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HPV Vaccine Goes Underused

MANAGED CARE September 2012. © MediMedia USA

HPV Vaccine Goes Underused

Only about 35 percent of girls get the full three doses of the vaccine for the human papillomavirus, which causes most cervical cancers

Joseph Burns
Contributing Editor

Only about 35 percent of girls get the full three doses of the vaccine for the human papillomavirus, which causes most cervical cancers

Joseph Burns

Contributing Editor

The evidence is not pretty, and Chuck McKinzie, MD, knows it well. After 28 years as an Ob-Gyn in rural Minnesota, McKinzie has seen too many cases of HPV infection.

If teenage girls could see what he’s seen, he says, they would be much more willing to get the vaccine that prevents the spread of the human papillomavirus (HPV). If the girls’ mothers could see the vulvar, vaginal, and anal warts and recognize the associated stigma, more of them would want their girls vaccinated, McKinzie adds.

But the rates of immunization are disappointingly low, despite McKinzie’s efforts and those of other physicians and health plans nationwide. Six years after the HPV vaccine, Gardasil, was introduced, only 35 percent of girls ages 13 to 17 who were surveyed last year received the recommended three doses of HPV vaccine, according to the most recent report of the National Immunization Survey — Teen (NIS-Teen) by the federal Centers for Disease Control and Prevention (CDC).

Underused

The report shows the administration rates for other vaccines for adolescents: tetanus, diphtheria, acellular pertussis (TDAP, one dose), 72 percent; and meningococcal conjugate (MenACWY, two doses), 70.5 percent.

The HPV vaccine helps prevent infections that can lead to cervical cancer in women and are believed to lead to a growing and alarming rise in the percentage of head and neck cancers attributable to HPV. Despite the benefits of immunization, a vaccine that has the potential to prevent cancer is underused.

Among several reasons for the low rates of HPV immunization, the most frequently cited are a lack of understanding about it, a fear of side effects that is not supported by the medical literature, and a failure to pay pediatricians enough to stock and administer the vaccine.

Another difficult hurdle to overcome is the idea that parents must envision their preteen children as needing a vaccine to protect them against HPV, the most common sexually transmitted infection. The CDC recommends the vaccine for 11- or 12-year-old girls to protect against the two strains of the virus that are linked to 70 percent of cervical cancers. To ensure the highest level of protection, girls must get three shots over six months.

Since 2006, the CDC has recommended the HPV vaccines for all teen girls and women through age 26. Last fall, the CDC recommended the HPV vaccine for all teen boys and men through age 21. There are more than 100 strains of the virus, and more than 40 of them can infect the genital areas, mouth, and throat of males and females, the CDC says. Most of those infected with HPV do not even know they have it.

The FDA has approved two HPV vaccines. Gardasil from Merck was approved in 2006 and protects against four types of HPV. In females ages 9 to 26, the vaccine helps protect against two types of HPV that cause about 75 percent of cervical cancer cases and two other types that cause 90 percent of genital warts cases, Merck says. In males ages 9 to 26, Gardasil helps protect against 90 percent of genital warts cases, the company says.

Information needed

Cervarix from GlaxoSmithKline was approved in 2009. This vaccine is used for females ages 10 to 45 to prevent early stage cervical cancers (pre-cancerous lesions), Pap smear abnormalities, and two types of cervical cancer caused by HPV, the company says. It is not recommended for males.

Gregory D. Zimet, PhD, an HPV researcher and professor of pediatrics at Indiana University School of Medicine, says health plans can do a better job of informing pediatricians and family practice doctors about gaps in immunization rates.

“When health plans set expectations in terms of performance and make those expectations explicit by emphasizing the importance of vaccinating 11- and 12-year-olds, that can make a difference,” he says. “It should be simple enough for plans to put reminders into electronic medical record systems.”

The fact that HPV vaccination rates have not risen much despite the efforts of health plans and the CDC disappoints Zimet. “The HPV vaccine is an achievement we should celebrate,” he says. “There should be parades. To have a vaccine that can actually prevent substantial numbers of cancers is an amazing achievement. It is sad that people would argue about issues that have no basis in fact. To withhold cancer prevention because of unfounded concerns about the potential for increased sexual activity seems to me a crime.”

