SYMLIN, Pramlintide Acetate Form

Pramlintide (Symlin®) is an amylin analog. FDA Approved Indication(s) Symlin is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. 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 Symlin is 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. Prescribed by or in consultation with an endocrinologist;
   3. Age ≥ 18 years;
   4. Member meets one of the following (a or b): a. Failure of three or more daily mealtime insulin (e.g., Apidra®, Humalog®, Humulin® N, Humulin® R, Novolog®) injections, each used for ≥ 3 months, unless clinically significant adverse effects are experienced or all are contraindicated; b. Currently using insulin pump;
2. Dose does not exceed one of the following (a or b): a. For type 1 diabetes: 60 mcg prior to each major meal;
   b. For type 2 diabetes: 120 mcg prior to each major meal. Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to member’s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

3. 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): Page 1 of 6

   CLINICAL POLICY Pramlintide 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

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 of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Diabetes Mellitus (must meet all):
5. 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);
6. Member is responding positively to therapy as evidenced by reduction in HbA1c at end of initial authorization period;
7. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. For type 1 diabetes: 60 mcg prior to each major meal;
   b. For type 2 diabetes: 120 mcg prior to each major meal. Approval duration:
   Medicaid/HIM – 12 months Commercial – 6 months or to member’s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
8. 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

9. 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 Page 2 of 6

   CLINICAL POLICY Pramlintide 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 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 Apidra (insulin glulisine) Individualize dosage Humalog (insulin lispro) 0.5 to 1 U/kg SC daily
   Humulin R (regular insulin human) 0.5 to 1 U/kg SC daily Humulin N (NPH human isophane) 0.5 to 1 U/kg SC daily Novolog (insulin aspart) 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. Individualize dosage Dose Limit/ Maximum Dose Individualize dosage Individualize dosage Individualize dosage Individualize dosage Individualize dosage Appendix C: Contraindications/Boxed Warnings • Contraindication(s): prior serious hypersensitivity reaction to Symlin or its ingredients; hypoglycemia unawareness; confirmed gastroparesis • Boxed warning(s): severe hypoglycemia V. Dosage and Administration
   Indication Type 1 or type 2 diabetes Dosing Regimen 1 injection SC prior to each major meal (≥ 250 kcal or containing ≥ 30 g of carbohydrate) • Type 1 diabetes: start at 15 mcg • Type 2 diabetes: start at 60 mcg Maximum Dose Type 1: 60 mcg/injection Type 2: 120 mcg/injection VI. Product Availability
   • Disposable 1.5 mL multidose pen-injectors: 15 mcg, 30 mcg, 45 mcg, 60 mcg • Disposable 2.7 mL multidose pen-injectors: 60 mcg, 120 mcg Page 3 of 6

   CLINICAL POLICY Pramlintide VII.