Jul 7, 2015 - created the Nexus: Connecting Health Care and. Innovation conference. ..... 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient ..... the call for AMCP volunteers every September.
J MCP
■ Journal of Mana g ed Care & Specialty Pharmac y® ■ July 2015
Journal of Managed Care & specialty Pharmacy ®
Volume 21
■
Number 7
■
July 2015
■ Vol. 21, No. 7
■■ SPECIALTY PHARMACY
■ Pa g es 523-606
Pharmacist Substitution of Biological Products: Issues and Considerations Edward Li, PharmD, BCOP; Sundar Ramanan, PhD; and Larry Green, PharmD Intravenous Versus Subcutaneous Anti-TNF-Alpha Agents for Crohn’s Disease: A Comparison of Effectiveness and Safety Jinan Liu, PhD; Gosia Sylwestrzak, MA; Alexander P. Ruggieri, MD, MHS; and Andrea DeVries, PhD ■■ BENEFIT MANAGEMENT
Proceedings of the AMCP Partnership Forum: NCPDP Electronic Prior Authorization Standards—Building a Managed Care Implementation Plan AMCP Electronic Prior Authorization Work Group Health Care Resource Utilization and Costs for Influenza-like Illness Among Midwestern Health Plan Members Donald G. Klepser, PhD, MBA; Carolyn E. Corn, PharmD; Michael Schmidt, PharmD; Allison M. Dering-Anderson, PharmD; and Michael E. Klepser, PharmD Financial Analysis of CYP2C19 Genotyping in Patients Receiving Dual Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention Samuel G. Johnson, PharmD, FCCP, BCPS; Don Gruntowicz, PharmD, BCPS, CGP; Theresa Chua, PharmD Candidate; and Robert J. Morlock, PhD ■■ CLINICAL MANAGEMENT
Discontinuation/Interruption of Warfarin Therapy in Patients with Nonvalvular Atrial Fibrillation Christina A. Spivey, PhD; Yanru Qiao, MS; Xianchen Liu, MD, PhD; Jack Mardekian, PhD; Robert B. Parker, PharmD; Hemant Phatak, PhD; Abigail B. Claflin, MPH; Sumesh Kachroo, PhD; Younos Abdulsattar, PharmD, BCPS; Anwesa Chakrabarti, PharmD Candidate; and Junling Wang, PhD Risk Factors, Clinical Characteristics, and Treatment Differences Between Residents With and Without Nursing Home- and Non-Nursing Home-Acquired Clostridium difficile Infection Barbara J. Zarowitz, PharmD; Carrie Allen, PharmD; Terrence O’Shea, PharmD; and Marcie E. Strauss, MPH Impact of COPD Exacerbation Frequency on Costs for a Managed Care Population Anand A. Dalal, PhD, MBA; Jeetvan Patel, MS; Anna D’Souza, BPharm, PhD; Eileen Farrelly, MPH; Saurabh Nagar, MS; and Manan Shah, PharmD, PhD
Journal of Managed Care & Specialty Pharmacy®
Previously published as JMCP, the Journal of Managed Care Pharmacy®
A Peer-Reviewed Journal of the Academy of Managed Care Pharmacy ■ www.jmcp.org ■ www.amcp.org
TAKE THE
Plunge
WHERE HEALTH CARE AND INNOVATION INTERSECT The issues and challenges faced by managed care professionals are never simple. That’s why AMCP created the Nexus: Connecting Health Care and Innovation conference. Come to the heart of Florida this October and immerse your professional learning in education tracks such as:
>
Current Aspects in Specialty Pharmacy Management
> > > >
The Changing Health Care Environment Drugs, Diseases and Managed Care Impact Practical Applications of Managed Care Research Inside the Crystal Ball The Innovation Interchange general session will feature Dr. Siddhartha Mukherjee, author of the Pulitzer Prize-winning The Emperor of All Maladies: A Biography of Cancer. There are also a wealth of opportunities to network in The Exchange, the Residency Showcase, poster presentations, and more at AMCP Nexus 2015. See you in Orlando!
AMCP 2015
NEXUS Orlando OC TOBER 26–29
Save when you register by September 25 at www.amcpmeetings.org.
AMCP Nexus 2015 runs Monday through Thursday, October 26–29, Gaylord Palms Hotel and Convention Center, Orlando.
An option for type 2 diabetes therapy starts here
Trulicity™ is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.
Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, and see Brief Summary of Prescribing Information on following pages. Please see Instructions for Use included with the pen.
Trulicity™: An option for your plan members Trulicity offers proven A1C reduction* and once-weekly dosing in the Trulicity pen.1 *In clinical trials, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1
Trulicity is an option for adult patients with type 2 diabetes who need more control than oral medications are providing.1 To learn more about Trulicity, visit www.trulicity.com or contact your Lilly Account Manager.
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.
Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.
Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components. Risk of Thyroid C-cell Tumors: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with elevated serum calcitonin (if measured) and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapy in patients with a history of pancreatitis. Please see Important Safety Information continued on following page.
DG95067
02/2015 PRINTED IN USA
©Lilly USA, LLC 2015. All rights reserved.
A1C reduction from baseline
Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, to sulfonylureas) or insulin. Patients A1C reduction from baseline week 52 may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in clinical trials in patients receiving Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice.
8.2 8.0 7.8
Renal Impairment: In patients treated with GLP-1 RAs there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, -0.8 or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor -1.1 severe adverse renal function in patients experiencing gastrointestinal reactions.
7.6 7.4 7.2 7.0 6.8 6.6 6.4 6.2 Baseline
8.4
nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%,
Trulicity (1.512.6%), mg) (n=279; Baseline(2.3%, A1C: 8.1%) vomiting 6.0%, 12.7%), abdominal pain Injections: ~52/year (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%,
8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%,
P
