CurrentCignaPolicy N/A

Drug Quantity Management Policy - Wakix (pitolisant) per Rx

Defines per-prescription quantity limits and coverage criteria for Wakix (pitolisant) tablets for Cigna-administered health benefit plans; affects prescribers and pharmacists requesting Wakix at point of sale or for home delivery.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Wakix (pitolisant) per Rx

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 27, 2024

Key ActionApprove quantity limits and exceptions per the policy; approvals are provided for 1 year unless otherwise noted.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

304.45 mg retail max

904.45 mg home delivery max

6017.8 mg retail max

18017.8 mg home delivery max

1 yrtypical approval duration

Coverage Criteria — Wakix (pitolisant)

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy - Wakix (pitolisant) per Rx

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateAug 27, 2024

Key ActionApprove quantity limits and exceptions per the policy; approvals are provided for 1 year unless otherwise noted.

SourceLink

On This Page

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.

Quantity Limits and Exceptions - Wakix 4.45 mg

Wakix products are covered as medically necessary when dispensed within the following per-prescription quantity limits or when exception criteria are met.

4.45 mg tablets - Standard quantity limits: Retail maximum 30 tablets per prescription; Home delivery maximum 90 tablets per prescription.see text

Approvals provided for 1 year; quantities exceeding these limits are not medically necessary unless exception criteria below are met.

Dose-specific exception for 4.45 mg tablets: If the patient requires a daily dose of 8.9 mg, approve 60 tablets per dispensing at retail and 180 tablets per dispensing at home delivery.see text

Exception applies only for documented need for 8.9 mg daily dose.

Quantity Limits - Wakix 17.8 mg

17.8 mg tablets quantity limits and override guidance.

17.8 mg tablets - Standard quantity limits: Retail maximum 60 tablets per prescription; Home delivery maximum 180 tablets per prescription.see text

Approvals provided for 1 year; no overrides recommended for this strength.

Any quantity per prescription that exceeds the specified maximums for the strength and distribution channel is not medically necessary. The Drug Quantity Limit establishes these maximums per prescription: for Wakix 4.45 mg tablets the retail maximum is 30 tablets per Rx and the home delivery maximum is 90 tablets per Rx; for Wakix 17.8 mg tablets the retail maximum is 60 tablets per Rx and the home delivery maximum is 180 tablets per Rx. Coverage at point of sale is determined against these limits and claims exceeding them will be considered not medically necessary unless an approved exception applies.

Exceptions that do not meet the Drug Quantity Management rule are considered not medically necessary. In other words, any request for quantities above the stated per‑prescription maximums must meet the policy’s exception criteria (for example, the specific dose‑based exception for 4.45 mg tablets described elsewhere) to be approved; requests that fail to satisfy those criteria will be denied as not medically necessary.

Per-prescription Quantity Limits

inv-12: Wakix 4.45 mg tablets — retail max (30)

Strength & formWakix (pitolisant) 4.45 mg tablets

Retail maximum per prescription30 tablets per Rx

Home delivery maximum per prescription90 tablets per Rx

inv-13: Wakix 4.45 mg tablets — home delivery max (90)

Strength & formWakix (pitolisant) 4.45 mg tablets

Home delivery maximum per prescription90 tablets per Rx

Retail maximum per prescription30 tablets per Rx

inv-14: Wakix 17.8 mg tablets — retail max (60)

Strength & formWakix (pitolisant) 17.8 mg tablets

Retail maximum per prescription60 tablets per Rx

Home delivery maximum per prescription180 tablets per Rx

inv-15: Wakix 17.8 mg tablets — home delivery max (180)

Strength & formWakix (pitolisant) 17.8 mg tablets

Home delivery maximum per prescription180 tablets per Rx

Retail maximum per prescription60 tablets per Rx

inv-16: Wakix 4.45 mg tablets for patients requiring 8.9 mg daily — alternate limits (60 retail / 180 home delivery)

