Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1This is a patient with apparent left-sided chronic ulcerative colitis who has continued symptoms despite topical and systemic therapy with mesalamine preparations. She is said to have been unresponsive to corticosteroids in the past; however, a review of the medical records provided documents no use of prednisone or other corticosteroids since at least the fall of 2003. Imuran was started in September 2003. The treatment notes from December 2003 indicate the patient was in remission and away from steroids. The patient was no longer on Imuran when she presented with a flare-up of her disease in March 2004, which may be an indication the patient will respond to immunomodulator therapy if maintained on the drug. The treatment notes suggest the patient might have had trouble with nausea while on Imuran but this is not clearly documented. The patients provider has recommended a trial of Remicade. The Health Plan has denied coverage for Remicade on the basis that it is considered investigational for treatment of this patients condition.There has not been appropriate clinical trials or widespread and long-standing clinical experience documenting the efficacy of Remicade therapy for ulcerative colitis. The only data regarding the efficacy of Remicade is in open label observational studies. Additionally, there is no evidence to suggest that Remicade will be more beneficial for treatment of this patients condition than other available treatment such as reinstitution of Imuran, initiation of methotrexate or cyclosporine or surgery. Furthermore, Remicade can be associated with potentially life-threatening toxicity. As such, consideration of Remicade therapy should not be undertaken until all other accepted and investigated alternative therapies have been exhausted.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2The patient is a 32-year-old woman with a history of ulcerative colitis dating to approximately 1995. She has been treated with standard therapy including various mesalamine preparations, Levaquin, azathioprine, and 6-mercaptopurine. Notes from March 2004 indicate it had been some time since the patient was on oral prednisone. She notes lack of response to Proctofoam as well as Cipro. The patient was described as having ulcerative proctitis as demonstrated by a colonoscopy in 2003. At that time, it was noted only the rectum was involved. The patients provider further indicated exacerbation was difficult to control as the patient was resistant to all medications recently attempted. Remicade therapy has been recommended. The Health Plan has denied authorization and coverage for Remicade on the basis that it is considered investigational for treatment of ulcerative colitis.The citations included with this case include abstracts and peer-reviewed journal reports of the use of infliximab (Remicade) for the short-term treatment of ulcerative colitis only. A randomized trial is cited, and as noted, the trial was discontinued because of slow enrollment. The use of Remicade has certainly not reached anything approaching acceptance by the gastroenterology specialty community as safe and useful therapy for ulcerative colitis. Indeed, the best data available indicates Remicade is not useful in patients with steroid resistant ulcerative colitis. In the largest randomized, controlled trial with ulcerative colitis to date there was no difference in response between placebo and Remicade (Probert, et al.). The authors concluded the data did not support the use of Remicade in the management of moderately active glucocorticoid resistant ulcerative colitis. The authors of another article concluded the potential for increased infectious complications and poor response rate among corticosteroid-refractory patients emphasizes the need for careful consideration of the potential risks and benefits of Remicade therapy in patients with corticosteroid-refractory disease (A-Rahim et al.).In the case of this patient, it appears she is a candidate for surgical intervention. It has not been established that Remicade is likely to be more efficacious for treatment of this patients condition than surgery. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3The patient is a 32-year-old female with a five-year history of ulcerative colitis. A colonoscopy in 2003 confirmed the disease. The patient is symptomatic and has not responded to Pentasa, Asacol, Colazal, Imuran, and systemic steroids. The submitted treatment notes indicate the patient is losing weight and experiencing diarrhea. The patients provider has recommended Remicade therapy. The Health Plan indicates the requested therapy is considered investigational in this clinical setting. At this stage of the patients therapy, the patient is likely to benefit from Remicade. Short of surgical resection of her colon, other standard medical therapies are unlikely to be beneficial. There are multiple reports in the literature regarding the usefulness of Remicade in treatment of patients with ulcerative colitis. A trial of Remicade is medically reasonable and appropriate as it represents the least invasive treatment option available. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.