- unspecified ST criteria Step Therapy Exists in PA
- Prior Authorization: EDS due to OSA:
Documented Diagnosis: Yes
Age Requirement: >= 17
Duration: 1 plan year
- EDS due to OSA:
Age Requirement: >= 17
Duration: 1 plan year
Documented Diagnosis: Yes
Medical Test Required: No
Reauthorization Required: No
Duration of Reauthorization: = 1 plan year
Neurology: Narcolepsy:
Age Requirement: >= 17
Duration: 12 Month(s)
Specialist Required: Yes
Medical Test Required: No
Specialist Type(s): 1 of Neurologist;Sleep Disorders Specialist
Reauthorization Required: Yes
Duration of Reauthorization: = 12 month(s)
Number of Episodes of Cataplexy Required in Policy: N/A
Documented Duration of Daily EDS Occurrences: N/A
Other causes of sleepiness have been ruled out.: No
Patient must have CSF hypocretin 1 deficiency: No
Patient Does Not Have a Deficiency of Succinic Semialdehyde Dehydrogenase: No
Patient Does Not Have a History of Substance Abuse: No
Patient is Not Using a Sedative Hypnotic: No
Patient Will Not Be Using with Alcohol: No
Documentation Requiring Patient to be Enrolled in REMS Success Program: No
Documentation of prescriber enrollment in REMS program: No
Prescriber Must Check Patient's Drug History on Controlled Substance Database: No
Documented Time Period or Frequency of Time That the Precriber Must Regularly See the Patient: N/A
Diagnosis Type(s): Unspecified
Documented Diagnosis: Yes
Patient has >1 Cataplexy Episodes: No
Documented Daily EDS occurrences >= 3 months: No
MSLT <8min with evidence of 2 SOREMP's: No
MSLT with evidence of >= 1 SOREMP's and SOREMP, 15 min from preceeding night PSG: No
CSF Hypocretin-1 Deficiency: No
Prescriber Must See Patient Every 3 Months: No
- Coverage of drugs is first determined by the member's pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document. I. FDA Approved Indications: a. To improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. II. Health Net Approved Indications and Usage Guidelines: a. Confirmed diagnosis of one of the following: i. Narcolepsy. ii. Obstructive Sleep Apnea (OSA). iii. Shift Work Disorder (SWD). iv. Multiple Sclerosis-related Fatigue. III. Coverage is Not Authorized For: a. 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. IV. GENERAL INFORMATION: a. 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. b. 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. c. Cephalon filed a sNDA for modafinil for the treatment of ADHD under the brand name of Sparlon. 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. d. 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. e. 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. f. 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. g. 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. V. THERAPEUTIC ALTERNATIVES: i. Drug: Amphetamine salts (Adderall). ii. Drug: Methylphenidate (Ritalin, Methylin, Ritalin SR). iii. Drug: Dextroamphetamine (Dexedrine, Dextrostat, Dexedrine Spansule).
- Step Therapy: EDS due to OSA:
ST Single Generic
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