Diagnosis: Crohn's disease.
Treatment: Humira CF Pen 40 mg/0.4 ml injection kit.
The insurer denied Humira CF Pen 40mg/0.4 ml injection kit.
The denial is overturned.

The patient is a male who has severe fistulizing Crohn's disease and has had required prior incision and drainage (I&D) of an abscess. He also has ankylosing spondylitis. He has previously tried and failed certolizumab and secukinumab. He was started on Humira at standard dosing and initially responded but did not achieve remission. He required seton placement during which Humira was temporarily held for two weeks. He still did not achieve clinical remission. Therapeutic drug monitoring showed low adalimumab levels. He had elevated inflammatory markers (fecal calprotectin). Therefore, his attending gastroenterologist would like to escalate the dose of Humira to 40 milligrams (mg) every week to treat this patient's severe Crohn's disease.

The requested health service/treatment of Humira CF (citrate-free) Pen 40 mg (milligrams)/0.4 ml (milliliters) injection kit for quantity increased to weekly dosing 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 standard of the biological medication they are currently on. 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 standard dosing of the medication. Dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose of the current biological agent before switching to another agent. Humira dose escalation to weekly in this patient who is failing standard dosing of Humira is appropriate and medically necessary.