Nuvigil denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for brand name Nuvigil 150 mg daily. The patient underwent an adequate normal in lab polysomnogram (PSG) with an apnea/hypopnea index (AHI) of zero events per hour, oxygen nadir of 95% and adequate sleep time. The PSG was followed by a multiple sleep latency test (MSLT), which noted that the patient had four naps with a sleep latency 7.5 minutes and no SOREM, which is consistent with a diagnosis of idiopathic hypersomnia. A negative MSLT for narcolepsy does not rule out narcolepsy when the clinical suspicion is high, as in this patient’s case. Nuvigil is an oral non-amphetamine wake-promoting agent, the R-isomer of racemic modafinil. Nuvigil and modafinil share many clinical and pharmacologic properties and are distinct from central nervous system stimulants.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xyrem, Wakix, and/or Nuvigil. Findings: The physician reviewer found that records provided for review document that this patient presents with a history of narcolepsy as demonstrated on polysomnogram followed by a multiple sleep latency test (MSLT). The patient has failed treatment with Vyvanse and Sunosi. The patient’s provider has recommended combination treatment with Xyrem, Wakix and Nuvigil. Per the American Academy of Sleep Medicine (AASM) guidelines, the requested combination therapy consisting of Xyrem, Wakix, and Nuvigil are appropriate to treat this patient’s narcolepsy . Xyrem, Wakix, and Nuvigil and each considered first-line medications for the treatment of patients with narcolepsy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nuvigil 200 mg three times per day for treatment of the enrollee’s idiopathic hypersomnia. Findings: The physician reviewer found that Currently, there are no U.S. Food and Drug Administration (FDA) approved medications for the treatment of hypersomnia. In addition, a comprehensive review of the current medical literature does not reveal any peer-reviewed publications supporting the use of dosing at 600 mg of Nuvigil for the treatment of idiopathic hypersomnia. The FDA cautions against the use of doses of Nuvigil greater than 250 mg daily.

Nature of Statutory Criteria/Case Summary: An enrollee has requested armodafinil (Nuvigil) for treatment of the enrollee’s narcolepsy. Findings: The physician reviewer found that, in this case, the patient is not documented to have cataplexy, which is why the diagnostic criteria for type 2 narcolepsy are being utilized. The patient’s multiple sleep latency test was notable for both having a mean sleep latency greater than eight minutes and for an absence of any sleep onset REM periods. In this regard, the current clinical diagnostic criteria are not met. The presence of a possible REM sleep behavior disorder is notable. However, a REM sleep behavior disorder is not a clinical finding commonly associated with narcolepsy and is a separate and distinct sleep disorder (Schenck and Mahowald).

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