Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's disease
Treatment: Quantity Exception of Stelara SQ 90MG every Six Weeks

The insurer denied the Quantity Exception of Stelara SQ 90MG every Six Weeks.
The denial is upheld.

The patient is a female who has the diagnosis of ileocolonic Crohn's disease, longstanding. The patient had been receiving Stelara at an interval of every eight weeks and had developed symptoms. The patient then had the dosing increased to an interval of every six weeks.  The patient was approved for this dosing for a period of six months. As this period has now ended, the Plan has ended its approval of the every six week dosing interval.

No, the proposed quantity exception of Stelara subcutaneous (SQ) 90 milligrams (MG) every six weeks is not medically necessary.
The provider has requested Stelara at a dosing not approved by the Food and Drug Administration (FDA) or the Plan guidelines. A review of the literature indicates that there have been no significant studies to date demonstrating the safety and efficacy of Stelara dose escalation to every six weeks in Crohn's disease. The reports are anecdotal and involve small numbers of patients. As such, the usefulness, efficacy and safety of dose escalation of Stelara in patients with refractory Crohn's disease requires further study and would not be considered medically necessary. 

Despite the patient's presentation and history, there is no cogent medical literature or society guidelines to recommend dosing Stelara at an interval of every six weeks for maintenance. There is no medical literature to show that this dosing frequency has a positive effect on healthcare outcomes. The formulary medications, including Stelara at a dosing of every eight weeks for maintenance, is as effective and without more adverse side effects than the requested non-formulary medication. 
Therefore, the request is denied and not medically necessary for this patient.

"A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses." (Ollech, et al.).

"Crohn's disease is an immune-mediated disease that results in panenteric chronic inflammation in genetically predisposed individuals exposed to an appropriate environment. The past two decades have witnessed the emergence of an important class of drugs known as anti-tumour necrosis factor (TNF) agents in the treatment of Crohn's disease. Unfortunately, the utility of these agents have been hampered by primary and secondary nonresponse in a significant proportion of patients. Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin (IL) 12 and 23, is a novel pharmacotherapy for this patient cohort that offers an out-of-class option. It is approved for use in psoriasis and psoriatic arthritis, and has now been evaluated in phase II trials for moderate-to-severe Crohn's disease." (Simon, et al.).

"Biological medicines have revolutionised the treatment of Crohn's disease [CD]. Yet, the management of patients not responding to tumour necrosis factor [TNF] antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab has recently been approved for the treatment of adult patients with moderately to severely active CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF (tumour necrosis factor) antagonist, or have medical contraindications to such therapies. Herein, we review the new biological drug's efficacy and safety data reported from randomised controlled trials and real-world observational studies conducted in populations with CD, in order to identify the patient groups most likely to benefit, and to appropriately place ustekinumab into treatment algorithms for CD." (Danese, et al.).

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.
There is insufficient medical literature to support extended use of Stelara at a maintenance dosing of more frequently than every eight weeks as noted in detail above.  As such the plan has acted reasonably based on currently available evidence and information.