Was Ocrelizumab (Ocrevus) medically necessary for a patient with Multiple Sclerosis (G35)?

Medical Necessity Determination for Ocrelizumab in Multiple Sclerosis

Cannot Confirm Medical Necessity Due to Insufficient Documentation

Based on the available clinical documentation, medical necessity for ocrelizumab (Ocrevus) cannot be confirmed because critical required documentation elements are missing, despite the diagnosis of multiple sclerosis (G35) being appropriate for this therapy.

Documentation Deficiencies Preventing Approval

The case file lacks essential documentation required by the clinical policy bulletin criteria 1:

Missing Prescriber Specialty Verification

• No documentation confirms prescription by or consultation with a neurologist, which is a mandatory requirement for ocrelizumab therapy 1
• The policy explicitly states "This medication must be prescribed by or in consultation with a neurologist" 1

Missing Continuation of Therapy Documentation

• No clinical notes demonstrate disease stability or improvement while receiving ocrelizumab 1
• Continuation criteria require documentation that "members are experiencing disease stability or improvement while receiving the requested medication" 1
• The case history shows prior MRI brain studies were performed, but no results or clinical assessments are included in the submitted documentation 1

Missing Concomitant Medication Documentation

• No medication list confirms the patient is not using ocrelizumab concomitantly with other disease-modifying MS agents (excluding Ampyra and Nuedexta) 1
• This is a specific exclusion criterion that must be documented 1

Missing Required Safety Monitoring Documentation

• No evidence of hepatitis B virus screening prior to treatment, which is FDA-mandated before the first dose 2
• No documentation of quantitative serum immunoglobulin levels, also required before initial dosing 2
• No confirmation of pre-medication protocol with methylprednisolone (or equivalent corticosteroid) and antihistamine prior to infusion 2

Clinical Context Supporting Potential Appropriateness

Diagnosis Appropriateness

• Multiple sclerosis (G35) is an FDA-approved indication for ocrelizumab in both relapsing forms and primary progressive disease 2, 3
• Ocrelizumab demonstrates 39% reduction in relapse rate and 40% reduction in disability progression at 96 weeks in relapsing MS 1

Treatment History Considerations

• The case history shows this appears to be continuation therapy (prior authorization was certified previously) rather than initial treatment 1
• For continuation therapy, documentation of clinical stability, MRI stability, or functional improvement is essential 1
• The patient has undergone brain MRI studies, suggesting appropriate disease monitoring, but results are not provided 1

Required Documentation for Approval

To establish medical necessity, the following must be submitted:

Prescriber Documentation

• Letter or consultation note from a neurologist confirming diagnosis and treatment recommendation 1
• If prescribed by non-neurologist, documentation of neurologist consultation 1

Clinical Status Documentation

• Recent clinical assessment notes (within 3-6 months) documenting 1:
  • Current EDSS (Expanded Disability Status Scale) score
  • Relapse history since starting ocrelizumab
  • Functional status and any disability progression or improvement
  • Tolerability of current therapy

MRI Documentation

• Most recent brain MRI report showing 1:
  • Presence or absence of new/enlarging T2 lesions
  • Presence or absence of gadolinium-enhancing T1 lesions
  • Comparison to prior studies demonstrating stability or improvement

Safety Monitoring Documentation

• Hepatitis B surface antigen, surface antibody, and core antibody results 2
• Quantitative immunoglobulin levels (IgG, IgM, IgA) 2
• Documentation of pre-medication administration with each infusion 2

Medication Reconciliation

• Complete current medication list confirming no concomitant use of other disease-modifying therapies such as interferon beta, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab, alemtuzumab, or other anti-CD20 agents 1

Clinical Pitfalls to Avoid

• Do not assume continuation therapy is automatically appropriate without documented clinical benefit - even stable patients require objective evidence of stability 1
• Do not overlook mandatory safety screening - hepatitis B reactivation is a serious risk with anti-CD20 therapy and screening is non-negotiable 2
• Do not approve based on diagnosis alone - MS diagnosis is necessary but not sufficient; clinical course and treatment response must be documented 1, 3