What do most insurance companies require for prior authorization for modafinil (provigil)?

Insurance Prior Authorization Requirements for Modafinil

Most insurance companies require documentation of a specific FDA-approved diagnosis and often failure of first-line treatments before approving modafinil (Provigil) for coverage. 1

Required Documentation for Prior Authorization

1. Diagnosis Verification

• FDA-approved diagnoses:
  • Narcolepsy
  • Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) with residual sleepiness despite CPAP therapy
  • Shift Work Sleep Disorder (SWSD)
  • Idiopathic hypersomnia (strongly recommended by AASM guidelines) 2

2. Diagnostic Testing Requirements

• For narcolepsy:

  • Documentation of Multiple Sleep Latency Test (MSLT) showing sleep-onset REM periods
  • Evidence of excessive daytime sleepiness
  • Cataplexy documentation (when present)

• For OSA/HS:

  • Polysomnography confirming diagnosis
  • Documentation of adequate CPAP compliance
  • Evidence of residual sleepiness despite optimal CPAP therapy 2, 3

• For SWSD:

  • Documentation of work schedule (night shifts)
  • Evidence of excessive sleepiness during work hours
  • Impact on daily functioning 3

• For idiopathic hypersomnia:

  • MSLT results
  • Exclusion of other causes of hypersomnia 2

3. Age Requirements

• Documentation that patient is ≥17 years old (modafinil is not FDA-approved for younger patients due to risk of Stevens-Johnson syndrome) 2, 1

4. Prior Treatment Attempts

• Evidence of failure with or contraindication to first-line therapies
• For OSA/HS: Documentation of ongoing CPAP use (modafinil is approved only as adjunctive therapy) 4, 3

5. Prescriber Qualifications

• Prescription from or consultation with a sleep specialist, neurologist, or psychiatrist may be required by some insurers

Common Pitfalls in Prior Authorization Process

• Incomplete documentation of diagnosis: Ensure diagnostic criteria are fully documented with appropriate testing results
• Missing sleep study data: Many insurers require objective sleep study data, not just clinical impressions
• Inadequate trial of first-line treatments: Document specific treatments tried, duration, and reasons for failure
• Off-label use: Insurance companies typically deny coverage for conditions not FDA-approved or strongly supported by guidelines
• Pediatric use: Special justification needed for patients under 17 years due to black box warnings 2, 1

Special Considerations

• Pregnancy: Document discussion of risks/benefits as modafinil may cause fetal harm and reduce contraceptive effectiveness 1
• Controlled substance monitoring: As a Schedule IV controlled substance, documentation of substance abuse screening may be required 1
• Renewal criteria: Most insurers require documentation of clinical response and continued need at regular intervals

Alternative Diagnoses Sometimes Covered

Some insurers may cover modafinil for other conditions with strong supporting evidence:

• Hypersomnia secondary to medical disorders (Parkinson's disease, traumatic brain injury, multiple sclerosis) 2
• Myotonic dystrophy with hypersomnia 2, 5

The authorization process typically requires detailed clinical documentation demonstrating that the patient meets all diagnostic criteria and has failed or cannot tolerate first-line treatments for their specific condition.