CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Provigil (modafinil) prior authorization and coverage criteria for excessive sleepiness indications

Defines prior authorization and coverage criteria for Provigil (modafinil) for excessive sleepiness indications (narcolepsy, OSA, shift work disorder, idiopathic hypersomnia, MS-related fatigue) for members covered by the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyProvigil (modafinil) prior authorization and coverage criteria for excessive sleepiness indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with required documentation (sleep specialist involvement and confirmatory testing) and indicate if request is for continuation of therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5indication groups

>=1 moCPAP/BIPAP trial

>=14 dactigraphy/sleep log

<=8 min / >=660 minIH objective thresholds

60 tablets30-day quantity max

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12 moapproval duration

Coverage Criteria for Provigil (modafinil)

Obstructive Sleep Apnea (OSA)

Covered when ALL of the following are met for OSA:

OSA - diagnosis: Patient has a diagnosis of obstructive sleep apnea (OSA)

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OSA - continuation status: The request is NOT for continuation of therapy

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OSA - prescriber: Requested drug is prescribed by, or in consultation with, a sleep specialist

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OSA - diagnostic confirmation: Diagnosis confirmed by polysomnography

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OSA - airway therapy trial: Patient has been receiving CPAP or BIPAP for at least one month and will continue therapyat least one month

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Narcolepsy

Covered when ALL of the following are met for Narcolepsy:

Narcolepsy - diagnosis: Patient has a diagnosis of narcolepsy

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Narcolepsy - continuation status: The request is NOT for continuation of therapy

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Narcolepsy - prescriber: Requested drug is prescribed by, or in consultation with, a sleep specialist

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Narcolepsy - diagnostic confirmation: Diagnosis confirmed by sleep lab evaluation

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Shift Work Disorder (SWD)

Covered when ALL of the following are met for Shift Work Disorder (SWD):

SWD - diagnosis: Patient has a diagnosis of shift work disorder

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SWD - continuation status: The request is NOT for continuation of therapy

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SWD - prescriber: Requested drug is prescribed by, or in consultation with, a sleep specialist

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SWD - monitoring: A sleep log and actigraphy monitoring completed for at least 14 days showing a disrupted sleep/wake patternat least 14 days

Idiopathic Hypersomnia (IH)

Covered when ALL of the following are met for Idiopathic Hypersomnia (IH):

IH - continuation status: The request is NOT for continuation of therapy

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IH - prescriber: Requested drug is prescribed by, or in consultation with, a sleep specialist

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IH - symptom duration: Daytime lapses into sleep or irrepressible need to sleep for at least 3 months3 months

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IH - rule out insufficient sleep: Insufficient sleep syndrome ruled out by lack of improvement after adequate trial of increased nocturnal time in bed, preferably confirmed by at least a week of sleep log with wrist actigraphy

Continuation Therapy and MS-related fatigue

Continuation therapy / other covered situations:

Continuation - general: Request for continuation of therapy when patient has achieved or maintained a positive response from baseline

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Continuation - SWD specifics: For SWD, continuation allowed if patient maintained positive response, remains a shift-worker, and is compliant with CPAP/BIPAP use

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MS-related fatigue: Requested drug is being prescribed for multiple sclerosis-related fatigue (request is NOT for continuation of therapy when used as initial therapy for MS-related fatigue)

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Coverage criteria

Coverage for Provigil is provided when the following criteria are met depending on initial vs continuation therapy and indication:

Indication for use: The requested drug is being prescribed for multiple sclerosis-related fatigue OR for hypersomnolence disorders as indicated elsewhere in the policy.

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Continuation of therapy requirement: If the request is for continuation of therapy, the patient must have achieved or maintained a positive response to treatment from baseline.

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Diagnostic exclusion for hypersomnolence: Hypersomnolence or MSLT results must not be better explained by any of: A) another sleep disorder, B) other medical or psychiatric disorder, C) use of drugs or medications.

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Provigil (modafinil) is indicated to treat excessive daytime sleepiness in obstructive sleep apnea (OSA) but does not treat the underlying airway obstruction. For patients with OSA, a maximal effort at airway therapy is required: the policy requires an adequate trial of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) prior to and during Provigil therapy. Specifically, CPAP/BIPAP must have been used for at least one month and continued while on Provigil.

Hypersomnolence or abnormal multiple sleep latency test (MSLT) findings that are better explained by another condition are excluded. Coverage requires that hypersomnolence/MSLT results are not better explained by any of the following: A) another sleep disorder, B) another medical or psychiatric disorder, or C) use of drugs or medications.

Requests for Provigil that lack required diagnostic confirmation, required specialist involvement, or completion of indicated baseline trials/monitoring do not meet coverage criteria. The policy specifies that the drug must be prescribed by or in consultation with a sleep specialist and that diagnosis be confirmed by the appropriate testing (e.g., polysomnography for OSA, sleep lab evaluation for narcolepsy, actigraphy/sleep log for shift work disorder, MSLT/24-hour monitoring for idiopathic hypersomnia). Baseline trials such as a CPAP/BIPAP trial for OSA and required monitoring for SWD (≥14 days of actigraphy/sleep log) must be documented.

Provigil is not covered for hypersomnolence when symptoms or MSLT results are attributable to another cause. Specifically, use is not covered if the hypersomnolence or MSLT findings are better explained by another sleep disorder, another medical or psychiatric disorder, or use of drugs/medications.

Coding and Quantity Limits

Quantity limit details (no explicit billing codes in provided text)mixed

NDC or specific codes not listed

Document lists quantity limits but does not provide specific NDC, CPT, HCPCS, or ICD-10 codes in these chunks.

