RSV Review for Clinical Program Managers


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This slide deck was bulit as a clinical refresher for sales teams at Express Scripts.

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RSV Review for Clinical Program Managers

  1. 1. Overview of Respiratory Syncytial Virus (RSV) and RSV Logic<br />Designed for <br />Clinical Program Managers<br />
  2. 2. 2<br />OBJECTIVES<br /><ul><li>Understand key background information related to the Respiratory Syncytial Virus (RSV)
  3. 3. Describe key aspects of RSV prophylaxis and pharmacotherapy
  4. 4. Describe the overview of our clinical program, RSVLogic</li></ul>July 2009<br />
  5. 5. 3<br />RSV: A Priority for Payers<br /><ul><li>Respiratory Syncytial Virus (RSV)
  6. 6. Most common cause of lower respiratory tract infection (LRTI) in children <1 year of age1
  7. 7. Infection can be severe and costly
  8. 8. Leading cause of infant viral death2
  9. 9. Annual infant hospitalizations
  10. 10. 125,000/yr4-6 and $700 million/yr1
  11. 11. The key to Synagis therapy and controlling cost is to TARGET THE RIGHT PATIENTS AT THE RIGHT TIME</li></ul>July 2009<br />
  12. 12. RSV: Background Information<br />4<br /><ul><li>Few patients will have infection that progresses to lungs
  13. 13. At least 90% of children have been infected by age 21
  14. 14. Reinfection with mild symptoms is common and may occur throughout life</li></li></ul><li>5<br />Pathophysiology of the RSV Virus<br /><ul><li>Causes mild cold-like symptoms in healthy adults and children
  15. 15. Can cause pneumonia and bronchiolitis in premature and high risk infants</li></ul><br />July 2009<br />
  16. 16. 6<br />RSV: Disease Information <br />July 2009<br />
  17. 17. 7<br />When is Medical Treatment Needed?<br />Usually diagnosis and specific medical treatment are not needed<br />However, treatment is need for more severe infection<br />July 2009<br />
  18. 18. 8<br />RSV: Prophylaxis<br /><ul><li>Key measures include proper hand washing and avoiding tobacco smoke1
  19. 19. Synagis® (palivizumab) can </li></ul>reduce RSV hospitalizations<br /><ul><li>Synagis® therapy is costly
  20. 20. Approximate costs
  21. 21. $2,000/month
  22. 22. $10,000/5 month course
  23. 23. Synagis is covered 60% of the time under the payer’s medical benefit and 40% of the time under the prescription benefit</li></ul>July 2009<br />
  24. 24. 9<br />Synagis® (palivizumab)<br /><ul><li>Indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease
  25. 25. Premature babies (<35 weeks)
  26. 26. Chronic Lung Disease (CLD)
  27. 27. Congenital Heart Disease (CHD)</li></ul><br />July 2009<br />
  28. 28. 10<br />Documented RSV Risk Factors For 32-35 Week GA Infants<br />School-age siblings, Daycare attendance, Exposure to environmental air pollutants, Severe neuromuscular disease, Congenital abnormalities of the airways, Low birth weight , Crowded living conditions, Multiple birth, Family history of asthma, Young chronologic age ≤ 12 weeks<br /><br />
  29. 29. What is RSV season?<br />11<br /><ul><li>Typically 5 months in duration
  30. 30. Varies by geographical location
  31. 31. Varies year to year and is based on historic data as well as current season data</li></ul><br />
  32. 32. AAP Guidelines<br />The American Academy of Pediatrics (AAP) 2006 Guidelines<br />virtually the same as MedImmune and the FDA’s indications<br />2009 AAP Guidelines<br />substantially different from current <br /> practice and the 2006 edition of the <br /> guideline<br />lack reference to scientific evidence <br />New guidelines are being evaluated <br /> by ESI and MedImmune<br />not likely to be accepted by either as standard of care<br />12<br /><br />
  33. 33. 13<br />Synagis®: Dose/Administration<br /><ul><li>Recommended dose is 15 mg/kg
