GLP-1 (glucagon-like peptide-1) Agonists (Byetta, Bydureon, Tanzeum, Trulicity, Victoza ) Step Therapy and Quantity Limit Criteria Program Summary

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1 OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) s (Byetta/exenatide, Bydureon/ exenatide extended-release, Tanzeum/albiglutide, Trulicity/dulaglutide, and Victoza/liraglutide) Step Therapy (ST) program is to ensure appropriate selection of patients based on product labeling, and/or clinical guidelines, and/or clinical studies. Appropriate patients for exenatide or liraglutide therapy are those who are concurrently receiving or have tried metformin, a sulfonylurea, an oral combination product containing metformin or a sulfonylurea, or insulin. The step edit allows continuation of therapy when patients have been receiving albiglutide, dulaglutide, exenatide or liraglutide. Patients without prerequisite agents in claims history or those who are unable to take a prerequisite agent due to documented intolerance, FDA labeled contraindication, or hypersensitivity will be reviewed when patient-specific documentation has been provided. TARGET DRUGS Byetta (exenatide) Bydureon (exenatide extended-release) Tanzeum (albiglutide) Trulicity (dulaglutide) Victoza (liraglutide) GLP-1 (glucagon-like peptide-1) s (Byetta, Bydureon, Tanzeum, Trulicity, Victoza ) Step Therapy and Quantity Limit Criteria Program Summary Commercial and Health Insurance Marketplace formularies target all agents listed in the program. For GenPlus formulary the target is Victoza. All other agents are non-formulary. PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Byetta, Bydureon, Tanzeum, Trulicity, or Victoza will be approved when ONE of the following is met: 1. The patient s medication history includes one or more of the following antidiabetic agents; metformin, sulfonylurea, any combination with metformin or sulfonylurea, or insulin in the past 90 days OR 2. There is documentation that the patient is currently using the requested medication, Byetta, Bydureon, Tanzeum, Trulicity, or Victoza OR 3. The prescriber states the patient is using the requested medication, Byetta, Bydureon, Tanzeum, Trulicity, or Victoza AND is at risk if therapy is changed OR 4. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one of the following antidiabetic classes: metformin, sulfonylurea, or insulin Length of approval: 12 months NOTE: If Quantity Limit program also applies, please refer to Quantity Limit documents. AL_PS_GLP1_ST_QL_ProgSum_AR0116 Page 1 of 5

2 FDA APPROVED INDICATIONS AND DOSAGE 1,2,5,7,8 GLP-1 Byetta (exenatide) Injection 250 mcg/ml in: 5 mcg per dose, 60 doses, 1.2 ml prefilled 10 mcg per dose, 60 doses, 2.4 ml prefilled Not a substitute for insulin. Should not be d in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Concurrent with prandial insulin has not been studied and cannot be recommended. Byetta has not been studied in patients with a Inject ly within 60 minutes prior to morning and evening meals (or before the 2 main meals of the day, approximately 6 hours or more apart). Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response. Bydureon (exenatide extendedrelease) Injection 2 mg vial in single-dose tray with syringe of diluent and needle; 4 trays per carton 2 mg singledose supplied in cartons with 4 s and needle Not a substitute for insulin. Should not be d in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Concurrent with insulin has not been studied and cannot be recommended. Bydureon has not been studied in patients with a Inject ly 2 mg once weekly at any time of day, with or without meals. The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before. Injection should be in the abdomen, thigh or upper arm. AL_PS_GLP1_ST_QL_ProgSum_AR0116 Page 2 of 5

3 GLP-1 Tanzeum (albiglutide for injection, for (SC) single-dose s for injection, in cartons of 4 syringes plus needles, in doses of 30 mg and 50 mg Trulicity (dulaglutide for SC injection) Single dose s and prefilled syringes Victoza (liraglutide [rdna origin] injection), Tanzeum is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis; it is not a substitute for insulin in these patients. Not recommended as firstline inadequately controlled on diet and exercise. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Use is not recommended in patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with prandial insulin. Not recommended as firstline inadequately controlled on diet and exercise Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not for patients with preexisting severe gastrointestinal disease. Has not been studied in combination with basal insulin Victoza is not a substitute for insulin. Victoza should not be d in patients with type 1 diabetes Administer once weekly at any time of day, without regard to meals. Initiate at 30 mg ly once weekly. Dose can be increased to 50 mg once weekly in patients requiring additional glycemic control. Inject ly in the abdomen, thigh, or upper arm. Administer once weekly at any time of day Inject ly in the abdomen, thigh, or upper arm Initiate at 0.75 mg ly once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control Administer once daily at any time of day. The injection site and timing can be changed AL_PS_GLP1_ST_QL_ProgSum_AR0116 Page 3 of 5

