CurrentUnitedHealthcarePolicy N/A

Wakix (pitolisant) prior authorization / medical necessity

Defines UnitedHealthcare's coverage criteria and authorization requirements for Wakix (pitolisant) for treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy; applies to prescribers and member coverage determinations.

Policy Summary

PayerUnitedHealthcare

PolicyWakix (pitolisant) prior authorization / medical necessity

Policy CodePolicy N/A

Change TypeMaterial updates to criteria and documentation

Effective Date12/1/2024

Next Review DateN/A

Key ActionSubmit prior authorization with medical records and sleep study results (MSLT and preceding overnight PSG) documenting narcolepsy per criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement for history of Sunosi.

Added requirement for submission of documentation of sleep study with specific sleep study requirements.

Changed initial authorization duration to 12 months.

Added criteria for narcolepsy with cataplexy based on updated product labeling.

Added pulmonologist to the list of specialists authorized to prescribe.

12 monthsauthorization duration

<8 minsleep study threshold

≥2SOREMPs required

≥6 yrsapproved age

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Wakix (pitolisant)

Initial Authorization (Narcolepsy without cataplexy)

Covered when ALL of the following are met

Diagnostic documentation: Submission of medical records documenting a diagnosis of narcolepsy with: (a) daily periods of irrepressible need to sleep or daytime lapses into sleep for at least 3 months; AND (b) mean sleep latency < 8 minutes and two or more sleep onset REM periods (SOREMPs) on an MSLT performed according to standard techniques following a normal overnight polysomnogram (a SOREMP on the preceding nocturnal PSG may substitute for one MSLT SOREMP).

Physician attestation: 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, substance or medication effects).

Prior therapy or substance abuse: Either (a) history of failure, contraindication, or intolerance to all of the following: armodafinil or modafinil; an amphetamine or methylphenidate stimulant; and Sunosi (solriamfetol); OR (b) history of or potential for a substance abuse disorder.

Step therapy alternatives allowed.

Prescriber specialty: Prescribed by or in consultation with one of the following: neurologist, pulmonologist, or psychiatrist.

Initial Authorization (Narcolepsy with cataplexy)

Covered when ALL of the following are met

Diagnostic documentation: Submission of medical records documenting narcolepsy with cataplexy (Narcolepsy Type 1) with: (a) daily periods of irrepressible need to sleep or daytime lapses into sleep for at least 3 months; AND (b) mean sleep latency < 8 minutes and two or more SOREMPs on MSLT performed according to standard techniques following a normal overnight PSG (a SOREMP on the preceding nocturnal PSG may substitute for one MSLT SOREMP).

Cataplexy attestation: Physician attestation that the patient has experienced cataplexy, defined as more than one episode of sudden loss of muscle tone with retained consciousness.

Other causes: 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, substance/medication effects or withdrawal).

Prescriber specialty:

Reauthorization / Continuation of Therapy

Covered when ANY of the following are met

EDS improvement: Documentation of reduction in symptoms of excessive daytime sleepiness associated with Wakix therapy.

Cataplexy reduction: Documentation of reduction in frequency of cataplexy attacks associated with Wakix therapy.

Supply limits may be applied to Wakix (pitolisant) claims. UnitedHealthcare may use automated approval and re-approval processes that rely solely on prior claims/medication history, diagnosis codes (ICD-10), and claim logic; the availability and use of these automated pathways vary by program and therapeutic class.

Diagnostic Thresholds and Definitions

MSLT mean sleep latency — numeric threshold for diagnostic testing

MSLT mean sleep latency thresholdMean sleep latency < 8 minutes on MSLT performed according to standard techniques after a normal overnight polysomnogram

Required clinical history durationDaily periods of irrepressible sleepiness or daytime lapses into sleep for at least 3 months

Authorization noteMSLT must follow a normal overnight PSG; a SOREMP on the preceding PSG may substitute for one MSLT SOREMP

Number of SOREMPs required — diagnostic SOREMP threshold

SOREMP count requirement>= 2 SOREMPs on MSLT (two or more) to meet diagnostic criteria

PSG substitution allowance

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — initial and reauthorizations are issued for 12 months. Submit documentation including the diagnostic sleep study (MSLT/PSG) and relevant medical records to support the narcolepsy diagnosis and treatment history.

Authorization length: 12 months
Submit: chart notes, lab values, MSLT and overnight PSG results
State mandates, federal requirements, and member benefit design may affect coverage

Step Therapy

Prior Stimulant / Sunosi Trial or Substance Abuse Exception

Prior stimulant/Sunosi trial or substance abuse exception required. Document one of the following: (a) history of failure, contraindication, or intolerance to armodafinil or modafinil AND an amphetamine- or methylphenidate-based stimulant AND solriamfetol (Sunosi); OR (b) documented history of or potential for substance abuse that justifies an exception to the stimulant requirement.

