Is Ocrelizumab (Ocrevus) medically necessary for a patient with Multiple Sclerosis?

Medical Necessity Determination for Ocrelizumab (Ocrevus) in Multiple Sclerosis

Direct Answer

Based on the available documentation, ocrelizumab cannot be determined as medically necessary for this specific case due to insufficient clinical documentation to meet the insurer's established criteria, despite ocrelizumab being a high-efficacy, guideline-supported therapy for relapsing multiple sclerosis.

Critical Documentation Deficiencies

The case review identifies multiple unmet criteria that prevent approval:

• No documentation of specialist involvement: The insurer requires prescription by or consultation with a neurologist, which is not documented 1
• No evidence of continuation criteria: There is no documentation demonstrating disease stability or improvement while receiving ocrelizumab, which is required for continuation therapy 1
• No documentation of concomitant medication review: The insurer requires confirmation that the patient is not using ocrelizumab with other disease-modifying MS agents (excluding symptomatic treatments), which is not documented 1
• No documentation of required monitoring: The FDA label mandates hepatitis B and tuberculosis screening before first dose, plus premedication with corticosteroids and antihistamines prior to each infusion, none of which are documented 2
• No baseline or follow-up clinical data: The case file contains only a provider request for reconsideration and claim dispute form, with no clinical notes, MRI reports, or assessment of treatment response 1

Evidence Supporting Ocrelizumab Efficacy (When Properly Documented)

For Relapsing Multiple Sclerosis

Ocrelizumab is recognized by the American Academy of Neurology as a high-efficacy disease-modifying therapy with demonstrated superiority over interferon beta-1a, showing 39% reduction in relapse rate and 40% reduction in disability progression at 96 weeks 1

Key efficacy outcomes from pivotal trials include:

• Relapse reduction: 39% lower annualized relapse rate compared to interferon beta-1a (RR 0.61,95% CI 0.52-0.73) 3
• Disability progression: 40% reduction in confirmed disability progression (HR 0.60,95% CI 0.43-0.84) 3
• MRI activity suppression: 73% reduction in gadolinium-enhancing T1 lesions (RR 0.27,95% CI 0.22-0.35) and 37% reduction in new/enlarging T2 lesions (RR 0.63,95% CI 0.57-0.69) 3
• No evidence of disease activity (NEDA-3): 48.1% of patients with suboptimal response to prior therapies achieved NEDA over 96 weeks 4

Long-Term Safety Profile

• Ocrelizumab has been well tolerated with no new safety signals over ≥7.5 years of treatment in extension studies 1
• Most common adverse events are infusion-related reactions (manageable with premedication), nasopharyngitis, and urinary/upper respiratory tract infections 3, 5
• Serious adverse event rates show little to no difference compared to interferon beta-1a (RR 0.79,95% CI 0.57-1.11) 3

Required Documentation for Approval

To establish medical necessity, the following must be submitted:

Initial Approval Requirements

• Specialist documentation: Prescription or consultation note from a neurologist confirming MS diagnosis and treatment plan 1
• Diagnostic confirmation: Documentation of relapsing MS diagnosis per McDonald criteria with evidence of disease activity (clinical relapses or MRI lesions) 1, 2
• Baseline assessments: Pre-treatment hepatitis B surface antigen, hepatitis B core antibody, and tuberculosis screening results 2
• Exclusion of contraindications: Documentation that patient does not have active hepatitis B infection or active infections requiring treatment 2

Continuation Therapy Requirements (For This Case)

Since this appears to be continuation therapy based on the case history showing prior authorizations:

• Treatment response documentation: Clinical notes demonstrating disease stability or improvement, including:
  • Absence of new relapses or reduced relapse frequency 1
  • Stable or improved Expanded Disability Status Scale (EDSS) scores 1
  • MRI evidence showing no new or reduced gadolinium-enhancing lesions and T2 lesions 1, 6
• Medication reconciliation: Confirmation that patient is not receiving concomitant disease-modifying therapies (rituximab, natalizumab, fingolimod, dimethyl fumarate, etc.) 1
• Tolerability assessment: Documentation that patient has tolerated ocrelizumab without serious adverse events requiring discontinuation 1
• Dosing compliance: Confirmation of appropriate dosing schedule (600 mg every 24 weeks after initial loading doses) 2

Clinical Context: When Ocrelizumab Is Appropriate

First-Line Therapy Considerations

• In treatment-naive patients with early relapsing-remitting MS (disease duration ≤3 years, EDSS ≤3.5), ocrelizumab as first-line therapy resulted in 66.4% achieving NEDA-3 over 4 years 7
• Early treatment initiation is associated with better long-term outcomes and reduced risk of disability progression 7

Switch Therapy Considerations

• Ocrelizumab is appropriate for patients with suboptimal response to other disease-modifying therapies, defined as clinical relapse and/or MRI lesion activity after ≥6 months on another agent 4
• Switching from natalizumab (Tysabri) to ocrelizumab is appropriate when JC virus antibody positivity increases progressive multifocal leukoencephalopathy risk 6
• Critical caveat: Discontinuing effective ocrelizumab therapy in a stable patient would expose them to unnecessary risk of disease reactivation, particularly given the potential for breakthrough disease activity during any washout period 1

Common Pitfalls to Avoid

• Inadequate documentation of treatment response: Insurers require objective evidence (MRI, clinical assessments) rather than subjective provider statements 1
• Missing required pre-treatment screening: Failure to document hepatitis B and tuberculosis screening will result in denial 2
• Lack of specialist involvement: Many insurers require neurologist involvement for high-cost biologics 1
• Incomplete medication history: Must document all prior and current MS therapies to demonstrate appropriate sequencing and absence of contraindicated combinations 1

Recommendation for This Case

The provider must submit comprehensive clinical documentation including:

1. Neurology consultation notes with MS diagnosis confirmation and treatment rationale
2. Recent MRI reports (within past 6-12 months) showing disease activity or stability
3. Clinical assessment notes documenting EDSS scores and relapse history
4. Laboratory results for required screening tests
5. Medication list confirming no concomitant disease-modifying therapies
6. Documentation of treatment response if this is continuation therapy (comparison of clinical/MRI findings before and during ocrelizumab treatment)

Without this documentation, the claim appropriately cannot be approved, despite ocrelizumab being an evidence-based, guideline-supported therapy for multiple sclerosis 1, 3.