Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Remicade (J1745) 100mg Vial, 800mg by Intravenous Infusion Every 8 Weeks For One Year = 80 HCPCS Units Per Dose For A Total of 560 HCPCS Units, Pre-service. 

The insurer denied the Remicade (J1745) 100mg Vial, 800mg by Intravenous Infusion Every 8 Weeks For One Year = 80 HCPCS Units Per Dose For A Total of 560 HCPCS Units, Pre-service. 
The denial is overturned. 

This patient is a male with severe Crohn's disease with perirectal abscess diagnosed.  The patient has been treated with Humira in the past.  Remicade was started.  The Remicade level was low at 1.1.  The dose was escalated to 800 milligrams (mg) intravenously (IV) every eight weeks. 

Yes, the proposed treatment is medically necessary. 

Dose escalation of therapy by increasing the frequency of administration or by increasing the dose is conducted in clinical practice if a patient exhibits signs of increased disease activity. In a study by Regueiro, et al., of the 54 patients who had increased frequency of administration of Remicade or an increased dose of Remicade, 75.9% were able to regain response and remained on infliximab. Specifically, over three years there were 108 Crohn's disease (CD) patients receiving at least eight infliximab doses. At 30 months from initial infusion, 69.1% were event-free from an interval decrease, 48.5% from a dose increase, and 45.7% from any dose intensification. The authors concluded that, ''A significant proportion of Crohn's disease (CD) patients on long-term infliximab treatment lose response and require an increase in dose and/or decrease in infusion interval. The majority of these patients regain response with dose intensification.'' 

In a meta-analysis by Gisbert, et al., 16 studies looking at patients who lost response to Remicade were included. The mean percentage of patients with loss of infliximab response was 37%.In a study by M Chaparro, et al., they looked at 33 patients who lost response to Remicade requiring dose intensification. Seventy-nine percent of patients had a clinical response (33.5% complete response, 45.5% partial response) after the first dose was intensified. They concluded that more than ten percent per patient-year of infliximab treatment will lose response and will require an increase in dose and/or decrease in infusion administration interval. In the ACCENT I trial, an increase in the dosage to ten milligrams per kilograms resulted in a 90% response in luminal Crohn's disease (CD) patients (Hanauer SB, et al. Lancet). Similarly, in ulcerative colitis (UC), Seow, et al., found that escalation of infliximab therapy, by shortening the interval to six to seven weeks, achieved remission in 44% of the patients and in 25% in cases of doubling the dose. In a retrospective European multicenter study in ulcerative colitis (UC) patients treated with infliximab, a clinical response after the first escalated dose in 13 of 15 patients (86.7%) with a doubled dosage and in 24 of 26 patients (92.3%) with a shortened interval was noted. The patients who achieved a rapid clinical response had significantly higher colectomy-free rates at week 52 than patients who did not (Cesarini M, et al. Dig Liver Dis.). 

Yes, the health plan act reasonably, with sound medical judgment and in the best interest of the patient.