CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2174-9

Wakix (pitolisant) prior authorization / medical necessity

Defines initial and reauthorization medical necessity criteria, prescriber requirements, and documentation requirements for coverage of Wakix (pitolisant) for narcolepsy (with and without cataplexy) including pediatric indication (6+). Includes allowance for automated approvals based on prior claims/diagnosis and notes authorization duration and supply limits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWakix (pitolisant) prior authorization / medical necessity

Policy CodePolicy 2025 P 2174-9

Change TypeAnnual review; prior criteria additions

Effective DateNov 16, 2025

Next Review Date

Key ActionProviders must submit medical records documenting narcolepsy diagnosis and MSLT/polysomnogram results per specified criteria for initial authorization.

POLICY UPDATE CHANGES

Annual review and updated references performed in 9/2025; effective date 11/16/2025.

Added requirement for submission of documentation of sleep study with specific sleep study requirements (mean sleep latency ≤ 8 minutes and ≥2 SOREMPs).

Added requirement for prescriber specialty (Neurologist, Psychiatrist, Pulmonologist; Sleep Medicine Specialist for Type 1).

Added requirement for history of Sunosi failure/intolerance as alternate prior therapy.

2Covered Indications (narcolepsy w/ and w/o cataplexy)

12Authorization Duration

Mean Sleep Latency Threshold

≥2Required SOREMPs on MSLT

Coverage Summary

Coverage stance: covered_with_criteria for Wakix (pitolisant) for narcolepsy (with and without cataplexy), including pediatric indication for patients 6 years of age and older.

Scope: Defines initial and reauthorization medical necessity criteria, prescriber requirements, required documentation (including specific sleep study/MSLT thresholds), and prior therapy requirements. Authorizations will be issued for 12 months and supply limits may apply. UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated processes vary by program.

Headline scope: Wakix (pitolisant) is covered with criteria for narcolepsy (with and without cataplexy) including pediatric indication (6+). Authorization duration is 12 months, and automated approvals based on claims/diagnosis/claim logic are allowed per the scope.

Thresholds / Authorization Duration

Mean Sleep Latency≤ 8 minutes

SOREMPs on MSLT≥ 2 SOREMPs on MSLT (one may be replaced by a nocturnal SOREMP occurring within 15 minutes of sleep onset)

Symptom durationDaily irrepressible need to sleep or daytime lapses into sleep for at least 3 months

Authorization Duration12 months

Initial Therapy Criteria

Initial Authorization for Narcolepsy (general: EDS, without cataplexy)

Wakix will be approved based on all of the following criteria:

ALL of the following

ALL of the following
- The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months.
- A mean sleep latency of ≤ 8 minutes and two or more sleep onset REM periods (SOREMPs) are found on a MSLT performed according to standard techniques following a normal overnight polysomnogram.Mean Sleep Latency ≤ 8 minutes; ≥2 SOREMPs
  A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal polysomnogram may replace one of the SOREMPs on the MSLT.

Continuation / Reauthorization Criteria

Reauthorization - Narcolepsy without cataplexy

Wakix will be approved for continuation of therapy based on the following:

Reduction in symptoms of excessive daytime sleepiness associated with Wakix therapy.

Reauthorization - Narcolepsy with cataplexy (Type 1)

Wakix will be approved for continuation of therapy based on one of the following:

ANY of the following

Reduction in frequency of cataplexy attacks associated with therapy.
Reduction in symptoms of excessive daytime sleepiness associated with therapy.

Provider Actions & Documentation Requirements

Prior Authorization

Submit medical records and sleep study documentation

For initial authorization, providers must submit medical records (e.g., chart notes, lab values) documenting a diagnosis of narcolepsy and results of a polysomnogram followed by an MSLT meeting the specified thresholds: mean sleep latency ≤ 8 minutes and ≥ 2 SOREMPs (a nocturnal SOREMP within 15 minutes of sleep onset may replace one MSLT SOREMP). Also submit documentation of daily irrepressible sleepiness or daytime lapses occurring for at least three months.

Documentation Required

Physician attestation

Physician must attest that other causes of sleepiness have been ruled out or treated (examples include obstructive sleep apnea, insufficient sleep syndrome, shift work, substance or medication effects/withdrawal, sleep phase disorder, or other sleep disorders). For Narcolepsy Type 1 the physician must also attest the patient has experienced cataplexy (more than one episode of sudden loss of muscle tone with retained consciousness).

Applicable Codes

ICD-10 Diagnosis Codes (used for automated approvals / claim logic)ICD-10

No codes listed

Clinical Evidence & References

Product labeling reference: Wakix [package insert]. Harmony Biosciences; June 2025.

Guideline: Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: An American Academy of Sleep Medicine clinical practice guideline. Journal of Clinical Sleep Medicine. 2021.

Background & Definitions

Background: Wakix is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and for EDS in pediatric patients 6 years of age and older.

