Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal/Crohn's Disease
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested medication, Humira, as not medically necessary. 
The health plan's determination is overturned, in whole.

The patient is a female with Crohn's disease. She has had diarrhea, rectal bleeding, abdominal pain, and fatigue. A colonoscopy showed an ulcerated and erythematous terminal ileum. 
At issue is the medical necessity of Humira for the treatment of Crohn's disease.

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

Yes, the request for Humira (Adalimumab) is supported as medically necessary. The patient has moderate to severe Crohn's disease. Per American College of Gastroenterology guidelines for primary therapy, immunosuppressants such as Azathioprine, 6-Mercaptopurine, and Methotrexate are given a weak recommendation (level 2 evidence), and tumor necrosis factor (TNF) inhibitors such as Infliximab are strongly recommended (level 1 evidence) [1]. These recommendations are corroborated by the American Gastroenterological Association (AGA) Guidelines for Initial Medical Treatment in Crohn's Disease [2,3]. For patients with moderate-severe Crohn's Disease, these guidelines state: use anti-TNF monotherapy over no therapy or Thiopurine monotherapy (such as immunosuppressants); no other alternatives are recommended - immunosuppressants may take up to 17 weeks to be effective, and amino salicylates, corticosteroids, and antibiotics are not recommended as long-term primary therapy as they are unlikely to prevent complications [1-4]. The guidelines state that "Thiopurine agents and Methotrexate are not effective agents for short-term induction in active, symptomatic disease because of their relatively slow onset of action, between 8 and 12 weeks" and "a disadvantage of the Thiopurine analogs and Methotrexate is the slow time to clinical response that may not be evident for as long as 12 weeks" [1]. The guidelines state that Azathioprine and 6-Mercaptopurine are "not more effective than placebo to induce short-term symptomatic remission and should not be used in this manner" and "Anti-TNF agents (Infliximab, Adalimumab, Certolizumab Pegol) should be used to treat Crohn's disease that is resistant to treatment with corticosteroids" [1]. American Gastroenterological Association guidelines for the treatment of Crohn's disease do recommend Adalimumab as initial therapy, and do not recommend Azathioprine or other immunomodulators to induce remission, stating "In adult outpatients with moderate to severe Crohn's disease, the AGA suggests against the use of Thiopurines over no treatment for achieving remission" [5]. In this case, the patient is unlikely to respond to conventional alternatives for induction of remission [1-5]. Comparative trials have shown improvement in outcomes with early initiation of anti-TNF medications with Azathioprine compared with Azathioprine alone, and with initiation of biologic therapy compared with immunomodulators [6]. The patient is at risk for Crohn's disease complications such as fistula, stricture, hospitalization, and the need for surgery if effective therapy is not initiated; for these reasons, the use of Humira for the treatment of Crohn's disease is supported as medically necessary per current medical literature.