Managed Care - November 2008 - (Page RSV8)

least as high, if not greater, in infants born 32 to 35 completed weeks of gestation (Horn 2003). Prevention of RSV hospitalization through immunoprophylaxis is likely to have a positive economic impact beyond inpatient admissions, as it has been found that infants hospitalized for RSV also have greater subsequent health care utilization. In a comparison with a control group of 20,254 infants of 32 to 35 weeks GA but no RSV hospitalization during a mean follow-up of 1.66 years, a cohort of 2,415 infants hospitalized for RSV infection had not only more hospital stays (2.96 versus 1.28; P=.001) and a longer mean length of stay (14.71 versus 5.04 days; P<.001), but also more outpatient visits (18.4 versus 7.54; P=.001) and greater mortality (8.1 versus 1.6 percent; P=.001) (Sampalis 2003). In the IMpact-RSV trial (IMpact-RSV Study Group 1998), palivizumab immunoprophylaxis reduced hospitalization rates by 55 percent overall (10.6 versus 4.8 percent) compared with placebo, but by 80 percent in infants 32 to 35 weeks GA without CLD or CHD. Further study and analysis is needed, however, to define the severity and utilization risks for this subset of infants, and to establish better criteria for immunoprophylaxis. RSV prevention RSV immunoprophylaxis with palivizumab should be initiated just prior to the onset of the local RSV season and terminated at its end with intramuscular injections administered every 30 days. American Academy of Pediatrics (AAP) guidelines (AAP 2006) recommend, in general, five monthly doses from November to March. The AAP also states that any deviation from this recommendation requires careful consideration of the benefit and cost. Because of the geographical and seasonal variability of RSV, I recommend that pediatricians monitor local virology data in their respective communities along with historical virology data to prepare for timely, appropriate administration of immunoprophylaxis. If the RSV season should begin unexpectedly early, timely immunoprophylaxis may be difficult because of the logistical challenges involved in obtaining the necessary approvals and supply of palivizumab. Preparation for dosing should Michael P. Frogel, MD, is a recognized expert and researcher on the use of palivizumab to prevent lower respiratory tract infections due to respiratory syncytial virus (RSV) in high-risk infants and children. He has given platform presentations and presented abstracts at the Pediatric Academic Societies and American Academy of Pediatrics yearly meetings since 1998. Frogel is an advocate for greater access to care for underprivileged patients, as well as a leader in the development of systems to ensure the comprehensive screening of all patients and the delivery of user-friendly, efficient compliant care. Frogel’s main areas of interest are child advocacy, sports medicine and weight management, emergency preparedness, and preventive pediatrics, especially immunization practices to prevent infectious disease. begin in advance of the start of the RSV season in the infant’s community. For example, if the season usually starts in November, pediatricians should begin to obtain insurance/health plan approvals during the first or second week of October and begin to schedule appointments to provide immunoprophylaxis during the last week of October, as it takes 48 to 72 hours to achieve protective levels with palivizumab. This approach will obviate any difficulty in receiving the necessary insurance approvals or in scheduling patient visits before the RSV season starts. High-risk infants will thereby receive their first injections just prior to the start of the RSV season and achieve appropriate prophylaxis levels to prevent hospitalization. In my practice, we screen patients year-round to identify high-risk patients who are candidates for immunoprophylaxis. We maintain an ongoing, coordinated list of eligible patients discharged from our neonatal unit or otherwise entering my practice. In early October, my dedicated palivizumab nurse (a major impact on practice manpower) studies our roster of patients and begins to set up medical appointments and to contact insurers for coverage approval and to check if reimbursement policy has changed. Throughout the RSV season, we receive a report from our virology laboratory of all RSV specimens submitted. We then track the number of tests performed and the number of positive and negative results. AAP guidelines The AAP guidelines for RSV immunoprophylaxis have evolved over the past decade. Since 1998, the AAP guidelines consistently have recommended palivizumab immunoprophylaxis for children with severe CLD who are less than 2 years of age at the start of the RSV season (AAP 1998, 2003, 2006). For children with hemodynamically significant CHD who are younger than 2 years at the start of the season, the 2003 and 2006 guidelines recommend that monthly injections of palivizumab be considered during the RSV season. Current AAP guidelines (AAP 2006) state that immunoprophylaxis should be administered usually in five monthly injections during the RSV season and that immunoprophylaxis should be considered for premature infants who are born 32 weeks GA or earlier and for infants 32 to 35 weeks GA with two or more risk factors during their first RSV season (Table 1). The AAP guidelines also mention five demonstrated risk factors drawn from epidemiological data that may point to an increased risk for severe RSV infection (Table 2). Other risk factors also have been identified (Table 2), some of which are supported by evidence in the literature, but most insurers will consider only those risk factors mentioned in the AAP guidelines. Timing of immunoprophylaxis The question of when the first dose of palivizumab should be administered is a major issue confronting 8 MANAGED CARE / SUPPLEMENT

Table of Contents Feed for the Digital Edition of Managed Care - November 2008

Managed Care - November 2008 Editor’s Memo Contents News and Commentary Legislation & Regulation Letters Medication Management Compensation Monitor Do It Yourself for Less Biomarkers Promise, but Do They Deliver? Oncologists Complain About Drug Payment Consider Blood Pressure Self-Monitoring Q&A: Keep Industry in the Game Formulary Files Plan Watch Tomorrow’s Medicine Outlook Respiratory Syncytial Virus Managed Care Considerations Contents Continuing Education Objectives RSV Disease in the Pediatric Population In the Trenches RSV Infection in the Adult Population Health Plan Medical Director Health Plan Pharmacy Director RSV Issues and Solutions Assessment/Evaluation/Certificate Request Post-Test

Managed Care - November 2008

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