Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90 mg (milligram) syringe every 4 weeks
The insurer denied coverage for Stelara 90 mg syringe every 4 weeks.
The denial is overturned.

The patient has a past medical history of small bowel Crohn's Disease (CD), diagnosed many years ago. The disease is complicated by an intrabdominal abscess that was treated by drainage. His other diagnoses include enterovesicular fistula, enteroenteric fistula, penoscrotal involvement and perianal fistula.

The patient is status post small bowel resection and fistula takedown; he presented to the gastroenterology clinic for follow up of Crohn's disease. The patient had a secondary loss of response to Humira. He was started on Stelara standard dose of 90mg every eight (8) weeks.

A colonoscopy showed ulceration at the anastomosis and two discrete ulcerations seen in the neo-terminal ileum. The patient was found to have anemia with a hemoglobin of 11.9, ferritin of eight (8) and vitamin D deficiency. The patient continued to have symptoms and was changed to every six (6) weeks dosing of Stelara. The patient currently is having six to seven bowel movements per day with a loose consistency. He also has fatigue and bilateral knee pain on occasions.

The patient had a repeat colonoscopy recently that showed multiple ulcers in the Neo terminal ileum consistent with active disease. At this time, the provider is requesting approval for escalation of frequency to Stelara every four (4) weeks.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. There are multiple studies that support the use of Stelara every four(4) weeks with improved clinical response.

"Shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe." (Ollech, J. E., et al., 2021).

The Stelara 90 milligram (mg) syringe every four (4) weeks does not need final approval from the appropriate regulatory bodies for this diagnosis. There is significant data to support the use of shorter intervals such as every four (4) weeks for the treatment of Crohn's disease.

"In real word settings, ustekinumab dose escalation was effective in achieving response in patients with CD with inadequate response, or loss of response to standard dose induction and/or maintenance therapy." (Meserve, J., et al., 2022).

The patient is a good candidate for Stelara 90 milligram (mg) syringe every four (4) weeks.

Stelara 90 milligram (mg) syringe every four (4) weeks is the best available treatment for this patient at this time.

There are not many alternative treatment options for Crohn's Disease, so optimizing treatment with the current regimen is ideal.

The studies have found no increase risk of adverse events compared to standard dosing. In this case benefit of the medication outweigh risks of adverse events.

The medical reviewer believes the patient is at very high risk for disease progression given the above mentioned risk factors. He already has evidence of active disease despite surgery and optimizing the medication to every four (4) weeks would be beneficial to control disease activity. This patient is young and there are not many alternative treatments for Crohn's Disease, so optimizing medication rather than jumping to a different treatment would be a better option to prevent further disease progression.

In summary, the denial of Stelara 90 milligram (mg) syringe every 4 weeks and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.