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I believe the time has come to consider cost-effectiveness when deciding which vaccines the government—that's your tax dollars—will pay for.

At its October meeting, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention made a paradoxical decision: The committee gave a “permissive” recommendation for use of Merck's quadrivalent human papillomavirus (HPV) vaccine (Gardasil) in males aged 9–26 years, but then voted for coverage of the vaccine under the federal Vaccines for Children (VFC) program, which provides free vaccine to children up through 18 years of age who fall into certain need categories. The program covers approximately 48% of all U.S. children.

A permissive recommendation generally indicates that the vaccine is safe and effective but not cost effective. Permissive recommendations usually are not voted into the VFC program. Although the permissive recommendation still awaits approval by the CDC's director, ACIP's vote for VFC coverage is binding, so it is now official. We will have to wait and see what insurance companies do with the dichotomous signal.

A decade ago, ACIP rarely discussed cost when making its vaccine use recommendations. Now, cost-effectiveness analyses are routine. At the October ACIP meeting, Harrell Chesson, Ph.D., of the CDC, presented data from six studies—four published, two unpublished—demonstrating wide variation in cost per quality-adjusted life year (QALY) estimates for use of Gardasil in adolescent and young adult men, depending in large part on the vaccination status of the female population. In general, he showed that as coverage of Gardasil among females increases, the cost per QALY gained by male vaccination decreases.

Use of the vaccine in males is aimed primarily at preventing warts caused by HPV serotypes 6 and 11. The rates of penile and head/neck cancer caused by the cervical cancer HPV serotypes 16 and 18 are miniscule and do not even factor into the cost calculation. Prevention of transmission of HPV-16 and −18 to females through sexual contact is also a goal of the vaccine, but if it's already being routinely offered to females, the data suggest that there's very little additional gain costwise from giving it to males.

Indeed, Dr. Chesson concluded, “In most scenarios, adding male vaccination to female-only vaccination is not the most cost-effective use of public health resources. Improving vaccination coverage of females is likely to be a more effective—and cost-effective—strategy to reduce the overall burden of HPV-associated conditions.”

As readers who follow this column and my other writings know, I am a strong proponent of vaccines. In fact, I serve on the advisory boards for both Merck & Co. and GlaxoSmithKline, which manufactures the bivalent HPV vaccine Cervarix. But in an era where we're debating how to provide even basic health insurance for uninsured Americans, I am becoming concerned about whether our country can afford every vaccine for every person.

I'm looking ahead to other vaccines in the very near pipeline. In December we're likely to see approval of the 13-valent pneumococcal conjugate vaccine for the U.S. market. That vaccine is expected to cost more than the current PCV7 (Prevnar), thus raising the overall costs of routine immunization when the switch is made to the new vaccine. Beyond that we will need to provide catch-up vaccination as well for kids who already received PCV7 in order to provide protection against the newly emerging, virulent, and multidrug-resistant serotype 19A, which is included in PCV13 but not PCV7. This new “superbug” causes fatal sepsis, meningitis, and pneumonia. How can ACIP not vote that into VFC as well?

On the heels of PCV13, there are two new meningococcal conjugate vaccines awaiting licensure: GSK's Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C (MenC) and Y (MenY)–tetanus toxoid combination, and Novartis's MenACWY-CRM (Menveo). The Hib-MenCY-TT conjugate is likely to be licensed for infants at 2, 4, and 6 months of age, with a booster at 15–18 months. Menveo, which will compete with Menactra, is expected to first be licensed for use in adolescents, then toddlers, then infants. These vaccines also prevent a significant amount of serious and potentially fatal disease.

Although competition usually lowers cost in the marketplace, the same phenomenon generally isn't seen when new vaccine competitors enter the market. Rather, the major companies with competing vaccines make combination products with ingredients that differ from others so that staying within their family of products is more convenient than switching between companies.

Moreover, companies also provide price advantages to physicians through national buying groups that provide bigger discounts to those who purchase vaccines within their own family of products. This impacts any price reduction that might occur with brand competition.

So where should we draw the line? At one point or another, ACIP may have to say the government can't afford to pay for vaccines that do not have a strong cost-benefit argument behind them. Yes, the alternative is a two-tiered system where those who can afford the vaccine can get it, and those who can't, don't. ACIP has tried to avoid that scenario in the past, but I fear it won't be able to do so much longer.

Consider Vaccine Cost-Effectiveness