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Wakix (pitolisant) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1122

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

4/1/2023

4/1/2020

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Wakix®

(pitolisant)

Tablet

Treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Narcolepsy

Narcolepsy is a chronic neurological disorder caused by the inability to regulate sleep-wake cycles. At various times throughout the day, patients with narcolepsy experience irresistible bouts of sleep and could fall asleep. If left undiagnosed or untreated, narcolepsy can interfere with psychological, social, and cognitive function and development and can inhibit academic, work, and social activities.(2) Symptoms may include excessive daytime sleepiness (EDS), cataplexy, sleep paralysis, and hallucinations. All patients diagnosed with narcolepsy will have excessive daytime sleepiness. However, sleepiness in narcolepsy is more like a “sleep attack”, where an overwhelming sense of sleepiness comes on quickly.(2) There is limited evidence to advise on treatment of special populations such as children, pregnant women, and breastfeeding mothers.(5)

The American Family Physician recommends referral to a sleep clinic if narcolepsy is suspected.(3) The American Academy of Sleep Medicine indicates treatment goals should be to alleviate daytime sleepiness and produce the fullest possible return of normal function for patients at work, school, home, and socially.(4)

Excessive daytime sleepiness (EDS) is characterized by persistent sleepiness regardless of how much sleep an individual gets at night. In between sleep attacks, individuals have normal levels of alertness, particularly if doing activities that keep their attention. The most common causes of EDS include narcolepsy, obstructive sleep apnea, shift work disorder, sleep deprivation, medication effects, and other medical and psychiatric conditions.(5) Narcolepsy has two types, narcolepsy with cataplexy and without cataplexy. Narcolepsy with cataplexy involves the sudden loss of voluntary muscle tone while awake. It is often triggered by sudden, strong emotions such as laughter, fear, anger, stress, or excitement. The symptoms of cataplexy may appear weeks or even years after the onset of EDS.(2)

The American Academy of Sleep Medicine (AASM) 2021 guidelines combined the recommendations for narcolepsy with cataplexy and EDS associated with narcolepsy. The AASM recommend the following for the pharmacologic treatment with narcolepsy:(6)

  • Strong treatment recommendations:
    • Modafinil
    • Pitolisant
    • Sodium oxybate
    • Solriamfetol
  • Conditional treatment recommendations:
    • Armodafinil
    • Dextroamphetamine
    • Methylphenidate
  • There was insufficient evidence to make recommendations for SSRI and SNRIs for the treatment of narcolepsy.

Efficacy(1)

Excessive Daytime Sleepiness (EDS) in Patients with Narcolepsy

The efficacy of Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies (Study 1; NCT01067222 and Study 2; NCT01638403). EDS was assessed using the ESS, an 8-item questionnaire by which patients rate their perceived likelihood of falling asleep during usual daily life activities.

Wakix demonstrated statistically significantly greater improvement on the primary endpoint, the least square mean final ESS score compared to placebo.

Cataplexy in Patients with Narcolepsy

The efficacy of Wakix for the treatment of cataplexy in adult patients with narcolepsy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies (Study 3; NCT01800045 and Study 1; NCT01067222). 

Wakix demonstrated statistically significantly greater improvement on the primary endpoint, the change in geometric mean number of cataplexy attacks per week from baseline to the average of the 4-week stable dosing period for Wakix compared to placebo.

Safety(1)

Wakix has the following contraindications for use:

  • Patients with severe hepatic impairment
  • Known hypersensitivity to pitolisant or any component of the formulation

REFERENCES                                                                                                                                                                           

Number

Reference

1

Wakix prescribing Information. Harmony Biosciences, LLC. March 2021.

2

National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. NIH Publication No. 17-1637. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet. Accessed September 2022. Last updated July 2022.

3

Ramar, Kannan MD and Olson, Eric MD. Management of Common Sleep Disorders. Am Fam Physician. 2013 Aug 15; 88(4): 231-238.

4

Krahn, Lois MD, et al. Quality Measures for the Care of Patients with Narcolepsy. Journal of Clinical Sleep Medicine. 2015; Vol. 11(3).

5

Pagel J. Excessive daytime sleepiness. Am Fam Physician. 2009;79(5): 391-395.

6

Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(9):1881-1893.

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

Wakix

pitolisant hcl tab

17.8 MG ; 4.45 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

Wakix

pitolisant hcl tab

17.8 MG ; 4.45 MG

60.0

TABS

30

Days

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Wakix

pitolisant hcl tab

17.8 MG ; 4.45 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Wakix

pitolisant hcl tab

17.8 MG ; 4.45 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has a diagnosis of excessive daytime sleepiness associated with narcolepsy OR narcolepsy with cataplexy AND ONE of the following:
    1. The patient has tried and had an inadequate response after 1-month of therapy with armodafinil OR modafinil OR
    2. The patient has an intolerance or hypersensitivity to armodafinil OR modafinil OR
    3. The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil OR
    4. The patient has been prescribed the requested non-controlled agent due to comorbid conditions OR concerns about controlled substance use AND
  2. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  3 months

 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  2. The patient has had clinical benefit with the requested agent AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

Note: If Quantity Limit applies, please refer to Quantity Limit Criteria. 

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
  3. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: Initial: 3 months; Renewal: 12 months

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy

Severe hepatic impairment

 

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

Commercial _ PS _ Wakix (pitolisant) Prior Authorization with Quantity Limit _ProgSum_ 4/1/2023