ACIP consideration of vaccine cost is appropriate in coverage decisions, CDC official testifies.

ACIP CONSIDERATION OF VACCINE COST-BENEFIT IS APPROPRIATE, CDC's ORENSTEIN testified at a July 16 Senate Appropriations/Labor & HHS Subcommittee hearing on vaccines. "It is extremely important that [the Advisory Committee on Immunization Practices] take cost-benefit and cost effectiveness into account in their recommendations because...their recommendations go beyond what the government purchases. These are recommendations that basically address public health practices," Centers for Disease Control & Prevention National Immunization Program Director Walter Orenstein, MD, testified.

Wyeth-Lederle Vaccines & Pediatrics VP-Scientific Affairs & Research Strategy Peter Paradiso, PhD, asserted at the hearing that ACIP's consideration of cost in its coverage recommendations violates the intent of Congress in establishing the Vaccines for Children program.

"Intent on avoiding previous circumstances in which vaccines had been recommended by the ACIP but not purchased promptly by the federal government because of budgetary concerns, Congress effectively made the decision to cover vaccines under VFC automatic, once the ACIP had made its recommendation," Paradiso said. "Unfortunately, at some point in the implementation of the VFC program this Congressional intent appears to have been lost."

"A consideration of the costs and benefits of a vaccine is routinely part of the ACIP discussions surrounding the development of a recommendation for general usage of a vaccine, but the advisory committee is now repeating that analysis -- in fact, in some cases asking for additional data on costs and benefits -- before making a purchase decision," Paradiso said. "This approach has resulted in a delay in the acceptance of certain new vaccines -- most recently the varicella vaccine -- while ACIP weighs matters of cost."

"This is troubling to manufacturers because we now have a very large purchaser of vaccines that does not necessarily accept its own decisions regarding routine vaccine usage and delays the uptake of new products," the Wyeth-Lederle exec added.

Subcommittee Member Bumpers (D-Ark.), who convened the hearing, suggested that "it is hard to extricate" cost considerations from scientific decisions of coverage, particularly for combination vaccines. "Combinations we pick are going to have everything to do with the cost of this program," Bumpers pointed out. "If you make one doctor visit and get five antigens as opposed to making three, you save a lot of money."

ACIP is working on a set of recommendations for combination vaccines with industry input, Orenstein pointed out. However, he cautioned, the process is likely to be "murky...where it won't be crystal clear which combinations are better than others."

The committee is "attempting to...set forth some basic principles," such as "the preference whenever feasible for combination vaccines [to] avoid extra injections and extra visits," Orenstein said. Among questions the committee is considering are what guidance to offer physicians on interchangeability of vaccines and whether "it is time for simplicity's sake [to say] it may be necessary and it may be acceptable to administer extra antigens." Using a combination DTaP-Hib vaccine for the full DTP series, for example, would involve more than the recommended dose of Hib but would avoid having to stock a separate vaccine.

ACIP is planning to add two people to the 10-member group to "include more people with expertise in delivery in the private sector," Orenstein said.

The increasing participation of multiple suppliers in the vaccine business has led CDC to test a new contracting procedure for DTaP vaccines, Orenstein reported.

CDC typically awards the low-bidder on a contract 50% of VFC program purchases and all purchases under Sec. 317 or using state funds. The losing bidder receives the other 50% of the VFC program but none of the other purchases. This process worked because "until recently there had not been more than two licensed suppliers for a particular product," Orenstein remarked.

However, with three firms licensed to market DTaP vaccines and two more pending, CDC "is testing a procurement strategy for DTaP vaccines which more closely approximates the private-sector market," Orenstein said. "As long as ACIP considers each manufacturer's products essentially equivalent from a public health perspective, manufacturers of all licensed vaccines are given access to the public market, and states can then choose which product or products they want to use."

The contracts now set a "low guaranteed minimum purchase requirements, and manufacturers are able to change the negotiated price every three months, as long as the price does not exceed the originally negotiated price," Orenstein explained. "It is hoped that this procurement strategy will further encourage innovation in vaccine development while providing product choice to states, where choice did not exist in previous contracts."