CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nuvigil (armodafinil) prior authorization — coverage criteria

Prior authorization criteria for Nuvigil (armodafinil) for treating excessive daytime sleepiness in adults with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD); applies to members of Neighborhood Health Plan of Rhode Island under CVS Caremark criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNuvigil (armodafinil) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis-specific criteria, required documentation (sleep study, sleep log/actigraphy), and for OSA confirm ≥1 month of CPAP/BIPAP treatment before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3covered indications listed

1m/3mquantity-limit fill periods

60/30/180/90tablet quantity limits

≥1 moOSA CPAP/BIPAP minimal duration

Coverage Criteria for Nuvigil (armodafinil)

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Narcolepsy

Covered when ALL of the following are met

Narcolepsy coverage: Diagnosis of narcolepsy

Continuation or specialist: Either the request is for continuation of therapy with documented positive response OR the drug is prescribed by, or in consultation with, a sleep specialist

Diagnostic confirmation: Diagnosis confirmed by sleep lab evaluation

Shift Work Disorder (SWD)

Covered when ALL of the following are met

SWD coverage: Diagnosis of shift work disorder (SWD)

Continuation and current status: Request is for continuation of therapy with documented positive response and the patient remains an active shift-worker

Specialist alternative: Or the drug is prescribed by, or in consultation with, a sleep specialist

Objective documentation: Sleep log and actigraphy monitoring completed for at least 14 days showing a disrupted sleep/wake pattern, with symptoms present for 3 or more months>= 14 days; symptoms >= 3 months

Obstructive Sleep Apnea (OSA)

Covered when ALL of the following are met

OSA coverage: Diagnosis of obstructive sleep apnea (OSA)

Continuation and response: Request is for continuation of therapy with documented positive response and the patient is compliant with CPAP or BIPAP

Specialist alternative: Or the drug is prescribed by, or in consultation with, a sleep specialist

Diagnostic and treatment confirmation: Diagnosis confirmed by polysomnography; patient has received CPAP or BIPAP for at least one month and will continue this treatment>= 1 month

Use of Nuvigil (armodafinil) to treat the underlying airway obstruction in obstructive sleep apnea (OSA) is not an accepted use. For members with OSA, Nuvigil is indicated only to treat excessive daytime sleepiness and is not a substitute for CPAP/BIPAP. Prior to initiating Nuvigil for OSA-related sleepiness, providers must document that a maximal effort to treat the airway obstruction with continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) has been tried for an adequate period of time (e.g., at least one month) and will be continued when Nuvigil is used.

Covered Drug Products, Strengths, and Quantity Limits

Covered drug products and strengthsNDC|drug_descriptionCovered

Nuvigil 50 mg	Nuvigil (armodafinil) 50 mg tablet
Nuvigil 150 mg	Nuvigil (armodafinil) 150 mg tablet
Nuvigil 200 mg	Nuvigil (armodafinil) 200 mg tablet
Nuvigil 250 mg	Nuvigil (armodafinil) 250 mg tablet

Quantity limits — tablet strength and processing periods

1-month limit — 50 mg60 tablets per 25 days (used for a 30-day fill period)

1-month limit — 150–250 mg30 tablets per 25 days (used for a 30-day fill period)

3-month limit — 50 mg180 tablets per 75 days (used for a 90-day fill period)

3-month limit — 150–250 mg90 tablets per 75 days (used for a 90-day fill period)

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests for Nuvigil (armodafinil) must meet diagnosis-specific criteria and include required supporting documentation as noted below. Missing required documentation or failure to meet the diagnosis criteria will result in denial.

Prior authorization required for narcolepsy, shift work disorder (SWD), and obstructive sleep apnea (OSA) indications.
Continuation requests must document prior positive response to therapy.

Prior Authorization

OSA treatment requirement

For members with obstructive sleep apnea (OSA), the patient must be compliant with and receiving maximal effort CPAP or BIPAP therapy for the underlying airway obstruction before Nuvigil will be authorized for residual daytime sleepiness. A trial of CPAP or BIPAP must have been used for at least one month and will continue during Nuvigil therapy.

Documented compliance with CPAP or BIPAP.
CPAP/BIPAP therapy in place for ≥ 1 month prior to authorization.
Plan to continue CPAP/BIPAP while on Nuvigil.

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the prior authorization request to establish the diagnosis and response to therapy. Requests that do not include the documentation below will be denied.

Narcolepsy: documentation of diagnosis (sleep specialist notes, sleep study results) and prior response to therapy.
Shift Work Disorder (SWD): 14-day sleep log and actigraphy showing disrupted sleep/wake pattern, and symptoms present ≥ 3 months; documentation that the patient remains a shift worker.
OSA: diagnostic polysomnography confirming the diagnosis and documentation of CPAP/BIPAP use and compliance for at least one month.
General: documentation that the request is for continuation of therapy and that the patient had a positive response to Nuvigil.

Denial Risk

Denial Triggers

Requests will be denied if diagnosis-specific criteria or the required supporting documentation are not provided.

Denial triggers include: missing polysomnography for OSA, absence of a 14-day sleep log/actigraphy for SWD, lack of documentation of CPAP/BIPAP trial and compliance for OSA, or failure to document prior positive response and continuation intent.

Indications and Limitations

Indications and limitation — FDA‑approved uses and OSA restriction

FDA‑approved indicationsNarcolepsy; obstructive sleep apnea (OSA); shift work disorder (SWD)

Limitation for OSANuvigil treats excessive sleepiness in OSA but is not a treatment for the underlying airway obstruction

OSA treatment prerequisiteMaximal effort with CPAP (continuous positive airway pressure) for an adequate period should be made prior to initiating Nuvigil for excessive sleepiness

Intended effectImproves wakefulness in adults with excessive daytime sleepiness associated with the listed conditions

Background on Armodafinil (Nuvigil)

Armodafinil (Nuvigil) is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). Its therapeutic effect is on wakefulness and daytime sleepiness rather than on the primary cause of airway obstruction in OSA.

Because Nuvigil does not treat the mechanical airway problem in OSA, when used for OSA-related sleepiness it is considered adjunctive therapy and should be prescribed only after appropriate airway therapy (such as CPAP/BIPAP) has been attempted and is being maintained.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNuvigil (armodafinil) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

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