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Synagis® (Palivizumab) Synagis® (palivizumab) (Intramuscular) Document Number: IC-0120 Last Review Date: 07/28/2015 Date of Origin: 11/28/2011 Dates Reviewed: 12/13/11, 02/07/2013, 02/25/2014, 08/26/2014, 07/28/2015 I. Length of Authorization • Authorize for a maximum of 5 doses during RSV season (five monthly doses of 15 mg/kg IM). • In infants and children < 24 months, already on prophylaxis and eligible, one post-op dose can be approved after cardiac bypass or after extracorporeal membrane oxygenation (ECMO). II. Dosing Limits A. Quantity Limit (max daily dose) [Pharmacy Benefit]: − 15mg/kg IM monthly up to 5 doses − Synagis 50 mg vial: 1 vial every 28 days − Synagis 100 mg vial: 2 vials every 28 days B. Max Units (per dose and over time) [Medical Benefit]: − 5 billable units every 28 days III. Initial Approval Criteria Coverage is provided in the following conditions: Prevention of serious lower respiratory tract disease caused by Respiratory syncytial virus (RSV) Infant/Child Age at Start of RSV Season± Criteria (must meet at least one of the following) <12 months (1st year of life) . GA <29 wks, 0 d (otherwise healthy) . CLD of prematurity (GA <32 wks, 0 d and >21% O2 x first 28 d after birth) . Anatomic pulmonary abnormalities, or neuromuscular disorder, or congenital anomaly – impairs ability to clear secretions . Profoundly immunocompromised . CF with CLD and/or nutritional compromise Proprietary & Confidential © 2015 Magellan Health, Inc. Infant/Child Age at Start of RSV Season± Criteria (must meet at least one of the following) ≤ 12 months (1st year of life) . CHD (hemodynamically significant) with acyanotic HD on CHF medications and will require cardiac surgery or moderate to severe PH. For cyanotic heart defects consult a pediatric cardiologist >12 months (2nd year of life) . CLD of prematurity (GA <32 wks, 0 d and >21% O2 x first 28 d after birth) and medical support (chronic systemic steroids, diuretic therapy, or supplemental O2) within 6 months before start of 2nd RSV season . CF with severe lung disease* or weight for length <10th percentile <24 months (2nd year of life) . Cardiac transplant during RSV season . Already on prophylaxis and eligible: give post-op dose after cardiac bypass or after ECMO . Profoundly immunocompromised GA=gestational age; wks=weeks; d=day; CLD=chronic lung disease; CHD=congenital heart disease; O2=oxygen; HD=heart disease; CHF=chronic heart failure; PH=pulmonary hypertension; CF=cystic fibrosis; ECMO=extracorporeal membrane oxygenation *Examples of severe lung disease: previous hospitalization for pulmonary exacerbation in the 1st year of life, abnormalities on chest radiography [chest X-ray], or chest computed tomography [chest CT] that persist when stable ±RSV Season • There is variability in the onset and offset of RSV season. Generally it runs from November to April within the continental US. A maximum of 5 doses during RSV season provides 6 months of RSV prophylaxis. • Alaska- Due to the varied epidemiology of RSV infection, clinicians can use RSV surveillance data by the state of Alaska to determine the onset and offset of RSV season. • Florida- Data from the Florida Department of Health can be used to determine the onset and offset of RSV season in different regions of Florida. • Native American Indian infants- There is limited information about the burden of RSV infection among American Indian populations. Prophylaxis can be considered for Navajo and White Mountain Apache infants in the 1st year of life. • Despite onset and offset of RSV infection in some states or regions, only a maximum of 5 doses will be approved during RSV season. If prophylaxis is initiated later in the RSV season, the infant or child will receive less than 5 doses. For example if prophylaxis is initiated in January, the 4th and final dose, will be administered in April. For eligible infants born during RSV season, fewer than 5 monthly doses will be needed. SYNAGIS® (palivizumab) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy Page 2 | without