A Systematic Review of Compliance with Palivizumab Administration for RSV Immunoprophylaxis

Abstract

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks; (b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses. It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice.

A systematic review of predictive modeling for bronchiolitis

“…If a high-risk child misses one or more doses of prescribed palivizumab, he/she could experience hospitalization with high cost, and the value of the high expense already incurred for previously administered doses would be diminished [187]. Thus, it is important to ensure patient compliance with palivizumab.…”

“…The rate of noncompliance with palivizumab varies across different care settings: 70% for physician offices, 26% for day health centers, 12% for pulmonologists' offices, 11% for outpatient clinics, and 9% for at-home administration of palivizumab by a visiting nurse [187]. Known risk factors for noncompliance with palivizumab include parental smoking, Medicaid enrollment, minority race, low socioeconomic level, low parental expectations for the benefits of RSV prophylaxis, lack of transportation, and language difficulties [186,187].…”

“…Known risk factors for noncompliance with palivizumab include parental smoking, Medicaid enrollment, minority race, low socioeconomic level, low parental expectations for the benefits of RSV prophylaxis, lack of transportation, and language difficulties [186,187]. At present, multiple models exist for predicting medication compliance in patients with various diseases such as heart failure [188].…”

“…If a child is predicted to be unlikely to be compliant with palivizumab, we can adopt one or more interventions to increase his/her likelihood of being compliant. Examples of such interventions include reminder phone calls, comprehensive multidisciplinary programs including extensive counseling of parents, calendars with sticker reminders, multilingual call center, and administering palivizumab in a care setting that is known to have a high compliance rate [187]. When choosing interventions, we should consider both the intervention's cost and the child's predicted likelihood of being noncompliant.…”

Evaluation of a Novel Web-Based Prior Approval Application for Palivizumab Prophylaxis of Respiratory Syncytial Virus in a State Medicaid Program

“…19 In a claims analysis of Florida Medicaid recipients, 67.9% of Medicaid recipients were considered fully compliant with at least 4 doses of palivizumab, and 41.3% received at least 5 doses, where 5 doses represented ideal coverage. 20 Several studies have attempted to identify strategies for increasing compliance through in-home administration programs, telephone calls, and education of caregivers with positive results.…”