SUNOSI, Solriamfetol HCl Form

Solriamfetol (Sunosi™) is a wakefulness-promoting agent. FDA Approved Indication(s) Sunosi is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Limitation(s) of use: Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating Sunosi for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities. 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 Sunosi 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 ≥ 18 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 or modafinil at up to maximally indicated doses, unless clinically significant side effects are experienced or both are contraindicated; *Prior authorization may be required for armodafinil and modafinil

6. Dose does not exceed both of the following (a and b): a. 150 mg per day; b. 1 tablet per day. Approval duration: Page 1 of 6

   CLINICAL POLICY Solriamfetol Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less B. Obstructive Sleep Apnea (must meet all):

   1. Diagnosis of OSA;
7. Age ≥ 18 years;
8. Documented evidence of residual sleepiness despite compliant CPAP use as monotherapy for at least 1 month;
   4. Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses, unless clinically significant side effects are experienced or both are contraindicated; *Prior authorization may be required for armodafinil and modafinil
9. Dose does not exceed both of the following (a and b): a. 150 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. 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: 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);

10. Member is responding positively to therapy; Page 2 of 6

    CLINICAL POLICY Solriamfetol

    3. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 150 mg per day; b. 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):
    4. 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
    5. 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 CNS: central nervous system FDA: Food and Drug Administration MAOI: monoamine oxidase inhibitor OSA: obstructive sleep apnea 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/ Narcolepsy Page 3 of 6

    CLINICAL POLICY Solriamfetol Drug Name Dosing Regimen Dose Limit/ Maximum Dose ) dextroamphetamine (Adderall®) dextroamphetamine (Dexedrine®, ProCentra®,
    Zenzedi® amphetamine (Evekeo®) methylphenidate (Ritalin®
    LA or SR, Concerta®, Metadate® CD or ER, Methylin® ER, Daytrana®) armodafinil (Nuvigil®) modafinil (Provigil®) 5 to 60 mg/day PO in divided doses Narcolepsy Dosing varies; 10-60 mg PO divided 2 to 3 times daily 30-45 min before meals 60 mg/day Narcolepsy/OSA 150 mg PO once a day in the morning Narcolepsy/OSA 200 mg PO once a day in the morning 250 mg/day 400 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant treatment with MAOIs, or within 14 days following discontinuation of MAOI • Boxed warning(s): none reported V. Dosage and Administration
    Indication Dosing Regimen Narcolepsy OSA Initiate at 75 mg PO once a day; dose may be doubled at intervals of at least 3 days
    Initiate at 37.5 mg PO once a day; dose may be doubled at intervals of at least 3 days Maximum Dose 150 mg/day 150 mg/day VI. Product Availability
    Tablets: 75 mg, 150 mg VII.