NUVIGIL, Armodafinil Form

Armodafinil (Nuvigil®) is a wakefulness-promoting agent. FDA Approved Indication(s) Nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitation(s) of use: In OSA, Nuvigil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Nuvigil for excessive sleepiness. 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 armodafinil is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Narcolepsy (must meet all):

1. Diagnosis of narcolepsy;
2. Prescribed by or in consultation with a neurologist or sleep medicine specialist;
3. Age ≥ 17 years;
4. Member must use generic armodafinil, unless contraindicated or clinically significant adverse effects are experienced;
   
   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

5. Dose does not exceed both of the following (a and b): a. 250 mg per day; b. 1 tablet per day. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less Page 1 of 7

   CLINICAL POLICY Armodafinil B. Obstructive Sleep Apnea/Hypopnea Syndrome (must meet all):

   1. Diagnosis of OSA;
6. Age ≥ 17 years;
7. Member must use generic armodafinil, unless contraindicated or clinically significant adverse effects are experienced;
   4. Documented evidence of residual sleepiness despite compliant CPAP use as monotherapy;
   5. Dose does not exceed both of the following (a and b): a. 250 mg per day; b. 1 tablet per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
      C. Shift Work Disorder (SWD) (must meet all):
   6. Diagnosis of SWD;
8. Age ≥ 17 years;
9. Member must use generic armodafinil, unless contraindicated or clinically significant adverse effects are experienced;
   4. Dose does not exceed both of the following (a and b): a. 150 mg per day; b. 1 tablet per day. Approval duration: 12 months D. Fatigue Associated with Multiple Sclerosis (MS) (off-label) (must meet all):
   5. Diagnosis of MS-associated fatigue;
10. Age ≥ 17 years;

11. Failure of 200 mg/day of amantadine and ≥ 10 mg/day of methylphenidate, unless contraindicated or clinically significant adverse effects are experienced;

    4. Member must use generic armodafinil, unless contraindicated or clinically significant adverse effects are experienced;
    5. Dose does not exceed both of the following (a and b): a. 250 mg per day; b. 1 tablet per day. Approval duration:
       Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
       E. Other diagnoses/indications (must meet 1 or 2):
    6. 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: Page 2 of 7

    CLINICAL POLICY Armodafinil 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

    2. 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):
    3. 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);
12. Member is responding positively to therapy;

13. Member must use generic armodafinil, unless contraindicated or clinically significant adverse effects are experienced;

    4. If request is for a dose increase, new dose does not exceed: a. Narcolepsy, OSA, and MS-associated fatigue (both i and ii):
       i. 250 mg per day; ii. 1 tablet per day; b. SWD (both i and ii):
       i. 150 mg per day; ii. 1 tablet 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):
    5. 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 Page 3 of 7

    CLINICAL POLICY Armodafinil

    2. 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.
       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 CPAP: continuous positive airway pressure
       FDA: Food and Drug Administration IR: immediate-release MS: multiple sclerosis OSA: obstructive sleep apnea
       SWD: shift work disorder 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 Narcolepsy 5 to 60 mg/day PO in divided doses Dose Limit/ Maximum Dose 60 mg/day amphetamine (Evekeo®) amphetamine/ dextroamphetamine (Adderall®) dextroamphetamine ER (Dexedrine® Spansule®) dextroamphetamine IR (Zenzedi®, Procentra®) methylphenidate (Ritalin® LA or SR, Concerta®, Metadate® CD or ER, Methylin® ER, Daytrana®) amantadine (Symmetrel®) Narcolepsy Dosing varies; 10-60 mg PO divided 2 to 3 times daily 30-45 min before meals 60 mg/day MS-related fatigue† Usual effective dose: 10-20 mg PO QAM and noon MS-associated fatigue† 200 mg PO once daily or 100 mg PO twice daily 200 mg/day Page 4 of 7

    CLINICAL POLICY Armodafinil 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. †Off-label indication V. Dosage and Administration
    Indication Narcolepsy
    OSA SWD MS-associated fatigue (off-label) Dosing Regimen 150 mg to 250 mg PO once a day Maximum Dose 250 mg/day 150 mg PO once a day as a single dose approximately 1 hour prior to the start of work shift 150 mg PO every morning 150 mg/day 250 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to modafinil or armodafinil • Boxed warning(s): none reported VI. Product Availability
    Tablets: 50 mg, 150 mg, 200 mg, and 250 mg VII.