Is Riabni (rituximab-abbs) considered medically necessary for a patient with rheumatoid arthritis and polyneuropathy who has failed multiple medications, including NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), Prednisone, and Rinvoq (upadacitinib), and has a contraindication to Methotrexate?

Is Riabni (Rituximab-arrx) Medically Necessary for This Patient?

Yes, Riabni is medically necessary for this patient with rheumatoid arthritis who has failed multiple DMARDs including a JAK inhibitor (Rinvoq) and has a documented contraindication to methotrexate. 1

Medical Necessity Criteria Met

Prior Treatment Failures

• The patient has documented failure of multiple treatment lines including NSAIDs, prednisone, hydroxychloroquine (Plaquenil), and upadacitinib (Rinvoq), meeting the requirement for prior biologic or targeted synthetic DMARD failure 1
• EULAR guidelines specifically recommend that after failure of a first targeted synthetic DMARD (such as Rinvoq), treatment with a biologic DMARD should be considered 1
• The patient has demonstrated moderate to severe active disease with documented knee and feet pain/swelling, and polyneuropathy that improved with rituximab therapy 2

Methotrexate Contraindication Requirement

• The plan's CPB 0314 criteria require rituximab to be prescribed in combination with methotrexate OR the patient must have a clinical reason not to use methotrexate 1
• The provider has documented that methotrexate is contraindicated, though the specific contraindication is not detailed in the appendix 1
• Common acceptable contraindications per the plan's own appendix include: alcohol use disorder, chronic liver disease, drug interactions, risk of treatment-related toxicity, significant comorbidity (liver/kidney disease, blood dyscrasias), or history of intolerance/adverse events 1

Disease Activity Documentation

• The patient has documented moderate to severe rheumatoid arthritis with multiple sites involved (M06.09) 2
• Clinical notes from 07/25/24 and 08/19/24 document that the patient's polyneuropathy and rheumatoid arthritis improved with rituximab therapy, demonstrating objective clinical benefit 2
• The 08/19/24 note indicates worsening numbness, pain in skin and joints when rituximab was overdue, further supporting efficacy 2

Prescriber Specialty Requirement

• The plan's CPB 0314 requires prescription by or in consultation with a rheumatologist, immunologist, or nephrologist for rheumatoid arthritis 1
• This criterion appears to be met based on the clinical documentation pattern 1

Evidence Supporting Rituximab Efficacy

Clinical Trial Data

• Rituximab (two 1000 mg doses) in combination with methotrexate demonstrates ACR 50 response rates of 29% versus 9% for controls at 24 weeks (NNT=6) 2
• At 52 weeks, 22% of patients achieve clinical remission (DAS28 <2.6) versus 11% of controls (NNT=7) 2
• Rituximab prevents radiographic progression in 70% of patients versus 59% of controls at 24 weeks 2

Rituximab Without Methotrexate

• Real-world data from the Italian GISEA register demonstrates that rituximab monotherapy (without methotrexate) shows comparable efficacy to rituximab plus methotrexate combination therapy 3
• After 52 and 104 weeks, both groups showed significant DAS28 and HAQ score reductions without differences between rituximab alone versus rituximab-methotrexate 3
• This is particularly relevant since the patient cannot use methotrexate 3

Safety Profile

• Rituximab demonstrates a good safety profile with no significant increase in serious adverse events compared to placebo 2
• The most common adverse events are infusion reactions (26% after first infusion), which are typically mild to moderate 2, 4
• Serious infections do not increase significantly with rituximab compared to controls, and infection rates remain static over time 4

Critical Pitfall to Avoid

• The initial denial cited lack of documentation regarding methotrexate use or intolerance as the reason for non-certification 1
• The appeal letter and clinical notes document that methotrexate is contraindicated, satisfying this requirement 1
• Requiring specific documentation of the exact contraindication mechanism when the treating physician has stated methotrexate is contraindicated may constitute an inappropriate barrier to care, particularly when the patient has already failed a JAK inhibitor 1

Dosing and Duration

• The requested Q5123 (rituximab-arrx biosimilar, 10 mg units) for dates 08/14/2024-08/29/2024 represents the standard two-dose induction regimen (1000 mg x 2 doses given 2 weeks apart) 2, 5
• Per the MLR guidelines noted in the case, initial certification for 3 months is appropriate 1
• Retreatment intervals typically range from 6-12 months based on disease activity 4

Experimental/Investigational Status

• Rituximab is FDA-approved for rheumatoid arthritis in patients who have failed TNF inhibitors, and biosimilars like Riabni are FDA-approved as equivalent 5, 4
• The use for rheumatoid arthritis after failure of other biologics/targeted synthetic DMARDs is well-established and supported by EULAR guidelines 1
• This is NOT experimental or investigational therapy 1, 2