Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Remicade 1200 mg every 8 weeks.
The denial is overturned. 

This female patient has severe ulcerative colitis. She was started on Remicade several years ago after failing 5-aminosalicylic acid (5-ASA) agents, steroids and Humira (adalimumab). She was on a standard dosing of Remicade (5 milligrams (mg)/kilograms (kg) every 8 weeks) which was then escalated to every 10 mg/kg every 8 weeks based on her body weight as she had continued symptoms of active ulcerative colitis (UC) on standard dosing. Her UC is in remission on Remicade 10 mg/kg every 8 weeks. Therefore, the attending provider would like to continue the escalated the dose of infliximab (Remicade) 10 mg/kg every 8 weeks to treat this patient's ulcerative colitis.
At issue is the medical necessity of Remicade 1200 mg every 8 weeks.

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Remicade 1200 mg every 8 weeks is medically necessary for this patient.
Dose escalation is the standard of care when using biological agents to treat inflammatory bowel disease and can be done either by shortening the interval between infusions or increasing the dose of the drug or sometimes both shortening the interval and dose increase. Remicade was the first anti-tumor necrosis factor (TNF) agent United States Food and Drug Administration (FDA) approved for the treatment of moderate to severe ulcerative colitis since 2005. The use of anti-tumor necrosis factor (TNF) agents is standard of care in moderate to severe Ulcerative Colitis. Anti-TNF therapy should be initiated in patients with acute severe (refractory to corticosteroids) ulcerative colitis and in patients with moderate-to-severe ulcerative colitis who are not responsive to conventional treatment with aminosalicylates, corticosteroids and immune modulators. The only reason to stop Remicade or any other anti-TNF agent used for treatment of ulcerative colitis is an adverse reaction or a contraindication or loss of response to the medication. Up to now, no prospective head-to-head comparison has been performed in UC between infliximab (Remicade), adalimumab, and golimumab, although most clinical experience has been gained with infliximab.
Infliximab (Remicade) leads to higher remission rates and mucosal healing, at least in the short term. Remicade has been available for a longer duration than anti TNF agents and there are more safety data on Remicade than there are for any other biologic therapy used in the treatment of ulcerative colitis. A study by Dumitrescu and colleagues showed that Infliximab dose doubling led to short- and long-term event-free survival in UC patients, who had a loss of response to infliximab, in greater than 50% of the cases. The benefits of such a strategy were significantly improved by adding a concomitant immunomodulator. Another study by Taxonera and colleagues showed that UC patients who lost response to infliximab during maintenance, infliximab dose escalation enabled recovery of short-term response in nearly 70% of patients. In the long term, 58% of patients maintained sustained clinical benefit, and 9 of 10 avoided colectomy. Short-term response was associated with an 86% reduction in the relative risk of colectomy. Govani and colleagues showed that in a retrospective review, 69.7% of those failing to respond to single-dose infliximab were able to avoid colectomy with an accelerated rescue induction strategy without worsening postoperative outcomes.
Based on the clinical data provided, the continued use of Remicade (infliximab) at the escalated dose of 10mg/kg every 8 weeks to treat this patient's ulcerative colitis is appropriate and medically necessary.
Therefore, the requested health service/treatment of Remicade 1200 mg every 8 weeks is medically necessary.