Pitolisant (Wakix) Form

Wakix® (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist. FDA Approved Indication(s) Wakix is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Wakix is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Narcolepsy with Cataplexy (must meet all):

1. Prescribed for the treatment of cataplexy in narcolepsy;
   2. Prescribed by or in consultation with a neurologist or sleep medicine specialist;
   3. Age ≥ 18 years;
   4. Documentation of one of the following (a or b): a. EDS associated with narcolepsy as confirmed by documented multiple sleep latency test (MSLT) and one of the following (i or ii): i. Mean sleep latency ≤ 8 minutes with evidence of two or more sleep-onset rapid eye movement periods (SOREMPs); ii. At least one SOREMP on MSLT and a SOREMP (less than 15 minutes) on the preceding overnight polysomnography (PSG); b. Lumbar puncture shows cerebrospinal fluid (CSF) hypocretin-1 level ≤ 110 pg/mL;
2. Failure of 2 of the following antidepressants, each used for ≥ 1 month, unless member’s age is ≥ 65, clinically significant adverse effects are experienced, or all are contraindicated: venlafaxine, fluoxetine, atomoxetine, clomipramine, protriptyline;
   *If member’s age is ≥ 65 years, tricyclic antidepressants are not required for trial.

3. Dose does not exceed both of the following (a and b): a. 35.6 mg per day; b. Two 17.8 mg tablets per day. Approval duration: Medicaid/HIM – 12 months
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   CLINICAL POLICY Pitolisant Commercial – 12 months or duration of request, whichever is less
   B. Narcolepsy with Excessive Daytime Sleepiness (must meet all):

4. Diagnosis of narcolepsy with EDS;
   2. Prescribed by or in consultation with a neurologist or sleep medicine specialist;
   3. Age ≥ 18 years;
   4. Documentation of both of the following (a and b): a. EDS associated with narcolepsy as confirmed by documented MSLT and one of the following (i or ii): i. Mean sleep latency ≤ 8 minutes with evidence of two or more SOREMPs; ii. At least one SOREMP on MSLT and a SOREMP (less than 15 minutes) on the preceding overnight PSG; b. Member has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months;
5. Failure of a 1-month trial of one of the following generic central nervous system stimulant-containing agent at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: amphetamine, dextroamphetamine, or methylphenidate;
   Prior authorization may be required for CNS stimulants
   6. Failure of a 1-month trial of armodafinil (Nuvigil®) or modafinil (Provigil®) at up to maximally indicated doses, unless clinically significant side effects are experienced or both are contraindicated;
   Prior authorization may be required for armodafinil/modafinil
   7. Failure of a 1-month trial of Sunosi™ at up to maximally indicated doses, unless contraindicated or clinically significant side effects are experienced; *Prior authorization may be required for Sunosi
6. If request is for concomitant therapy with other antinarcoleptic agents (e.g., Xyrem®, Xywav™, Sunosi), failure of combination therapy with modafinil or armodafinil and Sunosi, unless contraindicated or clinically significant adverse effects are experienced;
7. Dose does not exceed both of the following (a and b): a. 35.6 mg per day; b. Two 17.8 mg tablets per day. Approval duration: Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less
   C. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 7

   
   
   

   CLINICAL POLICY Pitolisant CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
10. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
11. Member is responding positively to therapy as evidenced by, but not limited to, improvement in any of the following parameters: reduction in frequency of cataplexy attacks, reported daytime improvements in wakefulness;
12. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 35.6 mg per day; b. Two 17.8 mg tablets per day. Approval duration:
    Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
    B. Other diagnoses/indications (must meet 1 or 2):
13. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

14. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
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    CLINICAL POLICY Pitolisant III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CNS: central nervous system EDS: excessive daytime sleepiness FDA: Food and Drug Administration IR: immediate-release MSLT: multiple sleep latency test PSG: polysomnography SOREMP: sleep-onset rapid eye movement period Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Cataplexy venlafaxine (Effexor ® † ) 75–150 mg PO BID, or 75–150 mg (extended release) PO QAM
    375 mg/day (IR tablets);
    225 mg/day (extended release)
    80 mg/day
    250 mg/day
    60 mg/day
    100 mg/day
    fluoxetine (Prozac ® † ) clomipramine (Anafranil ® † ) protriptyline (Vivactil ® † ) ® † ) atomoxetine (Strattera Excessive Daytime Sleepiness amphetamine/ dextroamphetamine (Adderall®) dextroamphetamine (Dexedrine®, ProCentra®,
    Spansule®, Zenzedi®) amphetamine (Evekeo®) methylphenidate (Ritalin®
    (LA, SR), Concerta®, Metadate® (CD, ER), Methylin® (ER), Daytrana®) armodafinil (Nuvigil®) modafinil (Provigil®) 20 to 80 mg PO QAM
    10 to 150 mg PO as a single dose every morning or in divided doses
    5 to 60 mg PO as a single dose every morning or in divided doses
    40–60 mg PO QD
    5 to 60 mg PO QD in divided doses 60 mg/day Dosing varies; 10 to 60 mg PO divided 2 to 3 times daily 30 to 45 min before meals 60 mg/day 150 mg PO QD in the morning 200 mg PO QD in the morning 250 mg/day 400 mg/day Page 4 of 7

    CLINICAL POLICY Pitolisant Drug Name Dosing Regimen Sunosi™ (solriamfetol) Initiate at 75 mg PO once a day; dose may be doubled at intervals of at least 3 days Dose Limit/ Maximum Dose 150 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *Non-indication specific (maximum dose for the drug) †Off-label indication Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity, severe hepatic impairment • Boxed warning(s): none reported V. Dosage and Administration
    Indication Dosing Regimen Narcolepsy Dose range is 17.8 to 35.6 mg PO once daily in the morning upon wakening. Titrate dosage as follows: • Week 1: Initiate with a dosage of 8.9 mg once daily • Week 2: Increase dosage to 17.8 mg once daily • Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily VI. Product Availability
    Tablets: 4.45 mg, 17.8 mg Maximum Dose 35.6 mg/day VII.