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GLP-1 (Glucagon-Like Peptide-1) ® Agonists (Adlyxin™, Byetta , Bydureon™, Tanzeum™, Trulicity™, Victoza®)

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GLP-1 (Glucagon-Like Peptide-1) ® Agonists (Adlyxin™, Byetta , Bydureon™, Tanzeum™, Trulicity™, Victoza®) GLP-1 (glucagon-like peptide-1) ® Agonists (Adlyxin™, Byetta , Bydureon™, Tanzeum™, Trulicity™, Victoza®) Step Therapy and Quantity Limit Criteria Program Summary This program applies to Commercial, GenPlus and Health Insurance Marketplace formularies. OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) Agonists [Adlyxin (lixisenatide), 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 GLP-1 agonist therapy are those who are concurrently receiving or have tried an agent containing metformin or sulfonylurea, insulin, or insulin/GLP- 1. The step edit allows continuation of therapy when patient is currently receiving the requested agent. 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 AGENTS Adlyxin™ (lixisenatide) Byetta® (exenatide) Bydureon™ (exenatide extended-release) Tanzeum™ (albiglutide) Trulicity™ (dulaglutide) Victoza® (liraglutide) PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Target Agents will be approved when BOTH of the following are met: 1. The patient has a diagnosis of type 2 diabetes mellitus AND 2. ONE of the following: 1. The patient’s medication history includes one or more of the following antidiabetic agents; an agent containing metformin or sulfonylurea, insulin, or insulin/GLP-1 in the past 90 days OR 2. There is documentation that the patient is currently using the requested agent OR 3. The prescriber states the patient is using the requested agent 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 agents: metformin, sulfonylurea, or insulin Length of approval: 12 months NOTE: If Quantity Limit program also applies, please refer to Quantity Limit documents. This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case- by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) AL_CS_GLP1_ST_QL_ProgSum_AR0317_r0717 Page 1 of 7 © Copyright Prime Therapeutics LLC. 07/2017 All Rights Reserved information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients. Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment. AL_CS_GLP1_ST_QL_ProgSum_AR0317_r0717 Page 2 of 7 © Copyright Prime Therapeutics LLC. 07/2017 All Rights Reserved FDA APPROVED INDICATIONS AND DOSAGE1-6 GLP-1 Agonist Indication Important limitations for Dosage and use Administration Adlyxin Adjunct to diet and Adlyxin has not been Starting dose of 10 (lixisenatide) exercise to improve studied in patients with mcg subcutaneously glycemic control in chronic pancreatitis or a once daily for 14 days. Available as: adults with type 2 history of unexplained Increase the dose to Starter Pack: diabetes mellitus. pancreatitis. Consider the maintenance dose For treatment other antidiabetic of 20 mcg once daily initiation, 1 therapies in patients with a starting on Day 15. prefilled green history of pancreatitis pen of 10 mcg Adlyxin is not a substitute and 1 prefilled for insulin. Adlyxin is not burgundy pen of indicated for use in 20 mcg patients with type 1 diabetes mellitus or for Maintenance treatment of diabetic Pack: ketoacidosis 2 prefilled The concurrent use of burgundy pens Adlyxin with short acting of 20 mcg insulin has not been studied and is not recommended Adlyxin has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis Byetta Adjunct to diet and Not a substitute for insulin. Inject subcutaneously (exenatide) exercise to improve Should not be used in within 60 minutes prior Injection glycemic control in patients with type 1 to morning and adults with type 2 diabetes or for the evening meals (or Available as: diabetes mellitus. treatment of diabetic before the 2 main 250 mcg/mL in: ketoacidosis. meals of the day, 5 mcg per dose, Concurrent use with approximately 6 hours 60 doses, 1.2 prandial insulin has not or more apart). mL prefilled pen been studied and cannot Initiate at 5 mcg per be recommended. dose twice daily; 10 mcg per Byetta has not been increase to 10 mcg dose, 60 doses, studied in patients with a twice daily after 1 2.4 mL prefilled history of pancreatitis. month based on clinical pen Consider other antidiabetic response. therapies in patients with a history of pancreatitis. AL_CS_GLP1_ST_QL_ProgSum_AR0317_r0717 Page 3 of 7 © Copyright Prime Therapeutics LLC. 07/2017 All Rights Reserved GLP-1 Agonist Indication Important limitations for Dosage and use Administration Bydureon Adjunct to diet and Not a substitute for insulin. Inject subcutaneously (exenatide exercise to improve Should not be used in 2 mg once weekly at extended- glycemic control in patients with type 1 any time of day, with release) adults with type 2 diabetes or for the or without meals. The Injection diabetes mellitus. treatment of diabetic day of weekly ketoacidosis. administration can be Available as: 2 Concurrent use with insulin changed if necessary mg vial in has not been studied and as long as the last dose single-dose tray cannot be recommended. was administered 3 or with syringe of Bydureon has not been more days before. diluent and studied in patients with a Injection should be in needle; 4 trays history of pancreatitis. the abdomen, thigh or per carton Consider other antidiabetic upper arm. therapies in patients with a 2 mg single- history of pancreatitis. dose pen supplied in cartons with 4 pens and needle AL_CS_GLP1_ST_QL_ProgSum_AR0317_r0717 Page 4 of 7 © Copyright Prime Therapeutics LLC. 07/2017 All Rights Reserved GLP-1 Indication Important limitations for Dosage and Agonist use Administration Tanzeum Adjunct to diet and Tanzeum is not indicated in Administer once weekly (albiglutide for exercise to improve the treatment of patients at any time of day, injection, for glycemic control in with type 1 diabetes without regard to subcutaneous adults with type 2 mellitus or for the meals. (SC) use diabetes mellitus. treatment of patients with Initiate at 30 mg diabetic ketoacidosis; it is subcutaneously once Available as: not a substitute for insulin weekly. Dose can be single-dose in these patients. increased to 50 mg pens for Not recommended as first- once weekly in patients injection, in line therapy for patients requiring additional cartons of 4 inadequately controlled on glycemic control. syringes plus diet and exercise. Inject subcutaneously needles, in Has not been studied in in the abdomen, thigh, doses of 30 mg patients with a history of or upper arm. and 50 mg 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. Trulicity Adjunct to diet and Not recommended as first- Administer once weekly (dulaglutide for exercise to improve line therapy for patients at any time of day SC injection) glycemic control in inadequately Inject subcutaneously adults with type 2 controlled on diet and in the abdomen, thigh, Available as: diabetes mellitus. exercise or upper arm Single dose Has not been studied in Initiate at 0.75 mg pens and patients with a history of subcutaneously once prefilled pancreatitis. weekly. Dose can be syringes Consider another increased to 1.5 mg antidiabetic therapy once weekly for Not for treatment of type 1 additional glycemic diabetes mellitus or control diabetic ketoacidosis. Not for patients with pre- existing severe gastrointestinal disease. Has not been studied in combination with basal insulin Victoza Adjunct to diet and Victoza is not a substitute Administer once daily (liraglutide exercise to improve for insulin. Victoza should at any time of day. [rDNA origin] glycemic control in not be used in patients The injection site and injection), adults with type 2 with type 1 diabetes timing can be changed AL_CS_GLP1_ST_QL_ProgSum_AR0317_r0717 Page 5 of 7 © Copyright Prime Therapeutics LLC. 07/2017 All Rights Reserved GLP-1 Indication Important limitations for Dosage and Agonist use Administration solution for diabetes mellitus. mellitus or for
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