Rituximab for the Treatment of Rheumatoid Arthritis

Restricted Product(s)

• ***Rituximab-abbs (Truxima®) 
• ***Rituximab-pvvr (Ruxience™) 
• *Rituximab (Rituxan® ) 
• *Rituximab-arrx (Riabni™) 
• *Any other approved rituximab biosimilars 

***preferred agent(s)

*non-preferred agent(s)

Indications for Use

• For treatment of rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary for covered when the following criteria are met:

1. The patient is 18 years of age or older; AND 
2. If the request is for Rituxan (rituximab) or non-preferred rituximab biosimilars [e.g., rituximab-arrx (Riabni)], ONE of the following:
   1. The patient has tried and had an inadequate response to BOTH of the following preferred rituximab biosimilar products: rituximababbs (Truxima) AND rituximab-pvvr (Ruxience) [medical record documentation required]; OR 
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL preferred rituximab biosimilar products [i.e., rituximab-abbs (Truxima), rituximab-pvvr (Ruxience)] that is NOT expected to occur with the requested product [medical record documentation required]; OR 
   3. The patient has a documented serious adverse event that required medical intervention to BOTH preferred rituximab biosimilar products [i.e., rituximab-abbs (Truxima), rituximab-pvvr (Ruxience)] that is not anticipated with the requested product [medical record documentation required]; AND
      1. The prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form [medical record documentation required]; AND 
3. The patient has a diagnosis of moderately to severely active rheumatoid arthritis; AND 
4. ONE of the following: 
   1. The requested agent will be used in combination with methotrexate; OR 
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate [medical record documentation required]; AND 
5. ONE of the following:
   1. The patient has tried and had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors [medical record documentation required]; OR 
   2. The patient has a contraindication to treatment with TNF inhibitors [medical record documentation required]; OR 
   3. The patient has had an inadequate response to methotrexate or other conventional synthetic disease modifying anti-rheumatic drug (DMARD) [medical record documentation required]; AND 
6. The requested agent will not be used in combination with a TNF-inhibiting drug or another biologic immunomodulator agent that is used for the treatment of rheumatoid arthritis; AND 
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).
   
   Duration of Approval: 365 days (1 year) 

Note: This policy only applies to rituximab (Rituxan) and rituximab biosimilars (Truxima, Riabni, and Ruxience) when used for the treatment of Rheumatoid Arthritis

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care & Research. 2021;73(7):924-39. 
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of diseasemodifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. 
3. Singh JA, Saag KG, Bridges SL, Jr., et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1):1-26.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

September 2024: Criteria change: Updated requirement for use of preferred rituximab biosimilars (Truxima and Ruxience) prior to Rituxan or non-preferred rituximab biosimilars to also allow for trial and failure of both preferred rituximab biosimilars OR presence of an intolerance, FDA labeled contraindication, or hypersensitivity to all preferred rituximab biosimilar products that is NOT expected to occur with the requested product. Updated references.
October 2021: Coding update: Added the following applicable diagnosis codes to policy effective 10/1/2021: M45.A0, M45.A1, M45.A2, M45.A3, M45.A4, M45.A5, M45.A6, M45.A7, M45.A8, and M45.AB.
July 2021: Coding update: Added HCPCS code Q5123 to dosing reference table effective 7/1/2021, deleted non-specific codes C9399, J3490, and J3590 termed 6/30/2021.
June 2021: Criteria change: Medical record documentation required for trial and failure of preferred and conventional agents.
June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy