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New recommendations issued for palivizumab in RSV prophylaxis

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Palivizumab further restricted following new data

To many of us in the northern hemisphere, January through March is "flu season." To pediatricians, it’s bronchiolitis season. We wish it weren’t; about one-third of all hospitalizations in children under 5 years are due to bronchiolitis, specifically to respiratory syncytial virus.

Life would be so much easier for all of us, let alone infants, if we could prevent RSV disease. And we can: Palivizumab (Synagis) has been passively preventing RSV since 1998. Its use has been restricted by its cost: If a season’s course of palivizumab cost $5 or even $50 instead of a yearly cost of upward of $5,000 (including the cost of administration), discussion of its use would be much different.


Dr. Lance Chilton

Some argue that other physicians don’t watch costs, so why should we? If we can prevent a nasty disease, why shouldn’t we, at any price? Where bronchiolitis is especially common, severe, and costly, such as Alaska’s Yukon-Kuskokwim Delta, it has been proposed that palivizumab be given to all newborns. But it won’t be paid for, even there.

Insurance companies and Medicaid payers have long used AAP standards to determine which infants can be given this expensive preventive measure. It is very likely that they will seize upon these new standards as well, and we will have to follow suit. I don’t have many parents of patients in my practice who will choose to pay out of pocket for palivizumab.

The new guidelines further restrict the use of palivizumab, continuing a process of restriction as more information has become available over the past 16 years. Hospitalization for bronchiolitis has become less common, even in premature infants. The technical report clearly lays out the committee’s reasoning and the new data underlying it. Many practitioners will be unhappy with the changes. Some of our patients will be hospitalized with RSV bronchiolitis when previous guidelines would have had them receiving palivizumab. Some of our patients will also die from having driven coupes instead of Panzer tanks. I’ll trust the careful analysis of the Committee on Infectious Diseases.

Lance Chilton, M.D., is a professor of pediatrics at the University of New Mexico in Albuquerque and a pediatrician at Young Children’s Health Center. He is on the speakers bureau for Merck.


 

FROM PEDIATRICS

References

New guidelines regarding the use of palivizumab to reduce the risk of respiratory syncytial virus now further restrict which infants should receive the prophylaxis. The new guidelines, issued by the American Academy of Pediatrics, replace the previous ones from 2012.

Approximately 2.1 million children under age 5 develop an RSV infection requiring medical care each year, including about 58,000 who are hospitalized during their first few years of life. The highest-risk age for RSV hospitalization is 2 months.

However, palivizumab (Synagis), an immunoglobulin monoclonal antibody, can reduce the risk of hospitalization for RSV. The standard prophylactic dose is 15 mg/kg every 30 days during RSV season, for up to five doses. Palivizumab does not interfere with immunizations and can be administered at the same time as vaccines.

The main changes in the updated guidelines reduce the number of infants who will qualify for the prophylaxis, according to the policy statement published online by the AAP Committee on Infectious Diseases, chaired by Red Book Associate Editor Michael T. Brady, and the AAP Bronchiolitis Guidelines Committee (Pediatrics 2014 July 28 [doi: 10.1542/peds.2014-1665]).

Whereas all otherwise healthy preterm infants born at less than 32 weeks were previously recommended to receive palivizumab, now only those born at less than 29 weeks are recommended to receive it.

However, recommendations for palivizumab remain in place for preterm infants younger than 32 weeks’ gestational age who have chronic lung disease of prematurity and needed more than 21% oxygen for at least the first 28 days after birth. In addition, as in the previous guidelines, these children should receive palivizumab only during their first year of life unless, in their second year, they still need medical support in the 6 months before RSV season starts. Medical support includes supplemental oxygen, chronic corticosteroid therapy, or diuretic therapy.

Infants less than 12 months old with hemodynamically significant congenital heart disease should still receive palivizumab, particularly if they have moderate to severe pulmonary hypertension or if they have acyanotic heart disease and either take medication to control congestive heart failure or else will need heart surgery. However, children older than 12 months are no longer recommended to receive the prophylaxis (previous guidelines went up to 24 months), nor are those who have hemodynamically insignificant heart disease, who have surgically corrected lesions, who do not need drugs for congestive heart failure, or who have mild cardiomyopathy but do not need therapy.

Unless they have another qualifying condition, children with Down syndrome or cystic fibrosis also are not recommended to receive palivizumab, even though some evidence shows that these children may be at higher risk for RSV. The 2012 guidelines did not have a recommendation for or against palivizumab for children with cystic fibrosis, but data from studies since then bolster the case to exclude these children from receiving the prophylaxis because of limited evidence of clinical benefit.

Further, a group no longer recommended to receive palivizumab are those born between 32 and 35 weeks who were born within 3 months of RSV season and either attended childcare or had a sibling under age 5.

As in 2012, palivizumab "may be considered" for two groups of children: those less than 24 months old undergoing chemotherapy or otherwise severely immunocompromised, and those with pulmonary abnormalities or neuromuscular disorders that prevent them from coughing sufficiently to clear upper-airway secretions.

Another change in the updated recommendations is to cease prophylactic doses of palivizumab if a child is hospitalized with a breakthrough RSV infection. Previous guidelines advised that doses continue through the maximum recommended amount, but this has been removed in the new statement because fewer than 0.5% of infants are rehospitalized with RSV in the same season. Palivizumab is still not recommended for prevention of health care–associated RSV or to treat RSV.

The updated guidelines are based on new data, including revised (lower) estimates of RSV mortality in hospitalized children, information on RSV seasonality, declining bronchiolitis hospitalizations, data on palivizumab benefits for children with cystic fibrosis or Down syndrome, and "reports describing palivizumab-resistant RSV isolates from hospitalized patients who receive prophylaxis." These data are summarized in the technical report by the AAP Committee on Infectious Diseases (Pediatrics 2014 July 28 [doi: 10.1542/peds.2014-1666]).

Palivizumab was licensed by the Food and Drug Administration in June 1998, largely based on the results of a randomized controlled trial in 1996-1997 involving 1,501 preterm infants and young children (some with chronic lung disease of prematurity). A second randomized controlled trial was performed in 1998-2002 involving 1,287 children with hemodynamically significant congenital heart disease.

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