Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative Colitis. 
Treatment: Stelara 90milligrams (MG)/milliliter (ML) subcutaneous (SC) syringe every 4 weeks. 

The insurer denied coverage for Stelara 90milligrams (MG)/milliliter (ML) subcutaneous (SC) syringe every 4 weeks. 

The denial is overturned. 

The insurer has denied coverage for Stelara 90milligrams (MG)/milliliter (ML) subcutaneous (SC) syringe every 4 weeks. In their Final Adverse Determination letter they write that the patient requested an appeal for Stelara dosed every 4 weeks for the treatment of Ulcerative Colitis (an inflammatory condition affecting the digestive tract). To approve this medication, the dosing frequency must be consistent with the United States Food and Drug Administration (FDA) product labeling. They indicate this criteria is not met because the request exceeds the maximum recommended dosing frequency of every 8 weeks for the treatment of Ulcerative Colitis based on the United States FDA product labeling. 

The patient's physician is appealing. In an appeal letter it is stated that the patient continued to be closely monitored and remained clinically stable until early this year  when the patient reported symptoms in the second half of the maintenance cycle, such as increased frequency, loud bowel sounds and liquid output. The patient needs higher drug level to sustain the clinical stability. The appealer notes the patient needs to continue with Stelara 90 milligram (mg)/ milliliter (ml) once monthly regimen. 

The patient was diagnosed with ulcerative colitis. The patient has tried and failed sulfasalazine, immunomodulators, and several biologics including Humira, Simponi, Remicade, and Cimzia. The patient had a proctocolectomy and J pouch [ileal pouch] creation. The patient then started Stelara. The patient was treated with Stelara every 8 weeks. Recently, the patient's symptoms increased especially prior to the next dose cycle and their ustekinumab level dropped. The patient did not have antibodies to ustekinumab. The patient's physician is now requesting to increase the Stelara dose to every 4 weeks. 

Clinical Gastroenterology and Hepatology article titled "Effectiveness of Ustekinumab Dose Escalation in Patients with Crohn's Disease" notes data was studied from patients who initially received ustekinumab every 8 weeks and then had their interval shortened to every 4 weeks. The conclusion was that shortening the ustekinumab dose to every 4 weeks, in patients who did not respond to dosing every 8 weeks, improved clinical and biological indices of disease activity. It was noted that dose interval shortening was effective and safe. 

An article submitted by the physician from Inflammatory Bowel Disease titled "Outcomes of Standard and Intensified Dosing of Ustekinumab for Chronic Pouch Disorders" concludes that most patients receiving ustekinumab would benefit from dose escalation which seems to be safe and effective. It is a recommended treatment for pouchitis when there is a loss of response to treatment. 

This patient has ulcerative colitis with pouchitis that was not adequately controlled on the standard every 8-week Stelara dose. Dose escalation of Stelara for IBD [inflammatory bowel disease] is well supported in the scientific literature. It is both effective and safe. The increased dose of Stelara is medically necessary. 

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably or in the best interest of the patient. 

The medical necessity for Stelara 90milligrams (MG)/milliliter (ML) subcutaneous (SC) syringe every 4 weeks is substantiated.