Medical Assistance Division Medicaid Drug Utilization Review Newsletter

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1 Medical Assistance Division Medicaid Drug Utilization Review Newsletter Volume 8 Issue 4 4th Quarter 2014 Introduction American Academy of Pediatrics Issues New Guidance on Use of Synagis Felice R. Slaughter RPh. DUR Board Members William J. Apfeldorf, MD Amy Bachyrycz, RPh, PharmD Greg D'Amour, RPh, PhC, CGP Rollin V. Oden, MD, MPH Dennis Raisch, RPh, PhD, MS John Seibel, MD Gregory Toney, RPh, PharmD, BCPP Dale Whittleton, RPh Inside This Issue Synagis Guideline Update The United States Food and Drug Administration approved Synagis (palivizumab) in June Palivizumab, also known as Synagis, is indicated for the reduction of serious respiratory tract infections caused by the respiratory syncytial virus (RSV) in children at risk of severe disease. The American Academy of Pediatrics (AAP) has established guidelines to help physicians determine which patients will benefit most from the use of palivizumab. The guidelines have been updated several times, with the most current update being July The current guideline recommendations are published in the August 2014 issue of Pediatrics, Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection, which is accompanied by a technical report. Pathophysiology: Respiratory syncytial virus, or RSV, is a respiratory virus that infects the lungs and breathing passages. RSV can cause upper respiratory infections, such as colds, and lower respiratory tract infections, such as bronchiolitis and pneumonia. RSV is the most common cause of bronchiolitis in children under 1 year. Most children have experienced an RSV infection by age 2. Children under the age of 6 months are usually hospitalized with RSV type infection. RSV infection usually lasts about 1 to 2 weeks, but in very young infants and children, symptoms can last up to 3 weeks. RSV is more severe in persons with weakened immune systems. RSV signs and symptoms usually present with a runny nose and decreased appetite. Coughing, sneezing and fever typically develop 1 to 3 days later. Some patients may also experience wheezing. The contagious period of RSV is 3 to 8 days. Persons with weakened immune systems may be contagious for as long as 4 weeks. RSV can spread by droplets of the virus in the air from an infected person. Virus droplets may be introduced into the air by a sneeze or cough from an infected person. Infection may also result from direct and/or indirect sources. Direct transmission can be from the direct contact with nasal droplets of an infected person. Indirect sources may include environmental sources, such as hands, doorknobs, or toys that are contaminated. The active virus can survive on a hard surface for several hours.

2 Palivizumab: Palivizumab is humanized monoclonal antibody that binds to the F-glycoprotein of the virus. This antibody is given intramuscularly at a dosage of 15 mg/kg body weight over the RSV season. The RSV season begins between October and November and ends between March and April each year. Patients generally receive a total of 5 injections over this period of time. Palivizumab has significantly reduced severe RSV infections resulting in decreased hospitalizations 2. The common side effects of palivizumab are fever and rash. Guideline Changes: Respiratory syncytial virus (RSV) has been related to morbidity in infants and children. High risk infants, defined as preterm infants or preterm infants with additional risk factors for morbidity attributed to RSV disease, prompted national recommendations for prophylaxis therapy with palivizumab. Table 1 exhibits past Synagis recommendation guidelines: Table 1: Synagis Past Recommendation Guidelines Max Condition Number of Doses Hemodynamically significant Congenital Heart Disease (CHD) Infants/children requiring medication to control congestive heart failure Infants/children with moderate to severe pulmonary hypertension Infants/children with cyanotic heart disease Chronic Lung Disease (CLD) formerly called bronchopulmonary dysplasia For infants <32 weeks: Oxygen requirement at 36 weeks gestational age or at discharge For infants > 32 weeks: Oxygen requirement at age 28 days or greater at discharge Infants/children who have received treatment for CLD within 6 months of the anticipated onset of the season with one of the following: supplemental oxygen or bronchodilator or diuretic or chronic corticosteroid therapy Premature infants < 28 weeks OR infants with a significant congenital abnormality of the airway or neuromuscular condition that compromises handling of respiratory secretions Premature infants between > 29 weeks and < 31 weeks Premature infants between > 32 weeks and < 34 weeks with one of the following two risk factors: child care attendance and sibling < 5 years of age Age (in months) at Onset of RSV Season 0 to < 3 3 to < 6 6 to < to < 24 > 24 5 Yes Yes Yes Yes No 5 Yes Yes Yes Yes No 5 Yes Yes Yes No No 5 Yes Yes No No No 3 Yes No No No No Infants of 35 weeks gestation (without CLD or Hemodynamically significant CHD) 0 No No No No No 2

