Last Review Date: 09/05/2024

Date of Origin: 11/28/2011

Dates Reviewed: 12/2011, 02/2013, 02/2014, 08/2014, 07/2015, 11/2016, 02/2019, 10/2019, 08/2021, 11/2021, 02/2022, 08/2022, 09/2023, 09/2024

1. Length of Authorization

• Coverage will be provided for a maximum of 5 monthly doses for use during the typical RSV season ± (Note: In regions experiencing high rates of RSV circulation, consistent with a typical RSV season onset, coverage may be provided if surveillance data from the CDC indicate a high percent positivity rate for RSV testing in the area.)
• In infants and children < 24 months already eligible and on prophylaxis with palivizumab, 1 additional post-op dose can be approved after cardiopulmonary bypass or after extracorporeal membrane oxygenation (ECMO), followed by the remaining monthly doses for the season.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• 50 mg/0.5 mL solution for injection in a single-dose vial: 1 vial every 28 days
• 100 mg/1 mL solution for injection in a single-dose vial: 2 vials every 28 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 5 billable units every 28 days

3. Initial Approval Criteria

Coverage is provided in the following conditions:

Prevention of serious lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) † ‡ ^1-3,14,22,24

• Patient has NOT had an RSV infection during the current RSV season; AND
• Patient has NOT received nirsevimab for the current RSV season; AND
• Patient does NOT have access to, or it is not feasible to administer nirsevimab; AND
  • Patient is < 12 months of age entering their first RSV season; AND
    • One of the following apply regarding the pregnant parent’s RSV vaccination status:
      • Patient is ≥ 8 months of age, regardless of pregnant parent’s RSV vaccination status; OR
      • The pregnant parent did not receive an RSV vaccine prior to birth; OR
      • The provider judges that the incremental benefit to administering palivizumab to the infant born to a vaccinated pregnant patient is warranted due to one of the following:
        • • Patient was born < 14 days after the pregnant parent’s RSV vaccination; OR
          • The pregnant parent did not mount an adequate immune response to vaccination or has a condition associated with reduced transplacental antibody transfer (e.g., persons with immunocompromising conditions); OR
          • The infant has experienced loss of transplacentally acquired antibodies (e.g., those who have undergone cardiopulmonary bypass or ECMO); OR
          • The infant has substantially increased risk for severe RSV disease (e.g., hemodynamically significant congenital heart disease or intensive care admission requiring oxygen at hospital discharge); AND
    • Patient meets one of the following risk factors:
      • Patient gestational age (GA) < 29 weeks, 0 days; OR
      • Patient has chronic lung disease (CLD) of prematurity (GA < 32 weeks, 0 days and the patient required > 21% supplemental oxygen for at least the first 28 days after birth); OR
      • Patient has hemodynamically significant congenital heart disease (CHD) with one of the following**:
        • • Acyanotic heart disease on CHF medications and will require cardiac surgery; OR
          • Moderate to severe pulmonary hypertension; OR
          • Cyanotic heart defects and the prescriber is a pediatric cardiologist or has consulted a pediatric cardiologist; OR
          • Undergoing cardiac transplant during the RSV season; OR
          • Cardiac lesions have been adequately corrected by surgery, but continues to require medication for CHF; OR
          • Mild cardiomyopathy and receiving medical therapy for the condition; OR
      • Patient has cystic fibrosis; AND
        • • Patient has clinical evidence of chronic lung disease (CLD) and/or nutritional compromise; OR
      • Patient has an impaired ability to clear upper airway secretions because of an ineffective cough due to congenital anomaly or a neuromuscular disease; OR
      • Patient is profoundly immunocompromised; OR
  • Patient is < 24 months of age entering their second RSV season; AND
    • Patient meets one of the following risk factors:
      • Patient has chronic lung disease (CLD) of prematurity (GA < 32 weeks, 0 days and the patient required > 21% supplemental oxygen for at least the first 28 days after birth); AND
        • • Patient has required medical support (chronic steroids, diuretic therapy, or supplemental oxygen) within 6 months prior to the start of the second season; OR
      • Patient has congenital heart disease (CHD) undergoing cardiac transplant during the RSV season**; OR
      • Patient has cystic fibrosis; AND
        • • Patient has weight for length < 10^th percentile; OR
          • Patient has severe lung disease (i.e., previous hospitalization for pulmonary exacerbation in the first year of life, abnormalities on chest radiography, or chest computed tomography that persist when stable); OR
      • Patient is profoundly immunocompromised

** Infants and children already eligible and on prophylaxis with palivizumab who are undergoing surgical procedures involving cardiopulmonary bypass should receive an additional dose of palivizumab as soon as possible after the cardiopulmonary bypass or after ECMO (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

• Coverage may not be renewed.

