Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: gastroesophageal reflux disease.
Treatment: Formulary Exception for Carafate Suspension.
The insurer denied the Formulary Exception for Carafate Suspension.
The denial is overturned.

The patient is a female adolescent with medical history significant for obsessive-
compulsive disorder, cluster headaches, drug withdrawal syndrome as a neonate,
reactive airway disease, acne vulgaris, and gastroesophageal reflux disease. She
has most recently been seen for longstanding abdominal pain (six months) with
pain after eating and early satiety. She has been treated with Nexium, omeprazole,
and famotidine without improvement, and most recently has experienced a five
pound weight loss over two weeks attributed to the pain. Because she has tried and
failed both proton pump inhibitors and histamine blockers, she has been prescribed
a trial of sucralfate (Carafate). In addition, she has had lab work-up including
Helicobacter pylori antibody, celiac disease panel, amylase and lipase for
pancreatitis, complete blood count (CBC), and complete metabolic panel.

Yes, the health plan should cover carafate suspension for this patient.
Gastroesophageal reflux is defined as the passage of gastric contents into the
esophagus with or without regurgitation or vomiting. Gastroesophageal reflux
disease is a pathologic condition when gastroesophageal reflux leads to troubling
symptoms and/or complications (eg esophagitis, strictures). In those that can report
such as older children and adolescents, symptoms include heartburn and
regurgitation. Additional signs and symptoms include discomfort, failure to thrive or
weight loss, dysphagia, wheezing, cough, hoarseness, and epigastric pain.
Untreated gastroesophageal reflux disease may lead to esophagitis, anemia, dental
erosions, asthma, apnea spells in infants, recurrent otitis media and pneumonia,
and over time Barrett's esophagus.

According to the current treatment guidelines, proton pump inhibitor (PPI)
medications are the first line treatment followed by histamine (H2) blockers.
Patients that are refractory to eight weeks of medication treatment as well as
lifestyle changes may be considered for surgical intervention if severe.

In the case of this young adolescent, she has had longstanding abdominal pain with
recent weight loss as a result. She was initially treated with proton pump inhibitors
(PPIs) and then histamine (H2) blockers and remains symptomatic. She is currently
undergoing medical work-up for potential other causes of her gastroesophageal
reflux disease (GERD) and abdominal pain (celiac disease, Helicaobacter pylori
infection, pancreatitis). Prior to more drastic and invasive interventions, she has
been offered a trial of sucralfate (Carafate), to be used in conjunction with her acid
suppression medications. Carafate is a topical agent that coats the upper
gastrointestinal tract and if ulceration is present, coats the ulcer bed and facilitates
healing. For this reason, suspension is used over tablet form. Based on the current
literature and guidelines as well as this patient's clinical situation, a trial of
sucralfate (Carafate) suspension is medically necessary and appropriate.