3 Table 2 represents the 2014 recommendations. The red font represents changes from previous recommendations. Table 2: Synagis (palivizumab) 2014 Recommendation Max Age (in months) at Onset of RSV Season Condition Number of Doses 0 to < 3 3 to < 6 6 to < 12 Premature Infant <32 weeks gestation with Chronic Lung Disease (CLD) require >21% oxygen for at least 28 days after birth (A second season of pavilizumab prophylaxis is recommended for patients with CLD of prematurity who satisfied the above criteria and continue to receive medical therapy during the 6-month period before the start of the second RSV season) Premature Infants less than 29 weeks gestation Younger than 12 months Premature infants 29 to 31 gestation (younger than 6 months)-no longer eligible Premature infants 32 to 34 gestation (younger than 3 months)-no longer eligble Premature infants < 28 weeks OR infants with a significant congenital abnormality of the airway or neuromuscular condition that compromises handling of respiratory secretions Immunocompromised children 24 months and younger Cystic Fibrosis Patients Yes if less than 24 months along with CF symptoms Congenital Heart Disease (CHD) Down Syndrome (unless qualifying heart disease, CLD, airway clearance issues, or prematurity less than 29 weeks) Premature infants (no other risk factors) in second year of life Infants with mild cardiomyopathy who are not receiving medical therapy for the condition Native American (Physician judgment) 12 to < 24 > 24 5 Yes Yes Yes Yes Yes 5 Yes Yes Yes No No 5 Yes Yes Yes No No 5 Yes Yes Yes Yes Yes 5 No No No No No 5 Yesacyanotic Yescyanotic Yesacyanotic Yescyanotic Yesacyanotic Yes-cyanotic No unless Cardiac transplants No unless Cardiac transplants No No No No No No No No No No No No No No No In addition, household members should be immunized against influenza and practice good hand and cough hygiene. Conclusion: There are significant changes in the 2014 guidelines impacting instances where children were eligible for treatment last year and are no longer candidates. 3

4 References: 1. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics 134:2 August Resch B. Palivizumab for the prophylaxis of respiratory syncytial virus infection. Paed Health. 2008;2: Resch B. Palivizumab in preventing respiratory syncytial virus-related hospitalization in high-risk infants. Expert Rev Pharmacoecon Outcomes Res. 2008;8: Technical Report. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for RSV infection. Pediatrics 2014;134:e620-e Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Available at Viewed September 11, Synagis Package Insert. Medimmune, LLC, Gaithersburg, M.D. March Stockman LJ, Curns AT, Fischer-Langley G. Respiratory syncytial virus-associated hospitalizations among infants and young children in the United States, Ped Infect Dis J 2012;31: Meissner, H. Cody; Brady, Michael T.; Byington, Carrie L.; Kimberlin, David W.; Liberthal, Alan S.; Maldonado, Yvonne A.; Meissner, H.Cody; Ralston, Shawn L.; Winterstein, Almut G. Severe RSV Disease in Preterm Infants Born at 29 to 35 Weeks Gestation in the United States. 9. Ambrose, Christopher S.; Anderson, Evan J.; Simoes, Eric A.F.; Wu, Xionghua; Elthefni, Hanaa; Park, C.Lucy; Sifakis, Frangiscos; Groothuis, Jessie R. Respiratory Syncytial Virus Disase in Preterm Infants in the US Born at Weeks Gestation Not Receiving Immunoprophylaxis. Pediatr Infect Dis J. Jun 2014; 33(6): Walker, Tracey. New AAP guidance for RSV drugs spurs manufacturer reaction. Formulary Watch. August 4, Bernhard, Resch. Respiratory Syncytial Virus Infection in High-risk Infants an Update on Palivizumab Prophylaxis. Open Microbiology Journal. July 11, : To report medical fraud, contact the Medicaid Quality Assurance Bureau. NMMedicaidFraud@state.nm.us or (505) We appreciate your continued support of our efforts to encourage quality care for our Medicaid clients. Questions and/or comments about this newsletter may be directed to Diana Moya, R.Ph. at (505) or DianaJ.Moya@state.nm.us. DUR newsletters are posted on the New Mexico Human Services Department website: 4

5 American Academy of Pediatrics Issues New Guidance on Use of Synagis Prescriber Response Form We would greatly appreciate if you would answer the following questions and return it via fax to: Thank you for your professional consideration. 1. What is your area of practice? A. General Family Practice B. Pediatrician C. Psychiatrist D. Specialty Please specify: 2. Did you find this newsletter to be informative? A. Yes B. No 3. Did the information affect the way you practice? A. Yes B. No Please share any drug topics suggestions you would like to address by a newsletter. 5

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