Subject:
Respiratory Syncytial Virus Infection Prophylaxis
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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In 1998, the US Food and Drug Administration FDA) approved Synagis (palivizumab) which is marketed by MedImmune, Inc. Synagis is humanized monoclonal antibody produced by recombinant DNA technology. It is administered by intramuscular injection. The FDA labeling warns that cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. FDA also recommends caution when using in children with thrombocytopenia or any coagulation disorders since it is an intramuscular injection.
Synagis is approved by the FDA for the prevention of serious lower respiratory tract infection caused by RSV in children under 24 months of age with chronic lung disease of prematurity (CLD), formerly called bronchopulmonary dysplasia (BPD), a history of premature birth (< 35 weeks gestation), or children with hemodynamically significant congenital heart disease (CHD). They have been demonstrated to be safe and effective in reducing the incidence and duration of RSV hospitalization and the severity of RSV illness in these high risk infants.
The American Academy of Pediatrics released an update in July 2014 to provide guidance for child health care topics, with an emphasis on evidence-based recommendations whenever possible. Policy statements are reviewed at least every 3 years and updated when appropriate. This policy statement updates and replaces the most recent AAP recommendations for the use of palivizumab prophylaxis published in 2012. The guidelines were again reviewed in 2017 with no updates. They latest version of the guidelines are noted in the 2018 Red Book and they still refer to the 2014 guidance.
[INFORMATIONAL NOTE: As of September 2004, MedImmune has ceased manufacturing RespiGam (RSV-IGIV). Supplies for RSV-IGIV have been depleted and no product is available for sale from MedImmune.
In August 2010, Motavizumab (proposed to be marketed as Rezield™, MedImmune, Inc) received a complete response letter from the FDA requesting additional clinical data on its biologics license application. Subsequently, AstraZeneca suspended Motavizumab development and upon the manufacturer’s request, the FDA withdrew its biological license application]
Policy:
[INFORMATIONAL NOTE: Please refer to a separate policy on Intravenous Immunoglobulin (IVIG) Therapy (Policy #016) under the Drug Section.]
I. Respiratory Syncytial Virus (RSV) infection prophylaxis with palivizumab (Synagis) must be prescribed by the treating physician.
II. Palivizumab (Synagis) is considered medically necessary for the following children who are under 12 months old when the RSV season begins:
A. premature infants with chronic lung disease (CLD) defined as a gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least first 28 days after birth; or
B. premature infants who were delivered at < 29 weeks, 0 days gestation; or
C. infants who have either congenital abnormalities of the airway or a neuromuscular disease that impairs the ability to clear secretions from the upper airways because of ineffective cough; or
D. children with hemodynamically significant acyanotic or cyanotic congenital heart disease for example, but not limited to, infants who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension; or
E. children who undergo cardiac transplantation during RSV season or
F. children with cystic fibrosis with clinical evidence of chronic lung disease (CLD) or nutritional compromise (defined as weight is at or below the 10th percentile based on growth charts); or
G. children who are profoundly immunocompromised during RSV season (e.g., severe combined immunodeficiency or advanced acquired immunodeficiency syndrome, or receiving chemotherapy).
III. Palivizumab (Synagis) is considered medically necessary for the following children who are between 12 and 24 months of age when the RSV season begins
A. premature infants with chronic lung disease (CLD) defined as a gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least first 28 days after birth who continue to require medical intervention (supplement oxygen, chronic systemic corticosteroids, or diuretic therapy) within 6 months before the start of second RSV season; or
B. children who undergo cardiac transplantation during RSV season; or
C. children who are profoundly immunocompromised during RSV season (e.g., severe combined immunodeficiency or advanced acquired immunodeficiency syndrome, or receiving chemotherapy); or
D. children with cystic fibrosis manifestations of severe lung disease (previously hospitalization for pulmonary exacerbation in the first year of life or abnormalities of chest radiography or chest computed tomography that persist when stable) OR nutritional compromise (defined as weight is at or below the 10th percentile based on growth charts)
IV. When palivizumab (Synagis) is considered medically necessary, prophylaxis will be approved based on the following number of doses:
- maximum of 5 doses per RSV season and qualifying infants born during RSV season may require fewer doses.
