BioTherapeutics. Diagnostic and Pharmaceutical News for You and Your Medical Practice

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1 BQ Diagnostic and Pharmaceutical News for You and Your Medical Practice BioTherapeutics Q u a r t e r l y Volume 13/Fall MS8876 Image: Influenza Virus

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5 Q u a r t e r l y Volume 13/Fall 2013 Table of Contents 13MS Letter to Henry Schein s Valued Customers 9 Summary Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee of Imunization Practices ACIP United States, CDC: Adult Appropriate Antibiotic Use Summary 20 CDC: Pediatric Careful Antibiotic Use 22 Testing Recommendations Ensure More Patients to Hepatitis C Treatment 24 NDEP: Identify People with Undiagnosed Diabetes and Pre-Diabetes 26 NDEP: Manage Pre-Diabetes or Delay the Onset of Type 2 Diabetes and Its Complications 28 New Drug Approvals 32 Clinical Study: Safety and Efficacy of Intravenous Ferric Carboxymaltose (750mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials The BioTherapeutics Journal is published four times a year by Henry Schein, Inc. Henry Schein s corporate headquarters are located at 135 Duryea Road, Melville, NY For journal sales information or to report corrections, BQJournal@henryschein.com or call Kim Crabtree at Note that although we attempt to ensure the currency of the information contained in this publication as of the publication date, new biotherapeutic developments occur continually and, therefore, may not be noted in this publication. Not responsible for typographical errors. 5

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7 A Letter to Henry Schein s Valued Customers As 2013 draws to a close, we find another year full of changes and advances in the prevention, diagnosis, and treatment of disease. It is the mission of the BioTherapeutics to provide you with current, relative information as it relates to these changes and advances. In this issue, you will find a summary of recommendations from the ACIP on the prevention and control of influenza with vaccines for the season. The routine annual influenza vaccination of all persons aged 6 months and older continues to be recommended. There are several new licensed vaccines which are described in the summary as well as revised abbreviations for currently available influenza vaccines. We have also provided helpful antibiotic use summaries for adult and pediatric patients published by the CDC. According to the CDC, antibotic resistance has been called one of the world s most pressing public health problems citing such concerns as antibiotics being prescribed in 68% of acute respiratory tract infections and of those, 80% were unnecessary, in accordance with the CDC guidelines. Hepatitis C continues to plague our population with approximately 3.2 million persons chronically infected. Testing is key to ensuring more patients are treated for the disease. You will find an article on page 22 that addresses this issue. November is National Diabetes Awareness Month. We have included principles from the National Diabetes Education Program to further the awareness of diabetes and identifying those that are undiagnosed along with the management of pre-diabetes. We are also featuring a clinical study this quarter beginning on page 32, Safety and Efficacy of Intravenous Ferric Carboxymaltose (750mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials. Our New Drug Approval section can be found on page 28. We wish you a joyous holiday season and look forward to serving you in the coming year. Sincerely, Louis Ferraro Vice President Merchandising and Product Management Henry Schein Medical OUR Mission To provide health care professionals with a practical and relevant source of information regarding diagnostics, pharmaceuticals, and vaccines in a quick and easy-to-read publication that provides educational updates and insight to assist you in prevention, diagnosis, and treatment of disease. 7

8 Look What s been added to the Henry Schein onestep+ Product Line Henry Schein onestep+ influenza A & B test NEW! Influenza A & B Test The ONE STEP line of diagnostic tests features superior clinical performance, accuracy, and quick results OneStep+ Influenza A & B Test This test provides a simple, rapid method to aid in the differential diagnosis of influenza A & B using nasal swab specimens. CLIA Waived Sensitivity (A/B): 93.8%/77.4% 10-minute results Specificity (A/B): 95.8%/98% # , Influenza A & B Test ( ) 25/box CPT Codes: Influenza A: 87804QW ; Influenza B:

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22 Testing Recommendations Ensure More Patients to Hepatitis C Treatment Today, the Hepatitis C virus is the most common blood borne chronic viral infection in the United States. According to the Centers for Disease Control and Prevention (CDC), approximately 3.2 million persons are chronically infected with the Hepatitis C virus (HCV). 1 Experiencing a lack of symptoms that a chronically ill patient would typically encounter is one reason the infection has been referred to as the silent killer. Prior to 2012, the CDC recommended HCV screening for only individuals with a previous history of certain behaviors or health indicators that are associated with HCV infection, such as injection drug use, hemodialysis, or abnormal liver function tests. 2,3 But in August 2012, the CDC published Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During recommending an important expansion of the target groups to include the baby boomer generation. The new recommendation came in response to the widespread presence of HCV infection among baby boomers (those born between 1945 and 1965), approximately 80 million individuals. The CDC estimates that one out of every 30 baby boomers is living with HCV infection. In June 2013, the U.S. Preventative Services Task Force (USPSTF) also revised its testing recommendations to include baby boomers, giving both HCV screening for at-risk individuals and age-cohort screening a B grade. The new recommendations entitled Screening for Hepatitis C Virus Infection in Adults: U.S. Preventive Services Task Force Recommendation Statement similarly marked a dramatic expansion of the USPSTF s previous recommendation of screening for HCV. The USPSTF recommendations are particularly important in light of the Affordable Care Act. Under the Affordable Care Act, preventive services that have received an A or B grade from the USPSTF must be covered by insurance policies without cost-sharing and be part of the essential health benefits for those individuals eligible for Medicare. Hepatitis C Today The prevalence of HCV is highest in middle-aged, non-caucasian men. 4 Despite improved testing recommendations, up to 75% of patients with chronic HCV are still unaware of their HCV infection status. 5 As a result, the burden of disease and death continues to grow despite recent advances in antiviral therapies. There are many reasons why patients with chronic HCV are not diagnosed, including: Asymptomatic patients without any other medical problems may not seek medical attention Many primary care physicians lack knowledge about risk factors and testing for HCV Patients may be reluctant to reveal risk factors Patients may be outside the health care system (young, poor, drug addicts) If left undetected and untreated, HCV can cause liver damage and liver failure. In fact, according to the CDC, HCV is the leading cause of liver cancer and the leading cause of liver transplants in the United States. The total medical costs for patients with HCV are expected to more than double over the next 20 years from $30 billion to $85 billion in 2024 according to the Millman Report entitled Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. If HCV is detected early, successful treatments can eliminate the virus from the body. Current testing options, including rapid tests have continued to make testing easy and accessible. CLIA-waived rapid HCV tests may be administered in physician offices or public health facilities and clinics, thus offering the advantage of allowing immediate discussion with HCV positive patients about follow up testing and care. 6 Now that the new testing recommendations are in place, it is critical to ensure they are being followed. Educational programs aimed at primary care providers can increase awareness of HCV risk factors (including birth cohort screening) that will lead to more HCV testing. Testing for HCV in a primary care setting with establishing linkages to HCV providers can improve the likelihood of linking patients to appropriate care Alter MJ, Seeff LB, Bacon BR, et al. Testing for hepatitis C virus infection should be routine for persons at increased risk for infection. Ann. Intern Med. 2004;141: htm Accessed 11/28/11 4 Armstrong GL, Wasley A, et al. The prevalence of hepatitis C infection in the United States, 1999 through Ann Intern Med 2006; 144(10): Colvin HM, Mitchell AE. Hepatitis and liver cancer: A national strategy for prevention and control of hepatitis B and C. Washington, DC: The National Academies Press; oraquick-hcv.asp 22

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28 NEW DRUG APPROVALS SEPTEMBER BRINTELLIX (VORTIOXETINE HYDROBROMIDE) Manufacturer: Takeda September 30, 2013 About this drug: brintellix is indicated for the treatment of major depressive disorder OCTOBER ADEMPAS (RIOCIGUAT) Manufacturer: Bayer Pharmaceuticals October 8, 2013 About this drug: adempas is a soluble guanylate cyclase (sgc) stimulator indicated for the treatment of adults with: Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. OPSUMIT (MACITENTAN) Manufacturer: Actelion October 18, 2013 About this drug: opsumit is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH. 28

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44 Call: P-SCHEIN ( ) 8am 9pm (et) Fax: Hours Henry Schein, Inc. No copying without permission. Not responsible for typographical errors. 13MS8876 ORDER YOUR FLU VACCINE NOW! Be Prepared for the Flu Season Henry Schein is the largest distributor of flu vaccine in the United States! Allow us to fulfill all your flu vaccine needs.