Appeal type: Medical Necessity
Decision: Overturned

The patient is a 36-year-old man with Crohns disease of the ileocolon for at least four years with a diagnosis established at surgery. He has been treated with Asacol, prednisolone, methonidazole, mercaptopurine, Entocort, and, most recently, infliximab.  In September 2004, the patient underwent a small bowel resection and stricturoplasty and the specimen was examined by the pathologist who thought this again represented active Crohns disease.  Although the patient had some initial response to infliximab, the response has waned with time. Citing theoretical reasons including antibody production to this agent, the enrollee and his providers have requested that the Health Plan approve adalimumab (Humira) as treatment for Crohns disease. The Health Plan has denied this request on the basis that Humira is not approved for use in Crohns disease and the patients recent laboratory tests indicate his sedimentation rate and white blood count are normal. Humira is a fully human IgG1 antibody to TNF that is administered subcutaneously. It has been approved for human use in rheumatoid arthritis in certain situations, and like infliximab, has significant potential for toxicity and side effects. One controlled trial has been accomplished in patients with active inflammatory Crohns disease and has shown efficacy. At the highest dose, 36% of patients had a response versus 12% for placebo. A prospective uncontrolled pilot study demonstrated Humira is well tolerated and clinically helpful in patients with Crohns disease who have lost response to infliximab, had delayed hypersensitivity reactions or developed intolerable infusion reactions. There are another two retrospective studies of Humira for patients who have lost response to infliximab in the literature and both showed similar promising response. There are two large phase III clinical trials underway aimed at evaluating maintenance of remission in patients with adalimumab induced remission and efficacy for induction of remission in patients who have become non-responsive to infliximab. The clinical management of Crohns disease remains very difficult and it appears the patient has been carefully and attentively managed. Still, he has demonstrated active Crohns disease as recently as September 2004, and there is no reason to doubt ongoing inflammation.  Standard therapy has failed to control his disease and he is in a difficult situation. Though use of Humira is off-label this can also be said for some of the most important drugs used to treat Crohns disease including azathioprine and mercaptopurine. Use of off-label medications is not ideal but is an essential reality. There is good evidence that Humira may be helpful in patients such as this patient. When considering the way in which treatment for Crohns disease is evaluated in clinical trial, we come to the point that the Crohns Disease Activity Index or CDAI is most typically employed. This imperfect instrument is a quantitative surrogate for the experienced clinicians judgment in such clinical trials, but it employs neither the white blood cell count nor sedimentation rate. In fact, the first three elements are number of stools, abdominal pain, and general well being. There is little reason to doubt active Crohns disease in this patient given his recent surgery and the pathologists report of the surgical specimen. In summary, the evidence supporting the efficacy of Humira is early and brief. However, in this particular patient, standard therapies have been exhausted and any further treatment will be based on agents for which the evidence of efficacy is incomplete. In this setting, and for this particular patient, the use of Humira is medically appropriate and indicated. Therefore, I have determined that the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.