Drug: ACCUTANE - Magellan Health Services || TennCare Portal

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ENDOCRINE & METABOLIC AGENTS RECOMMENDATION Canagliflozin is currently the only available sodium-glucose co-transporter 2 (SGLT2) inhibitor and is FDA-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. While results from clinical trials demonstrate that canagliflozin is an efficacious agent in reducing HbA 1 C, PPG, and FPG, this agent is also associated with a number of adverse effects. The 2013 guidelines from the AACE suggest SGLT-2 inhibitors as a fifth, fourth, and third choice in monotherapy, dual therapy, and triple therapy, respectively for glycemic control. The guidelines also warn prescribers to use SGLT-2 inhibitors with caution as there are other antihyperglycemic agents with fewer adverse events and/or even possible benefits. Due to the fact that SGLT-2 inhibitors are not considered first line therapy and other antihyperglycemic agents are available with fewer adverse events, it is recommended that SGLT-2 inhibitors should be subject to prior authorization. COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION PREFERRED N/A NEW: SGLT2 INHIBITOR NON-PREFERRED ® PA, QL INVOKANA Class Prior Authorization Criteria for SGLT2 INHIBITORS Will be approved if ALL of the following are true: Diagnosis of Diabetes Type II, AND Patient’s HbA1c level is greater than 6.5 (for initial approval), AND Patient has tried and failed metformin or a metformin containing product (unless, recipient has an adverse reaction, intolerance or contraindication to metformin), AND Patient has tried and failed at least ONE agent from any 2 of the following classes: o DPP4 Inhibitor o Sulfonylurea o Incretin Mimetic o Insulin o TZD o Alpha-glucosidase inhibitor o Meglitinide COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION Quantity Limits Invokana ® 1/day COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION References 1. Facts and Comparisons on-line. Version 4.0; Wolters Kluwer Health, Inc.; 2013. Accessed July, 2013. 2. Thompson MICROMEDEX on-line © 1974-2013. Accessed July, 2013. 3. Magellan Medicaid Administration. Invokana New Drug Update. April, 2013. 4. Invokana [package insert]. Titusville, NJ; Janssen Pharmaceuticals; March 2013. 5. American Association of Clinical Endocrinologists. AACE Comprehensive Diabetes Management Algorithm. Endocrine Practice. 2013; 19(2): 327-336. Available at: http://aace.metapress.com/content/a38267720403k242/p=def7091b7a8144b4905138a3 539d2ce5&pi=21. Accessed May 16, 2013. Page 6 of 14 August 13, 2013 Tennessee PAC
GASTROINTESTINAL AGENTS BACKGROUND NEW: DICLEGIS Doxylamine succinate/pyridoxine HCL is a fixed combination of an anticholinergic antihistamine and a vitamin B6 analog indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The most common adverse effect occurring in ≥ five percent of patients reported was somnolence (14.3 percent). In post marketing, adverse effects that occurred include dyspnea, palpitations, tachycardia, vertigo visual disturbances, abdominal distension, anxiety, dysuria and rash. o Due to the anticholinergic antihistamine component it is not recommended to be used with central nervous system depressants including alcohol and should be used with caution in patients with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction. o An extended anticholinergic effect may occur with concurrent use of an MOA inhibitor and doxylamine therefore it is not recommended. It should also not be administered with alcohol or other central nervous system (CNS) depressants. Nausea and vomiting of pregnancy symptoms was evaluated in a randomized, multicenter, double blind, placebo controlled study. With an intent to treat, the symptoms of a total of 256 pregnant patients, 18 years and older, with a seven to 14 week gestation (median nine weeks of gestation) were randomized to receive Diclegis (n=131) or placebo (n=125) for 14 days. Nausea and vomiting symptoms were evaluated daily using the pregnancy unique quantification of emesis (PUQE) scale with the primary efficacy endpoint being measured from baseline to Day 15. At baseline, the mean PUQE score was 9 for Diclegis patients and 8.8 for placebo patients. On Day 15, Diclegis demonstrated a 0.7 mean decrease in PUQE score compared to placebo (–4.8 ± 2.7 versus –3.9 ± 2.6; p=0.006). According to the American College of Obstetrician and Gynecologist (ACOG) and Association of Professors of Gynecology and Obstetrics, the treatment of nausea and vomiting of pregnancy also referred to as morning sickness with pyridoxine and vitamin B6 or vitamin B6 have been first-line recommendations for many years. Diclegis is the first FDA-approved, pregnancy category A delayed-release combination medication for the treatment of nausea and vomiting of pregnancy. RECOMMENDATION Doxylamine succinate/pyridoxine HCL is a fixed combination of an anticholinergic antihistamine and a vitamin B6 analog indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. ACOG guidelines consider pyridoxine and vitamin B6 among the first-line recommendations for the treatment of nausea and vomiting of pregnancy. Therefore, it is recommended doxylamine succinate/pyridoxine should be available for the treatment of nausea and vomiting in pregnancy. COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION Page 7 of 14 August 13, 2013 Tennessee PAC
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Drug: ACCUTANE - Magellan Health Services || TennCare Portal

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