ModifiedCignaPolicy Cnf_641_Coveragepositioncriteria_Wakefulness_Promoting_Agents_Wakix_Pa

Wakefulness-Promoting Agents - Wakix Prior Authorization with Step Therapy Policy

Defines Cigna's prior authorization and step therapy coverage criteria for Wakix (pitolisant tablets) for FDA-approved indications (cataplexy and excessive daytime sleepiness in narcolepsy) including age limits, diagnostic testing, prescriber specialty, required prior therapies, coverage duration, and disallowed concomitant uses.

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents - Wakix Prior Authorization with Step Therapy Policy

Policy CodePolicy Cnf_641_Coveragepositioncriteria_Wakefulness_Promoting_Agents_Wakix_Pa

Change TypeMODIFIED

Effective Date

Next Review Date

Key ActionPrior authorization required with step therapy; document polysomnography and multiple sleep latency testing and ensure prescription by or in consultation with a sleep specialist or neurologist.

SourceLink

POLICY UPDATE CHANGES

Age requirement changed to ≥ 6 years for both cataplexy and excessive daytime sleepiness in line with expanded labeling.

Step therapy options for excessive daytime sleepiness updated to include CNS stimulants as an option.

Exception added that patients currently receiving Wakix do not need to try step therapy agents.

2Covered Indications (FDA-approved)

1 yrApproval Duration

≥6Minimum Covered Age (years)

Step 2Step Therapy Line

Coverage Summary

Scope: Defines Cigna's prior authorization and step therapy coverage criteria for Wakix (pitolisant tablets) for FDA-approved indications — cataplexy and excessive daytime sleepiness in narcolepsy — including minimum age (≥ 6 years), diagnostic testing requirements, prescriber specialty, required prior therapies (step therapy), approval duration, and disallowed concomitant uses.

Overview: Wakix (pitolisant), an H3 receptor antagonist/inverse agonist, is covered with specific criteria: approvals are for 1 year when all criteria are met (age ≥ 6 years, documented polysomnography and multiple sleep latency testing, confirmation of narcolepsy by the prescriber, and prescription by or in consultation with a sleep specialist or neurologist). Step therapy requires trials of specified agents prior to Wakix (with age- and situation-based exceptions), and concomitant use with oxybate products or Sunosi is considered not medically necessary.

Medical Necessity Criteria

Coding

DrugNDCCovered

No codes listed

Related products referenced (not covered concurrently)mixedNot Covered

Sunosi	solriamfetol tablets (referenced — not to be used concomitantly with Wakix)
Xyrem	sodium oxybate oral solution (oxybate products — contraindicated concomitant use)
Lumryz	sodium oxybate extended-release oral suspension (oxybate product)
Xywav	oxybate oral solution (oxybate product)

Related products referenced (not covered concurrently)mixedNot Covered

No codes listed

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required with step therapy

Prior authorization is required for Wakix. A step therapy requirement directs patients to try specified prior therapies before approving Wakix. For cataplexy in patients ≥ 18 years, a trial of dextroamphetamine is required unless the prescriber documents contraindication/intolerance or the patient is currently receiving Wakix. For excessive daytime sleepiness, patients must try at least one of: a CNS stimulant, generic modafinil, or generic armodafinil, unless exceptions apply (history of substance use disorder necessitating a non-controlled-agent or the patient is currently receiving Wakix).

For cataplexy (patients ≥ 18 years): trial of dextroamphetamine required (or documented contraindication/intolerance, or current Wakix).
For excessive daytime sleepiness: trial of at least ONE of a CNS stimulant, generic modafinil, or generic armodafinil (exceptions: history of substance use disorder requiring non-controlled agent, or current Wakix).

Documentation Required

Background & Evidence

Wakix (pitolisant) is an antagonist/inverse agonist of the histamine-3 receptor indicated for treatment of excessive daytime sleepiness and cataplexy in patients aged ≥ 6 years. Unlike other wakefulness-promoting agents such as modafinil, armodafinil, and solriamfetol (Sunosi), which are Schedule IV controlled substances, Wakix is the only wakefulness-promoting agent that is not a controlled substance. Diagnosis of narcolepsy requires two specialized tests performed in a sleep disorders clinic: an overnight polysomnogram and a multiple sleep latency test (MSLT), with thresholds including mean sleep latency < 8 minutes and occurrence of REM within 15 minutes on at least two naps or the preceding night indicative of narcolepsy.

The American Academy of Sleep Medicine (AASM) 2021 practice parameters issue strong recommendations supporting modafinil, Wakix, sodium oxybate, and Sunosi as effective treatments for daytime sleepiness due to narcolepsy; additionally, Wakix and sodium oxybate have demonstrated efficacy for treating cataplexy.

Revision History

2024-07-03revised

Age for excessive daytime sleepiness changed to ≥ 6 years when Wakix indicated for adults and pediatric patients ≥ 6; step component qualified to apply only if patient is ≥ 18 years of age.

2024-09-04revised

Criteria updated to include central nervous system (CNS) stimulants as an option for patients ≥ 18 years to try prior to approval; examples of CNS stimulants were added to the Note.

2024-11-20revised

Restriction removed that limited requiring a trial of a CNS stimulant, generic modafinil, or generic armodafinil to patients ≥ 18 years of age (i.e., broadened applicability).

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents - Wakix Prior Authorization with Step Therapy Policy

Policy CodePolicy Cnf_641_Coveragepositioncriteria_Wakefulness_Promoting_Agents_Wakix_Pa

Change TypeMODIFIED

Effective Date

Next Review Date

SourceLink

On This Page

Diagnostic testing documentation required

Documentation of diagnostic testing is required. The provider must document that the patient was evaluated using polysomnography and a multiple sleep latency test, and the prescriber must attest that the diagnosis of narcolepsy has been confirmed.

Documentation Required

Prescriber specialty requirement

Prescriptions must be written by or in consultation with a sleep specialist physician or a neurologist; the medication must be prescribed by or in consultation with one of these specialists per the policy criteria.

Billing Rule

Duration of approval

Approvals for Wakix are provided for a duration of 1 year for the covered FDA-approved indications when criteria are met.

Denial Risk

Concomitant therapy denial

Concomitant use of Wakix with an oxybate product and/or Sunosi (solriamfetol) is considered not medically necessary; claims for such combinations may be denied.

2026-04-15revisedLatest

Cataplexy age requirement updated from ≥ 18 years to ≥ 6 years and step component adjusted to require dextroamphetamine only if patient is ≥ 18; exceptions added so patients currently receiving Wakix are exempt from prior trial requirements for both cataplexy and excessive daytime sleepiness.