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Overview of Respiratory Syncytial Virus (RSV) and RSV Logic Designed for  Clinical Program Managers
2 OBJECTIVES ,[object Object]
Describe key aspects of RSV prophylaxis and pharmacotherapy
Describe the overview of our clinical program, RSVLogicJuly 2009
3 RSV: A Priority for Payers ,[object Object]
Most common cause of lower respiratory tract infection (LRTI) in children <1 year of age1
Infection can be severe and costly
Leading cause of infant viral death2
Annual infant hospitalizations
125,000/yr4-6 and $700 million/yr1
The key to Synagis therapy and controlling cost is to TARGET THE RIGHT PATIENTS AT THE RIGHT TIMEJuly 2009
RSV: Background Information 4 ,[object Object]
At least 90% of children have been infected by age 21
Reinfection with mild symptoms is common and may occur throughout life,[object Object]
Can cause pneumonia and bronchiolitis in premature and high risk infantshttp://www.cnmcpc.com/announcements/8 July 2009
6 RSV: Disease Information  July 2009
7 When is Medical Treatment Needed? Usually diagnosis and specific medical treatment are not needed However, treatment is need for more severe infection July 2009
8 RSV: Prophylaxis ,[object Object]
Synagis® (palivizumab) can reduce RSV hospitalizations ,[object Object]
Approximate costs
$2,000/month
$10,000/5 month course
Synagis is covered 60% of the time under the payer’s medical benefit and 40% of the time under the prescription benefitJuly 2009
9 Synagis® (palivizumab) ,[object Object]

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RSV Review for Clinical Program Managers

  • 1. Overview of Respiratory Syncytial Virus (RSV) and RSV Logic Designed for Clinical Program Managers
  • 2.
  • 3. Describe key aspects of RSV prophylaxis and pharmacotherapy
  • 4. Describe the overview of our clinical program, RSVLogicJuly 2009
  • 5.
  • 6. Most common cause of lower respiratory tract infection (LRTI) in children <1 year of age1
  • 7. Infection can be severe and costly
  • 8. Leading cause of infant viral death2
  • 11. The key to Synagis therapy and controlling cost is to TARGET THE RIGHT PATIENTS AT THE RIGHT TIMEJuly 2009
  • 12.
  • 13. At least 90% of children have been infected by age 21
  • 14.
  • 15. Can cause pneumonia and bronchiolitis in premature and high risk infantshttp://www.cnmcpc.com/announcements/8 July 2009
  • 16. 6 RSV: Disease Information July 2009
  • 17. 7 When is Medical Treatment Needed? Usually diagnosis and specific medical treatment are not needed However, treatment is need for more severe infection July 2009
  • 18.
  • 19.
  • 23. Synagis is covered 60% of the time under the payer’s medical benefit and 40% of the time under the prescription benefitJuly 2009
  • 24.
  • 27. Congenital Heart Disease (CHD)http://pediatrics.about.com/od/newbornsandbabies/ig/Premature-Babies/Premature-Baby.htm July 2009
  • 28. 10 Documented RSV Risk Factors For 32-35 Week GA Infants 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 http://synagis.com/HCP/sub/potential-candidates.aspx
  • 29.
  • 31. Varies year to year and is based on historic data as well as current season datahttp://www.cdc.gov/Features/dsRSV/
  • 32. AAP Guidelines The American Academy of Pediatrics (AAP) 2006 Guidelines virtually the same as MedImmune and the FDA’s indications 2009 AAP Guidelines substantially different from current practice and the 2006 edition of the guideline lack reference to scientific evidence New guidelines are being evaluated by ESI and MedImmune not likely to be accepted by either as standard of care 12 www.chspediatrics.com
  • 33.
  • 34. Administration IM monthly, preferably into the anterolateral aspect of thigh 1st dose should be given prior to the areas RSV season Monthly doses should be continued throughout RSV season, even if RSV infection develops July 2009
  • 35.
  • 36.
  • 37. 16 Hospitalizations for RSV RSV Hospitalizations (%) 11 10 10 8,9 #1 cause of hospitalization in infants &lt;1 yr of age July 2009
  • 38. A Look at the Pipeline Motavizumab derivative of Synagis 10-20 times more potent Anticipated for 2010-2011 RSV Season 17 http://www.medimmune.com/pipeline/index.asp
  • 40. 19 RSV Logic A Look at our High-touch Care Management Program July 2009
  • 41.
  • 42.
  • 43.
  • 44. Gestational age, weight, diagnosis, risk factors
  • 46. RSV season, prophylaxis (e.g. smoking cessation, hygiene), when to call doctor
  • 48. Side effects, missed dose/complianceJuly 2009
  • 49. 22 Clinical Assessments: Examples Indications? Risk Factors? July 2009
  • 50. 23 Summary RSV is a common virus that leads to hospitalizations in some high risk patients Synagis® is a high cost medication that can prevent RSV hospitalizations in these patients RSV Logic is a clinical solution that is already in place, and it is designed to optimize outcomes and control cost For more information direct questions to your sales support director or see the RSV Client Facing Deck July 2009
  • 51. 24 References Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and Management of Bronchiolitis, American Academy of Pediatrics. 2006;1774-1793. Thompson WT et al. JAMA. 2003;289:179-86. Mayo Clinic Staff. Respiratory Syncytial Virus (RSV), http://www.mayoclinic.com,2007. Accessed November 2008. Shay DK, Holman RC, Newman RD, et al. JAMA. 1999;282:1440-1446. McLaurin KK, Leader S. Pediatric Academic Societies Meeting, May 14-17, 2005. Abstract #936. 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. Synagis (palivizumab) [package insert]. Galtherburg, MD: MedImmune; 2008. Shay DK et al. JAMA.1999;282:1440-1446. Hall CB.Respiratorysynctial virus. In:Feigin RD, Cherry JK.eds. Textbook of Pediatric Infectious Diseases. 4th ed. Philadelphia.PA:WB Saunders;1998. The Impact-RSV Study Group. Pediatrics. 1998; 102:531-537. Feltes TF et al.J Pediatr.2003;143:532-540. MedImmune. RSV Protection.com. http://www.rsvprotection.com/index.aspx. Accessed July 7, 2009. Other References as Cited on individual slides. Last Updated July 2009 July 2009