Late Breaking News
TRICARE Faces Challenges in Getting Males to Complete Three-Shot HPV Vaccine Series
By Annette M. Boyle
FALLS CHURCH, VA - In the year since TRICARE added coverage for the human papillomavirus (HPV) vaccine in all males up to age 27, the challenge has been both educating military personnel and their families about the need for the shots and assuring that the recommended three doses are received.
In February 2012, TRICARE adopted changes recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) and expanded HPV vaccination coverage to include men up to age 27 who, after consultation with their physician, determine that “getting vaccinated is right for them.” That means that many, if not most, active-duty military personnel are now eligible for free vaccination against HPV.
“We follow the latest CDC recommendations,” Rear Adm. Thomas McGinnis, chief, TRICARE Pharmaceutical Operations Directorate, told U.S. Medicine. “When the CDC added and extended recommendations of HPV vaccines for males, we moved to cover males also. Sometimes the guidelines change every year.”
The CDC recommends routine vaccination of all boys ages 11 or 12 years and “catch-up” vaccination of males aged 13 through 21 years of age who did not receive any or all of the shots. The vaccine is also recommended for men who have sex with men and those with compromised immune systems up to the age of 27. The CDC - and TRICARE - adopted broader guidelines just more than a year ago, adding that “all men may receive the vaccine through age 26 and should speak with their doctor to find out if getting vaccinated is right for them.”
The HPV vaccine is available in bivalent and quadrivalent formulations, both administered in a three-shot series. The quadrivalent vaccine (HPV4), which is directed against HPV types 6, 11, 16 and 18, gained Food and Drug Administration approval for use in 2006 for females and in 2009 for males. The bivalent vaccine targets HPV 16 and 18 and has not been approved for males. The CDC recommends that men receive the second dose two months after the first, and the third dose four months after the second.
As of February 28, 2013, 903 TRICARE beneficiaries have received 1,456 HPV vaccines at retail pharmacies, according to McGinnis. “It’s challenging to determine who’s completed the series,” McGinnis said. “Men may go back and forth between the local retail pharmacy, the military treatment facility (MTF) and their doctor’s office.”
More specific vaccination rate statistics are available for female servicemembers, however, and indicate that a small percentage actually complete the series of shots.
According to a poster presentation late last year at the infectious disease conference IDWeek, of 270,216 servicewomen eligible for HPV4 vaccination, 65,552 (24.2%) initiated the series. Of those, 40,517 (61.8%) were partially-vaccinated and 25,035 (38.2%) were fully-vaccinated. The study notes that the incidence of genital warts was significantly higher among servicewomen who received one dose or two doses compared to those who were fully-vaccinated.
The presentation also noted the high incidence of HPV overall among U.S. military personnel, noting that an estimated 169,682 incident cases were diagnosed during 2004-09.
Another study using a small sample before the HPV vaccine was approved for all males up to age 27 found that the adherence rate for females was 32% vs. 3% for males.1
TRICARE has some techniques to ensure the majority of young men get all of the shots. “Generally, we give patients a vaccine card they can take with them that shows which shots they’ve had. Kids have it for school; for men who may be transferred, it helps them keep up with the shots,” said McGinnis. “They may get their first dose at their annual physical, then two months later get the second with their flu shot at the pharmacy and the third at the MTF.”
A lost card need not mean a wasted dose, however. “Whether they get the vaccine at the retail pharmacy or elsewhere, it goes into the AHLTA [Armed Forces Health Longitudinal Technology Application] record,” McGinnis said. “Their primary care physician can see everything given or administered. They may give the patient the second or third shot or give them a prescription to get one at the pharmacy.”
Being able to get shots at retail pharmacies has proven quite popular. Through February 28, 2013, McGinnis said that TRICARE had administered 1,227,238 vaccinations for 845,740 unique beneficiaries in the retail network. While 80% of those vaccinations have been for seasonal influenza, the convenience has helped with all vaccinations.
“We encourage pharmacists, particularly in small towns, to talk to our Guard and Reserve beneficiaries. They know who has TRICARE coverage and can encourage them to get vaccinated,” said McGinnis. “It’s an easy discussion: ‘How much will it cost?’ ‘It’s free.’ ‘When can I do it?’ ‘Now.’ ‘OK, let’s do it.’”
Getting the HPV vaccination at the local pharmacy or elsewhere can make a significant difference in a man’s health. More than half of all sexually active men will contract HPV at some point in their lifetime. Two strains, HPV 6 and 11, cause more than 90% of the 250,000 annual cases of genital warts among men and the majority of cases of recurrent respiratory papillomatosis.
While many men might not notice the infection, they can transmit it to their partners, who might develop several HPV-related cancers, and they might also develop cancer themselves. American men are diagnosed with nearly 8,000 cases of HPV-associated cancers annually, according to a February 2013 presentation by Shannon Stokley, MPH, of the National Center for Immunization and Respiratory Diseases of the CDC. These include 5,900 cancers of the oropharynx, 1,600 cancers of the anus and 400 penile cancers, all primarily caused by HPV 16.
In recommending routine vaccination of young men and boys, the CDC cited data from U.S. cancer registries showing a steady increase in the incidence of oropharyngeal and anal cancers in men from 1973 to 2007. During the period, oropharyngeal cancers increased at a rate of 1% per year and anal cancers rose at a rate of 3% per year. 2
At TRICARE as elsewhere, some parental reluctance has surrounded the recommendation to start the HPV vaccine series at age 11 or 12, well before most parents see a need to protect their children from sexually transmitted diseases.
“Most primary care physicians have a discussion with the parents and put out the information and risks and benefits of the HPV vaccine, then the parents choose whether to have the child vaccinated or not. Each family decides based on their situation, their kids,” McGinnis noted.
“Generally, it’s going to be beneficial. The main risk is a sore arm, as with any shot, though sometimes we see fainting among slender preteen girls and others,” he added.
The CDC notes that the early age is recommended because the vaccine produces a more vigorous immune response when administered in younger people.
“Data on immunogenicity in males are available from the phase III trial conducted among males aged 16 through 26 years and from bridging immunogenicity studies conducted among males aged 9 through 15 years. Seroconversion was high for all four HPV vaccine types and postvaccination antibody titers were significantly higher in males aged 9 through 15 years compared with males aged 16 through 26 years,” according to the agency.
In addition, as a prophylactic vaccination, HPV4 is most effective when administered well before potential exposure through sexual activity. The CDC also notes that “the population level benefits decrease with increasing age at vaccination, especially after age 21 years.”
On the other end of the recommended ages, HPV4 was studied in men ages 9 through 26 and found to be safe. It is not approved for men age 27 and above, and its efficacy is unknown in older men.
1. Shen-Gunther J, Shank JJ, Ta V. Gardasil™ HPV vaccination: surveillance of vaccine usage and adherence in a military population. Gynecol Oncol. 2011 Nov;123(2):272-7. doi: 10.1016/j.ygyno.2011.07.094. Epub 2011 Aug 24. PubMed PMID: 21864887.
2. Recommendations on the use of quadrivalent human papillomavirus vaccine in males-Advisory Committee on Immunization Practices (ACIP), 2011. Morbidity and Mortality Weekly Report. December 23, 2011. 60(50); 1705-1708.
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