PROVIGIL, Modafinil Form

Modafinil (Provigil®) is a wakefulness-promoting agent. FDA Approved Indication(s) Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitation(s) of use: In OSA, Provigil 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 and during treatment with Provigil 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 modafinil 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. 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. Failure of a 1-month trial of armodafinil at up to maximally indicated doses, unless clinically significant side effects are experienced; *Prior authorization may be required for armodafinil
   6. Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced;
   7. Dose does not exceed both of the following (a and b): a. 400 mg per day; b. 2 tablets per day. Page 1 of 8

   CLINICAL POLICY Modafinil Approval duration: 12 months B. Obstructive Sleep Apnea/Hypopnea Syndrome (must meet all):

   1. Diagnosis of OSA;
5. Age ≥ 17 years;
6. Documented evidence of residual sleepiness despite compliant CPAP use as monotherapy;
   4. Failure of a 1-month trial of armodafinil at up to maximally indicated doses, unless clinically significant side effects are experienced;
      *Prior authorization may be required for armodafinil
   5. Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced;
   6. Dose does not exceed both of the following (a and b): a. 400 mg per day; b. 2 tablets per day. Approval duration: 12 months
      C. Shift Work Disorder (SWD) (must meet all):
   7. Diagnosis of SWD;
7. Age ≥ 17 years;
8. Failure of a 1-month trial of armodafinil at up to maximally indicated doses, unless clinically significant side effects are experienced;
   *Prior authorization may be required for armodafinil
   4. Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced;
   5. Dose does not exceed both of the following (a and b): a. 200 mg per day; b. 1 tablet per day. Approval duration: 12 months
      D. Fatigue Associated with Multiple Sclerosis (MS) (off-label) (must meet all):
   6. Diagnosis of MS-associated fatigue;
9. Age ≥ 17 years;

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

    4. Failure of a 1-month trial of armodafinil at up to maximally indicated doses, unless clinically significant side effects are experienced;
       *Prior authorization may be required for armodafinil
    5. Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced;
    6. Dose does not exceed both of the following (a and b): a. 400 mg per day; b. 2 tablets per day.
       Approval duration: 12 months
       Page 2 of 8

    CLINICAL POLICY Modafinil E. Other diagnoses/indications (must meet 1 or 2):

    1. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or
11. 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: 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):
    
    1. 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 modafinil, 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. 400 mg per day; ii. 2 tablets per day; b. SWD (both i and ii):
       i. 200 mg per day; ii. 1 tablet per day. Approval duration: 12 months
       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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or Page 3 of 8

    CLINICAL POLICY Modafinil

    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: 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 – 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 Dose Limit/ Maximum Dose 60 mg/day amphetamine (Evekeo®) amphetamine/ dextroamphetamine (Adderall®) Narcolepsy 5 to 60 mg/day PO in divided doses dextroamphetamine ER (Dexedrine® Spansule®) dextroamphetamine IR (Zenzedi®, Procentra®) methylphenidate (Ritalin® LA or SR, Concerta®, Metadate® CD or ER, Methylin® ER, Daytrana®) Narcolepsy Dosing varies; 10-60 mg PO divided 2 to 3 times daily 30-45 min before meals 60 mg/day amantadine (Symmetrel®) MS-related fatigue† Usual effective dose: 10-20 mg PO QAM and noon MS-related fatigue† 200 mg PO once daily or 100 mg PO twice daily 200 mg/day Page 4 of 8

    CLINICAL POLICY Modafinil Drug Name Dosing Regimen armodafinil (Nuvigil®)
    Narcolepsy and OSA 150 mg to 250 mg PO once a day SWD 150 mg PO once a day as a single dose approximately 1 hour prior to the start of work shift MS-related fatigue† 150 mg PO every morning Dose Limit/ Maximum Dose 250 mg/day for narcolepsy and OSA/HS; 150 mg/day for SWD 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 Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to modafinil or armodafinil • Boxed warning(s): none reported V. Dosage and Administration
    Indication Narcolepsy
    OSA SWD MS-associated fatigue (off- label) VI. Product Availability
    Tablets: 100 mg and 200 mg VII.