RSV is the Leading Cause of Hospitalization in Infants Less Than 1 Year of Age1

• Respiratory syncytial virus (RSV) is a common, seasonal virus that affects almost all children by the age of two.2, 3 While in most children RSV mimics the common cold or flu, RSV disease can be serious for premature babies, often leading to severe lung infections like pneumonia and bronchiolitis.1, 11
• Each year, severe RSV disease can lead to approximately 400 deaths in infants,7 and causes up to 125,000 infant hospitalizations.8, 9 In children less than one year of age, RSV is the leading cause of viral death,7 and is responsible for one of every 13 pediatrician visits and one of every 38 trips to the ER in children under five years of age.10
• Even babies born just a few weeks early are at an increased risk. A study of infants born between 33‐35 weeks gestational age showed that these late‐preterm infants were two times more likely to become hospitalized by RSV than full‐term infants.11
• This is because babies born prematurely have not received the full transfer of maternal antibodies to protect them against severe RSV disease.3 Additionally, premature birth interrupts the final stages of lung development, leaving preemies with only about half the lung volume of and smaller airways than their full‐term peers.4, 5, 6

The Premature Birth Rate in the U.S. is Significant

• There are more than half a million babies born prematurely in the U.S. each year.12 Across the nation, prematurity rates increased steadily between 1996‐2006.12
• RSV‐related hospitalizations increased from 1997 ‐ 2002 by approximately 25% among all infants under one year of age.8

Prematurity and RSV are Place Burdens on Public Health and Health Care Costs

• On average, preterm infants have much longer birth hospital stays compared to full‐term infants,* resulting in significantly higher hospital costs.13
• In 2003, hospital care for preemies cost $18.1 billion ‐ almost half of the total costs for all infants, despite making up only 9%* of the infant population.13 Recent data show that this cost has since increased to $26.2 billion, or $51,600 per preterm infant.14
• One of the common reasons for hospitalization in preemies is RSV disease; premature infants with RSV use significantly more hospital resources than full‐term infants infected by the virus.16
• While all children are at risk of becoming ill from RSV, high‐risk infants are much more likely to develop serious RSV disease.11, 16
• The average cost of RSV‐related hospitalization is $18,503 for late preterm infants (33‐36 weeks GA) – twice as high as for full‐term infants ($9,014).15

By urging Medicaid to appropriately protect high‐risk infants, we can help decrease RSV related hospitalizations in preterm infants and may reduce the emotional and financial tolls that hospitalization takes on their families.

References:
(1) Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. Pediatr Infect Dis J. 2002;21:629‐632. (2) Holberg CJ, Wright AJ, Martinez FD, et al. Am J Epidemiol. 1991; 133:1135‐1151 (3) Glezen WP, Taber LH, Frank AL, et al. Am J Dis Child. 1986;140:543‐546. (4) Yeung CY, Hobbs JR. Serum‐gamma‐G‐globulin levels in normal premature, post‐mature and “small for dates” newborn babies. Lancet.1968;7557:11 67‐11 70. (5) Moore KL, Persaud TVN. The Developing Human: Clinically Oriented Embryology. 7th ed. Philadelphia, PA: Saunders; 2003:245‐251 (6) Langston C, Kida K, Reed M et al. Am Rev Respir Dis, 1984;129:607‐613. (7) Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003; 289:179‐186. (8) Data on File: McLaurin KK, Leader S. Growing impact of RSV hospitalizations among infants in the US, 1997‐2002 (abstract 936). Presented at Pediatric Academic Societies Annual Meeting, May 14‐17, 2005; Washington, D.C. (9) Shay DK, Holman RC, Newman RD, et al. Bronchiolitis associated hospitalizations among US children. 1980 – 1996. JAMA. 1999; 282:1440‐1446. (10) Hall CB, Weinberg, GA.,Iwane, MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. NEJM, 2009; 360:588‐598 (11) Boyce TG, Mellen BG, Mitchel EF Jr, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000;137:865‐870. (12) March of Dimes. National Center for Health Statistics, Final Natality Data. www.marchofdimes.com/peristats. Accessed: September 21, 2009. (13) Agency for Healthcare Research and Quality, 2003. Nationwide Inpatient Sample. Prepared by March of Dimes Perinatal Data Center, 2006. (14)Behrman RE, Butler AS, eds. Institute of Medicine. Preterm birth:causes, consequences, and prevention. Washington (DC): National Academy Press; 2006. (15) Data on File: Forbes ML, Hall CB, Jackson A, Masaquel AS & Mahadevia PJ. (2009, May). Cost and Resource Utilization of Respiratory Syncytial Virus (RSV) or Winter Unspecified Bronchiolitis or Pneumonia (UBP) Hospitalizations During the First Year of Life Among Late‐preterm and Full‐term Infants. Poster presented at the ISPOR 14th Annual International Meeting, Orlando, FL. (16) Horn SD & Smout RJ. Journal of Pediatrics. 2003; 143: S133‐S141.

*Includes any diagnosis of prematurity/low birthweight
**According to most recent data available (2006)

Policy Position Current on March 10, 2010

Download RSV: RESPIRATORY SYNCYTIAL VIRUS (PDF, 118KB)

Background

Most state Medicaid drug reimbursement formulas are “one size fits all” in that they do not distinguish between biologics and chemical-based pharmaceuticals, nor do they fully recognize the extensive level of support services needed for patients using biologics. It is critical that states change this approach and recognize the unique nature of biologics and implement separate reimbursement mechanisms for biologics, since any reduction in reimbursement for biologics under existing Medicaid reimbursement formulas may result in inadequate compensation for patient support services and thereby reduce patient access to biologics; decrease the number of participating specialty distributor providers; and ultimately, increase costs to the state due to patients’ failure to obtain all necessary prescribed therapies.

Biotechnology drugs, or biologics, offer new hope to patients by providing novel therapies to treat unmet medical needs and debilitating health conditions. Biologics are complex medicines that are markedly different than most traditional chemistry-based pharmaceutical drugs in how they are developed, manufactured, stored, delivered and administered.

• Biologics consist of large, protein-based molecules that are manufactured using living organisms, and as such, are far more complex to produce than small molecule products.
• Biologics are generally prescribed by physician specialists (e.g., oncologists, rheumatologists, dermatologists, pediatricians, etc.) and historically target hard-to-treat diseases for which there are few, if any, effective therapeutic or preventive options.
• Biologics are most commonly administered via injection or infusion.
• Biologics are usually shipped by specialty distributors directly to the healthcare provider to ensure the proper storage and handling (referred to as maintaining proper “cold chain”) from manufacturer to the end user.
• Biologics require a variety of critical support services (often provided by the specialty distributors) to help ensure successful patient outcomes, including:
  • coordination of the drug’s delivery with scheduled patients’ visits to the provider;
  • patient tracking services (requiring compilation of data from several sources) to ensure patients receive follow-up doses as prescribed;
  • patient counseling and compliance education; and
  • educational services and product information for healthcare providers and office staff.

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Policy Position Current on October 1, 2009

Download POSITION ON STATE MEDICAID DRUG REIMBURSEMENT FOR BIOLOGICS (PDF, 30.4KB)