Appeal type: Medical necessity
Decision: Overturned

Diagnosis: K50.00 - Crohn's disease of small intestine
Treatment: Stelara SQ 90mg/ml syringe, every 28 days
The insurer denied the Stelara SQ 90mg/ml syringe, every 28 days.
The denial is overturned.

The patient is a female with obesity (BMI [body mass index] 31.31 and 30.99 approximately three months later), depression, asthma, anemia, GERD [gastroesophageal reflux disease], status post left foot surgery. Pertinent to this review, the patient was diagnosed with Crohn's enteritis and with psoriatic arthritis.

Per provided records, in treatment of both diseases, the patient has tried and failed sulfasalazine, methotrexate, Humira, infliximab and ultimately Stelara (90mg/ml [milligrams per milliliter]).  Provider's attestation letter documents oligoarthritis manifesting as trigger finger with joint swelling. Charting documents mild abdominal tenderness. CRP (C-reactive protein) has increased from 18.1 to 33.7 in approximately three months. 

The provider had advised Stelara dose optimization from every 8-weeks to every 4-weeks.

Yes, the Stelara every 4 weeks is medically necessary.
The FDA (United States Food and Drug Administration)-approved adult dosing of Stelara is "subcutaneous 90 mg [milligrams] dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter" for Crohn's disease. (2)  However, available literature is replete in support of safety and efficacy of Stelara dose-optimization in both adults and children with symptomatic and objective evidence of Crohn's disease activity.

Chao opines (8), "Up to one-third of IBD [inflammatory bowel disease] patients can experience that biologics become less effective and fail to maintain disease remission. In these cases, dose intensification or more frequent dosing have been considered and tried," with the goal of histologic remission.

Per Kotze et al (9), "In the open-label environment, dose adjustment of Stelara has been attempted for patients with inadequate primary response and secondary loss of response to therapy. Most frequently, patients are advanced from q8 [every eight]-week maintenance to q4 [every four]-week maintenance therapies. Alternative strategies to consider also include reloading with high-dose SC [subcutaneous] therapy or reloading with IV [intravenous] induction. Reported rates of escalation are mixed, primarily due to varying indications for dose adjustment. In the McGill cohort, almost half of patients underwent dose intensification and this was successful in 11/18 (61%) patients. In contrast, only 3/16 (19%) patients responded to escalated maintenance dosing in the UBC [University of British Columbia] cohort. These discrepancies may reflect differences in indication for dose escalation, use of concomitant therapy, or decision for concurrent re-induction prior to dose intensification."

Most recently, Ollech et al retrospectively collected data from 506 Crohn's patients that meet the patient's circumstance. The authors opined, "Shortening the ustekinumab 90 mg [milligrams] dose interval to 4 weeks for patients with Crohn's disease 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 benefit from dose interval shortening, which was effective and safe."

In summary, the disputed service is safe, appropriate and effective for the patient.  Medical necessity criteria are met for a three-month trial of dose-optimized Stelara 90mg (milligrams) every 4-weeks, with dose re-evaluation thereafter.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient's scenario meets medically necessity.