4 GLP-1 solution for (SC) Solution for injection, prefilled, multidose that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/ml, 3 ml) mellitus or for the treatment of or diabetic ketoacidosis, as it would not be effective in these settings. Concurrent with prandial insulin has not been studied. Not recommended as firstline inadequately controlled on diet and exercise. Has not been studied sufficiently in patients with a without dose adjustment. Initiate at 0.6 mg per day for one week. This dose is intended to reduce GI symptoms during initial titration, and is not effective for glycemic control. After 1 week, increase the dose to 1.2 mg. If 1.2 mg dose does not result in acceptable glycemic control, dose can be increased to 1.8 mg. When initiating, consider reducing the dose of concomitantlyadministered insulin secretagogues to reduce the risk of hypoglycemia. CLINICAL RATIONALE Guidelines 3,4 The American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommend lowering A1C to < 7.0% in most patients to reduce the incidence of microvascular disease. If implemented soon after the diagnosis of diabetes, A1Clowering is associated with long-term reduction in macrovascular disease. 3,6 To achieve and maintain this goal, the ADA/European Association for the Study of Diabetes (EASD) created a position statement for the management of hyperglycemia in type 2 This statement is considered a patient-centered approach. 6 Metformin is considered the optimal first-line drug unless there are prevalent contraindications. After metformin, there are limited data to guide therapy. Combination therapy with an additional 1-2 oral or injectable agents is reasonable, aiming to minimize side effects where possible. The choice is based on patients and drug characteristics, with the overriding goal of improving glycemic control while minimizing side effects. 6 The options given for two-drug combination therapy include combining metformin with either a sulfonylurea (SU), a thiazolidinediones (TZD), dipeptidyl peptidase 4 (DPP-4) inhibitors, a glucagon-like peptide 1 (GLP-1) receptor agonists, sodium-glucose co-transport 2 (SGLT-2) inhibitors, or insulin (usually basal, e.g., NPH, insulin glargine, or insulin detemir). SUs have a high efficacy in lowering A1C and have a moderate risk of hypoglycemia but ca weight gain and hypoglycemia. TZDs have high efficacy in lowering A1C and a low risk of hypoglycemia but ca weight gain, edema, heart failure, bone fracture, increased LDL (rosiglitazone) are major side effects. DPP-4 inhibitors have only an intermediate efficacy in lowering A1C, but have a low risk of hypoglycemia, and are neutral in terms of weight gain and major side effects are rare. SGLT-2 inhibitors have an intermediate efficacy in lowering A1C and a low risk of AL_PS_GLP1_ST_QL_ProgSum_AR0116 Page 4 of 5

5 hypoglycemia, but are associated with weight loss but ca genitourinary infections and dehydration. 6 The GLP-1 receptor agonists main advantage is weight loss, which is modest in most patients but may be significant in some. They do have a high efficacy in lowering A1C, a low risk of hypoglycemia, but naa and vomiting issues are the major side effect, particularly early in the course of treatment. Concerns regarding an increased risk of pancreatitis remain unresolved. C-cell hyperplasia and medullary thyroid tumors in animals have occurred. Insulin has the highest efficacy in decreasing A1C, but the disadvantages include both weight gain and hypoglycemia. Rapid-acting secretagogues (meglitinides) may be d in place of SUs. Other drugs may be d where available in selected patients but have modest efficacy and/or limiting side effects. 6 If the goal is not met with two-drug combination, a third agent can be added. The essential consideration is to agents with complementary mechanisms of action. Increasing the number of drugs heightens the potential for side effects and drug-drug interactions and negatively impacts patient adherence. Insulin is likely to be more effective than most other agents as a third-line therapy, especially when A1C is very high (e.g., > 9.0%). The therapeutic regimen should include some basal insulin before moving to more complex insulin strategies. 6 The statement notes that the injectable GLP-1 receptor agonists mimic the effects of endogenous GLP-1, thereby stimulating pancreatic insulin secretion in a glucose-dedent fashion, suppressing pancreatic glucagon output, slowing gastric emptying, and decreasing appetite. The guidelines do not prefer one GLP-1 receptor agonist over the other. 6 The American Association of Clinical Endocrinologists (AACE) consensus algorithm for diabetes management also recommends metformin as the cornerstone of monotherapy and combination therapy. The algorithm recommends GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, and alpha-glucosidase inhibitors as acceptable alternatives if metformin cannot be d first line and as second line agents to add to metformin. TZDs, sulfonylureas, and glinides may also be d, but these agents should be d with caution owing to the potential for weight gain, hypoglycemia, or other risks. The GLP-1-RA provides A1C lowering of 0.8 to 2.0% and weight loss ranges from 1-4 kg across studies. The risk of hypoglycemia is low when d as monotherapy or with metformin or with other low-risk medications but increases when d with SUs. Triple therapy may be d if A1C is not controlled by dual therapy. The AACE consensus algorithm does not prefer one GLP-1-RA over another. 4 REFERENCES 1. Byetta prescribing information. AstraZeneca Pharmaceuticals, Inc. March Victoza prescribing information. Novo Nordisk A/S. March American Diabetes Association. Standards of medical care in diabetes Diabetes Care 2015; 38(Supp 1): S1-S Handelsman Y, Bloomgarden ZT, Grunberger G et al. American Association of Clinical Endocrinology- clinical practice guidelines for developing a diabetes mellitus comprehensive care plan Endocrin Pract 2015; 21 (Suppl 1): Bydureon prescribing information. AstraZeneca Pharmaceuticals, Inc. September Inzucchi SE, Bergenstal RM, B JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: Tanzeum prescribing information. GlaxoSmithKline LLC. July Trulicity prescribing information. Eli Lilly and Company. July AL_PS_GLP1_ST_QL_ProgSum_AR0116 Page 5 of 5