CurrentUnitedHealthcarePolicy N/A

Anti‑narcolepsy agents prior authorization

This form governs prior authorization and medical necessity documentation requirements for armodafinil, modafinil, Lumryz, solriamfetol (Sunosi), pitolisant (Wakix), sodium oxybate (Xyrem/Xywav) and related agents for sleep disorders; it affects prescribers and UnitedHealthcare members seeking coverage.

Policy Summary

PayerUnitedHealthcare

PolicyAnti‑narcolepsy agents prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed prior authorization form with supporting clinical documentation (sleep study/MSLT, recent quantitative assessment, prior medication trials, and CPAP adherence when applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 hoursallow at least this time for review

866-940-7328fax number to submit completed form

800-310-6826phone number for questions

6 monthstime window for required quantitative assessments

Coverage Criteria

Diagnosis-specific coverage criteria

Covered when ALL of the following are met for the specified diagnosis

General requirements: Completed prior authorization form with member and provider information; diagnosis specified with ICD-10 code; documentation of prior medication trials, contraindications, or intolerance to preferred agents; prescriber specialty or consultation noted for complex cases.

See Section D for prior medication trials and reasons for failure

Idiopathic hypersomnia: Diagnosis confirmed with a sleep study and multiple sleep latency test (MSLT); provider attests the hypersomnia is not better explained by another medical disorder, substance use, or medication; quantitative assessment (e.g., Epworth Sleepiness Scale or Maintenance of Wakefulness Test) within the past 6 months.

Chunks 5 and 10

Narcolepsy (with or without cataplexy): Diagnosis confirmed with a sleep study and MSLT; quantitative assessment within the past 6 months; for narcolepsy with cataplexy provide documentation of cataplexy episodes and for continuation requests documentation of reduction in cataplexy events.

Policy Summary

PayerUnitedHealthcare

PolicyAnti‑narcolepsy agents prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Requests for pharmacologic treatment of excessive daytime sleepiness related to obstructive sleep apnea must include documentation that the patient has achieved normalized breathing on PAP (defined as < 5 apnea‑hypopnea incidents per hour) and objective evidence of adherence. Adherence documentation must show use of CPAP/BiPAP for at least 70% of nights for a minimum of 4 hours per night or documented mandibular advancement device compliance within the past 6 months. For narcolepsy or idiopathic hypersomnia, requests must include the required sleep testing (sleep study and MSLT) and a quantitative symptom assessment performed within the past 6 months (for example, Epworth Sleepiness Scale or Maintenance of Wakefulness Test).

Coding and Objective Measures

inv-05: CPAP adherence — CPAP/BiPAP used for >=70% of nights for a minimum of 4 hours per night

CPAP/BiPAP adherence thresholdCPAP or BiPAP used for >=70% of nights for a minimum of 4 hours per night

Alternate device complianceMandibular advancement device adherence may be accepted as alternative documentation of device compliance

Documentation time windowAdherence documentation must be from the last 6 months

inv-06: Normalized breathing on PAP — < 5 apnea-hypopnea incidents per hour

Normalized breathing definitionNormalized breathing defined as < 5 apnea‑hypopnea incidents per hour (AHI < 5)

Required therapy modalityNormalization must be demonstrated while using CPAP or BiPAP therapy

Evidence requirementProvide sleep study documentation showing AHI < 5 on PAP therapy

inv-07: Quantitative assessment recency — Within the past 6 months

Recency requirementQuantitative assessment must be completed within the past 6 months

Acceptable assessmentsExamples include Epworth Sleepiness Scale or Maintenance of Wakefulness Test

Applies to diagnosesRequired for idiopathic hypersomnia, narcolepsy, and obstructive sleep apnea with excessive daytime sleepiness

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit the completed prior authorization form and all required supporting clinical documentation to avoid delay. Allow at least 24 hours for review. For questions, call 800-310-6826 or fax the completed form to 866-940-7328.

Completed form (Sections A–D) with member and provider information, medication details, diagnosis and ICD-10 code, pregnancy status, and start date if continuation.
Fax number: 866-940-7328; Phone: 800-310-6826.
Allow at least 24 hours for review.

