Limited coverage criteria – ocrelizumab

ocrelizumab

300 mg/10 mL (30 mg/mL) concentrate for solution

Initial

For treatment of early primary progressive multiple sclerosis (PPMS) in adult patients who meet ALL of the following criteria:

• Between the ages of 18 and 55 years of age 
• Diagnosis of early PPMS is confirmed based on McDonald diagnostic criteria
• Diagnostic imaging features characteristic of inflammatory activity
• Level of disability from disease meeting the below:
  • A recent Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5 prior to initiation of ocrelizumab; AND
  • A Functional Systems Scale (FSS) score of at least 2.0 for the pyramidal system due to lower extremity findings (Note that FSS scores associated with disability in other systems such as brainstem or cerebellar can be considered);
• Disease duration from onset of multiple sclerosis meeting one of the below:
  • Less than 15 years for those with an EDSS score greater than 5.0
  • Less than 10 years for those with an EDSS score equal to or less than 5.0

Approval of up to the maximum dose of 600 mg every 6 months for 1 year

Continued coverage

For continued coverage beyond the initial coverage period, the patient must be assessed between 6 months and 12 months, and every 12 months thereafter, and the request must meet the following criteria:

1. The registered MS Neurologist must confirm a diagnosis of PPMS
2. A current updated EDSS score must be provided and the patient must not have an EDSS score of 7.0 or above

Continued coverage may be approved for one dose of ocrelizumab 600 mg every 6 months for up to 12 months

Approval of up to the maximum dose of 600 mg every 6 months for 1 year