Vaccine Approval Complicated by Costs
Nov 15, 2011

In last week’s Congress Blog, an article entitled Cost vs. Public Health expressed concerns over the current vaccine approval system in the United States.  The author suggests that the current system is “stifling innovation, creating an environment of uncertainty for new immunizations and, more importantly, reducing the public health impact of vaccines.”
One of the author’s main concerns is that the role of The Advisory Committee on Immunization Practices (ACIP)  has shifted in recent years.  While the FDA is tasked with determining if new vaccines are safe and effective, the ACIP’s role has historically been to determine which vaccines should be recommended for use in certain populations.  While the author believes the ACIP is best suited to evaluate immunizations, the concern is that the committee is also being tasked with evaluating the cost-effectiveness of vaccines.  The article suggests that if we are to remain a country committed to promoting prevention and wellness, we must find a way to separate financial decisions from public health considerations.
While that sounds logical, it’s also proving to be quite difficult, especially when programs and policies are constantly being evaluated based on financial impact.  Fortunately, when you put a dollar value on health, you can easily make a case for the benefit of immunizations.  In fact, for every $1 spent on immunization, the U.S. saves $10.20.  Since figures are based on real costs of care in treating patients with vaccine preventable diseases, it’s easy to see the cost versus benefit here.  But how does the cost benefit analysis break down when evaluating each new vaccine?
For instance, the ACIP is currently considering a recommendation for a vaccine that can prevent a specific type of bacterial meningitis in infants.  While this immunization is already recommended for pre-teen children, the vaccine has recently been approved by the FDA for infants.  Now, the ACIP is tasked with deciding whether to issue a “routine/universal” recommendation for infants, a “permissive” recommendation, or none at all.
It’s important to note that if the ACIP chooses to issue a “routine/universal” recommendation, than the vaccine would be added to the standard childhood immunization schedule that all health care workers follow.  The vaccine would then be offered through the Vaccines for Children program, which pays for the immunization in select populations and among children who are uninsured.  It’s also expected that Medicaid and most other health plans would also cover the cost of the vaccine.  Since this vaccine is considered a costly one, a universal recommendation would therefore have financial implications.
On the other hand, if the ACIP decides to make a “permissive” recommendation, then the cost of the vaccine would not be covered by the Vaccines for Children program, or by most major health plans.  It’s expected that the cost limitations would then prevent many children from receiving it.  Additionally, some argue that a permissive recommendation may downplay the importance of the vaccine among health care providers, who often regard universal recommendations as “important” and permissive recommendations as “optional”.   The concern is that this will significantly reduce the number of children who could ultimately be protected by the vaccine.
Not surprisingly, the ACIP vote regarding this vaccine has sparked numerous questions, several of which have addressed issues of cost versus benefit.  One specific question focused on the estimated number of lives that could be saved if the vaccine became universally recommended.  According to the ACIP, it is estimated that infant vaccination for meningococcal disease would prevent approximately 195 cases and an average of 5-10 infant deaths each year.  Yet, the question remains whether that number “justifies” a universal recommendation for all children.
But how is it that we can put a price on a child?  Is it appropriate to determine how many lives would need to be saved in order to warrant a universal recommendation or just acknowledge that lives would be saved?
Right now the issue remains that we have a vaccine that can save lives.  But how many lives and how much it will cost are not the only considerations to be made.  Take, for instance, the concern that this particular vaccine does not cover the most prevalent and dangerous strain of meningococcal disease.  There is also some uncertainty over how long the immunity will last and whether a booster shot will need to be added several years later.  Then there is the fact that the disease significance has dropped by about 85% in 1997-1997, which may be a result of the more recent vaccination coverage among the adolescent population.
It’s clear that the ACIP will be evaluating various aspects of this new vaccine before their decision is made.  While we await the final vote, parents can read more about the ACIP considerations to gain a better understanding of the decision process.  While some parents may remain leery of a new vaccine on the childhood immunization schedule, others applaud the new vaccine for its life-saving potential.
In the video below, you will hear from families whose children have suffered from meningitis.  They will provide facts about meningococcal disease and explain how you can help raise the level of awareness of this vaccine through a campaign called Protect Infants Now.
As the video demonstrates, many people feel strongly that the ACIP should make their decision based on public health needs and the fact that this vaccine may save a child’s life.   As the  Cost vs. Public Health article mentions, there is a  growing concern that the ACIP has had to shift its focus from “the safety, efficacy and impact of life-saving immunizations to unclear cost-effectiveness evaluations of these medicines”.
We wonder what your thoughts are on this subject.  Do you feel that immunization recommendations should be made independent of cost considerations?  Why or why not?

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