Sunosi (solriamfetol)
Indications for Prior Authorization
Sunosi (solriamfetol)
-
For diagnosis of Narcolepsy
Indicated to improve wakefulness in adults patients with excessive daytime sleepiness associated with narcolepsy. -
For diagnosis of Obstructive sleep apnea (OSA)
Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with obstructive sleep apnea (OSA).Limitations of use: Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating Sunosi for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.
Criteria
Sunosi
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy
- Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [A, B] AND
- BOTH of the following;
- Trial and failure, contraindication, or intolerance to ONE of the following:
- generic modafinil
- generic armodafinil
- ONE of the following:
- Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant OR
- History of or potential for a substance use disorder
Sunosi
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy
- Patient demonstrates positive clinical response to therapy.
Sunosi
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Obstructive Sleep Apnea (OSA)
- Diagnosis of obstructive sleep apnea defined by one of the following: [4]
- 15 or more obstructive respiratory events per hour of sleep confirmed by a sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [C] OR
- Both of the following:
- 5 or more obstructive respiratory events per hour of sleep confirmed by a sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [C] AND
- One of the following signs/symptoms are present:
- Daytime sleepiness
- Nonrestorative sleep
- Fatigue
- Insomnia
- Waking up with breath holding, gasping, or choking
- Habitual snoring noted by a bed partner or other observer
- Observed apnea
- Both of the following:
- Standard treatment(s) for the underlying obstruction (e.g., with continuous positive airway pressure [CPAP], bi-level positive airway pressure [BiPAP]) have been used for one month or longer AND
- Patient is fully compliant with ongoing treatment(s) for the underlying airway obstruction
- Trial and failure, contraindication or intolerance to ONE of the following:
- generic modafinil
- generic armodafinil
Sunosi
Prior Authorization (Reauthorization)
Length of Approval: 6 Month(s)
For diagnosis of Obstructive Sleep Apnea (OSA)
- Patient demonstrates positive clinical response to therapy. AND
- Patient continues to be fully compliant with ongoing treatment(s) for the underlying airway obstruction (e.g., CPAP, BiPAP)
P & T Revisions
2024-04-04, 2023-10-04, 2023-04-13, 2022-10-11, 2022-04-18, 2021-09-28, 2021-05-26, 2021-05-25, 2021-02-16, 2020-04-07, 2020-01-16, 2019-07-11
References
- Sunosi Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. October 2021.
- Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
- UpToDate. Clinical features and diagnosis of narcolepsy. Available by subscription at: https://www.uptodate.com/contents/clinical-features-and-diagnosis-of-narcolepsy-in-adults?search=Clinical%20features%20and%20diagnosis%20of%20narcolepsy&source=search_result&selectedTitle=1~116&usage_type=default&display_rank=1. Accessed March 30, 2020.
- UpToDate. Clinical presentation and diagnosis of obstructive sleep apnea in adults. Available by subscription at: https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-obstructive-sleep-apnea-in-adults?search=obstructive%20sleep%20apnea&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4. Accessed March 30, 2020.
End Notes
- International Classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy type 1 (narcolepsy with cataplexy) require: 1) Daily periods of irrepressible need to sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) occurring for at least 3 months. 2) The presence of one or both of the following: cataplexy and a mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques. A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT; or cerebrospinal fluid (CSF) hypocretin-1 concentration is low (less than or equal to 110 pg/mL or less than one-third of mean values obtained in normal subjects with the same standardized assay) [2,3].
- International Classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy type 2 (narcolepsy without cataplexy) include: 1) Daily periods of irrepressible need to sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) occurring for at least 3 months. 2) Cataplexy is absent. 3) CSF hypocretin-1 levels, if measured, is either greater than 100 pg/mL or greater than one-third of mean values obtained in normal subjects with the same standardized assay. 4) A mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques. A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT. 5) Hypersomnolence and/or MSLT findings are not better explained by other causes such as insufficient sleep, obstructive sleep apnea, delayed sleep phase disorder, or the effect of medication or substances or their withdrawal [2,3].
- Examples of obstructive respiratory events include: obstructive and mixed apneas, hypopneas, or respiratory effort related arousals (RERA) [2].
Revision History
- 2024-04-04: 2024 Annual Review
- 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
- 2023-04-13: 2023 Annual Review.
- 2022-10-11: Update UM Guideline
- 2022-04-18: 2022 Annual Review
- 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
- 2021-02-16: updated guideline to reflect change to non-specialty (was removed from Specialty on 6/30/2020); no other changes made to guideline.
- 2020-04-07: Annual Review: updated background & references
- 2020-01-16: Updated criteria
- 2019-07-11: New guideline created for Sunosi. Criteria mirrors indication and ICSD-3 guideline. Product is specialty.
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