Glucagon-like peptide-1 (GLP-1) Agonists Drug Class Prior Authorization Protocol

Transcription

1 Glucagon-like peptide-1 (GLP-1) Agonists 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: Adlyxin (lixisenatide), Bydureon (exenatide), Byetta (exenatide), Ozempic (semaglutide), Soliqua (lixisenatide-insulin glargine), Tanzeum (albiglutide), Trulicity (dulaglutide), Victoza (liraglutide) 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: Adlyxin, Bydureon, Byetta, Ozempic, Soliqua, Tanzeum, Trulicity, Victoza 1. Diagnosis: Diabetes Mellitus Type II Criteria: Must meet 1 of the following requirements: a. Documentation of all of the following: i. Failure or clinically significant adverse effects to all of the following requirements: Metformin One additional oral formulary alternatives (e.g. sulfonylurea, pioglitazone, etc.) Insulin therapy (e.g. Lantus) ii. Documented HbA1c greater than 7 percent after 3 months (90 consecutive days) of optimal therapy with the tried alternatives. b. Documentation of all of the following:

2 Specialist: N/A i. BMI of 30 or greater ii. Failure or clinically significant adverse effects to all of the following requirements: Metformin One additional formulary alternatives (e.g. sulfonylurea, pioglitazone, etc.) iii. Documented HbA1c greater than 7 percent after 3 months (90 consecutive days) of optimal therapy with the tried alternatives Quantity Limit: a. Adlyxin: 6mL per month (30 days) b. Bydureon, Tanzeum: 4 pens per 28 days c. Byetta: 1 pen per month (30 days) d. Ozempic: 3 ml per 28 days e. Trulicity: 2mL per 28 days f. Victoza: 9mL per 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

4

5 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% 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. Cardiovascular Outcomes Trials The empagliflozin and liraglutide trials demonstrated significant reductions in cardiovascular death. Exenatide once-weekly did not have statistically significant reductions in major adverse cardiovascular events or cardiovascular mortality but did have a significant reduction in all-cause mortality. In contrast, other GLP-1 receptor agonists have not shown similar reductions in cardiovascular events. Whether the benefits of GLP-1 receptor agonists are a class effect remains to be definitely established. For patients with type 2 diabetes who have ASCVD, on lifestyle and metformin therapy, it is recommended to incorporate an agent with strong evidence for cardiovascular risk

6 reduction especially those with proven benefit on both major adverse cardiovascular events and cardiovascular death after consideration of drug-specific patient factors. Combination Injection Therapy Studies have demonstrated the non-inferiority of basal insulin plus a single injection of rapid-acting insulin at the largest meal relative to basal insulin plus a GLP-1 receptor agonist relative to two daily injections of premixed insulin. Basal insulin plus GLP-1 receptor agonists are associated with less hypoglycemia and with weight loss instead of weight gain but may be less tolerable and have a greater cost. In November 2016, the FDA approved two different once-daily fixed-dual combination products containing basal insulin plus a GLP-1 receptor agonists: insulin glargine plus lixisenatide and insulin delgudec plus liraglutide. Obesity Management for the Treatment of Type 2 Diabetes When choosing glucose-lowering medications for overweight or obese patients with type 2 diabetes, consider their effect on weight. Whenever possible, minimize the medications for comorbid conditions that are associated with weight gain. Weight loss medications may be effective as adjuncts to diet, physical activity, and behavioral counseling for selected patients with type 2 diabetes and BMI 27 kg/m 2. Potential benefits must be weighed against the potential risks of the medications. If a patient s response to weight loss medication is <5% weight loss after 3 months or if there are any safety or tolerability issues at any time, the medication should be discontinued and alternative medications or treatment approaches should be considered American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm GLP-1 agonists have robust A1C-lowering properties, are usually associated with weight loss and BP reductions, and are available in several formulations. In the LEADER trial, liraglutide significantly reduced the risk of nephropathy and of death from any and from cardiovascular causes, and liraglutide recently received FDA approval to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in adults with T2D and established cardiovascular disease. The risk of hypoglycemia with GLP-1 receptor agonists is low, and they reduce fluctuation in both fasting and postprandial glucose levels. GLP-1 agonist should not be used in patients with personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2. Exenatide should not be used if creatinine clearance is <30 ml/min. No dose adjustment is required for liraglutide, albiglutide or dulaglutide in CKD stages 2 and 3, although all GLP1 receptor agonists are currently contraindicated in stages 4 and 5 CKD.

7 No studies have confirmed that incretin agents cause pancreatitis; however, GLP-1 receptor agonists should be used cautiously if at all in patients with a history of pancreatitis and discontinued if acute pancreatitis develops. Use in patients with gastroparesis or severe gastroesophageal reflux disease requires careful monitoring and dose adjustment American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm

8 2017 Recent Major Changes in FDA Package Insert: Victoza (liraglutide) o FDA new indication: 08/25/2017 Risk reduction of major cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke) in adults with type 2 diabetes and established cardiovascular disease o Contraindication Personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2 Prior serious hypersensitivity reaction to Victoza or any of the product components o Warnings and Precautions Pancreatitis: discontinue if pancreatitis is suspected. Do not restart if pancreatitis is confirmed Hypersensitivity: discontinue Victoza and seek medical advice Acute Gallbladder Disease: if cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated Tanzeum (albiglutide) o Contraindications Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 Prior serious hypersensitivity reaction to albiglutide or any of the product components o Warnings and Precautions Hypersensitivity Reactions: discontinue Tanzeum and seek medical advice Trulicity (dulaglutide) o Warnings and Precaution: Hypersensitivity Reactions: discontinue Trulicity, treat per standard of care, monitor until signs and symptoms resolve. Do not use in patients with previous hypersensitivity to Trulicity Use caution in patient with history of anaphylaxis and angioedema with other GLP-1 RA due to unknown anaphylaxis with Trulicity 2017 Agent Discontinuation Report per Manufacture: Tanzeum (albuglutide) o GlaxoSmithKline (GSK) announced plans to discontinue manufacturing and sale of Tanzeum (albuglutide) by July 2018

9 U.S. Food & Drug Administration Drug Safety Communication: Possible Increased Risk of Pancreatitis and Pre-Cancerous Findings of the Pancreas from Incretin Mimetic Drugs for Type 2 Diabetes 2013 The Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warning about the risk of acute pancreatitis. Further, FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer. References: 1. Byetta (exenatide injection solution) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Victoza (liraglutide injection solution) [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; Bydureon (exenatide injection suspension, extended release) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Tanzeum (albiglutide injection powder for solution) [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; TANZEUM (albulutide) Discontinuation Q&A GSK group of companies RO July Trulicity (dulaglutide injection solution) [package insert]. Indianapolis, IN: Eli Lilly and Company; Blevins T, Pullman J, Malloy J et al. J Clin Endocrinol Metab 2011 May; 96(5): Wysham C, Blevins T, Arakaki R et al. Diabetes Care 2014 Aug; 37(8): Buse JB, Rosenstock J, Sesti G, et al. Lancet 2009; 374(9683): Dungan KM, Povedano ST, Forst TG et al. Lancet 2014; 384: 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