CPAP/BIPAP trial — OSA

Required CPAP/BIPAP trial durationPatient must have been receiving CPAP or BIPAP for at least one month prior to and during Provigil therapy.

Prescriber requirementRequested drug must be prescribed by, or in consultation with, a sleep specialist.

Diagnostic confirmationDiagnosis of OSA must be confirmed by polysomnography.

Actigraphy / Sleep Log — SWD

Actigraphy/sleep log durationA sleep log and actigraphy monitoring must be completed for at least 14 days showing a disrupted sleep/wake pattern.

Prescriber requirementRequested drug must be prescribed by, or in consultation with, a sleep specialist.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization with quantity limit is required for Provigil (modafinil) when used as a narcolepsy agent. Requests must indicate whether they are for initial or continuation therapy.

Prior authorization required for both initial and continuation requests
Requests must specify therapy type (initial vs continuation)

Documentation Required

CPAP/BIPAP Requirement for OSA

If used for obstructive sleep apnea (OSA), a maximal effort with CPAP or BIPAP for at least one month is required prior to and during Provigil therapy. Treatment of the underlying airway obstruction (CPAP/BIPAP) must continue while on Provigil.

Patient must have been treated with CPAP or BIPAP for ≥ 1 month
CPAP/BIPAP therapy must continue during Provigil treatment

Background

Provigil (modafinil) is an FDA‑approved agent to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder. In OSA it is indicated as adjunctive therapy for daytime sleepiness and is not a treatment for the airway obstruction itself; appropriate airway management should be optimized prior to and during Provigil use.

Definitions and Scope

Provigil (modafinil) — Indications and role

Agent definitionProvigil (modafinil) is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Adjunctive role in OSAIn OSA, Provigil treats daytime sleepiness but is not a treatment for the underlying airway obstruction; CPAP is the treatment of choice and should be optimized.

Prescribing considerationsUse should be prescribed or in consultation with a sleep specialist per coverage criteria.

Compendial / Limited Uses

Compendial/limited uses — MS fatigueFatigue related to multiple sclerosis is listed as a compendial/limited treatment option for Provigil.

Compendial/limited uses — Idiopathic hypersomnia

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyProvigil (modafinil) prior authorization and coverage criteria for excessive sleepiness indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with required documentation (sleep specialist involvement and confirmatory testing) and indicate if request is for continuation of therapy.

SourceLink

On This Page

SWD - duration: Symptoms present for 3 or more months3 months

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IH - MSLT/SOREMPs: MSLT documented fewer than two SOREMPs or no SOREMPs if REM latency on preceding polysomnogram <= 15 minutes

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IH - objective sleep measure: Sleep lab evaluation showed at least ONE of: A) mean sleep latency on MSLT <= 8 minutes OR B) total 24-hour sleep time >= 660 minutes on 24-hour polysomnography or wrist actigraphy averaged over >=7 daysMSLT <=8 min OR 24-hour >=660 min

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IH - cataplexy exclusion: Patient does not have cataplexy

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Continuation statusRequest must NOT be for continuation of therapy for initial-therapy criteria to apply.

Symptom duration — IH and SWD

Minimum symptom durationSymptoms must have been present for 3 or more months for SWD or idiopathic hypersomnia (IH).

Prescriber requirementRequested drug must be prescribed by, or in consultation with, a sleep specialist.

Continuation statusRequest must NOT be for continuation of therapy when meeting initial-therapy diagnostic criteria.

Objective sleep thresholds — Idiopathic Hypersomnia (IH)

MSLT mean sleep latency thresholdMean sleep latency on MSLT less than or equal to 8 minutes.

24-hour total sleep time thresholdTotal 24-hour sleep time greater than or equal to 660 minutes on 24-hour polysomnography or wrist actigraphy averaged over at least 7 days.

Exclusion of cataplexyPatient must not have cataplexy (IH-specific criterion).

Quantity limits — Provigil (modafinil)

30-day fill maximum60 tablets per 25 days (used for a 30-day fill period).

90-day fill maximum180 tablets per 75 days (used for a 90-day fill period).

Quantity limits noteDurations of 25 and 75 days are used to allow time for refill processing.

Provigil treats excessive sleepiness in OSA, not the underlying obstruction

Note

Indication: MS-related Fatigue

Provigil is covered when prescribed for multiple sclerosis (MS)-related fatigue (a listed indication).

MS-related fatigue is an approved indication for coverage

Denial Risk

Required Clinical Response and Diagnostic Clarity

Continuation requests must document a positive clinical response from baseline and demonstrate diagnostic clarity for hypersomnolence. Requests lacking required specialist documentation, confirmatory testing, or evidence of treatment response may be denied.

Continuation requests must show the patient has achieved or maintained a positive response to treatment from baseline
Hypersomnolence/MSLT results must not be better explained by another sleep disorder, other medical or psychiatric disorder, or use of drugs/medications
Missing required documentation (specialist consult, confirmatory sleep testing, sleep logs/actigraphy, MSLT or polysomnography) is a common trigger for denial

Idiopathic hypersomnia is included as a compendial/limited treatment option.

Coverage contextRequests for these uses require meeting the policy's documentation and prior authorization requirements.

Hypersomnolence / MSLT — Explanatory exclusions

Alternative explanations exclude coverageHypersomnolence or MSLT results must not be better explained by another sleep disorder, another medical or psychiatric disorder, or use of drugs/medications.

Requirement for diagnostic clarityDocumentation must show hypersomnolence and objective testing are not attributable to alternative conditions before coverage is granted.

Continuation documentationFor continuation requests, evidence of maintained positive response from baseline is required and alternative explanations must be excluded.