| Subsequent Doses (one infusion) every 6 months) | Option 1 Infusion of approximately 3.5 hours duration | 600 mg in 500 mL | Start at 40 mL per hour Increase by 40 mL per hour every 30 minutes Maximum: 200 mL per hour Duration: 3.5 hours or longer |
| OR |
| ||
| Option 2 (If no prior serious infusion reaction with any previous OCREVUS infusion) Infusion of approximately 2 hours duration | 600 mg in 500 mL | Start at 100 mL per hour for the first 15 minutes Increase to 200 mL per hour for the next 15 minutes Increase to 250 mL per hour for the next 30 minutes Increase to 300 mL per hour for the remaining 60 minutes Duration: 2 hours or longer | |
I. Initiation of ocrelizumab (Ocrevus) meets the definition of medical necessity when ALL of the following are met:
a. Member meets ONE of the following:
i. Member is diagnosed with Primary Progressive MS
ii. Member is diagnosed with Relapsing-remitting MS [RRMS], active secondary progressive MS [SPMS], or first clinical episode and has MRI features consistent with MS
b. Member has been screened for hepatitis B virus and does not have an active hepatitis B virus infection
c. Ocrelizumab will NOT be used in combination with ANY of the following:
i. Alemtuzumab (Lemtrada)
ii. Cladribine (Mavenclad)
iii. Dimethyl fumarate (Tecfidera)
iv. Diroximel fumarate (Vumerity)
v. Fingolimod (Gilenya, Tascenso ODT)
vi. Glatiramer acetate (Copaxone, Glatopa)
vii. Interferon beta-1a (Avonex, Rebif)
viii. Interferon beta-1b (Betaseron, Extavia)
ix. Mitoxantrone (Novantrone)
x. Monomethyl fumarate (Bafiertam)
xi. Natalizumab (Tysabri)
xii. Ofatumumab (Kesimpta)
xiii. Ozanimod (Zeposia)
xiv. Peg-interferon beta-1a (Plegridy)
xv. Ponesimod (Ponvory)
xvi. Rituximab (Rituxan or biosimilars)
xvii. Siponimod (Mayzent)
xviii. Teriflunomide (Aubagio)
xix. Ublituximab (Briumvi)
d. The dose does not exceed 600 mg every 6 months*
*The first dose is given as a 300 mg infusion on day 1 and 15
Approval duration: 1 year
II. Continuation of ocrelizumab (Ocrevus) meets the definition of medical necessity for the treatment of multiple sclerosis when ALL of the following are met:
1. Ocrelizumab will NOT be used in combination with ANY of the following:
a. Alemtuzumab (Lemtrada)
b. Cladribine (Mavenclad)
c. Dimethyl fumarate (Tecfidera)
d. Diroximel fumarate (Vumerity)
e. Fingolimod (Gilenya, Tascenso ODT)
f. Glatiramer acetate (Copaxone, Glatopa)
g. Interferon beta-1a (Avonex, Rebif)
h. Interferon beta-1b (Betaseron, Extavia)
i. Mitoxantrone (Novantrone)
j. Monomethyl fumarate (Bafiertam)
k. Natalizumab (Tysabri)
l. Ofatumumab (Kesimpta)
m. Ozanimod (Zeposia)
n. Peg-interferon beta-1a (Plegridy)
o. Ponesimod (Ponvory)
p. Rituximab (Rituxan or biosimilars)
q. Simponimod (Mayzent)
r. Teriflunomide (Aubagio)
s. Ublituximab (Briumvi)
2. Member has demonstrated a beneficial response to therapy
3. The dose does not exceed 600 mg every 6 months
Approval duration: 1 year
Active hepatitis B virus infection
History of life-threatening infusion reaction to Ocrevus
As stated in the policy.
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) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.
1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2023 [cited 2023 Sept 29]. Available from: http://www.clinicalpharmacology.com/.
2. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2023 Sept 29].
3. Hauser SL, Bar-Or A, Comi G et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 2017; 376: 221-34.
4. Lublin FD, Reingold, SC, Cohen JA et al. Defining the clinical course of multiple sclerosis. Neurology. 2014; 83: 278-286.
5. Montalban X, Hauser SL, Kappos L et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med 2017; 376:209-20.
6. Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. Available at http://www.nationalmssociety.org/getmedia/5ca284d3-fc7c-4ba5- b005-ab537d495c3c/DMT_Consensus_MS_Coalition_color. Accessed 04/26/2016.
7. National Multiple Sclerosis Society. Available at http://www.nationalmssociety.org Accessed 10/02/19.
8. Ocrevus [prescribing information]. Genentech, Inc. South San Francisco, CA. August 2022.
9. Rae-Grant A, Day GS, Marrie RA et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis: Report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology. April 2018. Available at: https://www.aan.com/Guidelines/home/GuidelineDetail/898.
10. Florida Blue medical coverage guideline. http://mcgs.bcbsfl.com/MCG
| Codes | Number | Description |
|---|---|---|
| HCPCS | J2350 | Injection, ocrelizumab, 1 mg; 1 mg = 1 billable unit |
| ICD‐10 | G35 | Multiple Sclerosis |
Some modifiers.
| Date | Action | Description |
|---|---|---|
| 12/19/2025 | Review Medical Dug Criteria | Added InterQual® 2025, Oct. 2025 Release, CP:Specialty Rx Non-Oncology Ocrelizumab (Ocrevus). Added Assessments Prior to First Dose of OCREVUS criteria |
| 12/17/2024 | Review Medical Drug Criteria | Added InterQual® 2024, Mar. 2024 Release, CP:Specialty Rx Non-Oncology Ocrelizumab (Ocrevus). No change on PI. |
| 10/9/2024 | Review Medical Drug Criteria | Review sections of Policy Statement and Required Medical Information. |
| 12/04/2023 | Review Medical Drug Criteria | No changes |
| 12/16/2022 | New MDC | New medical drug criteria for Ocrevus™ (ocrelizumab) |