CurrentCignaPolicy N/A

Prior Authorization with Step Therapy Policy — Sunosi (solriamfetol)

Defines prior authorization and step therapy requirements for coverage of Sunosi (solriamfetol) for adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPrior Authorization with Step Therapy Policy — Sunosi (solriamfetol)

Policy CodePolicy N/A

Change TypeAnnual revision with material criteria updates

Effective DateSep 3, 2025

Next Review DateSep 3, 2025

Key ActionObtain prior authorization and document required trials (Step 1: generic modafinil, generic armodafinil, or a CNS stimulant) and diagnostic testing as specified.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered language changed from naming specific oxybate products to 'an oxybate product' to account for a new oxybate product (Lumryz).

Narcolepsy prior authorization criteria updated to allow prior trial of a CNS stimulant OR generic modafinil OR generic armodafinil.

OSA prior authorization requirement clarified to allow use in conjunction with positive airway pressure (PAP) generally, or when patient cannot initiate/tolerate PAP, and defines PAP to include CPAP, APAP, or BPAP.

2FDA indications covered

1 yearApproval duration

Step 1 → Step 2

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Coverage Criteria for Sunosi (solriamfetol)

inv-01: Excessive Daytime Sleepiness Associated with Narcolepsy

Covered when ALL of the following are met

Narcolepsy criteria: A) Patient is ≥ 18 years of age; AND B) Patient has been evaluated using polysomnography and a multiple sleep latency test (MSLT) confirming excessive daytime sleepiness; AND C) According to the prescriber, diagnosis of narcolepsy has been confirmed; AND D) The medication is prescribed by or in consultation with a sleep specialist physician or a neurologist; AND E) Patient has tried at least ONE of the following treatments: a central nervous system (CNS) stimulant (examples: methylphenidate, dexmethylphenidate, dextroamphetamine), generic modafinil, or generic armodafinil (exception allowed if the patient previously tried brand Provigil or brand Nuvigil).

Approve for 1 year if all criteria met.

inv-02: Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea

Covered when ALL of the following are met

OSA criteria: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: (i) Sunosi will be used in conjunction with positive airway pressure (PAP) therapy (e.g., CPAP, APAP, or BPAP); OR (ii) Patient is unable to initiate or tolerate PAP therapy; AND C) Patient has tried generic modafinil or generic armodafinil (exception allowed if the patient previously tried brand Provigil or brand Nuvigil).

Approve for 1 year if criteria met.

Concomitant use of Sunosi (solriamfetol) with an oxybate product and/or Wakix (pitolisant) is not covered. Oxybate products include Xyrem (sodium oxybate oral solution), Xywav (calcium, magnesium, potassium, and sodium oxybates oral solution), and Lumryz (sodium oxybate extended‑release oral suspension). These products share the active ingredient oxybate, a central nervous system depressant, and have not been studied in combination or as alternating treatments with Sunosi; therefore combination use is considered not medically necessary.

Sunosi is considered not medically necessary for any uses not explicitly listed as covered indications, including concomitant use with an oxybate product and/or Wakix (pitolisant). The policy rationale notes that no published studies evaluate combination use of these medications and oxybate products share the CNS‑depressant active ingredient, supporting exclusion of combined therapy.

Coding and Diagnostic Testing

inv-06: MSLT sleep latency and REM criteria

Mean sleep latency< 8 minutes (average over five naps)

REM sleep onsetREM onset within 15 minutes on ≥2 naps (including the nocturnal PSG), consistent with narcolepsy

Test componentsMSLT performed the day after an overnight polysomnogram (PSG) with five naps separated by ~2 hours

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sunosi. Approvals are provided for 1 year when all clinical criteria are met.

Prior Authorization required for Sunosi (solriamfetol).
Approvals granted for 1 year when criteria met.

Step Therapy

Step Therapy Requirement

Step therapy requires trial of at least one Step 1 product prior to Sunosi. For narcolepsy this is at least one of: a central nervous system (CNS) stimulant (examples: methylphenidate, dexmethylphenidate, dextroamphetamine), generic modafinil, or generic armodafinil. For OSA, patient must have tried generic modafinil or generic armodafinil. Exceptions allowed if patient previously tried brand Provigil or brand Nuvigil.

Step 1 options: generic modafinil or generic armodafinil, or a CNS stimulant (e.g., methylphenidate, dexmethylphenidate, dextroamphetamine).
Narcolepsy: trial of at least ONE Step 1 product required (modafinil/armodafinil or CNS stimulant).

Background on Sunosi

Sunosi (solriamfetol) is indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). For narcolepsy, diagnosis requires specialized sleep testing (overnight polysomnography followed by a multiple sleep latency test) and management in collaboration with a sleep specialist or neurologist. For OSA, underlying airway obstruction should be treated with positive airway pressure therapies (e.g., CPAP, APAP, BPAP) where appropriate; Sunosi is intended as a wakefulness‑promoting pharmacologic option when the clinical criteria in this policy are met.

Definitions and Abbreviations

inv-13: MSLT — Multiple sleep latency test

DefinitionMultiple sleep latency test (MSLT): daytime test measuring how quickly a person falls asleep and whether they enter REM sleep

Procedure timingConducted the day after an overnight polysomnogram (PSG) with five short naps separated by ~2 hours

InterpretationAverage sleep latency < 8 minutes indicates excessive daytime sleepiness; REM within 15 minutes on ≥2 naps suggests narcolepsy-related REM onset

inv-14: PAP — Positive airway pressure includes CPAP, APAP, or BPAP

DefinitionPositive airway pressure (PAP): therapy to treat underlying airway obstruction in OSA

Included modalitiesIncludes continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP), or bilevel positive airway pressure (BPAP)

Initial Therapy and Step Therapy Requirements

inv-15: Step therapy - initial trial

Prior to approval of Sunosi (Step 2), patient must have tried a Step 1 product

Step 1 options: Trial of generic modafinil OR generic armodafinil OR a central nervous system stimulant (examples: methylphenidate, dexmethylphenidate, dextroamphetamine).

Exception if patient previously tried brand Provigil or brand Nuvigil.

Step Therapy Details

Step	Requirement	Exceptions / Notes
Step 1	Trial of at least one Step 1 product prior to Sunosi: generic modafinil OR generic armodafinil OR a central nervous system (CNS) stimulant (examples: methylphenidate, dexmethylphenidate, dextroamphetamine).	Exception allowed if the patient has previously tried brand Provigil (brand modafinil) or brand Nuvigil (brand armodafinil).

Step	Drug	Coverage Label
Step 2	Sunosi (solriamfetol)	Covered when Step 1 requirement and applicable clinical criteria are met; approve for 1 year.

Approval Duration and Renewal

inv-16: Approval duration

Duration of approval

Continuation: Approvals are provided for 1 year when clinical criteria are met.