Pharmacy Prior Authorization Criteria

Wakix (pitolisant)

Indications for Prior Authorization

Wakix (pitolisant)

• For diagnosis of Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1)
  Indicated for the treatment of cataplexy in adult patients with narcolepsy.

• For diagnosis of Narcolepsy without Cataplexy (i.e., Narcolepsy Type 2)
  Indicated for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.

Criteria

Wakix

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1)

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are present
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Wakix

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1)

• Patient demonstrates a reduction in the frequency of cataplexy attacks associated with therapy
OR
• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy

Wakix

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without cataplexy (Narcolepsy Type 2)

• 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
• Symptoms of cataplexy are absent
AND
• Patient is 6 years of age or older
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• BOTH of the following:
• Trial and failure, contraindication (e.g., age), or intolerance to BOTH of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant UNLESS patient is not a candidate
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Wakix

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy without cataplexy (Narcolepsy Type 2)

• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy
AND
• BOTH of the following:
• Trial and failure, contraindication (e.g., age), or intolerance to BOTH of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant UNLESS patient is not a candidate

P & T Revisions

2024-07-26, 2023-07-28, 2022-07-11, 2021-08-12, 2020-12-29, 2020-08-11, 2020-01-16, 2019-12-16

References

1. Wakix Prescribing Information. Harmony Biosciences, LLC, Plymouth Meeting, PA. June 2024.
2. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
3. UpToDate. Clinical features and diagnosis of narcolepsy in adults. 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 August 11,2021.

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End Notes

1. 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].
2. 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].

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Revision History

• 2024-07-26: 2024 UM Annual Review. Updated reauth verbiage to standard "patient demonstrates." Updated verbiage for "history of or potential for a substance use disorder" to "unless patient is not a candidate." Added in embedded step for Narcolepsy Type 2 into reauth criteria. Added in age criteria to account for expanded indication for patients 6 years of age or older and added in "(e.g., age)" to trial and failure requirement for modafinil/armodafinil and Sunosi. Background updates
• 2023-07-28: 2023 UM Annual Review. No criteria changes. Update references
• 2022-07-11: 2022 Annual Review
• 2021-08-12: 2021 Annual Review
• 2020-12-29: updated guideline to include expanded indication of treatment of cataplexy in adult patients with narcolepsy; updated existing indication criteria
• 2020-08-11: 2020 Annual Review: updated reauthorization criteria and references.
• 2020-01-16: updated criteria
• 2019-12-16: New guideline created

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