Yet the vaccine is underused in part because not everyone recognizes its benefits let alone the emotional and financial burden these infections can impose on women, says McKinzie, the medical director at PrimeWest Health in Alexandria, Minn.

McKinzie participated in an HPV vaccine collaborative performance improvement project that nine Minnesota health systems started in 2008. Six health plans (Blue Plus, FirstPlan Blue, HealthPartners, Medica, Metropolitan Health Plan, and UCare Minnesota) worked with three Minnesota county-based purchasing groups (Itasca Medical Care, PrimeWest Health, and South Country Health Alliance) and a not-for-profit company, Stratis Health, in Bloomington, Minn., to improve immunization rates by 5 percentage points.

They succeeded in raising vaccination rates among girls in the Medicaid program ages 11 and 12 from a baseline in 2007 of 23.84 percent to 34.23 percent in 2008, to 33.81 percent in 2009, and to 32.60 percent in 2010. Though they exceeded their goal, McKinzie says the numbers could have been better.

“The cancer part is important but all the money is spent on dealing with the related issues that result from HPV such as the condyloma, the cervical dysplasia, and the vulvar vaginal warts that all get treated at various stages. It’s a tremendous amount of money,” he says.

Uphill battle

For the performance improvement effort, the health plans encouraged physicians to vaccinate girls starting at age 11, identified patients who hadn’t started the series, and sent brochures to school nurses and memos to doctors. “It’s an uphill battle, and we will keep doing it,” says McKinzie.

Health systems that serve Medicaid patients, such as McKinzie’s PrimeWest Health, may be among the best at raising vaccination rates.

But all health plans struggle to raise HPV immunization rates because of the nature of the vaccine, the cost of storing and administering the vaccine (see “Would a Payment Increase Boost HPV Immunization Rates?” on page 27), and because physicians may be unconcerned about accreditation measures.

HEDIS schmedis

This year, the National Committee for Quality Assurance (NCQA) added the HPV vaccine as a health plan performance measure under the Healthcare Effectiveness Data and Information Set.

“Making it a HEDIS measure will help,” McKinzie comments. “But out here HEDIS is hardly on anyone’s radar. It has more impact in the cities than it does out here. The doctors in these small rural towns think ‘HEDIS schmedis.’”

The fact that NCQA added the HPV vaccine as a HEDIS measure shows that it’s not just a health plan or CDC issue,” says Fred M. Volkman, MD, of Select Health.

Fred M. Volkman, MD, the chief medical officer for Select Health of South Carolina, agrees that making HPV vaccination rates a HEDIS measure will have a positive effect. Select Health is a managed care organization in Charleston that serves more than 240,000 members in the state, 80 percent of whom are children.

“The fact that NCQA added the HPV vaccine as a HEDIS measure shows that it’s not just a health plan or a CDC issue. The accreditation agencies are moving the HPV vaccine forward,” he says.

Like Prime West, Select Health uses a variety of techniques to educate members about vaccines. All immunizations are built into the plan’s Early Periodic Screening, Diagnosis, and Treatment program. Select Health’s HPV vaccination rate was not available.

“Our research shows unique cultural barriers related to HPV screening and prevention and so we identified HPV infections as a health disparity and created a culturally competent cervical cancer intervention program using four different brochures to appeal to women based on their race and ethnicity,” he says.

Compounding the challenge of getting adolescents and preadolescents into the office to receive the vaccine is that they must come two additional times.

Select Health faces two significant hurdles. “One is that the vaccine is for adolescents or preadolescents and it’s very hard to get them in for a shot,” says Volkman. “The other hurdle is the cultural, religious aspect because people know it is a sexually transmitted disease. And there is controversy involving all vaccines such as the issue of whether they cause autism, an issue a lot of people worry about.” Researchers at the History of Vaccines, a project of the College of Physicians of Philadelphia, say an accumulation of large-scale epidemiological studies has failed to show a causal relationship between vaccines and autism. One such study was published in Pediatrics in 2010 (http://tinyurl.com/d2w35c6).

Series of three shots

Compounding the challenge of getting adolescents and preadolescents into the office to receive the vaccine is that they must come two additional times. The HPV vaccine requires a series of three shots, which must be administered over three visits within six months.

