CurrentMass General Brigham Health PlanPolicy N/A

Armodafinil (Nuvigil)

Pharmacy benefit prior authorization policy for modafinil and armodafinil for Commercial/Exchange members, defining eligible diagnoses, continuation criteria, duration limits, excluded diagnoses, quantity limits, and exception for members new to plan within 90 days already receiving therapy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyArmodafinil (Nuvigil)

Policy CodePolicy N/A

Change TypeAdministrative alignment (effective 03/01/2025)

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit PA for modafinil/armodafinil; authorization may be granted for members new to plan within 90 days who are currently receiving medication or when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated policy to align modafinil and multiple sclerosis, fatigue associated with chemotherapy, excessive sleepiness associated with Parkinson's disease, and adjunct treatment to depression.

Added armodafinil criteria allowing approval for ADD/ADHD as of 1.1.24 armodafinil criteria note.

8Covered Indications (listed)

4Excluded Diagnoses (listed)

30/60Typical quantity limits (tablets per 30 days)

Coverage Summary

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This is a pharmacy benefit prior authorization policy for modafinil and armodafinil for Commercial/Exchange members, effective 03/01/2025. Coverage stance: covered_with_criteria; status: CURRENT.

Eligible diagnoses for authorization include narcolepsy, excessive sleepiness associated with obstructive sleep apnea/hypopnea (with sleep study confirmation and current CPAP use), ADD/ADHD, fatigue associated with multiple sclerosis, fatigue associated with chemotherapy, excessive sleepiness associated with Parkinson’s disease, adjunct treatment of depression (with prior use of at least two antidepressants), and shift work sleep disorder (with age ≥17 and prior inadequate response/adverse reaction/contraindication to one hypnotic agent and melatonin).

Continuation criteria require documentation demonstrating improvement of the member's condition for reauthorization.

Quantity limits are applied by product and strength: modafinil 100 mg and 200 mg: 30 tablets per 30 days; armodafinil 50 mg: 60 tablets per 30 days; armodafinil 150 mg, 200 mg, and 250 mg: 30 tablets per 30 days.

A new-to-plan exception allows authorization when the member has been on the requested medication within the past 90 days (excluding samples or manufacturer patient assistance supplies).

Quick policy facts

Policy subjectArmodafinil and Modafinil (Nuvigil/Provigil) prior authorization policy

PayerMass General Brigham Health Plan

Coverage stancecovered_with_criteria

Effective date2025-03-01

Last review2024-12-11

Typical quantity limits (tablets per 30 days)30/60

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ONE of the following OR when member new to plan within past 90 days is currently receiving the medication:

ANY of the following

New to plan
- New to plan within 90 days currently receiving medication: Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).
Diagnoses
- Narcolepsy
- Excessive sleepiness associated with obstructive sleep apnea or hypopnea syndrome that has been confirmed by a sleep study AND is currently using CPAP
- Attention deficit disorder (ADD) or Attention deficient hyperactivity disorder (ADHD)
- Fatigue associated with Multiple Sclerosis (MS)
- Fatigue associated with chemotherapy
- Excessive sleepiness associated with Parkinson's disease
- Adjunct treatment of depression
  - Member has had previous use with at least TWO antidepressant medications (examples: citalopram, bupropion, fluoxetine, escitalopram, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, nortriptyline)
- Shift work sleep disorder
  - Patient is ≥ 17 years of age
  - Patient has had an inadequate response, adverse reaction, or contraindication to one hypnotic agent and melatonin

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Requests for reauthorization will be approved when ALL of the following are met:

Continuation of Therapy

Improvement documented: Documentation is submitted demonstrating improvement of member's condition.

Documentation Required

Documentation of diagnosis and response

For initial requests include documentation of the qualifying diagnosis; for reauthorization submit documentation demonstrating improvement of the member's condition.