Coverage requires meeting diagnostic criteria (submission of medical records documenting daily irrepressible need to sleep or daytime lapses for at least 3 months and MSLT/MSLT-equivalent results showing a mean sleep latency of ≤ 8 minutes and ≥ 2 SOREMPs; a nocturnal SOREMP within 15 minutes of sleep onset may replace one MSLT SOREMP).

Members must also meet prior therapy and prescriber criteria: physician attestation that other causes of sleepiness have been ruled out or treated; history of failure, contraindication, or intolerance to armodafinil/modafinil, an amphetamine or methylphenidate stimulant, and Sunosi (unless history/potential for substance abuse is documented); and prescribed by or in consultation with specified specialists (Neurologist, Psychiatrist, Pulmonologist; Sleep Medicine Specialist included for Type 1 narcolepsy).

Term	Definition
SOREMP
Sleep Onset REM Period — REM sleep occurring within 15 minutes of sleep onset.
MSLT
Multiple Sleep Latency Test performed according to standard techniques following a normal overnight polysomnogram.

Revision History

04/2020addition

Added requirement for submission of sleep study documentation with specific MSLT thresholds (mean sleep latency ≤ 8 minutes and ≥2 SOREMPs; a nocturnal SOREMP within 15 minutes may replace one MSLT SOREMP).

04/2020addition

Added requirement for history of failure, contraindication, or intolerance to Sunosi as an alternate prior therapy.

03/2021addition

Added criteria for narcolepsy with cataplexy (Narcolepsy Type 1) based on updated product labeling (initial authorization criteria for Type 1).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWakix (pitolisant) prior authorization / medical necessity

Policy CodePolicy 2025 P 2174-9

Change TypeAnnual review; prior criteria additions

Effective DateNov 16, 2025

Next Review Date

Key ActionProviders must submit medical records documenting narcolepsy diagnosis and MSLT/polysomnogram results per specified criteria for initial authorization.

On This Page

Physician attestation that other causes of sleepiness have been ruled out or treated (including but not limited to obstructive sleep apnea, insufficient sleep syndrome, shift work, the effects of substances or medications or their withdrawal, sleep phase disorder, or other sleep disorders).

ONE of

ALL of the following
- armodafinil (Nuvigil) or modafinil (Provigil)
- an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate-based stimulant
- Sunosi (solriamfetol)
History of or potential for a substance abuse disorder

ALL of the following

Neurologist
Psychiatrist
Pulmonologist

Initial Authorization for Narcolepsy with Cataplexy (Narcolepsy Type 1)

Wakix will be approved based on all of the following criteria:

ALL of the following

ALL of the following
- The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months.
- A mean sleep latency of ≤ 8 minutes and two or more SOREMPs on an MSLT performed according to standard techniques following a normal overnight polysomnogram.Mean Sleep Latency ≤ 8 minutes; ≥2 SOREMPs
  A SOREMP on the preceding nocturnal polysomnogram (within 15 minutes of sleep onset) may replace one of the MSLT SOREMPs.
ALL of the following
- Patient has experienced cataplexy defined as more than one episode of sudden loss of muscle tone with retained consciousness.
- Other causes of sleepiness have been ruled out or treated (including but not limited to obstructive sleep apnea, insufficient sleep syndrome, shift work, the effects of substances or medications or their withdrawal, sleep phase disorder, or other sleep disorders).
ALL of the following
- Neurologist
- Psychiatrist
- Pulmonologist
- Sleep Medicine Specialist

Billing Rule

Authorization duration

Authorizations are issued for 12 months.

Prior Authorization

Specialist prescribing requirement

Wakix must be prescribed by or in consultation with one of the specified specialists: Neurologist, Psychiatrist, or Pulmonologist. For narcolepsy with cataplexy (Type 1) a Sleep Medicine Specialist is also listed among acceptable prescribers.

Neurologist
Psychiatrist
Pulmonologist
Sleep Medicine Specialist (required/acceptable for Type 1)

Prior Authorization

Trial or contraindication to alternatives

For non-cataplexy narcolepsy, documentation must show history of failure, contraindication, or intolerance to armodafinil or modafinil, a stimulant (amphetamine or methylphenidate), and Sunosi, unless there is a documented history of or potential for substance abuse disorder.

armodafinil or modafinil
an amphetamine or methylphenidate-based stimulant
Sunosi (solriamfetol)
Except if documented history/potential for substance abuse disorder

Documentation Required

Reauthorization evidence

For reauthorization, the provider must document clinical benefit: reduction in symptoms of excessive daytime sleepiness. For narcolepsy with cataplexy (Type 1) document reduction in cataplexy frequency and/or reduction in daytime sleepiness.

Documentation Required

Automated approval allowance

UnitedHealthcare may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval processes varies by program.

06/2021clarification

Clarified Type 1 (narcolepsy with cataplexy) section to require documentation of cataplexy and provider attestation; expanded prescriber specialty list to include Pulmonologist (Sleep Medicine Specialist included for Type 1).

09/2025 (effective 11/16/2025)annual_reviewLatest

Annual review and updated references performed; policy effective date set to 11/16/2025 (Program 2025 P 2174-9).