SUNOSI (solriamfetol) Coverage Criteria
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Prior authorization for SUNOSI (solriamfetol) in adults with narcolepsy or obstructive sleep apnea and associated excessive daytime sleepiness, including initial authorization, continuation, documentation, dosing, and authorization duration requirements.
No material clinical or coverage changes in this revision.
Covered Indications
Narcolepsy initial therapy
Covered for narcolepsy when all of the following are met.
- Age: The patient is 18 years of age or older.>= 18 years
Narcolepsy diagnosis or documented sleepiness
- The patient has a diagnosis of narcolepsy according to International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- The patient has excessive daytime sleepiness associated with narcolepsy as confirmed by documented sleep testing.
Examples include polysomnography and multiple sleep latency testing.
- Prior therapy failure: The patient has tried and failed modafinil or armodafinil.
Clinical documentation is required.
Obstructive sleep apnea initial therapy
Covered for obstructive sleep apnea when all of the following are met.
- Age: The patient is 18 years of age or older.>= 18 years
OSA diagnosis or documented sleepiness
- The patient has a diagnosis of obstructive sleep apnea according to ICSD-3 criteria.
- The patient has excessive daytime sleepiness associated with obstructive sleep apnea as confirmed by documented sleep testing.
Examples include polysomnography and multiple sleep latency testing.
- CPAP use: The patient has used continuous positive airway pressure (CPAP) compliantly for at least one month before the SUNOSI trial.At least 1 month before SUNOSI trial
- Prior therapy failure: The patient has tried and failed modafinil or armodafinil.
Clinical documentation is required.
- Underlying airway obstruction treatment: Modalities to treat the underlying airway obstruction continue during treatment with SUNOSI.
Continuation therapy
Continuation is covered when all of the following are met.
- Initial criteria: The patient met the applicable initial criteria.
- Clinical response: Documentation shows improved clinical response.
- Adverse effects: The patient has not experienced any treatment-restricting adverse effects.
- Dosing is appropriate as per labeling or is supported by compendia.
Authorization and Documentation Requirements
Prior Authorization and Indication Requirements
Prior authorization is required for Sunosi (solriamfetol) for patients 18 years of age or older who meet the applicable narcolepsy or obstructive sleep apnea (OSA) indication requirements.
- Applicable indication: narcolepsy or OSA.
- The diagnosis must meet the policy's applicable diagnostic criteria, or excessive daytime sleepiness must be confirmed by documented sleep testing.
Required Prior Therapies
Before Sunosi therapy, document a trial and failure of modafinil or armodafinil. For OSA, also document compliant CPAP use for at least one month before the Sunosi trial and continuation of modalities treating the underlying airway obstruction.
- Modafinil or armodafinil trial and failure requires clinical documentation.
- OSA requires compliant CPAP use for at least one month before the Sunosi trial.
- Continue modalities used to treat the underlying airway obstruction during Sunosi treatment.
Narcolepsy Prior-Treatment Documentation
For narcolepsy, submit clinical documentation showing a trial and failure of modafinil or armodafinil before Sunosi is initiated.
- Document the prior medication, trial, and treatment failure.
- The documentation supports the narcolepsy prior-treatment requirement.
OSA Clinical Documentation
For OSA, document the qualifying diagnosis or excessive daytime sleepiness confirmed by sleep testing, along with required prior therapy and airway-obstruction treatment documentation.
- OSA diagnosis must meet ICSD-3 criteria, or excessive daytime sleepiness must be confirmed by documented polysomnography, multiple sleep latency testing, or comparable sleep testing.
- Document compliant CPAP use for at least one month before the Sunosi trial.
- Document trial and failure of modafinil or armodafinil.
- Document that treatment modalities for the underlying airway obstruction will continue during Sunosi therapy.
Continuation Documentation
For continuation authorization, document that the patient met the initial coverage criteria, has demonstrated improved clinical response, and has not experienced treatment-restricting adverse effects. Dosing must be consistent with labeling or supported by compendia.
