Cigna Wakefulness‑Promoting Agents Prior Auth

Coverage Criteria

Narcolepsy (FDA-approved)

Covered for Excessive Daytime Sleepiness Associated with Narcolepsy when ALL of the following are met:

Narcolepsy initial approval: A) Patient is >= 18 years of age; AND B) Patient has been evaluated using polysomnography and a multiple sleep latency test; AND C) Prescriber confirms diagnosis of narcolepsy; AND D) Medication is prescribed by or in consultation with a sleep specialist physician or a neurologist; AND E) If brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

Obstructive Sleep Apnea/Hypopnea Syndrome (FDA-approved)

Covered for Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome when ALL criteria are met:

OSA approval: A) Patient is >= 18 years of age; AND B) Patient meets ONE of: i) armodafinil/modafinil will be used in conjunction with positive airway pressure (PAP) therapy (eg, CPAP, APAP, BPAP); OR ii) patient is unable to initiate or tolerate positive airway pressure therapy; AND C) If brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

PAP includes CPAP, APAP, or BPAP.

Shift Work Sleep Disorder (FDA-approved)

Covered for Excessive Sleepiness Associated with Shift Work Sleep Disorder when ALL criteria are met:

Shift work approval: A) Patient is >= 18 years of age; AND B) Patient works at least five overnight shifts per month; AND C) If brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

Adjunctive/Augmentation for Major Depressive Disorder

Covered for Adjunctive/Augmentation Treatment for Depression in Adults when ALL of the following are met:

Depression adjunctive approval: A) Patient is >= 18 years of age; AND B) Patient is concurrently receiving other medication therapy for depression (e.g., SSRI or SNRI); AND C) If brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

Examples of other medications include SSRIs and SNRIs.

Other supported indications (Myotonic dystrophy, Parkinson's disease, MS)

Covered for excessive daytime sleepiness associated with Myotonic Dystrophy, Parkinson's disease, Multiple Sclerosis, and other supported conditions when listed criteria are met (generally age ≥18 and step therapy if brand requested).

Myotonic dystrophy approval: Patient is >= 18 years of age; AND if brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

AASM suggests modafinil for myotonic dystrophy (conditional).

Parkinson's disease approval: Patient is >= 18 years of age; AND if brand Provigil or Nuvigil is being requested, BOTH: i) patient has tried generic modafinil or generic armodafinil; AND ii) brand product is being requested due to a formulation difference in the inactive ingredient(s) which, per the prescriber, would result in a significant allergy or serious adverse reaction.approve for 1 year

AASM suggests modafinil for Parkinson's disease (conditional).

Myotonic Dystrophy - Excessive Daytime Sleepiness

Approve for 1 year if the patient meets BOTH of the following (A and B):

A: Patient is ≥ 18 years of age

B: If brand Provigil or Nuvigil is being requested, the patient has tried generic modafinil or generic armodafinil AND brand is requested due to a formulation difference in the inactive ingredient(s) that, per the prescriber, would cause a significant allergy or serious adverse reaction

two subcriteria (i and ii)

Parkinson's Disease - Excessive Daytime Sleepiness

Approve for 1 year if the patient meets BOTH of the following (A and B):

A: Patient is ≥ 18 years of age

two subcriteria (i and ii)

Multiple Sclerosis - Fatigue

Approve for 1 year if the patient meets BOTH of the following (A and B):

A: Patient is ≥ 18 years of age

two subcriteria (i and ii)

Idiopathic Hypersomnia

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

A: Patient is ≥ 18 years of age

B: Diagnosis is confirmed by a sleep specialist physician or at an institution that specializes in sleep disorders (i.e., sleep center)

C: If brand Provigil or Nuvigil is being requested, the patient has tried generic modafinil or generic armodafinil AND brand is requested due to a formulation difference in the inactive ingredient(s) that, per the prescriber, would cause a significant allergy or serious adverse reaction

two subcriteria (i and ii)

Coverage of Nuvigil (armodafinil) and Provigil (modafinil) is subject to the terms of the member's specific benefit plan document. Plan exclusions, differing benefit terms, or a customer's benefit plan document may supersede the policy language in this document. Coverage determinations are ultimately determined by the applicable benefit plan document and may require review of relevant laws, regulations, and the specific facts of each request.

Nuvigil (armodafinil) and Provigil (modafinil) are considered not medically necessary for any uses not listed as covered in this policy. The policy explicitly lists multiple specific conditions as not medically necessary and notes the list may not be all inclusive; requests for uses not supported by the covered indications will be denied.

Use of modafinil or armodafinil for Attention Deficit Hyperactivity Disorder (ADHD), bipolar disorder (including bipolar depression), and cancer-related fatigue is considered not medically necessary based on limited or insufficient supporting evidence and current guideline recommendations.