- discontinue therapy if a child experiences a breakthrough RSV hospitalization during the current RSV season.
- maximum of 5 doses per RSV season for infants and children residing in Florida.
- 15mg/kg dose per injection per months, dosing less frequently than monthly is not recommended based on the FDA approved package insert
[INFORMATIONAL NOTE: The following clinical information is provided as a guide in the use of Synagis: According to the American Academy of Pediatrics, “Prophylaxis against RSV should be initiated just before onset of the RSV season and terminated at the end of the RSV season. In most seasons and in most regions of the Northern Hemisphere, the first dose of palivizumab should be administered at the beginning of November and the last dose should be administered at the beginning of March, which will provide protection into April. To understand the epidemiology of RSV in their area, physicians should consult with local health departments or diagnostic virology laboratories or the Centers for Disease Control and Prevention if such information is not available locally. Decisions about the specific duration of prophylaxis should be individualized according to the duration of the RSV season. Pediatricians may wish to use RSV rehospitalization data from their own region to assist in the decision-making process.”]
The AAP further recommends the following: in 2014 "Despite varying onset and offset dates of the RSV season in different regions of Florida, a maximum of 5 monthly doses of palivizumab should be adequate for qualifying infants for most RSV seasons in Florida."
The 2014 AAP guidelines were reviewed in 2017 with no changes as per this memo from the AAP: https://www.aappublications.org/news/2017/10/19/RSV101917.
Additionally the AAP reaffirmed this again in 2019 and the link they provided to the guidelines is for the 2014 publication: https://pediatrics.aappublications.org/content/144/2/e20191767.
"Policy Statement: Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):415–420. Available at: https://pediatrics.aappublications.org/content/134/2/415. Reaffirmed February 2019." These guidelines are noted in the 2018 edition of the Red Book.]
V. The use of palivizumab (Synagis) is not considered medically necessary for non-high-risk infants and children including, but not limited to, the following:
- reactive airway disease/asthma who do not meet any of the above-mentioned criteria (II-III);
- hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus) who do not meet the above-mentioned criteria (II-III);
- lesions adequately corrected by surgery and do not require medication for congestive heart failure
and who do not meet the above-mentioned criteria (II-III);
- mild cardiomyopathy who are not receiving medical therapy and do not meet the above-mentioned criteria (II-III);
- children in second year of life and do not meet the above-mention criteria (III);
- prevention of health-care associated RSV disease and do not meet the above-mentioned criteria (II-III);
- treatment of RSV disease (II-III);
- children with down syndrome without CLD, airway clearance issues or prematurity (II-III).
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Respiratory Syncytial Virus Infection Prophylaxis
Immune Globulin Prophylaxis, Respiratory Syncytial Virus
Palivizumab
Prophylaxis, RSV
RespiGam
RSV-IGIV
Synagis
References:
1. 2005 Physicians' Desk Reference. 59th Edition. Medical Economics Publishing Company.
2. American Academy of Pediatrics. Policy Statement. Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV. Pediatrics. November 1998;102(5):1211-1216.
3. The Prevent Group. Reduction of Respiratory Syncytial Virus Hospitalization Among Premature Infants and Infants With Bronchopulmonary Dysplasia Using Respiratory Syncytial Virus Immune Globulin Prophylaxis. Pediatrics. January 1997;99(1):93-99.
4. Fixler DE. Respiratory Syncytial Virus Infection in Children with Congenital Heart Disease: A Review. Pediatric Cardiology. May-Jun 1996;17(3):163-8.
5. Hay JW, Ernst RL, Meissner HC. Respiratory Syncytial Virus Immune Globulin: A Cost-Effectiveness Analysis. The American Journal of Managed Care. July/August 1996;2(7):851-61.
