BlueCross BlueShield of Tennessee Medical Policy Manual

Palivizumab (Synagis®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

          I.    INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A.    FDA-Approved Indication

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

·         with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season,

·         with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season,

·         with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

Limitations of Use:  

The safety and efficacy of Synagis have not been established for treatment of RSV disease.

B.    Compendial Uses

1.     RSV prophylaxis in infants with congenital abnormalities of the airway or neuromuscular disease that compromise handling of respiratory secretions

2.     RSV prophylaxis in immunocompromised pediatric patients

3.     RSV prophylaxis in pediatric patients with cystic fibrosis who have evidence of chronic lung disease or nutritional compromise in the first year of life

All other indications are considered experimental/investigational and not medically necessary.

         II.    CRITERIA FOR INITIAL APPROVAL

Authorization of up to 5 doses per RSV season may be granted for the prevention of serious lower respiratory tract disease caused by RSV when a member has any of the following diagnoses and meets the criteria pertaining to the diagnosis:

1.     Prematurity

2.     Chronic lung disease (CLD) of prematurity

3.     Congenital heart disease (CHD) (See Appendix B)

4.     Congenital airway abnormality

5.     Neuromuscular condition

6.     Immunocompromised children

7.     Cystic fibrosis

A.    Prematurity

All of the following criteria are met:

1.     Member’s gestational age is < 29 weeks, 0 days.

2.     Member’s chronological age at the start of RSV season is < 12 months.

B.    CLD of prematurity

ALL of the following criteria must be met:

1.     Member’s gestational age is < 32 weeks, 0 days.

2.     Requirement for > 21% oxygen for at least the first 28 days after birth.

3.     Member meets either of the following criteria:

                                  i.        Member’s chronological age at the start of their first RSV season is < 12 months.

                                 ii.        Member’s chronological age at the start of the subsequent RSV season is < 24 months and the member continues to require medical support (e.g., chronic corticosteroids, diuretic therapy, supplemental oxygen) during the 6-month period prior to the start of the RSV season.

C.    CHD

All of the following criteria are met:

1.     CHD is hemodynamically significant.

2.     Member meets either of the following criteria:

                                  i.        Member’s chronological age at the start of RSV season is < 12 months.

                                 ii.        Member’s chronological age at the start of RSV season is between 12 to 24 months and the member will be undergoing cardiac transplantation during the RSV season.

D.    Congenital airway abnormality

All of the following criteria must be met:

1.     The condition compromises handling of respiratory secretions.

2.     Member’s chronological age at the start of RSV season is < 12 months.

E.    Neuromuscular condition

All of the following criteria must be met:

1.     The condition compromises handling of respiratory secretions.

2.     Member’s chronological age at the start of RSV season is < 12 months.

F.    Immunocompromised children

All of the following criteria must be met:

1.     Member is profoundly immunocompromised during the RSV season (e.g., SCID, stem cell transplant, bone marrow transplant)

2.     Member’s chronological age at the start of the RSV season is <24 months

G.    Cystic Fibrosis

Either of the following criteria must be met:

1.     Member’s chronological age at the start of the RSV season is < 12 months and the member has evidence of CLD or nutritional compromise

2.     Member’s chronological age at the start of RSV season is between 12 to 24 months and the member has manifestations of lung disease (e.g., hospitalizations for pulmonary exacerbations) or weight for length less than the 10^th percentile

       III.    OTHER

For all off-season Synagis requests, authorization of 1 dose per request, up to a maximum of 5 doses per RSV season, may be granted if the RSV activity for the requested region is ≥ 10% (with rapid antigen testing) or ≥ 3% (with real-time polymerase chain reaction (PCR) test) within 2 weeks of the intended dose according to the CDC National Respiratory and Enteric Virus Surveillance System (NREVSS).³ The local health department or the CDC NREVSS will be consulted to assess the RSV activity for that region or state (http://www.cdc.gov/surveillance/nrevss/rsv/index.html). Other Specialty Guideline Management criteria apply.

Synagis Season will be from November 1^st to March 31^st. Other health plans may differ.

During 2022, the American Academy of Pediatrics (AAP) supports initiating the standard palivizumab regimen (five consecutive monthly doses) for eligible infants in regions of the United States with interseasonal rates of RSV activity similar to those in a typical fall-winter season.  During the COVID-19 pandemic, RSV has not followed its typical seasonality of late fall through spring, leading the AAP to support use of the monoclonal antibody at other times of the year if activity is comparable to a regular season. Currently, virus activity varies by region.

       IV.    APPENDIX

Appendix A: Recommended Use of Synagis for Prevention of RSV Infection 

Recommendations from the American Academy of Pediatrics for the prevention of RSV infection with Synagis are summarized in Table below.² Synagis should be administered intramuscularly at a dose of 15 mg/kg once per month beginning prior to the onset of the RSV season,^1,2 which typically occurs in November.² Because 5 monthly doses of Synagis will provide more than 6 months of serum Synagis concentrations above the desired serum concentration for most infants, administration of more than 5 monthly doses is not recommended within the continental United States.²

     Table. Recommended Use of Synagis for Prevention of RSV Infection 

Abbreviations: CHD = congenital heart disease; CLD = chronic lung disease (formerly bronchopulmonary dysplasia); RSV = respiratory syncytial virus.

* Medical support includes supplemental oxygen, diuretic therapy, or chronic corticosteroid therapy.

Appendix B: Examples of Congenital Heart Anomalies*

·         Atrial or ventricular septal defect

·         Patent ductus arteriosus 

·         Coarctation of aorta 

·         Tetralogy of Fallot  

·         Pulmonary or aortic valve stenosis 

·         D-Transposition of great arteries

·         Hypoplastic left/right ventricle

·         Truncus arteriosus

·         Total anomalous pulmonary venous return

·         Tricuspid atresia 

·         Ebstein’s anomaly

·         Pulmonary atresia 

·         Single ventricle

·         Double-outlet right ventricle

*Must be hemodynamically significant. See Table above for examples of infants and children who are most likely to benefit from Synagis.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1.     Synagis [package insert]. Waltham, MA: Sobi Inc; November 2020. 

2.     American Academy of Pediatrics. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):415-20.

3.     Rose EB, Wheatley A, Langley G, Gerber S, Haynes A. Respiratory Syncytial Virus Seasonality — United States, 2014–2017. MMWR Morb Mortal Wkly Rep 2018;67:71–76. DOI: https://dx.doi.org/10.15585/mmwr.mm6702a4.  Accessed May 4, 2022.  

4.     Bernstein D. Epidemiology and Genetic Basis of Congenital Heart Disease. In: Kliegman RM, St. Geme J. Nelson Textbook of Pediatrics, Edition 21. Chap. 451.  Philadelphia, PA: Elsevier; 2020. Accessed May 4, 2022.

5.     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. The Journal of Infectious Disease. 1 August 2017; 216(3): 345-355.

6.     American Academy of Pediatrics. Updated Guidance: Use of Palivizumab Prophylaxis to Prevent Hospitalization From Severe Respiratory Syncytial Virus Infection During the 2022-2023 RSV Season. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/. Updated Aug 26, 2022.  Accessed September 2, 2022.

ORIGINAL EFFECTIVE DATE: 12/4/97

MOST RECENT REVIEW DATE: 1/1/2024

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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