CurrentAnthemPolicy VABCBS-CD-086133-25 SRS85766

Narcolepsy Medications Prior Authorization (PA) Form — Virginia HealthKeepers Medicaid

A Virginia prior authorization form and requirements for Medicaid members enrolled in Anthem HealthKeepers Plus/HealthKeepers, Inc. for narcolepsy and related sleep disorder medications. Applies to prescribers requesting PA for listed stimulants and wakefulness-promoting agents.

Policy Summary

PayerAnthem

PolicyNarcolepsy Medications Prior Authorization (PA) Form — Virginia HealthKeepers Medicaid

Policy CodePolicy VABCBS-CD-086133-25 SRS85766

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionAttach required sleep study and documentation of prior medication trials and outcomes when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10listed medication formulations/brands on form

18+minimum age restriction noted

11pitolisant checklist items

3renewal questions

Coverage Criteria

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Initial and agent-specific coverage criteria

Coverage for a requested narcolepsy medication is approved when ALL of the following agent-specific and general criteria are met:

Primary diagnosis: Member has a selected diagnosis on the PA form (e.g., narcolepsy, excessive daytime sleepiness with narcolepsy, obstructive sleep apnea) with required supporting documentation where specified.

Sleep study attachment required for narcolepsy and obstructive sleep apnea

Age/medication-specific restriction: Member meets the minimum age requirement when specified on the form (minimum age noted for listed medications).>=18 years

Minimum age documented on form

Step therapy for solriamfetol (Sunosi): For solriamfetol (Sunosi), member must have tried and failed either modafinil or armodafinil.trial and failure documented

See preferred medications section

Generics prior to brand: For brand Nuvigil or Provigil, member must have tried and failed the preferred generic equivalents.trial and failure documented

See brand/generic section

Renewal/Continuation Therapy

For renewal, coverage continues when ALL of the following are met:

Continuation of initial criteria: Member continues to meet the initial coverage criteria for the requested medication.

Renewal question 1

Clinical benefit: Member reports a reduction in excessive daytime sleepiness from the pre-treatment baseline.improvement from baseline

Renewal question 2

Tolerability: Member has not experienced treatment-related adverse effects that would require discontinuation.no adverse effects

Renewal question 3

Use of pitolisant (Wakix®) is not supported unless the form documents that ALL agent-specific diagnostic and safety checks are met. Required diagnostic items include an ICSD-3 or DSM-5 diagnosis of narcolepsy, a baseline daytime sleepiness score on a validated scale, and MSLT results showing a mean sleep latency ≤ 8 minutes with ≥ 2 SOREMPs (with a nocturnal PSG SOREMP allowed to substitute for one MSLT SOREMP). Safety and exclusion criteria that must be confirmed include absence of concomitant QT-prolonging drugs or H1 antagonists, no history of prolonged QTc (e.g., > 450 ms), no severe hepatic impairment (Child‑Pugh C), and no end-stage renal disease (eGFR < 15 mL/min/1.73 m2). If these diagnostic thresholds or contraindications are not met or documented, pitolisant use is not supported.

Medications, Tests, and Clinical Thresholds

Listed medications and strengthsNDC | mixed

armodafinil 50 mg, 150 mg, 200 mg, 250 mg	Armodafinil tablet (generic for Nuvigil®)
modafinil 100 mg, 200 mg	Modafinil (generic for Provigil®)
Nuvigil® 50 mg, 150 mg, 200 mg, 250 mg	Brand Nuvigil®
Provigil® 100 mg, 200 mg	Brand Provigil®
Sunosi™ 75 mg, 150 mg	Solriamfetol (Sunosi™)
Wakix® 4.45 mg, 17.8 mg	Pitolisant (Wakix®)

Minimum age restrictionmixed

18+	Minimum age of 18 for the listed medications as specified on the form

inv-06: MSLT mean sleep latency

MSLT mean sleep latency thresholdMean sleep latency ≤ 8 minutes

Test methodMeasured on a Multiple Sleep Latency Test (MSLT) performed according to standard techniques