Required prior therapies: armodafinil (Nuvigil) or modafinil (Provigil)

Background on Wakix (pitolisant)

Pitolisant (Wakix) is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy aged ≥ 6 years. Diagnosis typically requires documentation of irrepressible daytime sleepiness for ≥ 3 months and objective sleep testing, generally an overnight polysomnography followed by a multiple sleep latency test (MSLT) demonstrating a mean sleep latency of < 8 minutes and ≥ 2 SOREMPs (a SOREMP on the preceding PSG may substitute for one MSLT SOREMP).

Clinical Definitions

SOREMP — Sleep onset REM period definition and diagnostic criteria

DefinitionSOREMP = REM sleep occurring within 15 minutes of sleep onset (sleep onset REM period)

Diagnostic requirementTwo or more SOREMPs on MSLT meet the SOREMP criterion for narcolepsy diagnosis

PSG-MSLT equivalenceA single SOREMP on the preceding nocturnal PSG may substitute for one MSLT SOREMP

Testing contextMSLT must be performed according to standard techniques following a normal overnight polysomnogram

Narcolepsy Type 1 (with cataplexy) — definition and clinical features

Core featuresDaily irrepressible need to sleep or daytime lapses into sleep for at least 3 months

Policy Summary

PayerUnitedHealthcare

PolicyWakix (pitolisant) prior authorization / medical necessity

Policy CodePolicy N/A

Change TypeMaterial updates to criteria and documentation

Effective Date12/1/2024

Next Review DateN/A

Key ActionSubmit prior authorization with medical records and sleep study results (MSLT and preceding overnight PSG) documenting narcolepsy per criteria.

SourceLink

On This Page

Prescribed by or in consultation with one of the following: neurologist, pulmonologist, psychiatrist, or sleep medicine specialist in internal medicine.

A SOREMP (within 15 minutes of sleep onset) on the preceding nocturnal PSG may replace one MSLT SOREMP

Test timingMSLT must be performed according to standard techniques following a normal overnight polysomnogram

AND an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate stimulant

AND solriamfetol (Sunosi)

Exception pathway: documented history or risk of substance abuse

Documentation Required

Required Medical Records and Sleep Study

Required medical records and sleep study — submit chart notes and the diagnostic sleep study results to support the diagnosis. For narcolepsy the MSLT must show a mean sleep latency < 8 minutes and ≥ 2 SOREMPs, performed after a normal overnight polysomnogram; a SOREMP on the nocturnal PSG may substitute for one MSLT SOREMP.

MSLT results: mean sleep latency < 8 minutes and ≥ 2 SOREMPs
Overnight PSG required prior to MSLT; PSG SOREMP may substitute for one MSLT SOREMP
Include clinical history documenting daily irrepressible sleepiness for ≥ 3 months and, when applicable, documentation of cataplexy

Documentation Required

Physician Attestation Requirements

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

Attestation: other causes of sleepiness ruled out or treated
For Type 1 narcolepsy: attest to documented cataplexy episodes
Prescriber requirement: prescribed by or in consultation with specialist (neurologist, pulmonologist, psychiatrist, or sleep medicine specialist)

Denial Risk

Failure to Document Diagnostic Sleep Study or Clinical History

Failure to document diagnostic sleep study or clinical history may result in denial. If the MSLT/PSG results or the required clinical history (daily irrepressible sleepiness ≥ 3 months; for Type 1, cataplexy) are not provided as specified, authorization will be denied.

Denial risk if MSLT and overnight PSG not submitted or do not meet criteria
Denial risk if clinical history of excessive daytime sleepiness (≥ 3 months) is absent or not documented
Denial risk if cataplexy documentation missing for Narcolepsy Type 1

Denial Risk

Prior Therapy Not Documented

Prior therapy not documented — denial risk when required prior stimulant trials, Sunosi trial, or documentation of contraindication/intolerance to these therapies are not provided.

Provide documentation of trial(s) and response or intolerance to: armodafinil/modafinil, an amphetamine- or methylphenidate-based stimulant, and Sunosi
If trials are not documented or exceptions not justified, request will be denied

Cataplexy definitionCataplexy = more than one episode of sudden loss of muscle tone with retained consciousness

Diagnostic testingMSLT mean sleep latency < 8 minutes and >=2 SOREMPs on MSLT after a normal overnight PSG (PSG SOREMP may replace one MSLT SOREMP)

Attestation requirementPhysician attestation that the patient has experienced cataplexy and that other causes of sleepiness have been ruled out or treated