Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

The patient is a 62-year-old female with rheumatoid arthritis (RA) of indeterminate duration who was described by her rheumatologist in June 2004 as having continuing active disease with synovitis despite ongoing treatment with methotrexate 25mg/wk, Plaquenil 200mg twice a day, and Celebrex 200mg twice a day. The patient is said to have ongoing morning stiffness and fatigue and is unable to participate in all of her activities of daily living.The patients primary complaint at the time of her visit seemed to be ongoing difficulty with shoulder pain and difficulty using her arms. Her history includes prior bilateral synovectomies of her shoulders. An exam described markedly restricted range of motion in both shoulders with improved swelling in her left thumb and right ring finger, and without full extension in the right elbow. Laboratory work performed in June 2004 showed ESR 44mm/hr, decreased albumin 3.2%, and CRP 7.8. No CBC or x-rays results have been submitted.The patients provider has recommended the patient receive Rituxan. The Health Plan has denied authorization and coverage for Rituxan on the basis it is not medically necessary for treatment of the patients RA.Review of the submitted information indicates the patient may indeed have significant rheumatoid synovitis. If so, she is inadequately controlled with methotrexate, but has had significant adverse experience with two different TNF inhibitors. Thus, it is not known if she would have the same reaction to Humira, which, due to being more fully humanized than Remicade or Enbrel, may be less likely to provoke a lupus-like reaction. Given other options, a decision to avoid Humira is reasonable. However, in this situation, Rituxan would not be the next appropriate agent for this patient. Though reports at the San Antonio meeting of the American College of Rheumatologists indicated that Rituxan appears to have significant benefit in RA, its side-effect/toxicity profile is not yet clear. Rituxan would be a possible treatment for continuing active RA after failure of all available appropriate options. In the present case, Kineret, (an IL-1 receptor antagonist, rather than a TNF or B-cell inhibitor) is approved for use in RA, and would be the next biologic agent to recommend in this patient.Another possible interpretation based upon the submitted clinical information is that the patient is experiencing primarily mechanical shoulder pain and dysfunction, in which case she would not benefit from any biologic agent. It would seem appropriate to obtain x-rays of the patients shoulders to see if extensive degenerative change is already present or if the joints are still preserved (implying inflammatory rather than mechanical cause for pain and limitation).  Her response to the described steroid injections would also help clarify this issue.In summary, there is no medical justification for the use of Rituxan in this patient at this time. Ongoing inflammation could next be treated with Kineret, whereas primarily mechanical dysfunction would not be an appropriate target for any biologic agent. However, if persistent active synovitis is present, and fails to respond to Kineret, then Rituxan would be an appropriate consideration. Therefore, I have determined that the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.