Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Esomeprazole DR. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Esomeprazole DR 40 mg, 60 per 30 days. Esomeprazole DR is requested for use in this enrollee with Barrett's esophagus with high grade dysplasia associated with chronic gastroesophageal reflux disease who has ongoing symptoms despite treatment with Dexilant 60 mg twice daily. The prescriber has indicated that the requested medication is medically necessary to reduce the disease burden related to Barrett's esophagus. It is noted that the enrollee has tried and failed Omeprazole, Pantoprazole and Dexilant. It is stated that the enrollee has tried and failed once daily dosages of PPI's; the medical records indicate that the enrollee had worsening Barrett's on Dexilant 30 mg twice daily, and persistent reflux symptoms and a suspicious area on biopsy while being treated with Dexilant 60 mg twice daily. The Plan has step therapy criteria for the requested drug. The Plan's step therapy criteria have been met.The Plan limits the amount of Esomeprazole DR 40 mg to, 30 per 30 days. The Plan's denial letter states that the request for twice daily Esomeprazole DR 40 mg was denied because the Medicare approved compendia to not contain any citations to support the use of Esomeprazole capsules that exceeds 40 mg per day, for the treatment of Barrett's esophagus. Medically accepted indication refers to the indication being treated, not the dose utilized to treat the condition. Barrett's esophagus is a sequelae of chronic gastroesophageal reflux disease which is a medically accepted indication for the use of Esomeprazole. Additionally, it is specifically stated in DRUGDEX in the monograph on the requested drug, in the non-FDA use section under the discussion of Gastroesophageal reflux disease, Refractory - Twice-daily dosing of proton pump inhibitors (PPIs) is recommended to improve symptom relief in patients with refractory GERD. The prescriber has provided a sufficiently strong statement as to why the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition, and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is met. Therefore, the Plan is required to cover the requested quantity of Esomeprazole DR 40 mg.We are dismissing this case for Dexilant DR. You did not file your written request for Reconsideration for Dexilant DR within 60 days from the date of the Plan's Redetermination Letter. Medicare does not permit us to make a decision about cases filed after the 60-day time limit, unless there is showing of good cause for the late filing. You can file a new request for reconsideration that includes the reason why your request was not timely filed. If you show good cause, we may extend the time frame for filing a new request.