5. Dosage/Administration ^1-3

6. Billing Code/Availability Information

HCPCS/CPT Code:

• 90378 – Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each; 1 billable unit = 50 mg
• S9562 – Home injectable therapy, palivizumab or other monoclonal antibody for rsv, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

NDC(s):

• 50 mg/0.5 mL solution for injection in a single-dose vial: 66658-0230-xx
• 100 mg/1 mL solution for injection in a single-dose vial: 66658-0231-xx

7. References

1. Synagis [package insert]. Waltham, MA; Sobi Inc.; November 2021. Accessed August 2024.
2. 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.  2014;134(2):415–420. Available at: https://pediatrics.aappublications.org/content/134/2/415. Reaffirmed February 2019.
3. American Academy of Pediatrics. Technical Report. Palivizumab prophylaxis in infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2023;152(1): e2023061803. DOI: 10/1542/peds.2023-061803. Available at: https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/.    
4. Munoz FM, Ralston SL, Meissner HC. RSV recommendations unchanged after review of new data. AAP News. October 19, 2017. Available at:  https://publications.aap.org/aapnews/news/13439.
5. AAP publications reaffirmed. Pediatrics. 2019; 144(2) e20191767. DOI: 10.1542/peds.2019-1767. Available at: https://pediatrics.aappublications.org/content/144/2/e20191767.  
6. Updated Guidance: Use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the 2022-2023 RSV season. Last updated November 17, 2022. Available at: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization.
7. CDC. Emergency Preparedness and Response. Increased interseasonal respiratory syncytial virus (RSV) activity in parts of the southern United States. June 10, 2021. Available at: https://emergency.cdc.gov/han/2021/han00443.asp.
8. Interim guidance for use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the current atypical interseasonal RSV spread. August 2021. Available at: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/.
9. Updated Guidance: Use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the 2021-2022 RSV season. December 17, 2021. Available at: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/.
10. AAP continues to support palivizumab use in areas with high rates of RSV. Available at: https://publications.aap.org/aapnews/news/22058/AAP-continues-to-support-palivizumab-use-in-areas?_ga=2.118694985.1389103254.1671122347-1984533065.1671122347.
11. American Academy of Pediatrics offers guidance on RSV prophylaxis, handling surge of pediatric patients with respiratory infections. November 18, 2022. Available at: https://www.aap.org/en/news-room/news-releases/aap/2022/american-academy-of-pediatrics-offers-guidance-on-rsv-prophylaxis-handling-surge-of-pediatric-patients-with-respiratory-infections/.
12. FDA news release. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. August 21, 2023; Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants.
13. Rose EB, Wheatley A, Langley G, et al. Respiratory Syncytial Virus Seasonality — United States, 2014–2017. January 19, 2018. MMWR Morb Mortal Wkly Rep. 2018;67(2):71-76. Available at: https://www.cdc.gov/rsv/references.html
14. American Academy of Pediatrics. Respiratory syncytial virus. In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021:628-636.
15. American Academy of Pediatrics. ACIP and AAP recommendations for nirsevimab. Available at: https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab?searchresult=1?autologincheck=redirected.
16. American Academy of Pediatrics recommends medication to prevent RSV be given to all infants and urges equitable access. Available at: https://www.aap.org/en/news-room/news-releases/aap/2023/american-academy-of-pediatrics-recommends-medication-to-prevent-rsv-be-given-to-all-infants-and-urges-equitable-access/.
17. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices — United States, 2023.  August 25, 2023. Available at: https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a4.htm/.
18. Midgley CM, Haynes AK, Baumgardner JL, et al. Determining the seasonality of respiratory syncytial virus in the United States: The impact of increased molecular testing. J Infect Dis. 2017;216(3):345-355. DOI: 10.1093/infdis/jix275. Available at: https://www.cdc.gov/rsv/references.html#rsv-seasonality.
19. CDC advises broader testing for RSV due to regional spikes. June 10, 2021. Available at: https://publications.aap.org/aapnews/news/17156?autologincheck=redirected.
20. Centers for Disease Control and Prevention. Emergency Preparedness and Response. Limited Availability of Nirsevimab in the United States—Interim CDC Recommendations to Protect Infants from Respiratory Syncytial Virus (RSV) during the 2023–2024 Respiratory Virus Season. October 23, 2023. Available at: https://emergency.cdc.gov/han/2023/han00499.asp.
21. Goldstein M, Hopkins B, Kadri M, et al. National Perinatal Association 2024 respiratory syncytial virus (RSV) prevention clinical practice guideline: clinical presentation, prevention strategies, and social impacts in children: an evidence-based interdisciplinary collaboration. Neonatology Today. 2024;19(1):9-38. 
22. AAP Recommendations for the Prevention of RSV Disease in Infants and Children. February 21, 2024. Available at: https://publications.aap.org/redbook/resources/25379
23. Hamid S, Winn A, Parikh R, et al. Seasonality of Respiratory Syncytial Virus — United States, 2017–2023. MMWR Morb Mortal Wkly Rep 2023;72:355–361. DOI: http://dx.doi.org/10.15585/mmwr.mm7214a1
24. Barr FE, Graham BS. (2024). Respiratory syncytial virus infection: Prevention in infants and children. In Edwards MS, Blake D (Eds.), UptoDate. Last updated: July 26, 2024. Accessed on: August 9, 2024. Available from: https://www.uptodate.com/contents/respiratory-syncytial-virus-infection-prevention-in-infants-and-children

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medical Necessity Criteria

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