Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD). 
Treatment: Lansoprazole oral disintegrating tablet. 

The insurer denied Lansoprazole oral disintegrating tablet. 
The determination is overturned. 

This male patient who has squamous cell carcinoma of the tongue with recurrent disease and is status/post (s/p) left hemiglossectomy and left neck dissection. He is fed via a gastrostomy tube (PEG tube) since he has dysphagia. At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug, Lansoprazole oral disintegrating tablet (ODT) or would have adverse effects. 

The formulary drugs, dexlansoprazole delayed release (generic Dexilant) esomeprazole delayed release, pantoprazole delayed release, will not be as effective as the non-formulary drug, Lansoprazole ODT but would not have adverse effects. This patient has a percutaneous endoscopic gastrostomy (PEG) tube and the formulary proton-pump inhibitors (PPIs) are not available in liquid form. The formulary PPIs are also not meant to be crushed or chewed and are not available as orally disintegrating tablets (ODT). 
This patient has gastroesophageal reflux disease (GERD) and has dysphagia due to head and neck cancer and cannot swallow pills and is currently being fed via a PEG tube. Therefore, it is appropriate to use Lansoprazole ODT to treat this patient's GERD. Of the seven available PPIs, four can be obtained over-the-counter (omeprazole, esomeprazole, lansoprazole, and omeprazole-sodium bicarbonate) and three are available only by prescription (rabeprazole, pantoprazole, and dexlansoprazole). Meta-analyses fail to show significant difference in efficacy for symptom relief between PPIs. However, since the other formulary PPIS cannot be crushed or chewed, it would be prudent to continue the medication that best controls the patient's symptoms. 
There is no scientific rationale or an evidenced-based standard that was applied to this case, more a common sense approach based on clinical judgement. It is well known that there are no major differences in efficacy between the different PPIs used to treat GERD. However, this is a unique situation in this case, where a patient cannot swallow pills. Lansoprazole ODT is a reasonable and appropriate treatment for this patient's GERD. A randomized controlled trial in patients with persistent GERD symptoms despite a single daily dose of PPI, showed that increasing PPI to twice daily or switching to another PPI both resulted in symptomatic improvement in roughly 20% of patients, without a clear advantage for either strategy. PPI therapy should be initiated at once a day dosing, before the first meal of the day. For patients with a partial response to once daily therapy, tailored therapy with adjustment of dose timing and/or twice daily dosing should be considered in patients with night-time symptoms, variable schedules, and/or sleep disturbance. Maintenance PPI therapy should be administered for GERD patients who continue to have symptoms after PPI is discontinued and in patients with complications including erosive esophagitis and Barrett's esophagus. For patients who require long-term PPI therapy, it should be administered in the lowest effective dose, including on demand or intermittent therapy because there are risks with long term use of PPIs that have been suggested by large, observational studies. These risks include: - Decreased calcium absorption and increased risk of fracture - Increased risk of Clostridium difficile infection - Increased risk of community and hospital acquired pneumonia and other infections - Drug interactions, most importantly to clopidogrel (Plavix) - Decline in vitamin B12 stores - Decline in serum magnesium - Increased risk of chronic kidney disease (CKD). Non responders to a PPI should be referred for further evaluation.