Use of modafinil or armodafinil for chronic fatigue syndrome, excessive daytime sleepiness associated with primary insomnia, performance enhancement in induced sleep deprivation, fibromyalgia, and other unspecified conditions is considered not medically necessary due to limited or inconclusive data.

Use of modafinil or armodafinil for post-stroke sleep-wake disorders or sleep disorders is considered not medically necessary because evidence is very limited (case reports and a single small study) and effectiveness has not been established.

Coding and Diagnostic Thresholds

Multiple Sleep Latency Test threshold — < 8 minutes average sleep latency

MSLT average sleep latency threshold< 8 minutes average sleep latency (average over five naps)

Test formatFive short naps separated by 2 hours on the day after an overnight polysomnogram

IndicatesAn average sleep latency < 8 minutes indicates excessive daytime sleepiness

REM onset threshold for narcolepsy — REM within 15 minutes at least 2 of 5 naps

REM onset criterion for narcolepsyREM sleep occurring within 15 minutes on at least 2 of the five MSLT naps (and the overnight PSG showing abnormal REM onset)

Clinical significanceAbnormally quick REM onset on naps suggests narcolepsy when present on ≥2 naps

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of modafinil and armodafinil (brand and generic). This policy includes a step therapy requirement directing a trial of a Step 1 product (generic modafinil or generic armodafinil) prior to approval of brand Provigil® or Nuvigil® when clinically appropriate. All approvals are provided for the durations noted in the FDA‑Approved Indications criteria (generally 1 year when criteria met).

Prior Authorization required for modafinil and armodafinil (brand and generic).
Step therapy: trial of one Step 1 product (generic modafinil or generic armodafinil) is required prior to brand Provigil or Nuvigil when clinically appropriate.
Approvals are generally issued for 1 year when criteria are met (e.g., patient ≥ 18 and indication-specific requirements).

Step Therapy

Step Therapy Requirement for Brand Products

When a brand product (Provigil or Nuvigil) is requested, documentation must show the patient previously tried generic modafinil or generic armodafinil unless the prescriber documents that the brand is required because of a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that would cause a significant allergy or serious adverse reaction.

Background & Definitions

Armodafinil and modafinil are Schedule IV, wakefulness‑promoting agents indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (as adjunctive therapy when appropriate), and shift work sleep disorder. Diagnosis of narcolepsy typically requires evaluation with a polysomnogram (PSG) and a Multiple Sleep Latency Test (MSLT).

Polysomnogram definition — Polysomnogram (PSG)

DefinitionPolysomnogram (PSG): overnight recording of brain and muscle activity, breathing, and eye movements.

PurposeUsed to evaluate sleep architecture and to precede diagnostic MSLT for narcolepsy

SettingTypically performed in a sleep disorders clinic or sleep center

Multiple Sleep Latency Test definition — MSLT

DefinitionMultiple Sleep Latency Test (MSLT): measures daytime sleepiness via five naps taken the day after PSG

Initial Therapy Criteria

Step 1 requirement

Step therapy directs trial of generic before brand

Step 1: Patient must try one Step 1 product: generic modafinil or generic armodafinil prior to approval of brand Nuvigil or Provigil unless there is prescriber-documented significant allergy or serious adverse reaction to inactive ingredients.

Applies when brand product requested.

Initial therapy requirements

Initial approval criteria and step requirements for starting therapy

Step 1: Patient meets age requirement (≥ 18)

Step 2: If brand is requested, trial of generic modafinil or generic armodafinil documented OR documentation that brand is required due to inactive-ingredient allergy/intolerance.

Step Therapy Details

Step	Requirement	Exception
Step 1
Patient must try one Step 1 product: generic modafinil or generic armodafinil prior to approval of brand Nuvigil or brand Provigil.
Brand may be used without prior trial of generic if the prescriber documents that a formulation difference in inactive ingredients would result in a significant allergy or serious adverse reaction (prescriber attestation).

Request type	Prior requirement	Supporting documentation
Brand Provigil or Nuvigil request
Requires documented trial of generic modafinil or generic armodafinil prior to approval.
If brand is requested due to inactive-ingredient issue, prescriber must document the formulation difference and that it would cause a significant allergy or serious adverse reaction; documentation of prior generic trial or intolerance should be provided.

OpenPayer

Wakefulness-Promoting Agents - Armodafinil, Modafinil Prior Authorization with Step Therapy Policy

Coverage Criteria

Coding and Diagnostic Thresholds

Provider Actions and Prior Authorization

Background & Definitions

Initial Therapy Criteria

Step Therapy Details