INSULIN UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: Insulin BRAND (generic) NAMES: Rapid-Acting Insulins NovoLog (insulin aspart)* Humalog (insulin lispro) Apidra (insulin glulisine) Afrezza (insulin human) Short Short-Acting Insulins Novolin R* Humulin R Humulin R U U-500 Intermediate-Acting Insulins Novolin N* Humulin N NPH-Regular Combinations Novolin 70/30* Humulin 70/30 NPH NPH-Lispro Combinations Humalog Mix 75/25 Humalog Mix 50/50 NPH – Novolog Combination NovoLog Mix 70/30* 70/30 *Preferred insulin products. FDA-APPROVED APPROVED INDICATIONS: Humalog (insulin lispro), NovoLog (insulin aspart) aspart), Apidra (insulin glulisine) • Treatment of patients with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus for the control of hyperglycemia. Humulin R, Novolin R • For the treatment of Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus inadequately managed by diet, exercise, and oral hypoglycemics. • For the treatment of gestational diabetes or for the treatment of patients with pre-existing pre diabetes mellitus (Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus) who are now pregnant: for pregnant patients with gestational gestational-onset diabetes not controlled by diet-therapy therapy alone. • For the treatment of diabetic ketoacidosis. • For the treatment of hyper-osmolar osmolar hyperglycemic state in patients with Type 2 Diabetes Mellitus. Humulin N, Novolin N • For the treatment of Type 1 Diabetes iabetes Mellitus or Type 2 Diabetes Mellitus inadequately managed manag by diet, exercise, and oral hypoglycemics. • For the treatment of gestational diabetes or for the treatment of patients with preexisting Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus who are now pregnant. Novolin 70/30, Humulin 70/30 • For the treatment of Type 1 Diabetes Mellitus or for Type 2 Diabetes Mellitus inadequately managed by diet, exercise, and oral hypoglycemics. Originated: January 2015 Page 1 Humalog Mix 75/25, Humalog Mix 50/50 • For the treatment of Type 1 Diabetes Mellitus or for Type 2 Diabetes Mellitus inadequately managed by diet, exercise, and oral hypoglycemics. NovoLog Mix 70/30 • Improve glycemic control in patients with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Afrezza • Improve glycemic control in patients with Diabetes Mellitus. COVERAGE AUTHORIZATION CRITERIA Nonpreferred insulin products may be eligible for coverage when: 1. If the request is for Humulin U-500 then: a. The patient is currently receiving Humulin U-500; OR b. The patient is not currently receiving Humulin U-500 and requires more than 200 units of insulin per day. 2. If the request is for Humalog Mix 50/50 then: a. The patient is currently receiving Humalog Mix 50/50 AND the prescriber states the patient is at risk of losing good control if switched to a different insulin; OR b. The patient is not currently receiving Humalog Mix 50/50 AND the prescriber states that the patient has tried and failed a preferred insulin mix (Novolin 70/30, NovoLog Mix 70/30). 3. If the request is for Afrezza, Apidra, Humalog, Humulin R, Humulin N, Humulin 70/30, and/or Humalog Mix 75/25 then: a. The patient has a documented adverse reaction, intolerance or FDA labeled contraindication to preferred insulin (Novolin, NovoLog) products. DOSAGE AND ADMINISTRATION: Dosing must be individualized. The total daily insulin requirement may vary and is usually between 0.5 and 1.0 unit/kg/day. REFERENCES: 1. 2. 3. 4. 5. Humalog (insulin lispro injection [rDNA origin] solution for subcutaneous injection). Eli Lilly and Company. November 2013. Novolog (insulin aspart [rDNA origin] injection) solution for subcutaneous use. Novo Nordisk, Inc. April 2014. Apidra (insulin glulisine [rDNA origin] injection) solution for injection. Sanofi-Aventis. May 2014. Humulin R (insulin human injection [rDNA origin]) solution for subcutaneous injection. Eli Lilly and Company. March 2013. Novolin R (human insulin injection [rDNA origin]). Novo Nordisk, Inc. March 2013. Originated: January 2015 Page 2 6. 7. 8. 9. 10. 11. 12. 13. Humulin N (insulin [rDNA origin] isophane suspension). Eli Lilly and Company. November 2013. Novolin N (human insulin isophane suspension injection) suspension. Novo Nordisk. March 2013. Novolin 70/30 (70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection, [rDNA]). Novo Nordisk. March 2013. Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection (rDNA origin). Eli Lilly and Company. November 2013. Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin). Eli Lilly and Company. November 2013. Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection [rDNA origin]). Eli Lilly and Company. November 2013. NovoLog 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection. Novo Nordisk Inc. March 2013. Afrezza (insulin human) Prescribing Information. MannKind Corporation. June 2014. Originated: January 2015 Page 3