SituationPatients requiring an 8.9 mg daily dose (two 4.45 mg tablets)

Approved retail quantity per dispensing60 tablets per dispensing at retail

Approved home delivery quantity per dispensing180 tablets per dispensing at home delivery

Provider Actions and Authorization Guidance

Prior Authorization

Quantity management and approval duration

All approvals are provided for 1 year in duration, unless otherwise noted. Drug Quantity Management (DQM) limits are enforced at point of service; quantities exceeding the per‑prescription limits may be denied. Requests for exceptions to DQM limits require clinical justification and supporting documentation.

Approvals: 1 year duration by default.
DQM limits enforced at point of sale; exceptions may be denied if limits exceeded.

Documentation Required

Documentation and review requirements

Providers must submit complete clinical documentation to support any request for an exception to the Drug Quantity Management limits. Coverage determinations will be made in accordance with the member's benefit plan, applicable laws and regulations, and relevant collateral materials. Medical Directors will exercise clinical judgment in individual coverage decisions.

Include dosing rationale, expected daily dose, and duration of therapy.
Attach relevant prior medical records, specialist notes, and previous authorization history if available.
Clearly state whether retail or home delivery dispensing is requested and the specific quantity per dispensing.

Denial Risk

Denial risk for exceeding per‑Rx limits

Quantities exceeding the Drug Quantity Management per‑Rx limits (retail: Wakix 4.45 mg = 30 tablets; home delivery = 90 tablets; pitolisant 17.8 mg retail = 60 tablets; home delivery = 180 tablets) are at high risk for denial if an appropriate exception rationale and supporting documentation are not provided at the time of request.

Wakix 4.45 mg retail limit: 30 tablets per Rx; home delivery limit: 90 tablets per Rx.
If patient requires 8.9 mg daily, approve up to 60 tablets retail and 180 tablets home delivery with documentation.

Note

Provider actions (placeholder)

(No additional provider‑action content provided in source.) If more provider instructions are needed, refer to the full policy source and the member's benefit plan for coverage specifics.

Definitions and Dosing

inv-10: Wakix (pitolisant) — indication summary and key facts

IndicationExcessive daytime sleepiness or cataplexy in adults with narcolepsy; excessive daytime sleepiness in patients ≥ 6 years with narcolepsy.

Drug class / mechanismHistamine‑3 receptor antagonist/inverse agonist (wakefulness‑promoting agent)

Coverage stanceCovered with criteria — subject to per‑prescription quantity limits and exception criteria described in the policy.

Typical approval durationApprovals are provided for 1 year unless otherwise noted.

inv-11: Dosing guidance — titration schedule, max doses, hepatic/renal adjustments

Adult titration scheduleWeek 1: 8.9 mg (two 4.45 mg tablets) QD; Week 2: 17.8 mg (one 17.8 mg tablet) QD; Week 3: may increase to 35.6 mg (two 17.8 mg tablets) QD.

Pediatric titration (≥6 years)Week 1: 4.45 mg QD; Week 2: 8.9 mg QD; Week 3: 17.8 mg QD (max if <40 kg); Week 4: may increase to 35.6 mg QD if ≥40 kg.

Hepatic/renal adjustmentsFor moderate hepatic impairment or moderate‑to‑severe renal impairment, maximum daily dose should not exceed 17.8 mg; contraindicated in severe hepatic disease; not recommended in end‑stage renal disease.

Maximum recommended adult dose35.6 mg once daily (two 17.8 mg tablets)

Background

Wakix (pitolisant) is a wakefulness‑promoting agent acting as an antagonist/inverse agonist at the histamine‑3 receptor and is indicated for treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy and for excessive daytime sleepiness in patients aged 6 years and older with narcolepsy. Dosing recommendations include a morning once‑daily administration with titration to achieve the effective dose range and adjustments for hepatic or renal impairment as clinically appropriate.