Is continuation of Ocrevus (ocrelizumab) medically necessary for a 60-year-old female with relapsing-remitting multiple sclerosis (RRMS)?

Continuation of Ocrevus for 60-Year-Old Female with RRMS

Yes, continuation of Ocrevus (ocrelizumab) is medically necessary for this 60-year-old female with RRMS, based on documented disease activity when switched to an alternative therapy, stable disease on Ocrevus, and established efficacy data supporting continued treatment in relapsing-remitting MS.

Clinical Justification for Continuation

Evidence of Treatment Efficacy

• This patient demonstrated disease activity (blurry vision) when switched from Ocrevus to Briumvi, indicating inadequate disease control with the alternative anti-CD20 therapy 1, 2.
• The patient was tolerating Ocrevus without reaction as of 9/2024, establishing good tolerability 1.
• Stable MRI in 12/2024 demonstrates effective disease control on Ocrevus, meeting continuation criteria 3, 1.
• Normal IgG levels and good drug monitoring results (May 2024) indicate the patient is not experiencing significant immunosuppression that would contraindicate continuation 2.

FDA-Approved Indication and Dosing

• Ocrelizumab is FDA-approved for relapsing forms of MS at 600 mg IV every 24 weeks, which matches this patient's diagnosis and proposed treatment regimen 1.
• The FDA label establishes that ocrelizumab reduces annualized relapse rate by approximately 46-47% compared to interferon beta-1a in pivotal trials 1.
• Confirmed disability progression was reduced by 40% (HR 0.60,95% CI 0.43-0.84) in patients with relapsing MS treated with ocrelizumab 1, 2.

Continuation Criteria Met

• Patients with RRMS who achieve disease stability on ocrelizumab should continue treatment, as discontinuation can lead to disease recurrence in approximately 10% of RRMS patients within 16-17 months 4.
• The American Academy of Neurology recommends ongoing monitoring with clinical assessment and MRI surveillance for RRMS patients on ocrelizumab, which this patient is receiving 3.
• Treatment duration in pivotal trials was 96 weeks with demonstrated sustained efficacy, and long-term data supports continuation beyond 7.5 years without new safety signals 2, 5.

Safety Profile Supporting Continuation

Tolerability Evidence

• Ocrelizumab is generally well tolerated, with the most common adverse events being infusion-related reactions, nasopharyngitis, and urinary/upper respiratory tract infections 2, 5.
• This patient has documented tolerance without reaction, meeting safety criteria for continuation 1.
• Treatment discontinuation due to adverse events occurred in only 3.7% of ocrelizumab-treated patients versus 6.4% with interferon beta-1a in pivotal trials 1, 2.

Monitoring Parameters

• Normal IgG levels indicate no significant hypogammaglobulinemia, which is a key safety concern with anti-CD20 therapies 2.
• Regular MRI monitoring (most recent 12/2024) and drug monitoring (May 2024) demonstrate appropriate safety surveillance is occurring 3, 1.

Risk of Treatment Interruption

Disease Reactivation Risk

• Focal inflammation recurs in approximately 9.8% of RRMS patients after ocrelizumab discontinuation, typically at a median of 17 months post-last infusion 4.
• This patient already experienced disease activity (blurry vision) when switched to Briumvi, demonstrating vulnerability to disease reactivation with treatment changes 4.
• MRI activity and clinical relapses can occur after stopping ocrelizumab, particularly in patients with previously active disease 4.

Comparative Efficacy

• Ocrelizumab demonstrates superior efficacy compared to interferon beta-1a with 61% reduction in relapse rate (RR 0.61,95% CI 0.52-0.73) 2.
• 48.1% of patients with suboptimal response to prior DMTs achieved NEDA (no evidence of disease activity) when switched to ocrelizumab over 96 weeks 6.
• In early RRMS, 66.4% of treatment-naive patients maintained NEDA-3 over 4 years with ocrelizumab, supporting long-term continuation 7.

Common Pitfalls to Avoid

• Do not discontinue ocrelizumab based solely on age (60 years old); efficacy and safety are maintained in older patients with RRMS 2, 5.
• Do not switch anti-CD20 therapies without clear medical indication; this patient's experience with Briumvi demonstrates that not all anti-CD20 agents are interchangeable 4.
• Do not delay continuation based on stable MRI alone; the goal is to maintain disease stability, not to wait for disease activity before resuming effective therapy 3, 1.
• Ensure neurologist involvement as required by treatment guidelines for ocrelizumab prescribing 3.