Medical Necessity Assessment for Ocrevus Zunovo Continuation
Yes, continuation of Ocrevus Zunovo 920mg subcutaneously every 6 months is medically necessary for this patient with multiple sclerosis, as she demonstrates clinical stability on therapy and meets FDA-approved indications for relapsing forms of MS. 1
Indication Analysis
The patient meets FDA-approved criteria for ocrelizumab treatment in relapsing forms of MS. 1 The neurology note from 9/29/2025 documents "RMS" (relapsing MS), and the patient has been successfully maintained on ocrelizumab since May 2018, demonstrating a 7-year treatment history with the medication. 1
Evidence of Treatment Response
The clinical documentation demonstrates clear therapeutic benefit:
- Patient reports clinical stability with "spasms have been good" and overall doing "okay" on current therapy 2
- MRI stability confirmed - October 2024 brain MRI showed "no acute/enhancing demyelinating lesion or interval demyelinating lesion" and stable findings compared to prior imaging 2
- Biomarker stability - NFL/GFAP Z-scores were "okay" per neurology assessment, supporting continued current therapy 2
- Successful transition to subcutaneous formulation - First Zunovo dose in June 2025 "went really well" with only mild fatigue 1
Standard of Care Evidence
Ocrelizumab is established standard of care for relapsing MS with robust evidence base. 3, 4 In randomized controlled trials, ocrelizumab demonstrated a 39% reduction in relapse rate compared to interferon beta-1a (RR 0.61,95% CI 0.52-0.73) and a 40% reduction in disability progression (HR 0.60,95% CI 0.43-0.84) at 96 weeks. 3
The every-6-month dosing interval is FDA-approved and evidence-based. 1 The approved regimen is 920mg subcutaneously every 6 months, with doses separated by at least 5 months. 1 Research suggests ocrelizumab may provide durable disease control with this dosing schedule, as CD19+ B cell depletion persists with median repletion exceeding 15 months after dosing. 5
Subcutaneous Formulation Equivalence
The subcutaneous 920mg dose was specifically selected to provide equivalent exposure to the 600mg intravenous dose. 6 The OCARINA I Phase 1b study demonstrated that subcutaneous ocrelizumab was well tolerated across all doses tested, and the 920mg subcutaneous dose was selected based on pharmacokinetic equivalence to achieve similar area under the concentration-time curve as the intravenous formulation. 6
Safety and Monitoring Compliance
The patient's care demonstrates appropriate safety monitoring per FDA requirements:
- Pre-treatment assessments completed - Labs ordered 4 weeks before dosing as required 1
- Hepatitis B screening documented - Required prior to initiation 1
- Infection surveillance maintained - Patient screened for active infections before each dose 1
- Appropriate premedication protocol - Dexamethasone and antihistamine administered 30 minutes prior to injection 1
- Post-injection monitoring performed - Patient monitored for at least 1 hour after initial dose and 15 minutes after subsequent doses 1
Comorbidity Considerations
The patient's acoustic neuroma does not contraindicate ocrelizumab continuation. 1 The schwannoma has remained stable on serial MRI imaging (stable from April 2024 to October 2024 to October 2025), indicating no adverse impact from immunosuppressive therapy. 2
Negative mammogram in April 2025 with family history of breast cancer documented - appropriate cancer surveillance is being maintained, which is critical given theoretical malignancy risks with B-cell depleting therapies. 3
Treatment Alternatives Context
Ocrelizumab is recognized as a high-efficacy disease-modifying therapy and is included as a comparator arm in ongoing randomized trials evaluating autologous hematopoietic stem cell transplantation for relapsing MS (RAM-MS, BEAT-MS, STAR-MS, NET-MS trials). 7 This positioning reflects its status as a standard high-efficacy treatment option.
Long-term safety data supports continued use - ocrelizumab has been well tolerated with no new safety signals emerging over ≥7.5 years of treatment in extension studies. 4 The most common adverse events are infusion-related reactions, nasopharyngitis, and urinary/upper respiratory tract infections. 3
Clinical Stability Justification
Discontinuing effective therapy in a stable patient would expose her to unnecessary risk of disease reactivation. 5 The patient has achieved:
- Radiographic stability (no new/enhancing lesions)
- Clinical stability (controlled spasticity, stable functional status)
- Biomarker stability (normal NFL/GFAP)
- Good tolerability of the subcutaneous formulation
Switching to an alternative therapy would require washout period and risk breakthrough disease activity during the transition, particularly given her 7-year stable course on ocrelizumab. 7
Conclusion Statement for Authorization
The treatment is medically necessary - Patient has relapsing MS requiring ongoing disease-modifying therapy to prevent relapses, disability progression, and new CNS lesions. 1, 3
The treatment is standard of care - Ocrelizumab is FDA-approved for relapsing forms of MS with Level 1 evidence from randomized controlled trials demonstrating superiority to active comparator (interferon beta-1a) for relapse reduction and disability progression. 1, 3, 4 The subcutaneous formulation provides pharmacokinetic equivalence to the established intravenous regimen. 6
The treatment is NOT experimental or investigational - Both the medication and the subcutaneous formulation have full FDA approval for this indication. 1