Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Prior Authorization Protocol

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1 Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Jentadueto (linagliptin/metformin), Kombiglyze XR (saxagliptin/metformin), Onglyza (saxagliptin), Oseni (alogliptin/pioglitazone), Tradjenta (linagliptin) Formulary Alternatives: Acarbose, alogliptin, alogliptin-metformin, glimepiride, glipizide, glipizide-metformin, glipizide ER, glyburide, glyburide-metformin, Invokamet (canagliflozin/metformin), Invokamet XR (canagliflozin/metformin), Invokana (canagliflozin), Janumet (sitagliptin-metformin), Janumet XR (sitagliptin/metformin), Januvia (sitagliptin), metformin, metformin ER, pioglitazone Criteria: A. Drugs: Jentadueto, Kombiglyze XR, Onglyza, Tradjenta 1. Diagnosis: Diabetes Mellitus Type II Criteria: Must meet all of the following requirements: a. Failure or clinically significant adverse effects to all of the following: i. Metformin. ii. One of the formulary DPP-4 inhibitor products (e.g. alogliptin, alogliptinmetformin, Januvia, Janumet). iii. One additional oral formulary alternatives (e.g. sulfonylurea, pioglitazone, etc.).

2 b. Documented HbA1c greater than 7 percent after 90 consecutive days of optimal therapy with the tried alternatives. Specialist: N/A Quantity Limit: a. Onglyza, Tradjenta: 30 tablets per month (30 days) b. Jentadueto, Jentadueto XR, Kombiglyze XR: 60 tablets per month (30 days) Duration of Therapy: 1 year (365 days) Reauthorization Criteria: Must meet all of the following requirements: a. Recent pharmacy claims within 6 months (180 days) of request. b. Confirmed stability or no disease progression. Duration of Reauthorization: 1 year (365 days)

3 Clinical Justification: 2018 American Diabetes Association: Standards of Medical Care in Diabetes Pharmacologic Therapy for Type 2 Diabetes Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacologic agent for the treatment of type 2 diabetes. Long-term use of metformin may be associated with biochemical vitamin B 12 deficiency, and periodic measurement of vitamin B 12 levels should be considered in metformintreated patients, especially in those with anemia or peripheral neuropathy. Consider initiating insulin therapy (with or without additional agents) in patients with newly diagnosed type 2 diabetes who are symptomatic and/or have A1C 10% and/or blood glucose levels 300mg/dL. Consider initialing dual therapy in patients with newly diagnosed type 2 diabetes who have A1C 9%

4 In patients without atherosclerotic cardiovascular disease, if monotherapy or dual therapy does not achieve or maintain the A1C goal over 3 months, add an additional antihyperglycemic agent based on drug-specific and patient factors. A patient-centered approach should be used to guide the choice of pharmacologic agents. Considerations include efficacy, hypoglycemia risk, history of atherosclerotic cardiovascular disease, impact on weight, potential side effects, cost and patient preferences. In patients with type 2 diabetes and established atherosclerotic cardiovascular disease, antihyperglycemic therapy should begin with lifestyle management and metformin and subsequently incorporate an agent proven to reduce major adverse cardiovascular events and cardiovascular mortality (currently empagliflozin and liraglutide), after considering drug-specific and patient factors. (Level A level of evidence) Continuous re-evaluation of the medication regimen and adjustment as needed to incorporate patient factors and regimen complexity is recommended. In patients with type 2 diabetes and established atherosclerotic cardiovascular disease, after lifestyle management and metformin, the antihyperglycemic agent canagliflozin may be considered to reduce major adverse cardiovascular events, based on drug-specific and patient factors. (Level C level of evidence) For patients with type 2 diabetes who are not achieving glycemia goals, drug intensification, including consideration of insulin therapy, should not be delayed. Metformin should be continued when used in combination with other agents, including insulin, if not contraindicated and if tolerated American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm Dipeptidyl peptidase 4 (DPP4) inhibitors exert antihyperglycemic effects by inhibiting DPP4 and thereby enhancing levels of GLP1 and other incretin hormones. This action stimulates glucose-dependent insulin synthesis and secretion and suppresses glucagon secretion. DPP4 inhibitors have modest A1C-lowering properties; are weight-neutral; and are available in combination tablets with metformin, and SGLT2 inhibitor and a TZD. The risk of hypoglycemia is low. The DPP4 inhibitors, except linagliptin, are excreted by the kidneys; therefore, dose adjustments are advisable for patients with renal dysfunction. These agents should be used with caution in patients with a history of pancreatitis (and stopped if pancreatitis occurs), although a causative association has not been established. DPP4 inhibitors have been shown to have neutral effects on cardiovascular outcomes. An increased risk of heart failure with saxagliptin and alogliptin was found in the respective cardiovascular outcome trials.

5 2018 American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm FDA Drug Safety Communication: Diabetes Medications Containing Saxagliptin and Alogliptin - Risk of Heart Failure (April 2016) An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue FDA recommendation: Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

6 References: 1. Zannad F, Cannon CP, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet May; 385(9982): Epub 2015 Mar Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and heart failure: A meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2014; 24: Li L, Li S, et al. Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systemic review and meta-analysis of randomised and observational studies. BMJ. 2016; 352:i Weir DL, AcAlister FA, et al. Stiagliptin Use in Patients With Diabetes and Heart Failure. JACC: Heart Failure December; 6(2): Green JB, et al. "Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes". The New England Journal of Medicine (3): The FDA Safety Information and Adverse Event Reporting Program. Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication Risk of Heart Failure. Available at: Products/ucm htm. Accessed January 15, Facts and Comparison, Dipeptidyl peptidase-4 inhibitors, Accessed February 01, Garber, AJ, Abrahamson MJ, et al. Endocrine Practice, Vol 24(1), January American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care, January 2018, Volume 41, Supplement 1. Change Control Date Change 02/21/2018 Updated 2018 ADA and AACE Guidance

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