Ramelteon (Rozerem) Form

Ramelteon (Rozerem®) is a melatonin receptor agonist. FDA Approved Indication(s) Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. 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 Rozerem 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 zolpidem or zolpidem CR, unless member meets one of the following (a, b or c):
   a. Age ≥ 65 years; b. Contraindicated or clinically significant adverse effects are experienced; c. Member has a previous history of substance abuse;

   4. For brand Rozerem requests, member must use generic ramelteon, unless contraindicated or clinically significant adverse effects are experienced;
   5. Dose does not exceed 8 mg (1 tablet) per day. Approval duration:
      Medicaid – 6 months Commercial – 12 months or duration of request, whichever is less B. 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: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Ramelteon
   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 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 and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Insomnia (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);
4. Member is responding positively to therapy;

5. For brand Rozerem requests, member must use generic ramelteon, unless contraindicated or clinically significant adverse effects are experienced;

   4. If request is for a dose increase, new dose does not exceed 8 mg (1 tablet) per day. Approval duration:
      Medicaid – 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 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 and CP.PMN.16 for Medicaid; or
   6. 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 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 and CP.PMN.53 for Medicaid, or evidence of coverage documents. Page 2 of 5

   CLINICAL POLICY Ramelteon
   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.
   . Drug Name Dosing Regimen zolpidem (Ambien®) Adults: 5-10 mg PO HS PRN Elderly: 5 mg PO HS PRN HS PRN Adults: 6.25-12.5 mg PO QHS Elderly: 6.25 mg PO HS PRN zolpidem extended- release (Ambien CR®) 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. 12.5 mg/day Dose Limit/ Maximum Dose 10 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o In patients who develop angioedema after treatment with Rozerem (should not be re- challenged) o In conjunction with fluvoxamine (Luvox®) • Boxed warning(s): none reported V. Dosage and Administration
   Indication Insomnia Dosing Regimen 8 mg PO HS PRN Maximum Dose 8 mg/day VI. Product Availability
   Tablet: 8 mg VII.