Prior Auth Protocol

FDA Approved Indications:

To improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder

Health Net Approved Indications and Usage Guidelines:

For Provigil requests, failure or clinically significant adverse effects to Nuvigil

AND

Confirmed diagnosis of one of the following:

Narcolepsy
Obstructive Sleep Apnea (OSA)
Shift Work Disorder (SWD)
Multiple Sclerosis-related Fatigue

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

Nuvigil is the R-enantiomer of Provigil. The apparent terminal half-life of Nuvigil is approximately 15 hours. For comparison, the effective elimination half-life of Provigil after multiple doses is also 15 hours
Excessive Daytime Sleepiness (EDS) associated with Parkinson’s disease (PD): The literature supporting the use of Provigil for this indication consists of 2 randomized trials and one open-label study, all with small sample sizes and improvement in mostly subjective scales of sleepiness. One additional randomized trial found that Provigil did not significantly improve EDS compared to placebo. Based on the available data, the routine use of Provigil for the treatment of EDS associated with PD is not supportable at this time
Cephalon filed a sNDA for modafinil for the treatment of ADHD under the brand name of Sparlo^R. The FDA deemed the medication non-approvable for the treatment of ADHD in children and adolescents up to 17 years of age due to safety concerns over high rates of serious adverse dermatological reactions
Overall results of studies evaluating the use of Provigil for ADHD support the efficacy of Provigil for this indication, especially in pediatric patients. However, due to the potential for serious rash, and especially in light of the FDA's no-approval of Sparlon citing this as one of the reasons, the routine use of Provigil for ADHD cannot be endorsed at this time.
For depression: The lack of data supporting the use of Provigil for depression is consistent with findings from two evidence-based review articles, both of which state that there are "mixed findings". The author of one review assigns Provigil a "C" level of evidence with a caveat for level "B" evidence for SSRI non-responders with fatigue and/or hypersomnolence.
Provigil's warning section contains a bolded warning that reads in part, "Modafinil is not approved for use in pediatric patients for any indication." Pediatric is later defined as less than 17 years of age
Nuvigil's warning section states, "Armodafinil has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication." Pediatric is later defined as less than 17 years of age

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Amphetamine salts (Adderall^R)	Narcolepsy 5-60 mg PO QD	60 mg
methylphenidate (Ritalin^R, Ritalin SR^R,Methylin^R)	Narcolepsy 10-60 mg PO QD	60 mg
dextroamphetamine (Dexedrine^R, Dextrostat^R, Dexedrine Spansule^R)	Narcolepsy 5-60 mg PO QD	60 mg

Amphetamine salts (Adderall^R)

Narcolepsy
5-60 mg PO QD

60 mg

methylphenidate (Ritalin^R, Ritalin SR^R,Methylin^R)

Narcolepsy
10-60 mg PO QD

60 mg

dextroamphetamine (Dexedrine^R, Dextrostat^R, Dexedrine Spansule^R)

Narcolepsy
5-60 mg PO QD

60 mg

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Provigil	Narcolepsy 200 mg PO QD Obstructive Sleep Apnea 200 mg PO QD Shift Work Disorder 200 mg PO QD Multiple Sclerosis 100-200 mg PO QD	Narcolepsy Length of benefit Obstructive Sleep Apnea HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months if patient continues CPAP on average > 4 hours/night while on Provigil. Shift Work Disorder HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months with chart note documentation of continuous therapeutic response. Multiple Sclerosis HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months with chart note documentation of continuous therapeutic response.
Nuvigil	Narcolepsy 150-250 mg PO QD Obstructive Sleep Apnea 150-250 mg PO QD Shift Work Disorder 150 mg PO QD Multiple Sclerosis 150-250 PO QD	Narcolepsy Length of benefit Obstructive Sleep Apnea HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months if patient continues CPAP on average > 4 hours/night while on Nuvigil. Shift Work Disorder HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months with chart note documentation of continuous therapeutic response. Multiple Sclerosis HNCA/HNMC: Length of Benefit NATL: Initial authorization of 12 months. Reauthorization for additional 12 months with chart note documentation of continuous therapeutic response.

Product Availability:

Provigil: 100 mg, 200 mg tablets
Nuvigil: 50 mg, 150 mg, 200 mg, 250 mg tablets

References:

Provigil [Prescribing Information] North Wales, PA: Cephalon, Inc.: January 2015.
Nuvigil [Prescribing Information] North Wales, PA: Cephalon, Inc.; April 2015.
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