approval. ©2015, Magellan Rx Management Synagis (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. IV. Renewal Criteria Renewal authorization is not applicable. V. Dosage/Administration Indication Dose RSV Prophylaxis The recommended dose is 15 mg/kg intramuscularly once a month throughout the RSV season. VI. Billing Code/Availability Information Jcode: 90378 – Synagis (MedImmune) 50, 100 mg injection: 1 billable unit = 50 mg NDC: N/A SYNAGIS® (palivizumab) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy Page 3 | without approval. ©2015, Magellan Rx Management VII. References 1. Synagis [package insert]. Gaithersburg, MD; MedImmune, LLC; March 2014. Accessed June 2015. 2. American Academy of Pediatrics. Position Statement. Updated guidance for palivizumab prophylaxis among Infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134;415. DOI: 10.1542/peds.2014- 1665. Appendix 1 – Covered Diagnosis Codes ICD-9 Codes Diagnosis 079.6 Respiratory syncytial virus (RSV) 279.00 Hypogammaglobulinemia, unspecified 279.01 Selective IgA immunodeficiency 279.02 Selective IgM immunodeficiency 279.03 Other selective immunoglobulin deficiencies 279.04 Congenital hypogammaglobulinemia 279.05 Immunodeficiency with increased IgM 279.06 Common variable immunodeficiency 279.09 Other deficiency of humoral immunity 279.10 Immunodeficiency with predominant T-cell defect, unspecified 279.11 Digeorge's syndrome 279.12 Wiskott-aldrich syndrome 279.13 Nezelof's syndrome 279.19 Other deficiency of cell-mediated immunity 279.2 Combined immunity deficiency 279.3 Unspecified immunity deficiency 279.41 Autoimmune lymphoproliferative syndrome 279.49 Autoimmune disease, not elsewhere classified 279.50 Graft-versus-host disease, unspecified 279.51 Acute graft-versus-host disease 279.52 Chronic graft-versus-host disease 279.53 Acute on chronic graft-versus-host disease 279.8 Other specified disorders involving the immune mechanism 279.9 Unspecified disorder of immune mechanism 358.00 Myasthenia gravis without (acute) exacerbation 358.01 Myasthenia gravis with (acute) exacerbation SYNAGIS® (palivizumab) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy Page 4 | without approval. ©2015, Magellan Rx Management ICD-9 Codes Diagnosis 358.1 Myasthenic syndromes in diseases classified elsewhere 358.2 Toxic myoneural disorders 358.30 Lambert-Eaton syndrome, unspecified 358.31 Lambert-Eaton syndrome in neoplastic disease 358.39 Lambert-Eaton syndrome in other diseases classified elsewhere 358.8 Other specified myoneural disorders 358.9 Myoneural disorders, unspecified 416.0 Primary pulmonary hypertension 416.1 Kyphoscoliotic heart disease 416.2 Chronic pulmonary embolism 416.8 Other chronic pulmonary heart diseases 416.9 Chronic pulmonary heart disease, unspecified 428.0 Congestive heart failure, unspecified 491.0 Simple chronic bronchitis 491.1 Mucopurulent chronic bronchitis 491.20 Obstructive chronic bronchitis without exacerbation 491.21 Obstructive chronic bronchitis with (acute) exacerbation 491.22 Obstructive chronic bronchitis with acute bronchitis 491.8 Other chronic bronchitis 491.9 Unspecified chronic bronchitis 493.20 Chronic obstructive asthma, unspecified 493.21 Chronic obstructive asthma with status asthmaticus 493.22 Chronic obstructive asthma with (acute) exacerbation 496 Chronic airway obstruction, not elsewhere classified 745.0 Common truncus 745.10 Complete transposition of great vessels 745.11 Double outlet right ventricle 745.12 Corrected transposition of great vessels 745.19 Other transposition of great vessels 745.2 Tetralogy of fallot 745.3 Common ventricle 745.4 Ventricular septal defect 745.5 Ostium secundum type atrial septal defect 745.60 Endocardial cushion defect, unspecified type SYNAGIS® (palivizumab) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy Page 5 | without approval. ©2015, Magellan Rx Management ICD-9 Codes Diagnosis 745.61 Ostium primum defect 745.69 Other endocardial cushion defects 745.7 Cor biloculare 745.8 Other bulbus cordis anomalies and anomalies of cardiac septal
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