PSG substitutionA SOREMP on the preceding nocturnal polysomnogram may substitute for one MSLT SOREMP

inv-07: MSLT SOREMPs

MSLT SOREMPs threshold≥ 2 sleep-onset REM periods (SOREMPs) on MSLT

SOREMP definition exampleSOREMP defined as REM within 15 minutes of sleep onset

Substitution ruleA SOREMP on preceding nocturnal polysomnogram may replace one MSLT SOREMP

inv-08: QTc prolonged example threshold

Clinical example threshold for prolonged QTc> 450 milliseconds (history of prolonged QTc such as QTc > 450 ms)

Concomitant medications cautionAvoid concurrent use of QT-prolonging drugs listed on form (e.g., quinidine, amiodarone, sotalol)

Documentation requirementHistory of prolonged QTc must be absent to meet criteria

inv-09: End-stage renal disease definition example

ESRD example definitioneGFR < 15 mL/min/1.73 m2 (end-stage renal disease)

Therapy exclusionTherapy will not be used in patients with ESRD as specified on the form

AssessmenteGFR threshold used to identify ESRD for exclusion from pitolisant therapy

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed narcolepsy-related agents. Submit a completed Narcolepsy Medications Prior Authorization (PA) Form and all supporting documentation; incomplete or illegible forms may delay or result in denial of the authorization.

Affected agents: armodafinil (generic Nuvigil), modafinil (generic Provigil), Nuvigil®, Provigil®, Sunosi™ (solriamfetol), Wakix® (pitolisant)
Fax completed form and documentation to 844-512-7020; include one form per member

Step Therapy

Step Therapy / Failed Trial Requirements

Step therapy and failed trial requirements apply for certain agents. For Sunosi (solriamfetol), the member must have tried and failed either modafinil or armodafinil. For branded Nuvigil® or Provigil®, the member must have tried and failed the preferred generic equivalents before brand coverage will be considered.

Sunosi (solriamfetol): documented trial and inadequate response or intolerance to modafinil or armodafinil required
Brand Nuvigil®/Provigil®: documented trial and failure of preferred generics required prior to approval of brand

Documentation Required

Required Documentation

Provide required clinical documentation with the PA submission: diagnosis, relevant sleep study results when indicated, prior medication trials and outcomes, validated daytime sleepiness scores (when required), and clinical rationale demonstrating medical necessity or why preferred agent(s) are not appropriate.

Attach sleep study for narcolepsy or obstructive sleep apnea diagnoses
List pharmaceutical agents attempted and outcome; include dates and reasons for discontinuation
For Wakix® (pitolisant): provide ICSD‑3 or DSM‑5 narcolepsy diagnosis, baseline validated sleepiness scale score, MSLT results (mean sleep latency ≤ 8 minutes and ≥ 2 SOREMPs) or equivalent, and CSF hypocretin-1 data if available
For renewals: documentation that initial criteria continue to be met, member reports reduction in EDS from baseline, and no treatment-related adverse effects

Denial Risk

Incomplete Form Risk

Incomplete, missing, or illegible information on the PA form may delay processing or result in denial. Ensure all required fields are completed, prescriber signature and date are provided, and supporting documentation is attached.

One form per member; include prescriber signature and date
Submission of documentation does not guarantee coverage

Background

Narcolepsy and related excessive daytime sleepiness disorders are evaluated with targeted diagnostic testing and treated with wakefulness‑promoting agents and stimulants. The PA form requires objective confirmation for certain agents: for example, pitolisant requires documentation of a formal narcolepsy diagnosis (ICSD‑3 or DSM‑5), baseline sleepiness measured by a validated scale, and MSLT findings consistent with narcolepsy (mean sleep latency ≤ 8 minutes and ≥ 2 SOREMPs, with specified substitution rules). These tests and measures are used to confirm diagnosis, determine severity, and inform agent selection and safety screening prior to authorization.

OpenPayer

Narcolepsy Medications Prior Authorization (PA) Form — Virginia HealthKeepers Medicaid

Coverage Criteria

Medications, Tests, and Clinical Thresholds

Provider Actions and Prior Authorization Requirements

Background

Definitions and Diagnostic Criteria