Yet another issue involves telling physicians when their patients need the vaccine. “We use our care gaps tool to alert doctors about patients who are overdue for preventive health screenings,” says Volkman. Despite these efforts, Volkman shares McKinzie’s disappointment that the vaccination rates are not higher.

Tonya R. Moody, associate vice president for health promotion and program development for Keystone Mercy Health Plan, recognizes the concerns regarding HPV vaccine rates. Keystone is a Medicaid managed care plan in Philadelphia that serves more than 300,000 beneficiaries in southeastern Pennsylvania. Select Health and Keystone Mercy Health Plan are sister plans operating under the same parent organization, AmeriHealth Mercy Family of Companies.

Educating members about the vaccine seems to have paid off for Keystone Mercy Health Plan, says Tonya R. Moody, who oversees health promotion at the insurer.

Like SelectHealth, Keystone Mercy uses data to identify members who are noncompliant and nonadherent with the HPV vaccine recommendations or who have gaps in care. “This information comes from our informatics department. Our six outreach representatives contact the individuals to educate them about our vaccination services and the importance of preventive care,” says Moody. “The outreach unit also schedules the individual for an appointment with his or her primary care doctor and calls the person again 24 hours before the appointment. If necessary, the outreach person will coordinate transportation.

“From there, the outreach staff follows up with a three-way call to the doctor’s office to review the specific screenings the member lacks,” she says.

The outreach unit is more than four years old and the effort to educate members and physicians about the need to raise HPV vaccination rates began in 2010. Select Health’s HPV vaccination rate was not available.

Just as Moody is educating health plans members, Eric M. Genden, MD, professor and chairman of the Department of Otolaryngology and chief of the Division of Head and Neck Oncology at Mount Sinai Medical Center in New York is conducting an education campaign. Over the past 10 years, he has seen a four- to five-fold increase in the number of tonsillar and base-of-the-tongue cancers from HPV. He advocates more screening for head and neck cancer and aggressive patient education programs.

“We are at the beginning of an epidemic,” warns Eric M. Genden, MD, of Mount Sinai Medical Center. He cites the rising number of cancers caused by HPV.

“Research indicates that approximately 80 percent of cases of a type of cancer in the head and neck area are HPV-positive, and this number is rising quickly,” Genden says.

Health plan medical directors should educate physicians, particularly primary care and Ob/Gyns, about HPV, Genden adds. “Also, when otolaryngologists see a 42-year-old nonsmoker who is otherwise healthy and comes in with a sore throat they should consider the epidemic and carefully follow the patient until complete resolution,” he says. “A sore throat is a common presenting symptom of throat cancer from HPV.

“We are at the beginning of an epidemic,” he says. “The number of HPV cases and the number of cancers both will grow exponentially over the next 20 years.”

Dangers

Officials at the CDC recognize the dangers. The CDC has a direct-to-consumer media campaign to promote vaccines for preteens and teens, including the HPV vaccine, says Lauri E. Markowitz, MD, a medical epidemiologist and the CDC’s team leader for epidemiology research.

“While we have not specifically begun any efforts with health systems, health plans, or managed care organizations, we aim to reach physicians within those networks during our research, and hope their responses will help inform how to best communicate and partner with them,” she says.

“The HPV vaccine is an achievement we should celebrate,” says Gregory D. Zimet, PhD, professor of pediatrics. “There should be parades.” Yet, vaccination rates have not risen as much as he’d like.

Would a payment increase boost HPV immunization rates?

To increase HPV immunization rates requires more than educating physicians about the importance of the vaccine, says Ryan Champlin, vice president of Cook Children’s Health Services. Champlin runs a group purchasing organization for pediatricians called PedsPal that has more than 2,500 physician members in 32 states. The GPO helps pediatricians buy office and medical supplies, including vaccines.

Most pediatrics and family practices have profit margins of only $400 to $500 per physician per day, Champlin says. The HPV vaccine costs $130 per dose, making the $390 that physicians must spend to stock the three doses a significant and risky investment, he says.

If physicians don’t administer the vaccine, the companies doing the vaccine research will lose the incentive to invest in the next breakthrough, says Ryan Champlin.

