ATLANTA - Torn by semantics, financial implications and questions of race-based recommendations, members of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted on guidelines for using the recently approved pneumococcal conjugate vaccine (Prevnar, Wyeth-Ayerst Laboratories).
ACIP guidelines include immunization of the birth cohort for infants up to age 23 months; immunization of children ages 24 to 59 months who are at high risk of invasive disease, including blacks, Native Americans and Alaskan Natives; and consideration for immunization of children ages 24 to 59 months who are in group child care, are socially or economically disadvantaged or those who have had frequent or complicated acute otitis media within the previous year.
The vaccine series should be given in four doses at 2, 4, 6 and 12 to 15 months of age. With a $58 price for each dose, a four-dose series will cost $232. The four-dose series will approximately double the current cost for childhood vaccines. Catch-up dosing schedules for children older than 2 years may vary, but will generally require only one dose.
Pneumococcal conjugate vaccine is being considered for inclusion into the Vaccines for Children program, but the committee decided to vote on the matter at a later date.
Prevnar was approved by the Food and Drug Administration Feb. 17.
"I don't think after this experience that there's any question whether we have to pay attention to price and cost effectiveness," said David Johnson, MD, MPH, deputy director and chief medical executive, Michigan Department of Community Health. "We've had the luxury over the past decades to clearly state that vaccines are cost saving to society, if not the health payer. Now given the list price of this vaccine, we're not able to say that. That doesn't mean we shouldn't pay for prevention or quality life years resulting from vaccine use, but it does prompt us to scrutinize price and cost effectiveness studies more closely."
Tom Ray, of the health maintenance organization Kaiser Permanente, forecasted break-even costs from the societal perspective, with medical and nonmedical costs associated primarily with the family (lost time from work while tending to a sick child or lost productivity due to disability), and the health care payer perspective, which includes only medical costs.
For most episodes of pneumococcal disease, nonmedical costs exceed medical costs. "It always looks better from a societal standpoint than from the health care payer standpoint," said Ray. "With healthy infants who receive four doses of the vaccine, we estimate from the society perspective $46 a dose, so if the price is under that, there is a net saving, over that is a net cost. From the health care payer perspective, the break even cost is $18. The proposed private-sector list price of $58 would be a net cost."
For toddlers who require a single dose, the break-even cost depends on the incidence of disease, said Ray. Because incidence of pneumococcal disease declines with age, break-even costs also decline with age. But children in day care are at an increased risk of contracting the disease vs. children not in day care.
Debate over who is at highest risk for the disease ended in the inclusion of blacks in the high-risk category.
"The problem I have with (the term) socially or economically disadvantaged is how do you define it? We should be driven by disease incidence," said Margaret Rennels, MD, professor of pediatrics, University of Maryland School of Medicine, Baltimore. "I understand the sensitivities about singling out African Americans, Native Americans and Alaskan Natives, but it's in their best interest that they receive the vaccine."
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