BELSOMRA, Suvorexant Form

Suvorexant (Belsomra®) is an orexin receptor antagonist. FDA Approved Indication(s) Belsomra is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Policy/Criteria Provider must submit documentation (including 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 Belsomra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Insomnia (must meet all):

1. Diagnosis of insomnia;
2. Age ≥ 18 years;
3. Failure of two preferred or formulary agents indicated for insomnia (see Appendix B for examples) at maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
   
   4. Dose does not exceed 20 mg (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

4. 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 Page 1 of 5

   CLINICAL POLICY Suvorexant of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Insomnia (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);
5. Member is responding positively to therapy;
6. If request is for a dose increase, new dose does not exceed 20 mg (1 tablet) per day. Approval duration: 12 months B. 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

7. 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 FDA: Food and Drug Administration 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.
   Page 2 of 5

   CLINICAL POLICY Suvorexant Drug Name Dosing Regimen Dose Limit/ Maximum Dose 2 mg/day Adults: 3 mg/day Elderly: 2 mg/day 8 mg/day 30 mg/day 1 mg PO HS PRN Adults: 1 mg – 3 mg PO HS PRN Elderly: 1 mg - 2 mg PO HS PRN estazolam eszopiclone (Lunesta®) ramelteon (Rozerem®) Adults: 8 mg PO HS PRN temazepam (Restoril®) Adults: 15 – 30 mg PO HS PRN Elderly: 7.5 – 15 mg PO HS PRN 0.25 mg PO HS PRN 10 mg PO HS PRN Adults: 6.25-12.5 mg PO HS PRN Elderly: 6.25 mg PO HS PRN 5 mg PO HS PRN triazolam (Halcion®) zaleplon (Sonata®) zolpidem CR
   (Ambien CR®) zolpidem IR (Ambien®) 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.
   Formulary status may differ based on line of business and health plan; verify formulary status prior to redirection. 0.5 mg/day 20 mg/day 12.5 mg/day 10 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): patients with narcolepsy • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen Insomnia 10 mg PO HS PRN If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg QD VI. Product Availability
   Tablets: 5 mg, 10 mg, 15 mg, 20 mg Maximum Dose 20 mg/day VII.