“If a physician buys a box of HPV vaccine and doesn’t give it all to a patient, that’s a direct cost that now falls to the bottom line as a loss,” he says. “That can cost him or her the profit margin for several days.”

Cook Children’s has vaccine agreements with UnitedHealthcare, Aetna, and Cigna under which the insurers will pay the posted retail price as a benchmark rate plus a negotiated margin to cover the cost of purchasing, storing, and giving vaccines. The CDC posted rate is available online at http://tinyurl.com/dmz8o5.

Overhead fee

The additional amount is an overhead fee, Champlin says, and is not the fee to administer the vaccine, for which a physician bills separately. Overhead costs range from about 17 percent to 28 percent of the cost of the vaccine, according to a report in March from the American Academy of Pediatrics (AAP) called “The Business Case for Pricing Vaccines.” The AAP report says, “Pediatric practices are the public health infrastructure for the nation’s childhood immunization program. It is imperative to incentivize pediatricians to participate in immunization efforts by appropriate payment for vaccines.”

Each physician who administers immunizations has an inventory of vaccines totaling $10,000 to $15,000, meaning vaccines are among the top overhead expenses, the AAP says.

Insurers’ payments for vaccines should include a physician’s total direct and indirect costs for these expenses, the AAP says, including:

  • The purchase price as posted by the CDC
  • Personnel costs for ordering and inventory
  • Storage costs for such equipment as freezers, freezer locks, alarm systems, and generators
  • Insurance against loss of the vaccine
  • Costs for inventory waste and nonpayment as when a patient declines the immunization or becomes uncooperative and combative after a physician prepares the vaccine for injection
  • The cost of maintaining a large vaccine inventory

The indirect expenses are estimated to range from about 17 percent to 28 percent of the direct cost of each vaccine, the AAP report says. One source for the estimate of 17 percent to 28 percent is a report called VaccineView from Athenahealth, a company in Watertown, Mass., that provides electronic medical record systems to physicians. Champlin worked with Athenahealth to develop VaccineView, which uses data from Athenahealth’s installed EMRs to show how much insurers pay physicians for vaccines plus the additional costs the AAP cites.

Domino effect

Over two years (January 2009 through December 2010), Athenahealth analyzed 158,983 charges and found that 47.2 percent of payments for eight childhood and adolescent vaccines were below the CDC acquisition cost plus the 17 percent minimum that AAP recommends, Athenahealth said.

“VaccineView shows that physicians are getting the CDC posted retail price for the vaccine, but they are losing their overhead, meaning the 17 percent to 28 percent,” Champlin says. “And if physicians don’t administer the vaccine, the companies doing the vaccine research won’t have a market, and won’t invest the millions needed to produce the next breakthrough vaccine.”

Plans help boost vaccine rates for managed Medicaid enrollees

For three years, six health plans worked with three Minnesota county-based purchasing groups and a not-for-profit company, Stratis Health, in Bloomington, Minn., to raise HPV immunization rates among girls ages 11 and 12 enrolled in the state’s Medicaid managed care program. The performance improvement project aimed to increase HPV vaccination rates by 5 percent among the target population. In the first year, the aggregated rate of members ages 11 and 12 who had at least one HPV vaccination rose from 23.84 percent to 34.23 percent, an increase of 10.39 percentage points. In the second year, the rate of female members ages 11 and 12 who had at least one HPV vaccination in 2009 was 33.81 percent, an increase of 9.97 percentage points from the baseline rate of 23.84 percent. In 2010, the rate was 32.6 percent.

Aggregate performance rates

Source: StratisHealth Inc., Bloomington, Minn., 2011

When addressing issues of science and safety, anecdotes sometimes trump research

Proponents of vaccines say research shows that they are safe and that the safety profile of the human papillomavirus (HPV) vaccine is similar to that of other vaccines for adolescents. Nevertheless, not all experts agree that the HPV vaccine is worth the expense and effort when cervical exams and Pap smear screening have been used effectively for years to identify cervical cancer. Other critics ask if the vaccine will still be effective if administered at age 11 and the child doesn’t become sexually active until years later.