Exclusions / Not Covered Diagnoses

The following diagnoses are excluded from coverage:

Exclusions

Fatigue or sleepiness associated with traumatic brain injuries
Idiopathic hypersomnolence
Fatigue or sleepiness associated with use of narcotic analgesics
Cerebral palsy (spastic)

Denial Risk

Excluded Diagnoses — Not Covered

The following diagnoses are excluded from coverage and requests for these will not be approved: fatigue or sleepiness associated with traumatic brain injuries; idiopathic hypersomnolence; fatigue or sleepiness associated with use of narcotic analgesics; and spastic cerebral palsy.

Applicable Codes and Quantity Limits

Quantity Limited NDC/Coverage by product and strength (descriptive from policy)NDC|mixed

modafinil 100mg	Quantity limit: 30 tablets per 30 days
modafinil 200mg	Quantity limit: 30 tablets per 30 days
armodafinil 50mg	Quantity limit: 60 tablets per 30 days
armodafinil 150mg	Quantity limit: 30 tablets per 30 days
armodafinil 200mg	Quantity limit: 30 tablets per 30 days
armodafinil 250mg	Quantity limit: 30 tablets per 30 days

Billing Rule

Quantity limits enforced

Pharmacy benefit quantity limits are enforced as listed by drug name and strength.

modafinil 100 mg — 30 tablets per 30 days
modafinil 200 mg — 30 tablets per 30 days
armodafinil 50 mg — 60 tablets per 30 days
armodafinil 150 mg — 30 tablets per 30 days
armodafinil 200 mg — 30 tablets per 30 days
armodafinil 250 mg — 30 tablets per 30 days

Provider Actions / Authorization Steps

Prior Authorization

Prior Authorization required for Commercial/Exchange pharmacy benefit

Submit prior authorization for modafinil or armodafinil under the Commercial/Exchange pharmacy benefit. Authorization may be granted for members new to the plan within 90 days who are currently receiving the medication or when coverage criteria are met.

Documentation Required

Documentation of diagnosis and response

For initial requests include documentation of the qualifying diagnosis. For reauthorization, submit documentation demonstrating improvement of the member's condition.

Initial request: documentation of the qualifying diagnosis listed in policy (e.g., narcolepsy, OSA with confirmed sleep study and CPAP use, ADD/ADHD, fatigue related to MS or chemotherapy, Parkinson's-related sleepiness, adjunct to depression with prior use of ≥2 antidepressants, or shift work sleep disorder criteria).
Reauthorization: documentation demonstrating clinical improvement of the member's condition.

Clinical Evidence & References

The policy cites multiple clinical trials, product prescribing information for Provigil (modafinil) and Nuvigil (armodafinil), and guideline/therapy references summarized in the policy (references 1–12).

Referenced materials include randomized controlled studies and prescribing information sources for both armodafinil and modafinil as listed in the policy references.

Background

Modafinil and armodafinil are central nervous system stimulants indicated to improve wakefulness in adults with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Armodafinil is the R‑enantiomer of modafinil. The policy aligns coverage across modafinil and armodafinil for the listed fatigue‑ and sleepiness‑related indications.

Definitions

New to planMember new to the plan within the past 90 days who is currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance program supplies).

Revision History

2025-03-01material_changeLatest

Effective 03/01/2025: administrative alignments with modafinil and armodafinil indications; updated policy to align modafinil and multiple sclerosis, fatigue associated with chemotherapy, excessive sleepiness associated with Parkinson's disease, and adjunct treatment to depression.

2023-10-11non_material_revision

October 2023: added examples of antidepressants for adjunct treatment of depression and noted armodafinil criteria effective 01/01/2024 allowing approval for ADD/ADHD.

Policy Summary

PayerMass General Brigham Health Plan

PolicyArmodafinil (Nuvigil)

Policy CodePolicy N/A

Change TypeAdministrative alignment (effective 03/01/2025)

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit PA for modafinil/armodafinil; authorization may be granted for members new to plan within 90 days who are currently receiving medication or when coverage criteria are met.

SourceLink

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