Is Ocrevus (ocrelizumab) 600mg iv every 6 months medically necessary for a patient with a reported history of multiple sclerosis?

Medical Necessity Assessment for Ocrevus Continuation

Ocrevus (ocrelizumab) 600mg IV every 6 months is medically necessary for this patient with multiple sclerosis, as she demonstrates clinical stability on therapy and meets standard continuation criteria, despite incomplete documentation in the current medical record. 1, 2

Evidence Supporting Medical Necessity

1. Established MS Diagnosis and Treatment Response

• The patient has documented MS with objective clinical findings including asymmetric motor weakness (4/5 right side, 2-3/5 left side), sensory deficits in the left lower extremity, coordination impairment, and neurogenic bladder requiring management 1

• Clinical stability on Ocrevus is documented in the 3/20/2025 neurology note, with the neurologist explicitly stating "Clinically stable" and continuing disease-modifying therapy 1, 3

• The patient successfully transitioned from a clinical trial (BN42082) to commercial insurance, indicating she met enrollment criteria for an Ocrevus trial and demonstrated adequate response to warrant continuation 1

2. Standard of Care for Multiple Sclerosis

Ocrelizumab is recognized as a high-efficacy disease-modifying therapy for relapsing MS with FDA approval based on randomized controlled trials demonstrating 39% reduction in relapse rate and 40% reduction in disability progression at 96 weeks 1, 2, 3

• The American Academy of Neurology recognizes ocrelizumab as standard of care for MS treatment 1

• Ocrelizumab has demonstrated long-term safety with no new safety signals emerging over ≥7.5 years of treatment in extension studies 1, 2

• The most common adverse events are infusion-related reactions, nasopharyngitis, and urinary/upper respiratory tract infections, all of which are manageable 2, 3

3. Risk of Treatment Discontinuation

Discontinuing effective ocrelizumab therapy in a stable patient would expose her to unnecessary risk of disease reactivation, particularly given:

• Her documented clinical stability on current therapy 1
• The presence of significant baseline disability (motor weakness, neurogenic bladder) that could worsen with disease reactivation 1
• Switching to alternative therapy would require a washout period and risk breakthrough disease activity during transition 1

4. Appropriate Monitoring and Safety

• The patient has up-to-date laboratory monitoring as documented in the 4/22/25 order note ("all labs up to date") 2

• Recent labs from 3/21/2025 show vitamin D 51.3, iron 95, and normal urinalysis, indicating appropriate monitoring 2

• The standard dosing regimen of 600mg IV every 6 months is FDA-approved and supported by extensive clinical trial data 2, 3

Addressing Documentation Gaps

While the current clinical record lacks comprehensive historical documentation of MS diagnosis, several factors support continuation:

• The patient was enrolled in a formal Ocrevus clinical trial, which requires rigorous diagnostic confirmation per protocol 1

• Objective neurological findings are documented including asymmetric weakness, sensory deficits, and coordination impairment consistent with MS 1

• The 7/10/2024 MRI brain was performed as a "research protocol" with specific instructions not to comment on white matter disease, suggesting ongoing MS monitoring 1

• The treating neurologist has assessed the patient as "clinically stable" and appropriate for continued therapy 1

Common Pitfalls to Avoid

• Do not discontinue effective therapy based solely on incomplete documentation transfer from clinical trial to commercial insurance 1

• Recognize that research protocol MRIs may have limited reporting per study requirements, which does not negate their diagnostic value 1

• Clinical stability on therapy is itself evidence of appropriate treatment, particularly in a patient with documented neurological deficits 1, 3

Recommendation Summary

This treatment plan is medically necessary and represents standard of care. The patient demonstrates:

1. Documented MS with objective clinical findings 1
2. Clinical stability on current therapy 1
3. Appropriate safety monitoring 2
4. Standard FDA-approved dosing regimen 2, 3

The next dose due 6/9/25 should be approved to maintain disease control and prevent unnecessary risk of disease reactivation 1, 2, 3