Anthem Blue Cross California Synagis (palivizumab) Form

Overview Coding References Clinical Criteria Document history Overview This document addresses the use of Synagis (palivizumab), a monoclonal antibody approved by the Food and Drug Administration for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection in select pediatric individuals. Randomized placebo-controlled clinical trials have demonstrated the safety and efficacy of Synagis in reducing hospitalizations due to RSV infection and in reductions in other measures of RSV infection severity for a very specific group of infants and children. Epidemiologic data indicate that the risk of severe RSV infection most likely to require hospitalization is greater in the presence of risk factors. In 2014, the American Academy of Pediatrics (AAP) issued updated guidelines regarding the use of immune prophylaxis for RSV. AAP reaffirmed this guidance in 2019. A summary of the AAP RSV guidance is as follows: Infants born before 29 weeks, 0 days gestation in the first year of life Preterm Infants without Chronic Lung Disease (CLD) of Prematurity or Congenital Heart Disease (CHD) • Preterm Infants with CLD • Infants born before 32 weeks, 0 days gestation and a requirement for >21% oxygen for at least 28 days after birth in the first year of life Infants with CHD • Prophylaxis may be administered in first year of life to certain infants with hemodynamically significant heart disease • Consultation with a cardiologist if recommended for patients with cyanotic heart disease for prophylaxis decisions Children with Anatomic Pulmonary Abnormalities or Neuromuscular Disorder • Prophylaxis may be considered in first year of life to children with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways Immunocompromised Children • Prophylaxis may be considered in children under 24 months who will be profoundly immunocompromised Insufficient data available to routinely recommend prophylaxis during the RSV season Children with Down Syndrome • Children with Cystic Fibrosis • Timing of Prophylaxis for Alaska Native and American Indian Infants • Greater flexibility in use of prophylaxis as a result of potentially higher disease burden • Use of government RSV surveillance data may be helpful in decision-making Discontinuation of Prophylaxis Among Children who Experience Breakthrough RSV Hospitalization Insufficient data available to routinely recommend prophylaxis • Discontinue prophylaxis Prophylaxis in the Second Year of Life • Recommended in children who require ≥28 days of supplemental oxygen after birth and continue to require medical intervention (supplemental oxygen, chronic corticosteroid therapy, diuretics) Number of Monthly Doses in Season 1 • Maximum of 5 Other • Prophylaxis is not recommended for prevention of primary asthma or reduction of subsequent wheezing episodes • Prophylaxis is not recommended for prevention of nosocomial disease • Not recommended for use in RSV treatment Because 5 monthly doses of Synagis will provide more than 6 months of adequate serum concentrations for most infants, administration should be limited to the peak RSV season in the continental United States of November through March. Qualifying infants born during RSV season will need fewer than 5 doses for protection until the season ends. Specific information about national and regional RSV trends, especially pertaining to the peak variations in Florida and Alaska, is available from the National Respiratory and Enteric Virus Surveillance System (NREVSS) at: http://www.cdc.gov/surveillance/nrevss/rsv/index.html. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Synagis (palivizumab) Requests for Synagis (palivizumab) may be approved if the following criteria are met (2014 AAP): I. A maximum of 5 doses of Synagis may be approved for infants during the first RSV season within the first year of life with any of the following: A. Born before 29 weeks, 0 days gestation (up to and including 28 weeks, 6 days) and younger than 12 months of age at the start of the RSV season; OR B. Documentation is provided indicating chronic lung disease of prematurity defined as birth at less than 32 weeks, 0 days gestation and a requirement for greater than 21% oxygen for at least 28 days after birth (not including asthma, reactive airway disease and cystic fibrosis without significant symptoms; OR C. Documentation is provided indicating hemodynamically significant congenital heart disease (including infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension); OR D. Documentation is provided indicating anatomic pulmonary abnormalities (for example, tracheal ring) or a neuromuscular condition that impairs the ability to clear secretions from the upper airway because of ineffective cough; OR E. Documentation is provided indicating cystic fibrosis with clinical evidence of chronic lung disease or nutritional compromise (weight for length less than tenth percentile); OR II. A maximum of 5 doses of Synagis may be approved for children during their second RSV season (the second RSV season may fall in the first or second year of life) with any