Narcolepsy 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 for Xyrem 500 mg/ml solution, 4.5 grams oral, two (2) times daily, 30-day supply. The submitted documentation supports the medical necessity of the requested medication regimen. Xyrem is FDA approved for treatment of two common symptoms of narcolepsy: excessive daytime sleepiness (EDS) and cataplexy. Alshaikh and colleagues have noted that narcolepsy patients on Xyrem have significant reductions in cataplexy and daytime sleepiness. Xyrem is well tolerated in patients with narcolepsy, and most reported adverse events were mild to moderate in severity. Boscolo-Berto and colleagues have also demonstrated, through meta-analysis of multiple peer reviewed studies, the effectiveness of Xyrem in treating major, clinically relevant narcolepsy symptoms and sleep architecture abnormalities.

Nature of Statutory Criteria/Case Summary: A 50-year-old female enrollee has requested authorization and coverage for the medication Xyrem for treatment of the enrollee’s narcolepsy. Findings: The physician reviewer found that At issue in this case is whether the requested medication Xyrem is medically necessary for treatment of the enrollee’s medical condition.Xyrem is Food and Drug Administration approved for treatment of two common symptoms of narcolepsy: excessive daytime sleepiness (EDS) and cataplexy. Alshaikh and colleagues noted that narcolepsy patients on Xyrem had significant reductions in cataplexy and daytime sleepiness. Xyrem is well tolerated in patients with narcolepsy, and most adverse events were mild to moderate in severity.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xyrem 500 mg/mL for treatment of the enrollee’s narcolepsy. Findings: The physician reviewer found that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the requested medication. The records provided for review do not support a diagnosis of type 1 or type 2 narcolepsy. The records indicate that the patient has a diagnosis of obstructive sleep apnea for which the patient has been prescribed and initiated on CPAP. The medical records do not contain the results of a multiple sleep latency test (MSLT) conducted in accordance with current practice guidelines that is required to establish a diagnosis of narcolepsy.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Wakix tablets. The U.S. Food and Drug Administration (FDA) approves the use of Wakix for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. The American Academy of Sleep Medicine sets forth the diagnostic criteria for narcolepsy, which include a diagnostic polysomnogram followed by multiple sleep latency testing (MSLT) or measured cerebral spinal fluid (CSF) hypocretin-1 concentration levels, which may support the diagnosis of narcolepsy without an overnight polysomnogram with MSLT. In this case, the patient has documented hypersomnia and cataplexy. While the patient completed an overnight polysomnogram in the past, a polysomnogram alone is insufficient to diagnose narcolepsy.

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 narcolepsy, then check the rights and deadlines that apply to your plan.