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

The patient is a male with a history of Crohn's disease. His disease is diffuse and affecting the upper gastrointestinal tract in addition to the colon (pan-enteric). The subject under review is the medical necessity for Humira.

The health plan's determination is overturned.

This patient has a diffuse, pan-enteric Crohn`s disease. Anti-tumor necrosis factor alpha (TNFa) (such as Humira) are the standard of care in managing severe and diffuse Crohn`s disease. The clinical practice guidelines recommend early biologic therapy for selected children with high risk for poor outcome such as patients with severe pan-enteric disease (Ruemmele FM, et al). Conventional therapies, such as immune-modulators, are less likely to be effective in treating severe Crohn`s disease in children. Azathioprine and methotrexate are not Food and Drug Administration (FDA) approved for the treatment of Crohn`s disease. Corticosteroids are not suitable for long term use. Sulfasalazine products have no role in pediatric Crohn`s disease treatment and lack efficacy.
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 TNFa 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.).
Therefore, the request for Humira is medically necessary and appropriate and supported by the clinical practice guidelines.