Can vaccine recommendations be based solely on individual and public health?

Have you heard the parable about the blind men and the elephant? Each is holding a different part of the animal and comes to a different conclusion about what he’s dealing with. The man holding the tail is sure it’s a rope; the one with the trunk fears a snake; the one holding the tusk is certain he has a spear. It’s all in their perspective. They’ll need to share what they each know and consider the others’ perspectives if they have any hope of understanding the true scope of what they’re facing.

And so it is when a group sits down to talk about the cost-effectiveness of vaccines. If you’re a parent who lost your child to meningitis, the cost of a vaccine dose is trivial. However, if you’re considering this from the population-based, public health decision-making perspective, the annual price tag of $387 million to administer meningococcal booster doses to all 16-year-olds is anything but trivial. If you sit on the Advisory Committee on Immunization Practices, considering, discussing and deciding how much weight to give each of these perspectives and many others is now all in a day’s work.

Cost as a factor in vaccine decision-making

There was a time not too long ago when discussions at ACIP did not even touch on vaccine cost — I mean that quite literally. We would examine and parse data on disease epidemiology, how much morbidity and mortality the disease caused, the anticipated immunogenicity and effectiveness of the vaccine and the feasibility of adding it to the current schedule. We rarely even knew or asked the price of a single dose of the vaccine, much less the aggregate cost of adding it to the immunization program. Those days are gone and unlikely to return.

We have to think more about vaccine cost now because, well, vaccines cost more. The cost to administer all universally recommended vaccines to one child through age 18 years increased from $370 10 years ago (year 2000 dollars) to between $1,322 and $1,620 today. The 2011 range represents the cost for boys (low) and the cost for girls (high); the difference is the human papillomavirus vaccine, recommended routinely for females but not for males, in large part because of cost considerations.

One reason for the jump in cost is simple numbers. We have more vaccines today than ever before. In 1985, the routine childhood and adolescent immunization schedule protected against seven diseases; by 1994, that number was nine. Today, we vaccinate against 16 diseases. Yet, numbers are not the only driver. Newer vaccines require more elaborate research than in the past, driving up vaccine development costs and affecting individual vaccine costs. Even on government contracts, it’s no longer unusual for one vaccine dose to cost $50, $100 or more.

In today’s economic environment in which revamping our health care system and harnessing costs are major issues, there’s no way for vaccination costs to escape notice. Someone has to be mindful of managing the public and private prevention purses, but who? How much is too much to save a life or reduce suffering? I can tell you that every member of the ACIP agonizes over every bit of information the group is given to review — whether it’s disease incidence, vaccine efficacy, cost-benefit analyses and, yes, also the testimony of parents and representatives of interest groups.

Comments by University of Pennsylvania health economist Mark Pauly in a recent National Public Radio story sum it up nicely. “You do have a rough idea that if it’s $1.98 per-life saved that sounds like a good thing to do and if its $198 million per-life saved, that sounds like not a good thing to do. But, where to draw the line is the part that any sensible person will run away screaming from trying to answer that question.” Indeed.

Higher standard for prevention vs. treatment

Prevention services are held to a higher cost-effectiveness standard than treatments. This is clear to me because I have one foot in each world. Developers of very expensive treatments such as cutting-edge chemotherapies and surgeries often do not even conduct cost-benefit analyses. Treatments are judged on clinical utility alone. If it has utility, it is available to patients. One reason why we have different standards: Treatments are used in patients, whereas prevention is used in people. Considering the cost of treating patients is greeted by choruses complaining of “rationing,” but the same singers don’t seem to care so much about rationing prevention. Again, it’s all in your perspective.

Not only do we have different standards for measuring treatment and prevention, but within prevention, the standards for vaccines are impossibly high. In general, preventing illness saves money. Because the earliest vaccines prevented a lot of illness, it was abundantly clear that they also saved a lot of money, not to mention human suffering and human lives.

Measles, for example, was a nearly universal rite of passage for children before vaccine introduction in 1963. Pre-vaccine era, the United States saw about 3 million to 4 million cases and 500 deaths from measles annually. Now, with the “major” diseases of childhood, such as measles, under control, many of today’s vaccines target infections that attack far fewer children. Does this really matter if it’s your child? The attack rate for meningococcal disease is measures of magnitude lower than it was for measles, but severity and death rates are much higher. Meningococcal disease kills about 10% of the people it infects and up to 20% of survivors may have lifelong disabilities — the cost of which is never adequately measured.

Older vaccines, such as measles and polio, were seen as nothing less than miraculous. Nowadays, vaccines that prevent cancer (HPV, hepatitis B) are greeted by a yawn. Whereas we are perfectly happy to pay for statin drugs that reduce our risk for heart attacks by 50% or less, the influenza vaccine that reduces risk by 70% is seen as “not very effective.”

Perils and place of cost-benefit analyses

As I pointed out in a previous blog entry, cost-benefit analyses for medical interventions are an imperfect model. Some who want these analyses to play a larger role in our decision-making may present cost-benefit results as conclusive. This is rarely, if ever, true. The example I gave back in February is a good one to repeat. A cost-effectiveness study published in the Oct. 8, 2009, issue of the British Medical Journal showed that vaccinating boys against HPV is not cost-effective. To get to this conclusion, the study assumed a 75% HPV vaccine coverage rate for both genders and “explored the implication of lower coverage (50%).” Well, only 32% of US adolescent females are fully immunized against HPV (49% start the three dose series).The long-recommended tetanus and diphtheria/tetanus-diphtheria-pertussis vaccine has just topped 80% coverage rate in teens for the first time this year. So, an assumption of even 50% for a vaccine that is not only newer, but also carries political baggage, doesn’t seem reasonable to me.

I long for the days when I, as a doctor, was asked to vote on vaccine recommendations based solely on individual and public health. I know as an alert citizen that we are in a new world where this is impossible. Cost and, more specifically, cost-benefit must be a consideration in our public health decision-making. That, I believe, is something most everyone can agree on. The hard part will be considering everyone’s perspective along the way and weighing each. The importance given to cost-benefit analyses may vary from one scenario to the next.

William Schaffner is President of the National Foundation for Infectious Diseases and Professor and Chair, Department of Preventive Medicine, Vanderbilt University School of Medicine. He blogs at Infectious Disease News.

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