- Initial eligibility criteria remain satisfied.
- Clinical improvement is documented.
- No treatment-restricting adverse effects have occurred.
- Dosing is appropriate according to labeling or supported by compendia.
Narcolepsy Criteria Not Met
Narcolepsy coverage is not authorized when the patient is under 18, lacks the required narcolepsy diagnosis or documented excessive daytime sleepiness, or has not failed modafinil or armodafinil with supporting clinical documentation.
- Patient is younger than 18 years of age.
- Narcolepsy is not established under ICSD-3 or DSM-5 criteria and qualifying excessive daytime sleepiness is not documented by sleep testing.
- A documented trial and failure of modafinil or armodafinil is absent.
OSA Criteria Not Met
OSA coverage is not authorized when the patient is under 18, lacks the required OSA diagnosis or documented excessive daytime sleepiness, or has not completed the required OSA prerequisites.
- Patient is younger than 18 years of age.
- OSA is not established under ICSD-3 criteria and qualifying excessive daytime sleepiness is not documented by sleep testing.
- Compliant CPAP use for at least one month before the Sunosi trial is not documented.
- A documented trial and failure of modafinil or armodafinil is absent.
- Continuation of modalities treating the underlying airway obstruction is not documented.
Continuation Criteria Not Met
Continuation is not authorized when initial eligibility is no longer supported, improved clinical response is not documented, treatment-restricting adverse effects are present, or dosing is not consistent with labeling or supported by compendia.
- Initial coverage criteria were not met or cannot be verified.
- No clinical improvement is documented.
- Treatment-restricting adverse effects have occurred.
- Dosing is inappropriate under labeling and lacks compendia support.
Policy Background
SUNOSI (solriamfetol) is covered under this policy for adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. For obstructive sleep apnea, modalities addressing the underlying airway obstruction should continue during SUNOSI treatment.
Initial Authorization Criteria
Narcolepsy initial therapy
Initial coverage for narcolepsy requires all applicable criteria.
Narcolepsy
- The patient is 18 years of age or older.>= 18 years
Narcolepsy diagnosis or documented sleepiness
- The patient has a diagnosis of narcolepsy according to International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- The patient has excessive daytime sleepiness associated with narcolepsy as confirmed by documented sleep testing.
Examples include polysomnography and multiple sleep latency testing.
- The patient has tried and failed modafinil or armodafinil.
Clinical documentation is required.
Obstructive sleep apnea initial therapy
Initial coverage for obstructive sleep apnea requires all applicable criteria.
Obstructive sleep apnea
- The patient is 18 years of age or older.>= 18 years
OSA diagnosis or documented sleepiness
- The patient has a diagnosis of obstructive sleep apnea according to ICSD-3 criteria.
- The patient has excessive daytime sleepiness associated with obstructive sleep apnea as confirmed by documented sleep testing.
Examples include polysomnography and multiple sleep latency testing.
- The patient has used continuous positive airway pressure (CPAP) compliantly for at least one month before the SUNOSI trial.At least 1 month before SUNOSI trial
- The patient has tried and failed modafinil or armodafinil.
Clinical documentation is required.
- Modalities to treat the underlying airway obstruction continue during treatment with SUNOSI.
Continuation Authorization
SUNOSI continuation criteria
Continuation is covered when all of the following are met.
SUNOSI continuation therapy
- Initial criteria: The patient met the applicable initial criteria.
- Clinical response: Documentation shows improved clinical response.
- Adverse effects: The patient has not experienced any treatment-restricting adverse effects.
- Dosing is appropriate as per labeling or is supported by compendia.
Required Treatment Sequence
| Step | Required prior therapy | Documentation / timing |
|---|---|---|
| 1 | Trial and failure of modafinil or armodafinil before SUNOSI | Clinical documentation required |
| Step | Required prior therapy | Documentation / timing |
|---|---|---|
| 2 | Compliant use of continuous positive airway pressure (CPAP) for obstructive sleep apnea | At least one month before the SUNOSI trial |
Authorization Duration
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