TRESIBA, Insulin Degludec Form

Insulin glargine (Rezvoglar™, Semglee®, Toujeo®) is a long-acting human insulin analog. FDA Approved Indication(s) Rezvoglar and Semglee are indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Toujeo is indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. Limitation(s) of use: Rezvoglar, Semglee and Toujeo are not recommended for treating diabetic ketoacidosis. 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 Rezvoglar, Semglee and Toujeo are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Diabetes Mellitus (must meet all):

1. Diagnosis of type 1 or type 2 diabetes mellitus;
   2. Age ≥ 6 years;
   3. Failure of Basaglar® and unbranded Tresiba® (insulin degludec, NDC 73070-0403-15, 73070-0503-15, or 73070-0400-11), unless clinically significant adverse effects are experienced, or all are contraindicated.
      Approval duration: 12 months
      B. Other diagnoses/indications (must meet 1 or 2):

2. 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; or Page 1 of 6

   CLINICAL POLICY Insulin Glargine 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; or

3. 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.
   II. Continued Therapy A. Diabetes Mellitus (must meet all):
4. 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);
   2. Member is responding positively to therapy.
      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; 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; 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: HIM.PA.154 for health insurance marketplace. 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 or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Page 2 of 6

   CLINICAL POLICY Insulin Glargine 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.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose Not applicable Basaglar® (insulin glargine) Type 1 diabetes mellitus: Initiation: Approximately one-third of the total daily insulin requirement administered SC QD
   insulin degludec (unbranded Tresiba®) Not applicable Type 2 diabetes mellitus: Initiation: 0.2 units/kg SC QD up to 10 units/day. Adjust dosage according to patient response Type 1 diabetes mellitus: Initiation: • Insulin-naïve: 1/3 to 1/2 of total daily insulin dose SC QD • Already on insulin: SC QD: o Adults: same unit dose as total daily long or intermediate-acting insulin unit dose o Pediatrics: 80% of total daily long or intermediate-acting insulin unit dose Type 2 diabetes mellitus: Initiation: • Insulin-naïve: 10 units SC QD • Already on insulin: SC QD: o Adults: same unit dose as total daily long or intermediate-acting insulin unit dose o Pediatrics: 80% of total daily long or intermediate-acting insulin unit dose 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): use during episodes of hypoglycemia, hypersensitivity to the requested product or one of its excipients • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name Insulin glargine (Toujeo) Indication Dosing Regimen Type 1 diabetes mellitus Initiation: • Insulin-naïve: 1/3 to 1/2 of total daily insulin dose SC QD • Already on insulin: SC QD: o Once-daily long or intermediate insulin: same unit dose as total daily long acting insulin unit Page 3 of 6 Maximum Dose Not applicable; dose is individualized and titrated based on metabolic needs, blood glucose monitoring results,

   CLINICAL POLICY Insulin Glargine Drug Name Indication Dosing Regimen dose. Expect higher daily dose of Toujeo will be needed to maintain the same level of glycemic control in patients on Lantus. o Twice-daily long or intermediate insulin: 80% of total daily long or intermediate- acting insulin unit dose Type 2 diabetes mellitus Initiation: • • Already on insulin: SC QD: Insulin-naïve: 0.2 units/kg SC QD o Once-daily long or intermediate insulin: same unit dose as total daily long acting insulin unit dose. Expect higher daily dose of Toujeo will be needed to maintain the same level of glycemic control in patients on Lantus. o Twice-daily long or intermediate insulin: 80% of total daily long or intermediate- acting insulin unit dose Initiation: Approximately one-third of the total daily insulin requirement administered SC QD Initiation: 0.2 units/kg SC QD or 10 units/day. Adjust dosage according to patient response Insulin glargine- yfgn (Semglee), Insulin glargine-aglr (Rezvoglar) Type 1 diabetes mellitus Type 2 diabetes mellitus VI. Product Availability
   Maximum Dose and glycemic control goal Not applicable; dose is individualized and titrated based on metabolic needs, blood glucose monitoring results, and glycemic control goal Not applicable Not applicable Drug Name Insulin glargine (Toujeo) Insulin glargine- yfgn (Semglee) Insulin glargine- aglr (Rezvoglar) Availability Single-patient-use prefilled pen 300 units/mL: 1.5 mL (Toujeo SoloStar), 3 mL (Toujeo Max SoloStar) • Multiple-dose vial: 10 mL containing 100 units/mL • Prefilled pen: 3 mL containing 100 units/mL KwikPen® prefilled pen: 3 mL containing 100 units/mL VII.