Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Eosinophilic esophagitis (EOE)
Treatment: Dupixent Pen 300mg (milligram)
The insurer denied coverage for Dupixent Pen 300mg.
The denial is upheld.
 
Patient is a early teenager with a past medical history notable for eosinophilic esophagitis (EOE) diagnosed since a baby. Presenting symptoms had included vomiting, dysphagia and failure to thrive. The patient's disorder is being managed with omeprazole 40mg (milligram) daily, swallowed Flovent and a restricted diet excluding milk, wheat, tree nuts and sesame.  On this regimen, he has had 2 follow-up endoscopies as follows:

1.	Upper endoscopy with biopsy several months ago- grossly normal and histologically normal 
2.	Upper endoscopy with biopsy recently - grossly normal and histology showing 6 eosinophils per high power field in the distal esophagus and normal histology in the proximal esophageal specimens.

According to a review of the treatment for eosinophilic esophagitis from UpToDate the authors describe the use of Dupixent (dupilumab) as follows:
For EOE (eosinophilic esophagitis), dupilumab is administered at a dose of 300mg (milligram) by subcutaneous injection once weekly. Laboratory monitoring is not required. Its role in the management of EOE remains to be fully defined compared with other options such as dietary therapy and topical glucocorticoids. While no US Food and Drug Administration (FDA)-approved formulation of the latter is available in the United States or in some other regions, many studies have demonstrated a clinical benefit and clarified its safety profile. In addition, patients with EOE plus one or more atopic conditions (e.g., severe asthma, eczema, sinus disease) may be candidates for dupilumab because it may consolidate their medical therapies.   Long-term safety of dupilumab is still being established. The most common side effects occurring more often than placebo in trials of EOE included injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections, but additional side effects have been described in trials using dupilumab for other indications. Preliminary data suggest that dupilumab use may be linked to an increased risk for developing other cytokine-mediated conditions including seronegative inflammatory arthritis, enthesitis, iridocyclitis (iritis with adjacent ciliary body inflammation), and psoriasis, possibly by shifting immune responses toward alternative cytokine pathways. Additional studies may help to describe the underlying mechanism and confirm these findings. The manufacturer lists several precautions, which should be considered before initiating, and while monitoring, therapy.

For this patient, his disease is not refractory as stated in the appeal. He has serial endoscopies documenting the effectiveness of his current regimen. Although approved for EOE, the agent is not medically necessary to treat his disorder. This in combination with the uncertainty of its long-term safety would suggest that the denial was both appropriate and in his best interest. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Dupixent Pen 300mg is not substantiated.