Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara 90mg every 6 weeks. 
The denial is overturned.

The patient is a female with Crohn's Colitis. She had been diagnosed with Crohn's disease  and has previously been treated with mesalamine, prednisone, and budesonide. She has been receiving Stelara [90 milligrams (mg) every 8 weeks]. She had colonoscopies revealing colitis. Her fecal calprotectin was greater than (>) 3,000, hemoglobin was 10.5, and C-reactive protein (CRP) was less than (<) 3. Her serum ustekinumab (Stelara) level was 3.5 micrograms (mcg)/milliliters (ml). She is currently receiving Stelara/Lialda/budesonide. She has continued to have intermittent symptoms, and a dosage escalation of ustekinumab to 90mg every 6 weeks has been recommended by her provider.
At issue is whether Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the patient's disease.

The health plan's determination is overturned in whole.

The proposed health service or treatment Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient has Crohn's Colitis. She has been receiving Stelara [90mg every 8 weeks]. She is currently receiving Stelara/Lialda/budesonide. She has continued to have intermittent symptoms, and a dosage escalation of ustekinumab (Stelara) to 90mg every 6 weeks has been recommended. The dosage escalation is likely to be more beneficial than any standard treatment for treatment of this patient's Crohn's disease. This is supported by current evidence-based peer-reviewed medical literature and is the standard of care.
"Following dose interval shortening, the patients' median Harvey Bradshaw Index (HBI) decreased from 4.5 to 3 (P = .002), the median level of CRP decreased from 8 mg/L to 3 mg/L (P = .031), and median level of fecal calprotectin decreased from 378 g/g to 157 g/g. Among patients who had an HBI >4, a level of CRP >5mg/dL, a level of fecal calprotectin >250ug/g, or endoscopic evidence for disease activity before dose interval shortening, after the dose interval was shortened, 28% achieved clinical remission (an HBI score less than or equal to [<=] 4), 22% had a normal level of CRP (< 5 mg/dL), 50% had reduced levels of fecal calprotectin, and 36% achieved endoscopic remission.
Shortening the ustekinumab 90mg dose interval to 4 weeks for patients with Crohn's Disease (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." [1]
In addition, "This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard-dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation...Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing." [2]
"Our results support ustekinumab (UST) every (Q)4-week dose escalation for selected CD patients who fail to achieve remission on standard Q8 week dosing. Dose escalation improves clinical outcomes, prevents worsening disease severity, and positively impacts CRP and albumin levels. Together these data indicate that clinicians should attempt Q4 week UST dosing in refractory CD patients before switching to an alternative class of biologic therapy." [3]
Therefore, the proposed health service or treatment Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the patient's life-threatening disease.