BlueCross BlueShield of Tennessee Medical Policy Manual

Palivizumab

NDC CODE(S)

60574-4114-XX Synagis 50 MG/0.5ML SOLN (MEDIMMUNE)

 

60574-4113-XX Synagis 100 MG/ML SOLN (MEDIMMUNE)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

DENIAL CRITERIA

Palivizumab will NOT be approved in the following scenarios:

Infant/Child Age at Start of RSV Season

Deny

>12 months (2nd year of life)

Based on prematurity alone

CLD without medical support (chronic systemic steroids, diuretic therapy, or supplemental O2)

CHD

Otherwise healthy children in 2nd year of life

Any age

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)

Asthma prevention

Reduce wheezing episodes

Down Syndrome

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.

INDICATION(S)

DOSAGE & ADMINISTRATION

Prevention of RSV

15mg per kg of body weight monthly up to 5 doses prior to & through RSV season

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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of palivizumab for the treatment or prevention of any other conditions or diseases.

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:

SOURCES

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 May 23, 2017 from http://pediatrics.aappublications.org/content/134/2/415.full.

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2016). Immune prophylaxis for respiratory syncytial virus (5.01.10). Retrieved May 23, 2017 from BlueWeb.

Lexi-Comp Online. (2017, March). AHFS DI. Palivizumab. Retrieved May 23, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Palivizumab. Retrieved May 23, 2017 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 May 23, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/4/1997

MOST RECENT REVIEW DATE:  8/8/2017

ID_MRx

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.

Pharmaceutical Decision Support Tree

Palivizumab (Synagis ®)

  1. Is the requested medication being used to treat a diagnosis of respiratory syncytial virus (RSV) or lower respiratory tract caused by RSV?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

  1. Is the request for five or fewer injections to fall between November 1 of the current year and March 31 of the following year?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. As of November 1 of the current year, is the child 12 months of age or younger?

If yes, go to question #4

If no, go to question #9

  1. Is the individual a preterm infant with ALL of the following?

If yes, go to question #13

If no, go to question #5

  1. Is there a diagnosis of chronic lung disease (CLD) in an individual with ALL of the following?

If yes, go to question #13

If no, go to question #6

  1. Does the infant have a diagnosis of congenital heart disease (CHD) that is hemodynamically significant (e.g., acyanotic heart disease receiving medication to control congestive heart failure and will require cardiac surgical procedures, moderate to severe pulmonary hypertension)?

If yes, go to question #13

If no, go to question #7

  1. Is the infant unable to clear secretions from the upper airway due to any one of the following conditions?

If yes, go to question #13

If no, go to question #8

  1. Does the infant have a diagnosis of cystic fibrosis with clinical evidence of ANY ONE of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. As of November 1 of the current year, is the child 24 months of age or younger?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there evidence of ANY ONE of the following?

If yes, go to question #13

If no, go to question #11

  1. Was the child a preterm infant diagnosed with CLD (chronic lung disease) with ALL of the following?

If yes, go to question #13

If no, go to question #12

  1. Is there a diagnosis of cystic fibrosis with ANY ONE of the following?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a maximum of 5 monthly doses of 15 mg/kg IM at 1 billable unit per 50mg/0.5mL vial (may approve for infants and children < 24 months, already on prophylaxis and eligible, one post-op dose after cardiac bypass or after extracorporeal membrane oxygenation [ECMO]?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.