of the following: A. Documentation is provided indicating the individual is a preterm infant born at less than 32 weeks, 0 days gestation who required at least 28 days of oxygen after birth AND continues to require medical intervention within 6 months of the start of the second RSV season (including supplemental oxygen, chronic systemic corticosteroid therapy or diuretics); OR B. Documentation is provided indicating cystic fibrosis with severe lung disease (history of hospitalization, abnormal chest x-ray or CT scan) or weight for length less than tenth percentile; OR III. A maximum of 5 doses of Synagis may be approved for children younger than 24 months of age with any of the following: A. Documentation is provided indicating profound immunocompromised status (such as severe combined immunodeficiency, advanced acquired immunodeficiency syndrome, undergoing organ or hematopoietic stem cell transplant, or an absolute lymphocyte count of less than 100 cells/mm3 ); OR 2 B. Documentation is provided indicating the individual is undergoing cardiac transplantation; OR IV. One additional dose of Synagis may be approved for children younger than 24 months of age who have approval for a course of treatment and who undergo cardiopulmonary bypass for a surgical procedure. *Synagis approval is limited to RSV season as determined by CDC surveillance data (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) or local health department. Up to 5 doses may be approved during the months of November through March. Initiating therapy or providing additional doses for continued therapy in regions with high levels of interseasonal RSV activity may be approved on a case by case basis. Synagis (palivizumab) may not be approved for any of the following: I. II. III. IV. V. VI. VII. VIII. IX. Continued RSV prophylaxis for children who experience breakthrough RSV hospitalization; OR Treatment of known RSV disease; OR Children who reach 24 months of age prior to the beginning of RSV season; OR More than two seasons of RSV prophylaxis (unless individual is profoundly immunocompromised or undergoing cardiac transplantation); OR Primary asthma prevention or to reduce subsequent episodes of wheezing; OR Children with surgically corrected congenital heart disease or hemodynamically insignificant heart disease (including secundum atrial septal defect, small ventricular septal defect, uncomplicated pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus) who do not otherwise meet approval criteria; OR Children with Down syndrome who do not otherwise meet approval criteria; OR Individual using in combination with Beyfortus (nirsevimab) during the same RSV season; OR May not be approved when the above criteria are not met and for all other indications. Quantity Limits Synagis (palivizumab) Quantity Limit Drug Limit Synagis (palivizumab) 50 mg, 100 mg vial 15 mg/kg once a month for up to 5 doses per RSV season Override Criteria One additional dose may be approved for individuals undergoing cardiopulmonary bypass for a surgical procedure as noted in clinical criteria. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. CPT 90378 HCPCS S9562 Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each [Synagis] Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem ICD-10 Diagnosis P07.21 P07.22 Extreme immaturity of newborn, GA <23 completed weeks Extreme immaturity of newborn, 3 GA 23 completed weeks Extreme immaturity of newborn, GA 24 completed weeks Extreme immaturity of newborn, GA 25 completed weeks Extreme immaturity of newborn, GA 26 completed weeks Extreme immaturity of newborn, GA 27 completed weeks Preterm newborn, GA 28 completed weeks Preterm newborn, GA 29 completed weeks Preterm newborn, GA 30 completed weeks Preterm newborn, GA 31 completed weeks Preterm newborn, GA 32 completed weeks Preterm newborn, GA 33 completed weeks* Preterm newborn, GA 34 completed weeks* Preterm newborn, GA 35 completed weeks* Bronchopulmonary dysplasia originating in the perinatal period Other chronic respiratory diseases originating in the perinatal period Unspecified chronic respiratory disease originating in the perinatal period Pulmonary hypertension of newborn Cardiomyopathy, unspecified Heart failure, unspecified Common arterial trunk Double outlet right ventricle Double outlet left ventricle Discordant ventriculoarterial connection Double inlet ventricle Discordant atrioventricular connection Isomerism of atrial appendages Other congenital malformations of cardiac chambers and connections Congenital malformation of cardiac chambers and connections, unspecified Ventricular septal defect Atrial septal defect Atrioventricular septal defect Tetralogy of Fallot Aortopulmonary septal defect Other congenital malformations of cardiac septa Congenital malformation of cardiac septum, unspecified Pulmonary valve atresia P07.23 P07.24 P07.25 P07.26 P07.31 P07.32 P07.33 P07.34 P07.35 P07.36 P07.37 P07.38 P27.1 P27.8 P27.9 P29.30 I42.9 I50.9 Q20.0 Q20.1 Q20.2 Q20.3 Q20.4 Q20.5 Q20.6 Q20.8 Q20.9 Q21.0 Q21.10-Q21.19 Q21.20-Q21.23 Q21.3 Q21.4 Q21.8 Q21.9 Q22.0 Document History Revised: 8/18/2023