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 17, 2024
Next Review:      December 20, 2025
 

Related MDC: NONE

Ocrevus™ (ocrelizumab)

Summary

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.

POLICY STATEMENTS

Initiation of ocrelizumab (Ocrevus) meets the definition of medical necessity when all the criteria below is met.

POLICY GUIDELINES

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.

DOSAGE/ADMINISTRATION

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).

REQUIRED MEDICAL INFORMATION

I. Initiation of ocrelizumab (Ocrevus) meets the definition of medical necessity when ALL of the following are met:

1. Multiple Sclerosis (MS)

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

EXCLUSION CRITERIA

Active hepatitis B virus infection

History of life-threatening infusion reaction to Ocrevus

BENEFIT APPLICATION

As stated in the policy.

OTHER CRITERIA

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.

References

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

Applicable Modifiers

Some modifiers.

PolicY History