Appeal type: Medical necessity
Decision: Overturned

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

This is a female patient, who has severe ileal Crohn's disease. She has previously tried and failed 5-aminosalicylic acid (ASA) agents and steroids. She was started on Humira at standard dosing but did not achieve remission. Therefore, her attending provider escalated the dose of Humira to 40 milligrams (mg) weekly. Her Crohn's disease is in remission on the escalated dose of Humira. Therefore, the attending provider is requesting the continued use of Humira at the escalated dose of 40mg every week to treat this patient's severe Crohn's disease.
At issue is the medical necessity of Humira 40mg.

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

The requested health service/treatment of Humira 40mg every week is medically necessary for this patient.
Dose escalation in inflammatory bowel disease (IBD) is the standard of care in patients who are not responding to the standard dose of the medication and have been dosed with Remicade (infliximab), Humira (adalimumab), Entyvio (vedolizumab) and Stelara (ustekinumab) but not Cimzia (certolizumab).
Treatment with an anti-tumor necrosis factor (TNF) agent with moderate to severe Crohn's disease is the generally accepted standard of care. However, only infliximab (Remicade) and adalimumab (Humira) are United States Food and Drug Administration (FDA) approved for Induction and Maintenance therapy in Crohn's disease. The anti TNF-alpha drugs infliximab or adalimumab are more likely than placebo to induce remission in patients with moderately severe Crohn's disease refractory to other therapies, including mesalamine, antibiotics, corticosteroids, and immunomodulators. The ability to induce remission in patients who have not responded to treatment with corticosteroids or immune modulators is an important feature of these drugs. The clinical data supporting the use of Humira in Crohn's disease is from well-conducted randomized controlled or comparative controlled cohort trials in the prevailing peer-reviewed published medical literature and is adequate to conclude that Humira is effective for the treatment of Crohn's disease. The standard dosage for Humira (adalimumab) is 160 mg initially (Day 1), followed by 80 mg at week 2 (Day 15), then 40 mg every other week starting at week 4 (Day 29).
Dose escalation in biological therapy used to treat inflammatory bowel disease is a well-accepted practice and supported by literature in patients who are not responding to the standard dosing of the medication. This can be done by a dose increase or shortening the interval between infusions and sometimes a combination of both dose increase and shortening the interval between doses.
Some patients require weekly dosing of 40mg every week if symptoms persist on every other week dosing. Duveau and colleagues showed that adalimumab dose escalation is an effective and well-tolerated therapeutic option in patients with secondary loss of response. A 40mg every week optimized regimen was predictive of a response to adalimumab dose escalation. Bouguen and colleagues showed that adalimumab 80 mg weekly seems to be well-tolerated and may be effective in inducing clinical remission in patients with luminal Crohn's disease who failed to respond to 40 mg weekly or 80 mg every other week. Humira dose escalation in this patient who failed standard dosing of Humira is appropriate and medically necessary.
Therefore, the requested health service/treatment of Humira 40mg every week is medically necessary.