  34. 34. Administration </li></ul>IM monthly, preferably into the anterolateral aspect of thigh<br />1st dose should be given prior to the areas RSV season <br />Monthly doses should be continued throughout RSV season, even if RSV infection develops<br />July 2009<br />
  35. 35. 14<br />Synagis®: Warnings/Precautions/ADRs<br /><ul><li>Contraindications</li></ul>Patients with severe prior reaction to palivizumab or its components<br /><ul><li>Adverse Drug Reactions (ADRs)</li></ul>Most common: upper respiratory tract or ear infections, fever, runny nose, diarrhea, rash, cough, vomiting<br />Less common: anaphylaxis and hypersensitivity reactions<br />July 2009<br />
  36. 36. 15<br />Synagis® :Benefits1<br /><ul><li>Reduced hospitalization by rates of 39% to 78%</li></ul>2 RCTs involving 2,789 infants and children with prematurity, CLD, or congenital heart disease<br /><ul><li>Reduction in mortality not demonstrated</li></ul>None of the 5 RCTs demonstrated a significant decrease in mortality from RSV infection in infants receiving prophylaxis<br />July 2009<br />
  37. 37. 16<br />Hospitalizations for RSV<br />RSV Hospitalizations (%)<br />11<br />10<br />10<br />8,9<br />#1 cause of hospitalization in infants &lt;1 yr of age<br />July 2009<br />
  38. 38. A Look at the Pipeline<br />Motavizumab<br />derivative of Synagis<br />10-20 times more potent<br />Anticipated for 2010-2011 RSV Season<br />17<br /><br />
  39. 39. 18<br />July 2009<br />
  40. 40. 19<br />RSV Logic<br />A Look at our High-touch Care Management Program<br />July 2009<br />
  41. 41. 20<br />Clinical Assessment: Examples<br /><ul><li>Initial assessment
  42. 42. Follow-up assessments</li></ul>As appropriate for each patient<br />Gather patient information<br />Education and empowerment<br />Disease and medication<br />Interactive and empathetic approach<br /><ul><li>Access to specially trained nurses and pharmacists, including 24 hr pharmacist support for urgent needs</li></ul>July 2009<br />
  43. 43. 21<br />Clinical Assessments: Examples<br /><ul><li>Patient history and demographic information
  44. 44. Gestational age, weight, diagnosis, risk factors
  45. 45. RSV education
  46. 46. RSV season, prophylaxis (e.g. smoking cessation, hygiene), when to call doctor
  47. 47. Medication education
  48. 48. Side effects, missed dose/compliance</li></ul>July 2009<br />
  49. 49. 22<br />Clinical Assessments: Examples<br />Indications?<br />Risk Factors?<br />July 2009<br />
  50. 50. 23<br />Summary<br />RSV is a common virus that leads to hospitalizations in some high risk patients<br />Synagis® is a high cost medication that can prevent RSV hospitalizations in these patients<br />RSV Logic is a clinical solution that is already in place, and it is designed to optimize outcomes and control cost<br />For more information direct questions to your sales support director or see the RSV Client Facing Deck<br />July 2009<br />
  51. 51. 24<br />References<br />Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and Management of Bronchiolitis, American Academy of Pediatrics. 2006;1774-1793.<br />Thompson WT et al. JAMA. 2003;289:179-86.<br />Mayo Clinic Staff. Respiratory Syncytial Virus (RSV),,2007. Accessed November 2008.<br />Shay DK, Holman RC, Newman RD, et al. JAMA. 1999;282:1440-1446. <br />McLaurin KK, Leader S. Pediatric Academic Societies Meeting, May 14-17, 2005. Abstract #936. <br />Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatrics. 2003;143(5 suppl):S127-S132. <br />Synagis (palivizumab) [package insert]. Galtherburg, MD: MedImmune; 2008.<br />Shay DK et al. JAMA.1999;282:1440-1446.<br />Hall CB.Respiratorysynctial virus. In:Feigin RD, Cherry JK.eds. Textbook of Pediatric Infectious Diseases. 4th ed. Philadelphia.PA:WB Saunders;1998.<br />The Impact-RSV Study Group. Pediatrics. 1998; 102:531-537.<br />Feltes TF et al.J Pediatr.2003;143:532-540.<br />MedImmune. RSV Accessed July 7, 2009.<br />Other References as Cited on individual slides.<br />Last Updated July 2009<br />July 2009<br />