Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease 

Treatment: Cimzia 400 milligrams/2 milliliter (400 MG/2 ML) every 2 weeks

The insurer denied coverage the medication Cimzia 400 milligrams/2 milliliter (400 MG/2 ML) every 2 weeks

The denial is overturned.

This case involves a female who has been diagnosed with severe Crohn's disease.  The documentation indicated that the patient has failed Remicade as well as Humira, Entyvio, Stelara, methotrexate, 6-MP, and azathioprine.  As per a telehealth visit note, the patient was diagnosed initially in 2011 with ileocolonic Crohn's disease.  The patient was status post left colectomy with end colostomy and revision with 15 cm of bowel removed.  The patient has failed multiple medications and has been maintained on Cimzia every 2 weeks.  It has been recommended that the patient increase her dose to 400 mg every 2 weeks in the process.  The documentation indicated that the patient was utilizing prednisone 15 mg daily in addition to Cimzia every 2 weeks and CellCept.  The patient continued to have oral ulcers but reported improvement with this treatment regimen.  The patient also reported improvement in her intermittent lip and facial swelling. The patient's colonoscopy revealed patchy erythema with large shallow ulcers beginning in the transverse colon and extending distally to the stoma.  This was consistent with active luminal disease.  However, the physician indicated that the procedure was completed with the patient 4 weeks overdue for Cimzia. Therefore, it is unclear if current disease activity is secondary to Cimzia being overdue versus failure.  The physician detailed that the patient is maintained on Cimzia 200 mg every 2 weeks and it has been recommended that she increase her dose to 400 mg.

Based on the review of the medical record and literature, the patient is a young female with severe structuring disease and is facing limited options to get her disease into remission.  The patient has tried and failed immunomodulators, Remicade, Entyvio, Stelara, and Humira. This patient has severe Crohn's disease that is in relapse with standard Cimzia maintenance dosing of 400 mg every 4 weeks.  There is no guideline or society recommending Cimzia for every 2 weeks although there are numerous abstracts and anecdotal studies showing efficacy.  In principle the American Gastroenterological Association (AGA) Guidelines references reducing time intervals or increasing the doses of biologics when a patient is not responding.  Unfortunately, this patient has no options except to reduce the interval of Cimzia to every 2 weeks or risk repeated surgical procedures and eventually short gut syndrome. On the basis of the American Gastroenterological Association (2017) commenting on the schedule or dose modification of a biologic and literature showing efficacy for patient having failed previous biologics the denial should be overturned and Cimzia approved at the 400mg every two weeks as a medical exception.

The requested treatment is likely to be more beneficial than any of the standard treatments for this patient.

The carrier's denial of Cimzia 400 milligrams/2 milliliter (400 MG/2 ML) every 2 weeks should be overturned.