Documentation Required

Required Clinical Documentation

Provide required clinical documentation with the authorization request. Incomplete or missing documentation may delay the decision or result in denial.

Idiopathic hypersomnia or narcolepsy: sleep study AND multiple sleep latency test (MSLT).
Obstructive sleep apnea with excessive daytime sleepiness: sleep study AND documentation of CPAP/BiPAP or mandibular advancement device adherence within the last 6 months.
All diagnoses: quantitative assessment of daytime sleepiness within the past 6 months (e.g., Epworth Sleepiness Scale or Maintenance of Wakefulness Test).
For continuation requests: clinical documentation demonstrating disease stability and/or positive clinical response (e.g., reduction in cataplexy events for narcolepsy with cataplexy).

Documentation Required

Form Completion Required

Complete all sections of the prior authorization form. Missing sections or pages may delay review.

Section A: Member information (name, Member ID, contact, DOB, allergies, primary insurance, new vs continuation, hospitalization/discharge dates).
Section B: Provider information (name, NPI, specialty, contact, fax).
Section C: Medical information (medication name, strength, directions, quantity, diagnosis with ICD-10 code, pregnancy status).
Section D/E: Previous medication trials and rationale why preferred medications are not appropriate (include dates, strengths, reasons for failure).

Step Therapy

Step Therapy / Prior Trial Documentation

Document trials, failures, contraindications, or intolerance to preferred medications per step therapy requirements before requesting a non-preferred agent.

Document trial duration (number of consecutive days) and reason for failure for amphetamine/methylphenidate-based stimulants, armodafinil, modafinil, pitolisant (Wakix), sodium oxybate (Xyrem), solriamfetol (Sunosi), and other relevant agents.
If agent is prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist, indicate this on the form.
If a contraindication or intolerance exists to preferred medications, provide specific details and supporting documentation.
Refer to the patient's PDL for preferred alternatives and include explanation in Section E.

Background

These agents are indicated to treat excessive daytime sleepiness (and cataplexy when applicable) in conditions such as narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea–related sleepiness. Diagnostic confirmation commonly requires a sleep study and a Multiple Sleep Latency Test (MSLT), and coverage decisions rely on recent quantitative symptom assessment (e.g., Epworth Sleepiness Scale or Maintenance of Wakefulness Test) performed within the past 6 months. For continuation requests, provide clinical documentation demonstrating disease stability or a positive clinical response; for narcolepsy with cataplexy, document reduction in cataplexy events, and for obstructive sleep apnea document ongoing adherence to PAP therapy or device use.

Definitions

inv-14: Idiopathic hypersomnia — A diagnosis requiring confirmation with a sleep study and multiple sleep latency test and exclusion of other causes (provider attestation...)

Diagnostic confirmationIdiopathic hypersomnia requires confirmation with a sleep study and multiple sleep latency test (MSLT)

Exclusion of other causesProvider must attest that hypersomnia is not better explained by another medical disorder, substance use, or medication

Required quantitative assessmentProvide a quantitative assessment (e.g., Epworth Sleepiness Scale or MWT) within the past 6 months

inv-15: Narcolepsy with cataplexy — Narcolepsy subtype where cataplexy is documented (episodes of sudden loss of muscle tone) and may include impairment of activities of dai...

Core diagnostic featuresNarcolepsy with cataplexy requires confirmation with a sleep study and MSLT and documentation of cataplexy (episodes of sudden loss of muscle tone)

Functional impactDocumented impairment or limitation of activities of daily living (e.g., unable to work, attend school, or drive) may be included

Quantitative assessmentProvide a quantitative assessment (e.g., Epworth or MWT) within the past 6 months

inv-16: Obstructive sleep apnea with excessive daytime sleepiness — OSA with daytime sleepiness where CPAP/BiPAP has achieved normalized breathing (<5 AHI) and documented adherence to PAP therapy or mandib...

Diagnostic confirmation for OSA-related sleepinessObstructive sleep apnea must be confirmed with a sleep study

PAP normalization requirementMedication coverage consideration requires documentation that PAP therapy normalized breathing (AHI < 5)

Adherence and recencyProvide documentation of adherence to CPAP/BiPAP (>=70% nights for >=4 hours) or mandibular advancement device compliance within the last 6 months