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Coverage criteria policies

Ocrelizumab (Ocrevus®) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Ocrelizumab (Ocrevus) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Initial authorization criteria

  1. Patient must be at least 18 years old; and,
  2. Must be prescribed by a provider specializing in neurology; and,
  3. Prescriber’s specialty must be provided at time of request; and,
  4. One of the following two criteria must be met:
    1. Patient must have a diagnosis of primary progressive multiple sclerosis (PPMS) as documented by objective findings (e.g., MRI); or,
    2. Patient must meet both of the following criteria:
      1. Patient must have a diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS [RRMS], secondary progressive MS [SPMS] with relapses or progressive relapsing MS [PRMS]) as documented by objective findings (e.g. MRI); and 
      2. Patient with relapsing forms of MS has documented prior trial and failure (or contraindication) of 2-year trial of continuous use of glatiramer or Glatopa.
  5. Patient has been screened for the presence of Hepatitis B virus (HBV) prior to initiating treatment and patient does not have active disease (i.e., positive for HBsAg and anti-HBV tests); and,
  6. Ocrevus is to be used as single agent therapy for MS (not to be used in combination with another MS disease modifying agent); and,
  7. Patient must not have any one of the following:
    1. Active hepatitis B virus infection; or,
    2. Concurrent administration of Ocrevus with live vaccine; and
  8. Prescriber must provide baseline assessment using at least one of the following:
    1. Increase in annualized relapse rate [ARR]
    2. Development of new brain lesions on MRI 
    3. Onset or progression of sustained disability as evidenced by Expanded Disability Status Scale [EDSS]
    4. 25-foot walk test
    5. 9-hole peg test (9-HPT)

Reauthorization criteria

  1. Patient continues to meet criteria defined for initial approval; and,
  2. Patient has not had a life-threatening infusion-related reaction with prior use; and,
  3. Absence of unacceptable toxicity from the drug (e.g., recurrent severe infections, severe immunosuppressive effectives, documented neutralizing antibodies); and,
  4. Patient with relapsing forms of MS has demonstrated improvement or lack of progression from baseline in at least one of the following:
    1. Increase in annualized relapse rate [ARR]
    2. Development of new brain lesions on MRI 
    3. Onset or progression of sustained disability as evidenced by Expanded Disability Status Scale [EDSS]
    4. 25-foot walk test
    5. 9-hole peg test (9-HPT)
  5. Patient with PPMS diagnosis has demonstrated a lack of meaningful progression.
  1. Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
  2. Subsequent doses: 600 mg intravenous infusion every 6 months

Definitions:

OCREVUS is a CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS Codes

Codes

Description

J2350

Injection, ocrelizumab, 1 mg

NDC Codes

Codes

Description

50242015001

Ocrevus 300 MG/10ML SOLN

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/ocrevus.jsp

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Policy activity

  • 09/01/2017 - Date of origin
  • 10/01/2018 - Effective date
Review date
  • 08/2018
Revision date
  • 05/07/2018

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