Some of the most vocal critics of vaccines say that one source of data that should lead parents and patients to be concerned about the HPV vaccine is the Vaccine Adverse Event Reporting System. VAERS is a national vaccine safety surveillance program co-sponsored by the federal Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration. VAERS contains data on miscarriages, severe outbreaks of genital warts, and death after injections of the vaccine, among other side effects of concern.

Surveillance system

Claudia Vellozzi, MD, MPH, a family practitioner and the deputy director of CDC’s Immunization Safety Office, says that VAERS is a passive surveillance system that anyone can use to report an adverse event after a vaccination. There is no denominator used to calculate the rate of adverse events.

“A lot of the reports in VAERS are adverse events reported to us regardless of whether the reporter thinks the vaccine is associated with or caused the adverse event,” she says. “Someone may report getting into a car accident after getting a vaccine; most people would not think a car accident is caused by the vaccine but still report it since it occurred following receipt of the vaccine. However, others might disagree and attribute the accident to the vaccine. Adverse events may be caused by vaccination or be coincidental, making VAERS data somewhat awkward to explain, but it is a very good tool for signal detection and that’s how we use it.”

To evaluate vaccine safety, the CDC also uses the Vaccine Safety Datalink. Established in 1990, the VSD is a collaborative project between the ISO and 10 managed care organizations to monitor safety and address the gaps in knowledge about rare and serious events after immunization, the CDC says. The 10 MCOs are:

  1. Group Health Cooperative of Puget Sound
  2. Harvard Pilgrim Health Care
  3. HealthPartners Research Foundation
  4. Kaiser Permanente Northwest, Portland
  5. Kaiser Permanente Medical Care Program of Northern California
  6. Kaiser Permanente Colorado
  7. Kaiser Permanente of Georgia
  8. Kaiser Permanente of Hawaii
  9. Marshfield Clinic Research Foundation, Wisconsin
  10. Southern California Kaiser Permanente Health Care Program, Los Angeles

The VSD uses the MCOs’ administrative data, usually electronic medical records, about the type of vaccine given to each patient, the date, concurrent vaccinations, medical outcomes (including inpatient, outpatient, and urgent care visits), birth data, and census data.

“Even though a lot of reports about the HPV vaccine safety are anecdotal, both of these systems have demonstrated that the HPV vaccine is safe,” she adds. “But I will say this: Anecdotes often can be more powerful than data, and the anecdotes about vaccine safety are a good example.”

No risk

In a study published last fall in Vaccine, CDC researchers used data from VSD to show that the HPV vaccine is safe, although further study is warranted on the link between the vaccine and venous thromboembolism (VTE). In a study of more than 600,000 HPV vaccine doses administered, no statistically significant increased risk for any of a list of prespecified adverse events was detected after vaccination.

“It’s safe. It’s effective. There’s no reason not to get it,” insists Paul A. Offit, MD, answering critics of the HPV vaccine.

Misconceptions about the safety of vaccines can obscure the importance of vaccines, says Paul A. Offit, MD, one of the nation’s leading vaccine safety experts. Offit is the chief of the Division of Infectious Diseases and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. The author of Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure and of Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, Offit also is the Maurice R. Hilleman Professor of Vaccinology and a professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania.

“The biggest burden is getting people to understand the importance of vaccine and of the HPV vaccine in particular,” he says. “At some level we all consider ourselves to be invulnerable. We can’t imagine that cancer is ever going to happen to us until it does.

“Now that we are recommending the HPV vaccine for boys, we are underlining the need for it, which will be a little easier to recommend it for two reasons,” he adds. “Number one, boys can get it and girls often get it from boys, and number two, by not having a recommendation for boys, we frankly ignore men who have sex with men who are at especially high risk for anal and genital cancers. Immunizing only women would never protect men.

“But perhaps the biggest issue to emphasize to medical directors is that we have a vaccine that prevents the only known cause of cervical cancer,” he says. “It was tested on 30,000 people before it was licensed and now more then 30 million doses have been given. Study after study shows the vaccine to be safe and there have been no important side effects other than fainting. It’s safe. It’s effective. There’s no reason not to get it.”

Fainting, also known as syncope or pre-syncope, is a known adverse event that occurs after administration of the HPV vaccine and other vaccines for adolescents, Vellozzi says. CDC researchers believe they know the cause of syncope and presyncope in adolescents and are conducting further research, she adds.