Diagnosis: Gastrointestinal/Digestive System.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied Remicade.
The denial is overturned.

This patient is a male with a history of Crohn's disease, diagnosed on the endoscopy and colonoscopy. His disease is complicated by growth failure, pain and diarrhea. His inflammatory markers are very high, and his albumin is low. His weight is approximately (~) 25 kilograms (kg). The subject under review is the medical necessity for Remicade.

The health plan's determination is overturned in whole.

Anti-tumor necrosis factor alpha (TNF-a) (such as infliximab) are considered the standard treatment for pediatric Crohn's disease. The clinical practice guidelines recommend early biologic therapy for selected children with high risk for poor outcome such as patients with upper gastrointestinal (GI) involvement, growth delay, pan-enteric disease or stricturing diseases (Ruemmele FM et al.).
Furthermore, there is growing scientific evidence supporting the early use of biologics in the treatment of pediatric Crohn's disease. Many peer reviewed literature reports showed superior efficacy and less disease complications when biologics are used early in the disease course.
Yun Seok Lee et al., showed that early anti-tumor necrosis factor (TNF) use led to decrease relapse rate compared to conventional therapies in pediatric Crohn's disease. Thomas D. Walters et al., showed improved effectiveness with early use of Anti-Tumor Necrosis Factor-a in pediatric Crohn`s and improved growth parameters. Other studies showed that early use of biologics can delay disease progression to stricturing and/or penetrating disease when compared to conventional therapy (Basavaraj Kerur et al.).
Finally, infliximab is Food and Drug Administration (FDA) approved for pediatric Crohn's disease. However, the proposed "conventional therapies", such as azathioprine and methotrexate, are not FDA approved for pediatric Crohn's disease and are associated with major side effects.
This child has severe Crohn's disease associated with deep ulcers, anemia and growth failure. He is considered at high risk of poor outcome. Therefore, the early use of infliximab is appropriate and medically necessary despite not trying and failing conventional therapy.

According to the clinical practice guidelines: "Intravenous administration of infliximab (Remicade) is usually at 5 milligrams per kilogram (mg/kg) with three induction doses over 6 weeks [weeks 0-2-6], followed by maintenance therapy of 5 mg/kg every 8 weeks. However, there is ample evidence that children less than 30 kg, and those with extensive disease and low serum albumin levels, require higher induction doses up to 10 mg/kg, shorter dosing intervals, or both, to reach target trough levels" (Van Rheenen, et al.). This patient is low albumin, and his weight is 25 kg. Using a higher dose for induction the maintenance is appropriate and consistent with the generally accepted practices.
Therefore, the requested service is medically necessary.