Idiopathic Hypersomnia denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 45-year-old female with idiopathic hypersomnia diagnosed in April 2002. There is documentation of severe pathological sleepiness with mean sleep latency of 4.3 minutes, otherwise normal sleep efficiency and normal sleep architecture with minimal snoring. The patient has been treated for three years with Provigil, with relief of symptoms. There have been no reported side effects to therapy. Her previous medication history included Ritalin 20mg, which was ineffective at clinically decreasing her daytime sleepiness. The patient changed carriers in October 2004, and her current Health Plan has denied authorization for Provigil on the basis that it is not medically necessary for treatment of the patient’s excessive sleepiness.The ICSD system lists four major categories of sleep disorders including dyssomnias.

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 modafinil tablets. Idiopathic hypersomnia is a central disorder of hypersomnolence. A diagnosis of idiopathic hypersomnia requires all of the following: daily periods of irrepressible need to sleep, or daytime lapses into drowsiness or sleep, that have occurred for at least three months; lack of cataplexy; polysomnography and multiple sleep latency test (MSLT) findings do not support a diagnosis of narcolepsy type 1 or 2; the presence of a MSLT finding indicating a mean sleep latency of less than or equal to eight minutes and/or total 24-hour sleep time is greater than or equal to 660 minutes, typically 12 to 14 hours, as measured by either 24-hour polysomnography that is performed after remediation of any chronic sleep deprivation or by wrist actigraphy in association with a sleep log, av…

Findings: The physician reviewer found that the patient has requested authorization and coverage for Xywav oral solution. The American Academy of Sleep Medicine (AASM) notes that idiopathic hypersomnia is a diagnosis of exclusion. In this case, the diagnosis of idiopathic hypersomnia remains in question as polysomnography (PSG) multiple sleep latency test (MSLT) testing showed normal findings on both tests, whereas a 24-hour PSG showed over 660 minutes of total sleep time over 24 hours, which may meet one of the criteria for idiopathic hypersomnia. However, the submitted documentation did not include sleep logs or actigraphy showing a stable sleep schedule with sufficient sleep time prior to the testing. The patient was noted to work frequent night shifts, so shift work sleep disorder cannot be entirely excluded.

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