60574-4114-XX Synagis 50 MG/0.5ML SOLN (MEDIMMUNE)
60574-4113-XX Synagis 100 MG/ML SOLN (MEDIMMUNE)
Palivizumab is a recombinant humanized monoclonal antibody which specifically binds to the respiratory syncytial virus (RSV) envelope fusion protein on the surface of the virus. This blocks a critical step in the membrane fusion process and also prevents cell-to-cell fusion of RSV-infected cells. Through these actions, palivizumab provides passive immunity against RSV.
Palivizumab was originally licensed by the FDA in June of 1998 to reduce the risk of serious lower respiratory tract infection caused by RSV in infants at high risk for the disease. Since then, the American Academy of Pediatrics has updated guidance for its use four times as increased data has allowed better understanding of those children at greatest risk of hospitalization from RSV infection. The most recent update, referenced by the CDC as the latest and most specific guidelines for the use of palivizumab, was published in Pediatrics, Volume 134, Number 2, August 2014. It replaces the recommendations published in 2012.
Palivizumab for the prevention of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Palivizumab for the treatment and / or prevention of other conditions/diseases, including, but not limited to, the treatment of respiratory syncytial virus, is considered investigational.
Palivizumab is considered medically appropriate if ALL of the following criteria are met:
Request is for prevention of RSV infection (i.e., lacks current diagnosis of RSV infection)
Maximum number of monthly doses is 5 to begin in RSV season (e.g., November 1 through March 31)
As of November 1 of current year, individual is ANY ONE of the following:
12 months or younger with ANY ONE of the following:
Preterm infant with gestational age of less than 29 weeks, 0 days
Preterm infant with chronic lung disease (CLD) defined as ALL of the following:
Gestational age of less than 32 weeks, 0 days
Requirement of greater than 21% oxygen for a minimum of first 28 days after birth
Hemodynamically significant congenital heart disease (CHD) (e.g., acyanotic heart disease receiving medication to control congestive heart failure and will require cardiac surgical procedures, moderate to severe pulmonary hypertension) Note: Cyanotic heart defects require consultation with pediatric cardiologist
Inability to clear secretions from upper airway from ineffective cough due to ANY ONE of the following:
Diagnosis of cystic fibrosis with clinical evidence of ANY ONE of the following:
CLD (i.e., requirement of greater than 21% oxygen for a minimum of first 28 days after birth)
Nutritional compromise (e.g., electrolyte imbalances, body weight for length less than 10th percentile)
24 months of age or younger with ANY ONE of the following:
Cardiac transplantation during RSV season (if already on prophylaxis and eligible, 1 post-op dose can be approved after cardiac bypass or after extracorporeal membrane oxygenation [ECMO])
Profoundly immunocompromised during RSV season (e.g., receiving chemotherapy, solid organ transplant, hematopoietic stem cell transplantation)
History as preterm infant with CLD if ALL of the following:
Gestational age of less than 32 weeks, 0 days
Required supplemental oxygen a minimum of 28 days after birth
Continued requirement for medical support during the 6 month period before start of second RSV season (e.g., chronic systemic corticosteroid therapy, diuretic therapy, supplemental oxygen)
Diagnosis of cystic fibrosis with ANY ONE of the following:
Manifestations of severe lung disease (e.g., previous hospitalization for pulmonary exacerbation, abnormalities on chest radiography or computed tomography that persist when stable)
Body weight for length less than the 10th percentile
Palivizumab is NOT considered medically appropriate for renewal
Palivizumab will NOT be approved in the following scenarios:
Infant/Child Age at Start of RSV Season
>12 months (2nd year of life)
Based on prematurity alone
CLD without medical support (chronic systemic steroids, diuretic therapy, or supplemental O2)
Otherwise healthy children in 2nd year of life
Outpatient RSV infection or Breakthrough RSV hospitalization**
Hemodynamically insignificant CHD***
CHD lesions corrected by surgery (unless on CHF meds)
CHD and mild cardiomyopathy not on medical therapy
CHD in 2nd year of life
No specific age defined
GA ≥29 wks, 0 d (otherwise healthy)
Reduce wheezing episodes
CF (otherwise healthy)
Healthcare-associated RSV disease****
**If any infant or child is receiving palivizumab prophylaxis and experiences a breakthrough RSV hospitalization, discontinue palivizumab, because the likelihood of a second RSV hospitalization in the same season is extremely low.
***Examples of hemodynamically insignificant CHD: secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, patent ductus arteriosus.
No rigorous data exist to support palivizumab use in controlling outbreaks
of health care-associated disease; palivizumab use is not recommended
for this purpose.
DOSAGE & ADMINISTRATION
Prevention of RSV
15mg per kg of body weight monthly up to 5 doses prior to & through RSV season
LENGTH OF AUTHORIZATION
Coverage will be provided for a maximum of 5 doses during RSV reason may not be renewed
In infants and children < 24 months, already on prophylaxis and eligible, 1 post-op dose can be approved after cardiac bypass or after extracorporeal membrane oxygenation (ECMO)
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
RSV prophylaxis should be initiated just before the onset of the RSV season and terminated at the end of the RSV season. In most areas of the United States, RSV season is typically November through April. Five doses will protect for 6 months and ideally the first dose is administered at the beginning of November and the last dose at the beginning of the following March. The onset of RSV infection may occur earlier in southern states. BlueCross BlueShield of Tennessee maintains communication with regional children’s hospitals and the CDC to research the optimal time to begin and end palivizumab administration outside of the typical RSV season.
No evidence was found to support the year round administration of RSV prophylaxis. Children receiving prophylaxis should be considered for a postoperative dose of palivizumab after surgical procedures that use cardiopulmonary bypass or at the conclusion of extracorporeal membrane oxygenation (ECMO).
The American Academy of Pediatrics recommends that the following infants and children are not at increased risk from RSV and generally should not receive RSV immunoprophylaxis:
The Center for Disease Control and Prevention recommends preventive measures:
Do not share items such as cups, glasses, and utensils with persons who have RSV illness
American Academy of Pediatrics. (2014, August). Guidelines Committee of the Committee on Infectious Diseases and Bronchiolitis. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Retrieved October 4, 2018 from http://pediatrics.aappublications.org/content/134/2/415.full.
Lexi-Comp Online. (2019, February). AHFS DI. Palivizumab. Retrieved April 5, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, March). Palivizumab. Retrieved April 4, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Synagis® (palivizumab) injection for intramuscular use. Retrieved April 5, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/4/1997
MOST RECENT REVIEW DATE: 7/31/2019
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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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 50 mg