Xyrem denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/ Case Summary: The enrollee’s representative is requesting authorization and coverage for the medication, Xyrem. The enrollee has classical narcolepsy type 1 with cataplexy, anxiety, depression, migraine, and post-traumatic stress disorder (PTSD). Her mother reports excessive daytime sleepiness (EDS) since age five. Symptoms progressed to lower extremity weakness and falling asleep during daytime activities. At age eleven, she underwent a sleep study with a resultant diagnosis of sleep apnea. She was referred to a neurologist, who performed a Multiple Sleep Latency Test (MSLT) that showed a single episode of sleep-onset rapid eye movement and normal sleep onset latency. The neurologist suspected narcolepsy, but because of the negative MSLT, opted to treat the enrollee symptomatically.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xyrem 500 mg/mL oral solution (9 grams nightly divided into two 4.5 gram doses). Idiopathic hypersomnia is a central hypersomnia disease that causes excessive daytime sleepiness during the day. Idiopathic hypersomnia is diagnosed by multiple sleep latency testing (MSLT) results consistent with a sleep latency of fewer than eight minutes with no sleep-onset rapid eye movement (SOREM) episodes which differentiate the condition from narcolepsy. This patient was diagnosed with idiopathic hypersomnia, which is consistent with the MSLT results reported. The treatment of patients with idiopathic hypersomnia is challenging and the U.S. Food and Drug Administration (FDA) has only approved a few medications for this condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xyrem (sodium oxybate solution). Medical guidelines, a diagnosis of narcolepsy type 1, formerly called narcolepsy with cataplexy, may be made with (1) severe daytime sleepiness combined with cataplexy and (2) abnormal findings on a multiple sleep latency test (MSLT) or a low cerebrospinal hypocretin level. In this case, the records do not document that the patient met this criterion. The submitted records did not include documentation of actigraphy and sleep logs prior to polysomnography and MSLT consistent with narcolepsy type 1, cataplexy, or other symptoms of narcolepsy such as excessive daytime sleepiness, dream enactment behavior, sleep paralysis, or hypnagogic/hypnopompic hallucinations. There was no documentation of cerebrospinal fluid (CSF) testing for low hypocretin levels.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Xyrem for treatment of her medical condition. Findings: The reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication in this patient’s case. The use of Xyrem in the treatment of narcolepsy is well-documented with current medical literature. The patient has previously failed a trial of a central nervous system stimulant. However, the records document concurrent prescriptions of multiple sedative agents which were prescribed by the patient’s non-sleep physician. The use of benzodiazepines and other sedative agents is an explicit contraindication to the use of Xyrem. In this case, there is no formal indication that the use of the sedative agents will be discontinued outside of a letter requested by the patient for submission to the insurance company.

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