6. Groothuis JR, Simoes EAF, Levin MJ, Hall CB, et al. Prophylactic Administration of Respiratory Syncytial Virus Immune Globulin to High-Risk Infants and Young Children. The New England Journal of Medicine. November 1993;329(21):1524-30.
7. St. Peter's Medical Center (New Brunswick, NJ) RespiGam Infusion Protocol. (November 1, 1996)
8. RespiGam package insert. MedImmune, Inc. Gaithersburg, MD. Apr 2011.
9. American Academy of Pediatrics. PedComm: AAP Member Alert. RSV-IGIV Use. (www.aap.org)
10. Synagis revisited. The Medical Letter. February 19, 2001;43(Issue 1098):13-14.
11. The Impact-RSV Group. Palivizumab, a humanized syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high–risk infants. Pediatrics. Sept 1998;102(3):531-37.
12. Medscape Drug Info: Intravenous Respigam – Uses from AHFS DI.(//promini.medscape.com/drugdb/drug_uses_dosage.asp?DrugCode=A%2D10293&DrugName=RESPIGAM+INTRAVEN%2E&DrugType=1)(accessed 10/26/01).
13. Arnold SR, Wang EE, Law BJ, et al. Variable morbidity of respiratory virus infection in patients with underlying lung disease: a review of the PICNIC RSV database. Pediatric Investigative Collaborative Network on Infections in Canada. Pediatr Infect Dis J. 1999 Oct;18(10):866-9.
14. Hiatt PW, Grace SC, Kozinetz CA, et al. Effects of viral lower respiratory tract infection on lung function in infants with cystic fibrosis. Pediatrics. 1999 Mar;103(#):619-26.
15. Cohen AH, et al. RSV prophylaxis using palivizumab in 86 high-risk children, outside AAP Red Book guidelines. APS/SPR/APA – 2001 Convention. April 28, 2001 (Abst # 2656).
16. Abman SH, Ogle JW, Butler-Simon N, et al. Role of respiratory syncytial virus in early hospitalizations for respiratory distress of young infants with cystic fibrosis. The Journal of Pediatrics. 1988 Nov;113(5):826-30.
17. Simoes EA. Treatment and prevention of respiratory syncytial virus lower respiratory tract infection. Long- term effects on respiratory outcomes. Am J Respir Crit Care Med 2001 Mar;163(3 Pt 2):S14-7.
18. Openshaw PJ. Potential mechanisms causing delayed effects of respiratory syncytial virus infection. Am J Respir Crit Care Med 2001 Mar;163(3 Pt 2):S10-3.
19. Kimpen JL. Prevention and treatment of respiratory syncytial virus bronchiolitis and postbronchiolitic wheezing. Respir Res 2002;3(Suppl 1):S40-S45.
20. Wenzel SE, Gibbs RL, Lehr MV, Simoes EA. Respiratory outcomes in high-risk children 7 to 10 years after prophylaxis with respiratory syncytial virus immune globulin. Am J Med 2002 Jun 1;112(8):627-33.
21. Piedimonte G. The association between respiratory syncytial virus infection and reactive airway disease. Respir Med 2002 Apr;96 Suppl B:S25-9.
22. Kimpen JL, Simoes EA. Respiratory syncytial virus and reactive airway disease. New developments prompt a new review. Am J Respir Crit Care Med 2001 Mar;163(3 Pt 2):S1.
23. American Academy of Pediatrics, Committee of Fetus and Newborn; Canadian Paediatric Society, Fetus and Newborn Committee. Postnatal corticosteroids to treat or prevent chronic lung disease in preterm infants. Pediatrics 2002 Feb;109(2):330-8. http://www.aap.org/policy/010117.html (accessed 10/08/02)
24. American Academy of Pediatrics. Red Book Online. Respiratory Syncytial Virus: Section 3. Summaries of Infectious Diseases. 2003.
25. American Academy of Pediatrics. Technical Report: Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections. Pediatrics 2003 December;112(6):1447-52.
26. American Academy of Pediatrics. Policy Statement: Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections. Pediatrics 2003 December;112(6):1442-46.
