Appeal type: Step Therapy
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: Dexilant.

The insurer denied the Dexilant.  The determination is upheld.

This is a patient with a request for the use of Dexilant (dexlansoprazole) to treat gastroesophageal reflux disease (GERD). This patient has tried and failed omeprazole, lansoprazole and pantoprazole in the past and apparently has relief of her GERD symptoms only with Dexilant. Therefore, the attending provider would like to use Dexilant to treat this patient's GERD.

At issue is the medical necessity of the Dexilant.

The requested health service/treatment of Dexilant capsule 60 milligrams (mg) is not medically necessary for this patient.

Dexilant is one of several proton pump inhibitors (PPIs) that are used in the treatment of GERD. However, there is no evidence in the published medical literature to suggest that Dexilant is superior to other PPIs for the management of GERD. Therefore, any of the formulary PPIs including over-the-counter (OTC) PPIs may be used to treat this patient's GERD. According to the current ACG Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease, there are no major differences in efficacy between the different PPIs. (Strong recommendation, high level of evidence). 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.
The first step in the management of refractory GERD is to optimize PPI therapy by confirming compliance and ensuring appropriate dosing as poor compliance is associated with lack of response to PPIs. The efficacy of PPIs is generally maximized when PPIs are taken before a meal. Once compliance and appropriate dosing are ensured, a single trial of a different PPI can be considered. This has been shown by evidence from a multicenter randomized trial showed this strategy to be helpful in some patients. 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 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: 1) Decreased calcium absorption and increased risk of fracture, 2) Increased risk of Clostridium difficile infection, 3) Increased risk of community and hospital acquired pneumonia and other infections, 4) Drug interactions, most importantly to clopidogrel (Plavix), 5) Decline in vitamin B12 stores, 6) Decline in serum magnesium, and 7) Increased risk of chronic kidney disease (CKD). Non responders to a PPI should be referred to for further evaluation.