Antacids denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage Dexilant (dexlansoprazole) 60 mg delayed-release capsules. Findings: The physician reviewer found that gastroesophageal reflux disease (GERD) and esophagitis are at least partially caused by mechanical defects in esophageal motility. Scarpignato and colleagues indicate that since proton pump inhibitors (PPIs) do not correct the underlying pathophysiological motor abnormalities responsible for reflux, ongoing treatment at a sufficient dose is likely to be needed to maintain remission. Usai and colleagues state that insufficient acid suppression can result in complications of GERD, such as persistent erosive esophagitis, esophageal stricture, esophageal ring, and Barrett's esophagus.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Nexium 40 mg twice per day for treatment of the enrollee’s gastroesophageal reflux disease (GERD). Findings: The physician reviewer found that compared with brand name medications, generic formulations may contain additional inactive ingredients such as dyes. Although differences in efficacy between generic medications and brand name medications have not been widely demonstrated, differences in tolerance and adverse effects may be present. The records document that this patient has already failed one generic formulation of Nexium. Therefore, the requested coverage of brand name Nexium is supported as medically necessary in this case. However, the use of Nexium 40 mg twice daily rather than once daily is not supported.

Where the denial was upheld

Physician 1: The patient is a 37-year-old male with chest pain, who has had a response to PPIs, but does not wish to take them any longer and it has been recommended to him that the Enteryx procedure for managing GERD may be a reasonable option to pursue. His diagnosis of GERD is questionable at best as his symptoms are not typical and his objective measures not diagnostic. A 48-hour Bravo study has a total intraesophageal acid exposure of ~2%, which is well within the normal range. Further, there was no esophagitis on endoscopy and a completely normal manometry.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for rabeprazole. Findings: The physician reviewer found that : the documentation provided does not support the medical necessity for the requested medication in this clinical setting. American College of Gastroenterology guidelines recommend twice-daily therapy when once-daily therapy is insufficient to control gastroesophageal reflux disease symptoms, including in patients with esophagitis . The medical literature does not show any difference between rabeprazole and most other proton pump inhibitors (including pantoprazole, omeprazole, and lansoprazole) for gastroesophageal reflux disease or esophagitis. As such, it is unlikely that trial of formulary alternatives will be helpful after the patient has failed omeprazole and esomeprazole . However, this patient has not attempted Dexilant.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Antacids, then check the rights and deadlines that apply to your plan.