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

Medical Necessity Determination for Ocrelizumab in Multiple Sclerosis

Yes, ocrelizumab (J2350) is medically necessary for this patient with multiple sclerosis (G35), as it is FDA-approved and guideline-recommended as a high-efficacy disease-modifying therapy for both relapsing and progressive forms of MS. 1

FDA-Approved Indications

Ocrelizumab is FDA-approved for treatment of adults with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), making it the only disease-modifying therapy approved for PPMS. 1, 2 The approved dosing regimen is 600 mg intravenously every 24 weeks, with initial treatment given as two 300 mg IV infusions administered 2 weeks apart. 1

Evidence of Clinical Efficacy

For Relapsing Multiple Sclerosis

Ocrelizumab demonstrates superior efficacy compared to interferon beta-1a across multiple outcome measures:

• Relapse reduction: 46-47% lower annualized relapse rate compared to interferon beta-1a (0.16 vs 0.29 in both pivotal trials, P<0.001) 3
• Disability progression: 40% reduction in confirmed disability progression at 12 weeks (hazard ratio 0.60,95% CI 0.43-0.84) 4, 3
• MRI activity: 94-95% reduction in gadolinium-enhancing T1 lesions compared to interferon beta-1a 3
• T2 lesion activity: 37% reduction in new or enlarging T2-hyperintense lesions 5

For Primary Progressive Multiple Sclerosis

Ocrelizumab is the only disease-modifying therapy that has demonstrated efficacy in slowing disability progression in PPMS, with a 25% reduction in confirmed disability progression (HR 0.75,95% CI 0.58-0.98) over at least 120 weeks. 2, 6

Guideline Recognition

The American Academy of Neurology recognizes ocrelizumab as a high-efficacy disease-modifying therapy for relapsing MS, with demonstrated benefits on both clinical and radiological outcomes. 4 This recognition is based on randomized controlled trials showing sustained efficacy over 96 weeks and beyond. 5, 1

Safety Profile

Ocrelizumab has been well-tolerated with no new safety signals emerging over ≥7.5 years of treatment in extension studies:

• Most common adverse events are infusion-related reactions (34.3%), nasopharyngitis, and urinary/upper respiratory tract infections 4, 2
• Serious infection rates are low (1.3% with ocrelizumab vs 2.9% with interferon beta-1a) 3
• The safety profile in real-world clinical practice matches that observed in clinical trials 6

Clinical Considerations

When Ocrelizumab is Particularly Appropriate:

• Patients requiring high-efficacy therapy due to active disease (relapses, new MRI lesions) 4
• Patients with inadequate response to other disease-modifying therapies 7
• Patients with PPMS, where ocrelizumab is the only approved option 2, 6
• Patients transitioning from natalizumab due to positive JC virus antibody status and PML risk 8

Important Monitoring Requirements:

• Vaccination: Live-attenuated vaccines are contraindicated while on ocrelizumab; complete two-dose vaccine regimens at least 4-6 weeks before starting treatment 4
• MRI surveillance: Regular MRI monitoring is recommended, with follow-up scans conducted at least annually using T2-weighted images, T2 FLAIR, and diffusion-weighted imaging 4, 8
• Immunoglobulin monitoring: Monitor for hypogammaglobulinemia, particularly in patients with baseline low immunoglobulin levels 9

Common Pitfall to Avoid:

Do not discontinue effective ocrelizumab therapy in clinically stable patients, as this would expose them to unnecessary risk of disease reactivation. Switching to alternative therapy would require a washout period and risk breakthrough disease activity during the transition. 4

Conclusion on Medical Necessity

Ocrelizumab meets criteria for medical necessity in patients with multiple sclerosis based on:

1. FDA approval for both relapsing and progressive MS 1
2. Superior efficacy demonstrated in randomized controlled trials 3
3. Recognition by major neurology guidelines as high-efficacy therapy 4
4. Favorable benefit-risk profile with manageable adverse events 2, 6

The request for J2350 (ocrelizumab injection, 1 mg) for a patient with diagnosis G35 (multiple sclerosis) is medically necessary and supported by the highest level of evidence from FDA approval, clinical guidelines, and randomized controlled trials. 4, 1, 3