Is ocrelizumab (Ocrevus) medically necessary for a patient with multiple sclerosis (G35)?

Medical Necessity Assessment for Ocrelizumab in Multiple Sclerosis

Primary Determination

Ocrelizumab is medically necessary for this patient with relapsing multiple sclerosis (G35), but the case documentation is critically incomplete and fails to meet multiple required criteria for approval. 1, 2

Critical Documentation Deficiencies

The case fails to meet the following mandatory requirements per the clinical policy criteria:

Missing Prescriber Specialty Verification

• No documentation of neurologist prescription or consultation 1
• Ocrelizumab must be prescribed by or in consultation with a neurologist for all MS indications 1
• This is a non-negotiable requirement that cannot be waived

Missing Continuation of Therapy Documentation

• No evidence of disease stability or improvement on current therapy 1
• For continuation approval, documentation must demonstrate the patient is experiencing disease stability or clinical improvement while receiving ocrelizumab 1
• Recent MRI results, relapse history, and disability status assessments are absent from the record

Missing Concomitant Medication Review

• No documentation confirming absence of concurrent disease-modifying therapies 1
• The policy explicitly requires confirmation that the patient is not using ocrelizumab concomitantly with other disease-modifying MS agents 1
• Current medication list must be reviewed and documented

Missing Required Safety Monitoring

• No documentation of hepatitis B virus screening 1, 2
• No documentation of quantitative serum immunoglobulin levels 1, 2
• No documentation of pre-medication with corticosteroids and antihistamines 1, 2
• The FDA label mandates hepatitis B screening before the first dose, as reactivation can occur with B-cell depleting therapies 2
• Pre-medication with methylprednisolone (or equivalent corticosteroid) and antihistamine is required prior to each infusion to reduce infusion-related reactions 2

Missing Dosing Interval Verification

• No documentation confirming appropriate 6-month dosing interval 1, 2
• Subsequent doses after initial treatment should be single 600 mg intravenous infusions every 6 months 2
• The date of service must align with the appropriate dosing schedule

Evidence Supporting Medical Necessity (When Criteria Met)

Efficacy in Relapsing MS

• Ocrelizumab demonstrates a 39% reduction in annualized relapse rate compared to interferon beta-1a in randomized controlled trials 1
• The therapy achieves a 40% reduction in disability progression at 96 weeks 1
• In real-world studies, 95.8% of relapsing MS patients remained relapse-free, and 91% achieved NEDA-3 (no evidence of disease activity) 3

Long-Term Safety Profile

• Ocrelizumab has been well tolerated with no new safety signals emerging over ≥7.5 years of treatment in extension studies 1, 4
• The most common adverse events are infusion-related reactions (manageable with pre-medication), nasopharyngitis, and urinary/upper respiratory tract infections 1, 5
• Serious adverse events occur at rates comparable to active comparators 5

Clinical Stability Considerations

• Discontinuing effective ocrelizumab therapy in a stable patient would expose them to unnecessary risk of disease reactivation 1
• Switching to alternative therapy would require a washout period and risk breakthrough disease activity during transition 1
• B-cell depletion pharmacodynamics support the 6-month dosing interval, with terminal half-life of 26 days 6

Required Actions for Approval

To establish medical necessity, the following documentation must be obtained:

1. Neurologist attestation confirming prescription or consultation 1
2. Recent clinical assessment (within 3-6 months) documenting:
   • Current EDSS score and comparison to baseline 2, 3
   • Relapse history since last ocrelizumab dose 2
   • Recent MRI results showing disease stability (absence of new/enlarging T2 lesions or gadolinium-enhancing T1 lesions) 2, 3
3. Laboratory confirmation of:
   • Hepatitis B surface antigen, core antibody, and surface antibody status 1, 2
   • Quantitative immunoglobulin levels (IgG, IgM) 1, 2
4. Medication reconciliation confirming no concurrent disease-modifying therapies 1
5. Pre-medication protocol documentation for the date of service 1, 2
6. Dosing schedule verification confirming 6-month interval from previous dose 2

Clinical Context

While ocrelizumab represents a high-efficacy disease-modifying therapy with strong evidence for relapsing MS 1, 5, 4, approval cannot be granted without meeting the mandatory documentation requirements established by the clinical policy. The diagnosis of multiple sclerosis (G35) alone is insufficient; the specific criteria for initial approval or continuation of therapy must be explicitly documented and verified.

The case should be pended for additional documentation rather than denied outright, given the established efficacy of ocrelizumab in relapsing MS when appropriately prescribed and monitored. 1, 5