Is Ocrevus (ocrelizumab) medically indicated for a patient with multiple sclerosis receiving home infusion every 6 months with codes J2350, S9379, J2919, S9490, 99601, 99602, and diagnosis code G35?

Medical Necessity of Ocrevus (Ocrelizumab) for Multiple Sclerosis

Yes, Ocrevus (ocrelizumab) administered every 6 months via home infusion is medically indicated for this patient with multiple sclerosis (diagnosis code G35), as it represents an FDA-approved, high-efficacy disease-modifying therapy for relapsing forms of MS with established safety and efficacy. 1

FDA-Approved Indication

• Ocrevus is FDA-approved for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults 1
• The diagnosis code G35 corresponds to multiple sclerosis, which falls within the approved indication 1
• The standard approved dosing regimen is 600 mg administered every 6 months (every 24 weeks), which aligns with the patient's current treatment schedule 1

Evidence Supporting Efficacy and Safety

• Ocrelizumab demonstrates superior efficacy compared to interferon beta-1a, with a 39% reduction in relapse rate (RR 0.61,95% CI 0.52-0.73) and 40% reduction in disability progression (HR 0.60,95% CI 0.43-0.84) at 96 weeks 2, 3
• The American Academy of Neurology recognizes ocrelizumab as a high-efficacy disease-modifying therapy for relapsing MS 2
• Long-term safety data spanning ≥7.5 years shows no new safety signals, with the most common adverse events being infusion-related reactions, nasopharyngitis, and urinary/upper respiratory tract infections 2, 3

Home Infusion Appropriateness

• The CPT codes provided (J2350 for ocrelizumab injection, S9379 for home IV therapy infusion, J2919 for methylprednisolone injection as premedication, S9490 for home infusion therapy, 99601/99602 for home infusion administration) are appropriate for home-based ocrelizumab administration 1
• Premedication with corticosteroids (20 mg dexamethasone or equivalent) and antihistamines is required at least 30 minutes prior to each administration to reduce injection/infusion reactions 1
• For patients receiving subsequent doses (beyond the initial dose), monitoring for at least 15 minutes post-injection is required, which can be safely performed in a home setting 1

Clinical Stability and Continuation Justification

• Discontinuing effective ocrelizumab therapy in a stable patient would expose them to unnecessary risk of disease reactivation, particularly given the established efficacy in preventing relapses and disability progression 2
• Switching to alternative therapy would require a washout period and risk breakthrough disease activity during transition 2
• The 6-month dosing interval is supported by pharmacodynamic data showing CD19+ B-cell depletion within 2 weeks, with slow repopulation beginning approximately 6 months after infusion 4

Safety Monitoring Requirements

• Prior to each dose, assess for active infection and delay administration until infection resolves 1
• Hepatitis B virus screening must be performed prior to initiating treatment, as ocrelizumab is contraindicated in patients with active HBV 1
• Quantitative serum immunoglobulin testing should be performed prior to treatment initiation and monitored during therapy 1
• Live-attenuated or live vaccines are contraindicated during treatment and after discontinuation until B-cell repletion; all immunizations should be completed at least 4 weeks prior to initiation for live vaccines and 2 weeks for non-live vaccines 1

Common Pitfalls to Avoid

• Do not confuse the subcutaneous formulation (OCREVUS ZUNOVO, 920 mg) with the intravenous formulation (600 mg), as they have different dosing and administration instructions 1
• Ensure adequate premedication is administered to reduce infusion-related reactions, which are the most common adverse events 1, 3
• Monitor for immunoglobulin deficiency, particularly IgM, which occurs more frequently with standard 6-month dosing compared to extended interval dosing (55% vs 17.3%) 5
• Do not delay scheduled doses unnecessarily; if a dose is missed, administer as soon as possible and reset the schedule to 6 months from that dose, with minimum 5-month separation between doses 1

Conclusion on Medical Necessity

The continued home infusion of Ocrevus every 6 months is medically necessary and appropriate for this patient with multiple sclerosis (G35), as it represents FDA-approved therapy with demonstrated efficacy in reducing relapses and disability progression, established long-term safety, and proper coding for home-based administration with required premedication and monitoring 2, 1, 3.