OCREVUS (Ocrelizumab) MB9941

Covered Service: Yes

Prior Authorization Required: Yes

Additional Information: Must be prescribed by a neurology specialist with prior authorization through Navitus.

Medicare Policy: Prior authorization is dependent on the member’s Medicare coverage. Prior authorization is not required for Medicare Cost products (Dean Care Gold) and Medicare Supplement (Select) when this drug is provided by participating providers. Prior authorization is required if a member has Medicare primary and the plan secondary coverage. This policy is not applicable to our Medicare Replacement products. BadgerCare Plus Prescription drug benefits are administered by the Wisconsin Policy: Medicaid program. Office administered pharmacy benefits are covered by the plan when covered under the Wisconsin Medicaid fee-for-service program and not paid on a fee-for-service basis by the State of Wisconsin Medicaid program.

Plan Approved Criteria: 1.0 Injections of drugs that are administered at an excessive frequency or dose are not medically necessary. Frequency or dosing are considered excessive when services are performed more frequently or at a higher dose than listed in the FDA-approved package insert, listed in this document or generally accepted by peers and the reason for additional services is not justified by submitted documentation of clinical evidence. Route of administration of injectable drugs should follow the FDA-approved package insert. 2.0 Hepatitis B virus screening and quantitative serum immunoglobulin testing is required before the first infusion. For those members with low serum immunoglobulin, consult immunology experts before initiating treatment.

Initial Criteria (approved for up to 8 months, subject to formulary changes): 1.0 A clinical diagnosis of primary progressive multiple sclerosis in adult members. 2.0 A clinical diagnosis of relapsing forms of multiple sclerosis (MS) in adult members and all of the following:

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Coverage of any drug intervention discussed in the plans prior authorization guideline is subject to the limitations and exclusions outlined in the member's benefit certificate or policy and to applicable state and/or federal laws. 2.1 Member has a contraindication, allergy, intolerance, or failure of an adequate trial of an interferon-based product (e.g. AVONEX, PLEGRIDY, COPAXONE, REBIF, EXTAVIA) or a glatiramer product (e.g. COPAXONE); AND 2.2 Member has a contraindication, allergy, intolerance, or failure of an adequate trial of TECFIDERA, GILENYA, or AUBAGIO; 2.3 These trials may be waived for members with high risk/aggressive disease defined as including at least ONE of the following (with chart documentation): 2.3.1 Multiple spinal cord lesions (≥2) 2.3.2 Brainstem/infratentorial lesions (≥1) 2.3.3 Significant disease burden on MRI (≥10 lesions) 2.3.4 Short interval between relapses (≥2 relapses in ≤2 years) 2.3.5 Treatment failure (clinically or radiographically) with a previous disease-modifying treatment 2.3.6 Incomplete recovery from previous relapse (e.g. residual symptoms remaining) 2.3.7 Motor-based relapse (e.g. gait disturbances) 2.4 No concurrent use with other disease modifying treatments (e.g. interferons, COPAXONE, GLATOPA, GILENYA, AUBAGIO, or TECFIDERA), B cell targeted therapy (e.g. rituximab, belimumab, ofatumumab), or lymphocyte trafficking blockers (e.g. alemtuzumab, mitoxantrone)

Continuation Criteria (approved for up to 12 months, subject to formulary changes): 1.0 Member continues to meet initial criteria; AND 2.0 Provider attestation of disease improvement or stability (e.g. improvement include no or decreasing relapses, decreased number of lesions or less lesion volume, and more stable or improved member neurological function); AND 3.0 Further quantitative serum immunoglobulin testing and consider discontinuation if members develop serious opportunistic or recurrent infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins

Comment(s): 1.0 Initial infusion and duration limits as follows: 1.1 300mg on day 1, followed by 300mg 2 weeks later; subsequent doses of 600mg every 6 months (beginning approximately 6 months after the first 300mg dose, with a total approval duration of 8 months from authorization approval) 2.0 Continuation of therapy limits and criteria:

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Coverage of any drug intervention discussed in the plans prior authorization guideline is subject to the limitations and exclusions outlined in the member's benefit certificate or policy and to applicable state and/or federal laws. 2.1 After the 3 infusions from the initial therapy, a maximum of 2 infusions in a 1 year period may be considered medically necessary when documentation indicate that the member is not receiving ocrelizumab in combination with any therapy with disease modifying therapy, B cell targeted therapy, or lymphocyte trafficking blockers noted in section 5.1 and is continued to be regularly seen by a provider specializing in care of MS members 2.2 Exceptions to infusion limits (splitting every 6 month infusion into two separate infusions of 300mg two weeks apart) during the maintenance phase may be made in cases with documented severe infusion reactions. 3.0 In use for MS: 3.1 For purpose of this policy, ‘failure’ is defined as: 3.1.1 Member has increasing relapses (defined as two or more relapses in a year, or one severe relapse associated with either poor recovery or MRI lesion progression); OR 3.1.2 Member has lesion progression verified by MRI (increased number or volume of lesions, T2 hyperintense lesions, or T1 hypointense lesions); OR 3.1.3 Member has worsening disability (sustained worsening of neurological examination findings). 4.0 *Coding specifications *Codes and descriptors listed in this document are provided for informational purposes only and may not be all inclusive or current. Listing of a code in this drug policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member’s policy of health coverage with the plan. Inclusion of a code in the table does not imply any right to reimbursement or guarantee claim payment. Other drug or medical policies may also apply. 4.1 NDC and HCPCS codes

Medication Name How Supplied National Drug Brand Generic Code (NDC) HCPCS code OCREVUS ocrelizumab 20 mg/mL single dose 50242-0150-01 J2350 vial

5.0 NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. OCREVUS (ocrelizumab) 3 of 4

Document Medical Policy Committee/Quality and Care Created: Management/Pharmacy Services July 19, 2017 Revised: Medical Policy Committee/Quality and Care Management Division/Pharmacy Services November 15, 2017 Medical Policy Committee/Quality and Care Management Division/Pharmacy Services July 18, 2018 Medical Policy Committee/Health Services Division/Pharmacy Services August 15, 2018 Medical Policy Committee/Health Services Division/Pharmacy Services April 17, 2019 Medical Policy Committee/Health Services Division/Pharmacy Services June 19, 2019 Medical Policy Committee/Health Services Division/Pharmacy Services April 15, 2020 Medical Policy Committee/Health Services Division/Pharmacy Services April 21, 2021

Reviewed: Medical Policy Committee/Quality and Care Management Division/Pharmacy Services November 15, 2017 Medical Policy Committee/Quality and Care Management Division/Pharmacy Services July 18, 2018 Medical Policy Committee/Health Services Division/Pharmacy Services August 15, 2018 Medical Policy Committee/Health Services Division/Pharmacy Services April 17, 2019 Medical Policy Committee/Health Services Division/Pharmacy Services June 19, 2019 Reviewed: Medical Policy Committee/Health Services Division/Pharmacy Services April 15, 2020 Medical Policy Committee/Health Services Division/Pharmacy Services April 21, 2021

Effective: 08/01/2021 Published: 05/01/2021

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