Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara SQ 90mg (every 4 weeks).

The insurer denied the Stelara SQ 90mg (every 4 weeks).
The denial is overturned.

The patient is a female. She was diagnosed with Crohn's disease (CD) (small bowel) and PSC (primary sclerosing cholangitis). Her history includes the following: Approximately 10 years prior she failed mesalamine. Approximately 10 years prior, she had a partial response to Humira. Approximately eight years prior, she lost response to Cimzia and 6MP (mercaptopurine). Approximately two years prior, she was started on Stelara and 6MP (mercaptopurine).

The patient's colonoscopy included the following findings:

1) The cecum had patchy erythema and congestion. Some inflammatory polyps in the proximal transverse colon. Otherwise normal mucosa was found in the entire colon. Biopsies were taken with a cold forceps for histology.

2) Just proximal to the IC (ileocecal) valve, in the terminal ileum there was one large shallow ulceration and a few small-to-aphthous ulcers. Proximal in the TI (terminal ileum), the mucosa was normal. Biopsies were taken.

The impression was as follows: Endoscopically Mild-to-Moderate Cohn's lleocolitis (SES-CD [Simple Endoscopic Score for Crohn Disease ] 6).

The patient was escalated to Stelara to every four weeks and 6MP (mercaptopurine) and cipro 500 mg (milligrams) BID (twice daily).

The patient's clinic visit showed improvement of symptoms, with 1 to 2 BM (bowel movements), and clinical remission.

The denial letter interacted that the case was reviewed by internal/family medicine provider and indicated that the FDA (United States Food and Drug Administration)-approved dose of every 8 weeks was medically necessary.

Yes, Stelara every 4 weeks is medically necessary.
The patient achieved clinical remission with dose escalation. Multiple studies have shown efficacy of this strategy.

A systematic review and meta-analysis done by Meserve et al. discussed how patients with Crohn's disease (CD) treated with ustekinumab who experience inadequate response, or loss of response after standard induction and/or maintenance dosing may benefit from dose escalation. They conducted a systematic review and meta-analysis examining the effectiveness of reinduction and/or dose interval shortening of ustekinumab in patients with active CD (Crohn's disease) despite standard induction and maintenance.

Through a systematic literature search, they identified 15 cohort studies in 925 adults with CD (Crohn's disease) with inadequate response or loss of response to standard dose ustekinumab, underwent dose escalation (reinduction and/or dose interval shortening to less than 8 weeks), and reported rates of achieving clinical response, corticosteroid-free clinical remission, endoscopic response, and/or remission. They calculated pooled rates (with 95% [percent] confidence intervals) using random effects meta-analysis and examined factors associated with response to dose escalation through qualitative synthesis of individual studies. Approximately 61% of patients were able to achieve endoscopic response, including 29% who achieved endoscopic remission. Dose interval shortening alone recaptured response in 57% patients. No consistent factors associated with response to dose escalation were identified on qualitative synthesis. The study concluded that in real word settings, ustekinumab dose escalation was effective in achieving response in patients with CD (Crohn's disease) with inadequate response, or loss of response to standard dose induction and/or maintenance therapy. (1)

The plan approved every 8 weeks, which is essentially dose de-escalation. The question here is the appropriateness of dose de-escalation. Per the AGA (American Gastroenterological Association) guidelines, "For patients that do respond well, such as among those who achieve endoscopic or histologic remission, we need data to guide us in when or how to deescalate or discontinue therapy" (2). Thus, dose de-escalation is not considered the standard of care due to lack of evidence to support it.

Therefore, given the above, the requested Stelara every 4 weeks is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.