Is Ocrevus (ocrelizumab) medically necessary for a 24-year-old female patient with multiple sclerosis without documentation of relapsing forms of MS, clinically isolated syndrome, or primary progressive multiple sclerosis?

Medical Necessity Determination: DENIED

Ocrelizumab (Ocrevus) is NOT medically necessary for this patient without explicit documentation of the specific MS subtype, as the clinical presentation clearly demonstrates relapsing-remitting multiple sclerosis (RRMS) based on the provided evidence, which meets FDA-approved indications and should be documented accordingly.

Rationale for Determination

Clinical Evidence Supports RRMS Diagnosis

The patient's clinical presentation unequivocally demonstrates relapsing-remitting multiple sclerosis:

• MRI evidence of active inflammatory disease: Brain MRI from January 21,2023 shows 3 new demyelinating lesions in the right cerebral hemispheric white matter that were not present on the July 7,2020 study 1
• Previous relapse history: The patient had "persistent flushing" and "systemic symptoms" requiring discontinuation of Tecfidera, and experienced "muscle twitching in her leg that lasted about 6 days" 1
• Disease activity pattern: Previously active lesions that enhanced no longer enhance and are smaller, demonstrating the relapsing-remitting pattern characteristic of RRMS 2
• Young age and early disease: At 24 years old with relatively recent diagnosis, this fits the profile of early relapsing-remitting MS 2

FDA-Approved Indications Are Met

Ocrelizumab is FDA-approved for "relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults" 1. The patient clearly has:

• Active inflammatory lesions on MRI (3 new demyelinating lesions) 1
• History of disease activity requiring treatment escalation 3
• Failed previous disease-modifying therapy (Tecfidera intolerance) 3

Evidence Supporting Ocrelizumab Use in This Clinical Scenario

For RRMS patients, ocrelizumab demonstrates:

• 61% reduction in relapse rate compared to interferon beta-1a (RR 0.61,95% CI 0.52-0.73) 3
• 40% reduction in disability progression (HR 0.60,95% CI 0.43-0.84) 3
• 73% reduction in gadolinium-enhancing T1 lesions (RR 0.27,95% CI 0.22-0.35) 3
• 37% reduction in new or enlarging T2 lesions (RR 0.63,95% CI 0.57-0.69) 3

In early-stage RRMS specifically:

• 66.4% of treatment-naive patients achieved NEDA-3 (no evidence of disease activity) at 4 years 4
• 90.9% remained relapse-free over 4 years 4
• Annualized relapse rate of only 0.020 (95% CI 0.015-0.027) 4

Documentation Deficiency Issue

The ONLY reason for denial is the lack of explicit documentation stating "relapsing-remitting multiple sclerosis" or "relapsing forms of MS" in the authorization request. The clinical evidence overwhelmingly supports this diagnosis:

• The diagnosis listed is simply "MULTIPLE SCLEROSIS" without specifying the subtype 1
• Aetna's criteria explicitly require documentation of "relapsing form of multiple sclerosis" 1
• The clinical notes describe new MRI lesions, previous treatment failures, and disease activity consistent with RRMS 2

Required Documentation for Approval

To approve this request, the following documentation must be provided:

1. Explicit diagnosis statement from the neurologist confirming "relapsing-remitting multiple sclerosis" or "relapsing forms of multiple sclerosis" 1
2. Evidence of disease activity (already present): MRI showing 3 new demyelinating lesions from January 21,2023 2
3. Prescriber specialty confirmation (already met): Prescribed by neurologist at Mayo Clinic 1
4. Treatment history (already present): Failed Tecfidera due to intolerance 3

Clinical Appropriateness Assessment

Despite the documentation gap, ocrelizumab is clinically appropriate for this patient:

• Age 24 years: Well within the optimal treatment window (<45 years preferred) 2
• Early disease stage: Disease duration appears <3 years based on previous MRI from 2020 4
• Active inflammatory disease: 3 new lesions demonstrate ongoing disease activity requiring treatment 2
• Treatment failure: Intolerance to Tecfidera necessitates escalation to higher-efficacy therapy 3
• Normal neurological exam: Affect, language, cognition, motor function, and gait are normal, indicating early intervention opportunity 2

Safety Considerations Met

Pre-treatment requirements are being addressed:

• Hepatitis B serologies performed (all negative, patient is non-immune) 1
• JC virus antibody status pending (appropriate for treatment planning) 5
• CBC and chemistry panel normal except slightly elevated platelets (405) 1
• Patient is completing hepatitis B vaccination series before starting therapy 1

Recommendation

DENY the current authorization request due to insufficient documentation of MS subtype, BUT provide immediate pathway for approval:

The treating neurologist should submit an addendum or updated clinical note explicitly stating:

• "The patient has relapsing-remitting multiple sclerosis as evidenced by new MRI lesions appearing between July 2020 and January 2023, representing disease activity consistent with relapsing forms of MS"

Upon receipt of this documentation, APPROVE ocrelizumab 600 mg IV every 6 months with:

• Initial approval period: 3 months (as per protocol) 1
• Monitoring requirements: Clinical assessment and MRI surveillance per American Academy of Neurology guidelines 5
• Pre-medication protocol: Corticosteroid and antihistamine as per FDA labeling 1

This represents a documentation technicality rather than a clinical appropriateness issue—the patient clearly has active RRMS requiring disease-modifying therapy, and ocrelizumab is an evidence-based, FDA-approved treatment for this indication 1, 3, 4.