27. Holman RC, et al. Risk factors for bronchiolitis-associated deaths among the infants in the United States. Pediatr Infect Dis J 2003;22(6):483-489.
28. Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997-2000. J Pediatr 2003;143(5):S127-S132.
29. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. October 6, 2000;49(RR-9).
30. McConnichie KM, Roghmann KJ. Parental smoking, presence of older siblings, and family history of asthma increase the risk of bronchiolitis. Am J Dis Child 1986;140(8):806-812.
31. American Academy of Pediatrics. In: Pickering LK, Baker CJ, long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.
32. Meissner HC, Bocchini JA. Reducing RSV hospitalizations: AAP modifies indications for use of palivizumab in high-risk infants, young children. 2009 Jun [cited 2009 Jun 10] Available from:URL: http://aapnews.aappublications.org/cgi/content/full/aapnews.20090604-1v1
33. American Academy of Pediatrics. Respiratory Syncytial Virus. In: Pickering LK, ed. Red Book: 2009 Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009:560-569. Available at: http://aapredbook.aappublications.org/cgi/content/full/2009/1/3.110. Accessed July 6, 2009.
34. American Academy of Pediatrics. Modified Recommendations for Use of Palivizumab for Prevention of Respiratory Syncytial Virus Infections. Released 8/24/09. Available at: http://aapredbook.aappublications.org/news/RSVPolicy-082409.pdf. Accessed September 17, 2009.
35. Clinical Trials.gov. RSV Disease in the Elderly. Available from: http://clinicaltrials.gov/ct2/show/NCT00246480?term=RSV&rank=23
36. ClinicalTrials.gov. Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation. Available from: http://clinicaltrials.gov/ct2/show/NCT00667303?term=RSV&rank=64
37. National Perinatal Association. Respiratory Syncytial Virus (RSV) Prevention 2010. Released 1/12/2010. Available at: http://www.nationalperinatal.org/advocacy/pdf/Respiratory-Syncytial-Virus-Prevention-2010.pdf.
38. Micromedex. Palivizumab (Synagis). Available at http://www.thomsonhc.com/hcs/librarian/ND_T/HCS/ND_PR/Main/CS/90A626/DUPLICATIONSHIELDSYNC/59DD10/ND_PG/PRIH/ND_B/HCS/SBK/1/ND_P/Main/PFActionId/hcs.common.RetrieveDocumentCommon/DocId/924765/ContentSetId/100/SearchTerm/palivizumab/SearchOption/BeginWith (Accessed on 2/10/11).
39. AAP (American Academy of Pediatrics). Respiratory Syncytial Virus. In: Pickering LK, ed. Red Book: 2012 (29 Edition). Report of the Committee on Infectious Diseases. Elk Grove Village, IL: American Academy of Pediatrics; pp 609-618.
40. American Academy of Pediatrics. Policy Statement. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics. ePub July 28. Avai 2014. Available at: http://pediatrics.aappublications.org/content/early/2014/07/23/peds.2014-1665.full.pdf+html
41. Synagis® [package insert]. Gaithersburg, MD : MedImmune,LLc; May 2017.
42. Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). April 20, 2015. http://www.cdc.gov/rsv/clinical/ (Acessed on 7/13/2016).
43. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infeciton. American Academy of Pediatrics. December 2014. (Accessed April 28, 2019).
44. American Academy of Pediatrics News and Journals. RSV recommendations unchanged after review of new data. Available at https://www.aappublications.org/news/2017/10/19/RSV101917. October 2017. Accessed April 28, 2019
45. AAP Publications Reaffirmed. Pediatrics August 2019, 144 (2) e20191767; DOI: https://doi.org/10.1542/peds.2019-1767. Available at: https://pediatrics.aappublications.org/content/144/2/e20191767.
46. Respiratory Syncytial Virus. Red Book 2018-2021. Section 3: Summaries of infectious diseases. Available at: https://redbook.solutions.aap.org/chapter.aspx?sectionid=189640170&bookid=2205
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
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