Is Ocrevus (ocrelizumab) 600mg IV every 6 months medically necessary and appropriate for treating relapsing multiple sclerosis?

Medical Necessity Assessment for Ocrevus Continuation in Relapsing Multiple Sclerosis

Yes, the continuation of Ocrevus 600 mg IV every 6 months is medically necessary and appropriate for this patient with relapsing MS who has demonstrated disease stability on therapy. 1

Treatment Plan Medical Necessity

The continuation of Ocrevus meets established medical necessity criteria for relapsing MS with documented disease stability. 2 The patient satisfies the key requirements:

• Confirmed diagnosis of relapsing MS - The patient has an established diagnosis of relapsing-remitting multiple sclerosis 1
• Appropriate prescriber involvement - The medication is ordered by neurology, meeting the requirement for neurologist consultation 2
• Disease stability on current therapy - The patient has experienced no progression of neurological symptoms since initiating Ocrevus, which fulfills continuation criteria requiring disease stability or improvement 2
• Appropriate dosing regimen - The 600 mg IV every 6 months dosing matches FDA-approved maintenance dosing after initial loading doses 1

Critical Documentation Gap

The primary concern is the outdated neurology documentation, not the medical necessity of the medication itself. While the treatment plan is appropriate, the insurance criteria require current neurologist involvement, and the most recent neurology visit documented is from a prior date 2. The patient is being followed by a different provider at the infusion center for convenience, which creates a documentation issue rather than a clinical appropriateness issue.

Standard of Care and Evidence Base

Ocrevus is FDA-approved standard of care for relapsing forms of MS and is supported by high-quality randomized controlled trial evidence. 1

Efficacy Evidence

• Significant reduction in relapse rates - In pivotal trials, Ocrevus reduced annualized relapse rate by 39% compared to interferon beta-1a (RR 0.61,95% CI 0.52-0.73) 3
• Disability progression prevention - Ocrevus reduced disability progression by 40% (HR 0.60,95% CI 0.43-0.84) in relapsing MS 3
• MRI disease activity suppression - Ocrevus reduced gadolinium-enhancing T1 lesions by 73% (RR 0.27) and new/enlarging T2 lesions by 37% (RR 0.63) 3

Safety Profile

Ocrevus demonstrates acceptable safety with manageable adverse events. 1

• Common adverse events include upper respiratory tract infections (40%) and infusion reactions (34%), which are typically mild to moderate 1
• Serious infection risk requires monitoring, particularly in patients who develop hypogammaglobulinemia (decreased IgG levels associated with increased serious infections) 1
• Malignancy surveillance is necessary, particularly for breast cancer, as 6 of 781 females developed breast cancer in clinical trials versus none in control groups 1
• No treatment discontinuations occurred due to infusion-related reactions in pivotal trials 1

Treatment Continuation Evidence

Patients demonstrating disease stability on Ocrevus should continue therapy to maintain disease control. 4 A study of 608 patients with suboptimal response to prior disease-modifying therapies showed that 48.1% achieved no evidence of disease activity on Ocrevus, with 89.6% remaining free from relapses and 89.6% free from confirmed disability progression over 96 weeks 4.

Clinical Recommendations

1. Approve Continuation with Documentation Requirements

The treatment should be approved based on demonstrated disease stability, with requirement for updated neurology documentation. 2

• Request current neurology consultation note documenting ongoing disease assessment and treatment plan 2
• Confirm the neurologist agrees with continuation of Ocrevus therapy 2
• Establish clear communication pathway between infusion center provider and neurologist 2

2. Required Monitoring

Ongoing surveillance is essential for safe Ocrevus continuation. 1

• Immunoglobulin levels should be monitored, as 1.5% of patients develop IgG below lower limit of normal by 96 weeks, with increased serious infection risk 1
• Infection screening before each infusion, with consideration for discontinuation if serious opportunistic or recurrent serious infections occur 1
• Breast cancer screening according to standard guidelines given increased malignancy risk 1
• MRI surveillance at regular intervals to confirm ongoing disease stability, as recommended by the American Academy of Neurology 2

3. Common Pitfalls to Avoid

• Do not discontinue therapy based solely on documentation gaps when clinical stability is evident - this would expose the patient to risk of disease reactivation 4
• Do not delay infusions while awaiting documentation, as the every-6-month dosing interval is critical for maintaining B-cell depletion and disease control 1
• Do not ignore the convenience factor - patient proximity to infusion center improves adherence, which is crucial for maintaining therapeutic benefit 5

4. Addressing the Coordination of Care Issue

The split care model (neurology ordering, different provider administering) is clinically acceptable but requires clear documentation. 2

• The infusion center provider can manage routine monitoring and infusion administration 5
• Neurology should provide at minimum annual comprehensive assessment with treatment plan documentation 2
• Any new neurological symptoms or disease activity should trigger immediate neurology consultation 2

Experimental vs. Standard Designation

Ocrevus is definitively standard of care, not experimental. 1, 3

• FDA-approved since March 2017 for relapsing forms of MS 3
• Supported by multiple high-quality randomized controlled trials with over 1,656 participants in relapsing MS studies 3
• Included in standard treatment algorithms for relapsing MS by the American Academy of Neurology 2
• Moderate to high-certainty evidence base per Cochrane systematic review 3

The request for Ocrevus continuation is medically necessary, clinically appropriate, and represents standard of care for this patient with stable relapsing MS. 2, 1, 3 The only modification needed is updated neurology documentation to satisfy insurance requirements, not any change to the treatment plan itself.