Tag Archives: cost-effectiveness

Oh Boy, Another Vaccine Conundrum

Should the human papillomavirus (HPV) vaccine Gardasil be recommended for routine use in boys aged 11-12 years, as it is now for girls? Or should the vaccine’s use in boys remain an option but not a routine recommendation? Alternatively, should it be routinely recommended for males who have sex with other males, a group that is at increased risk for anal infection and cancer due to HPV?

Policy decisions regarding vaccine use are often complex and nuanced, even for vaccines that aren’t already as controversial as Gardasil. The issue of vaccinating males is causing headaches for the panel tasked with making the decision, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Pat Ramsey photo via Flickr Creative Commons

Of the two HPV vaccines on the U.S. market, only Gardasil is licensed for use in males. It contains four strains of HPV, two (16 and 18) that are associated with cervical and other types of anogenital and oral cancers, and two (6 and 11) that are associated with genital warts. In December 2010, the Food and Drug Administration added the indication of prevention of anal cancer due to HPV vaccine strains in both males and females.

In 2009, ACIP said that Gardasil could be given to males aged 9 through 26 years, but didn’t make a routine recommendation. Some are now in favor of doing so, arguing that the vaccine protects males against both genital warts and anal cancer, it reduces HPV transmission to females by preventing infection in their male sex partners, and it’s simply more equitable and convenient for physicians to offer the vaccine to both male and female patients.

The main argument against the move is the vaccine’s cost, approximately $360 for the full three-dose series. A CDC-commissioned cost-effectiveness analysis posed a conundrum: Use of Gardasil in males is more cost-effective the less it is used in females, and vice versa. At current female coverage levels – just 27% for all three doses among 13- to 17-year-olds in 2009 ¬ use of the vaccine in males makes the cost-effectiveness cut-off in some models, depending on assumptions. But of course, public health officials are hoping that coverage among females will increase.

Restricting Gardasil’s use to males who have sex with males would dramatically increase the vaccine’s cost-effectiveness, as anal cancer in that group is actually more common than is cervical cancer among all women. While the vaccine’s use could certainly be promoted among older male teens and young adults who are already “out,” screening for sexual orientation among 11- to 12-year-old boys is unlikely to be a viable option.

A vote on this is likely to come later this year, but it won’t be an easy one, ACIP working group chair Dr. Janet A. Englund told me at the panel’s meeting last week in Atlanta. “The concern about cost and cost-effectiveness is a very important consideration for the committee.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Filed under Allergy and Immunology, Dermatology, Family Medicine, Health Policy, IMNG, Infectious Diseases, Internal Medicine, Obstetrics and Gynecology, Oncology, Pediatrics, Primary care, Uncategorized

A Difficult Vaccine Decision

In the 16 years that I’ve been covering the thrice-yearly meetings of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, I can’t recall a vaccine recommendation vote as close as the one last week on the meningococcal vaccine. The vote to add a booster dose for 16-year-olds passed by just 6 to 5, with 3 panel members abstaining.

In 2007, ACIP recommended the then-newly licensed conjugate meningococcal vaccine for all 11-12 year-olds. That age was chosen because other vaccines are also given then, as part of the so-called “adolescent platform.” The peak period of risk from Neisseria meningitidis is actually between the ages of 16 and 21 years and is particularly high for college freshman living in dorms, where the disease is easily spread. But, at the time of the recommendation, it was assumed that protection would last at least 10 years.

Credit: ©Sean Warren/iStockphoto.com

It has now become clear that immunity from the vaccine begins to wane after just 5 years. So, ACIP was obliged to revisit the issue. The panel was presented with three choices devised by a working group: Keep the 11-12 year status quo, move the vaccine out of the established adolescent visit to mid-adolescence, or keep it in place and add another dose later. The third choice won out, but barely.

Those who opposed cited cost — about $90/dose — as a primary reason. “I’m worried that we don’t have data that would support cost-effectiveness of a two-dose regimen,” said panel member Lance Chilton, one of the dissenters.

He told me he would have preferred moving the vaccine to mid-adolescence, without changing the 11-12 year visit for other vaccines. “Adding another platform is probably a good idea,” said Dr. Chilton, of the University of New Mexico, Albuquerque.

ACIP chair Dr. Carol Baker, who voted with the slight majority, said that the meningococcal vaccine decision illustrates the complexity of many of the decisions this committee faces. “Good people had varying opinions … one of the things the ACIP is charged to do is to grapple with these difficult decisions,” said Dr. Baker of Baylor College of Medicine, Houston.

I asked her about the role of vaccine cost in the decision. Her reply: “Things are not getting less expensive and that includes our new vaccines. It costs a lot of money to bring products to the market that will provide good health for our children, adolescents, and adults, and there are value judgments there. But, vaccines are one of the least expensive preventive health services we provide in this country.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Filed under Allergy and Immunology, Family Medicine, Health Policy, IMNG, Infectious Diseases, Internal Medicine, Pediatrics, Primary care, Uncategorized