Doctors praise U.S. expansion of HPV vaccine; Arkansas particularly at risk for cancers related to virus

The Food and Drug Administration's expanded licensure of a vaccine that can prevent some cancers caused by human papillomavirus presents an opportunity to fight cancer in Arkansas, some local physicians say.

The FDA this month expanded its approved uses of Gardasil 9, which vaccinates against nine strains of HPV, to include people who are between the ages of 27 and 45. Previously, the drug officially was approved only for children and young adults ages 9-26.

The greenlighting and subsequent expanded use could make a big difference in a state that stands out -- even amid the Southeast region, where HPV infections historically are elevated -- for its unusually high rates of HPV-related cancer and low vaccination rates, Dr. Kristin Zorn said.

"This is a particularly acute issue for Arkansas, compared to other places in the country. ... We are one of the states that could benefit ourselves the most," said Zorn, a University of Arkansas for Medical Sciences associate professor in the department of obstetrics and gynecology and division of genetics.

According to a 2016 U.S. Department of Health and Human Services and Centers for Disease Control and Prevention report, Arkansas had a rate of 13.5 HPV-associated cancers per 100,000 people, joining Florida, Kentucky, Louisiana, Mississippi and West Virginia as the states with the highest rates. The incidence for women alone was 16 per 100,000, the third-highest in the nation.

An umbrella term for a group of about 150 viruses, HPV is spread through sexual contact and often produces no visible symptoms, meaning most people don't know they are carrying it or spreading it to others, according to a CDC fact sheet. As many as 14 million people are infected with HPV each year.

But several strains of the virus are linked to cancers, including cervical cancer in women and oropharyngeal (throat) cancer, which has been on the rise in recent years, Zorn said. She described the vaccine as a "miracle in health care" that can stop as many as 90 percent of the roughly 31,000 HPV-related cancer cases diagnosed annually.

"We haven't really capitalized on that incredible opportunity we have" to limit cancers that could otherwise have been prevented in the state, Zorn said. "We've been hoping for this [announcement] ... for quite a while, ever since the HPV vaccines were first developed."

If the official endorsement by the FDA to license the vaccine for an additional age group spurs more widespread use, it could encourage "herd immunity," in which so many people are vaccinated that some infections drop dramatically or even vanish, she said. In one recent study she described, Australia has projected that that country will virtually eliminate cervical cancer through vaccination in the coming decades.

The vaccine also can prevent genital warts and more minor issues such as abnormal pap smears that can be emotionally and financially difficult for women, she said, but "as an oncologist, this is really about cancer prevention."

CONDITIONS AND COSTS

Dr. Richard Wyatt, an obstetrician-gynecologist at Arkansas Women's Center, also hailed the move by the FDA. He said Gardasil 9 has the potential to reduce the risk of cervical cancer and pre-cancerous conditions by as much as 70 percent, and fights cancers of the mouth, tongue and cheeks in men.

"I don't know why they had age limitations at all -- there's not something magical about it [that meant it] quit working at the age of 27," he said.

Even before the announcement, he sometimes suggested the vaccine as an off-label treatment for adults in the age group the FDA has now approved.

"If you're in the age range, and you're not going to be with your sex partner for the rest of your life, it makes sense for adults to get this," he said.

Patients often pay for off-label prescriptions out of pocket, and Wyatt said the cash price for the complete vaccine series typically runs about $450.

Expanded approval of the vaccine should continue trends she has seen since its introduction, said family physician Dr. Stephanie Ho. At Planned Parenthood in Fayetteville, "we're seeing less abnormal [pap smears], we're seeing less cervical cancer," she said.

In the past year, she's noticed an uptick in people in their 30s and 40s asking to be vaccinated against HPV. The FDA's announcement formally endorses use by that age group, she said, noting there are benefits even for people who already have been infected with an HPV strain in the past.

"We were very, very happy to see this. ... It's going to be even better if we can get insurance companies to go along with it," she said.

It's not yet clear that payers including private health insurers, Medicare and Medicaid will be willing to cover use by the age group cleared by the FDA, Arkansas Department of Health immunizations medical director and health literacy medical adviser Dr. Jennifer Dillaha said.

That's because there is an additional approval step at the CDC that many payers rely on to help decide what they are willing to cover.

A group of medical and public health experts called the Advisory Committee for Immunization Practices meets quarterly at the CDC to review newly licensed vaccines, reviewing safety studies and epidemiology as well as other factors such as cost effectiveness. (An Arkansan, Dr. Jose Romero of Arkansas Children's Hospital, sits on that committee.)

A discussion of the expanded age range for Gardasil 9 is listed on an Advisory Committee for Immunization Practices draft agenda for its Oct. 24-25 meeting. If approved, there is generally a lag of a few months before payers officially adopt those recommendations, Dillaha said.

A spokesman for Arkansas Blue Cross and Blue Shield, the state's largest insurer, said most changes for vaccine coverage are related to Advisory Committee for Immunization Practices endorsement, and that the insurance group has not made a determination in response to the FDA announcement.

FOCUS ON CHILDREN

Dillaha said the vaccine, which is available at many pharmacies and health department units throughout the state in addition to doctor's offices, has been integrated into the Vaccines for Children program, which covers vaccines for children under age 18 who are uninsured, underinsured or on Medicaid through federal funds.

She said the department has tried to communicate that although the virus is sexually transmitted, in no way does someone have to be promiscuous to contract it.

For example, it could affect anyone who plans to someday get married, who could contract it from their spouse.

"That's the tricky thing about [HPV]," she said. "It is so ubiquitous that most people, at least 80 percent of people, will get infected with it at some point in their life. ... It's like we're all at risk."

In the past, Dillaha said the idea had been to get the vaccine as a child before there is any exposure to the virus which can cause at least seven different kinds of cancer.

Among teens, "there's a lot more sexual activity going on out there than people are comfortable admitting to," she said, referring to the CDC's 2017 Youth Risk Behavior Survey that found that 30 percent of Arkansas high school students said they were sexually active.

But that strategy could change following the FDA's announcement.

Previously, the vaccine was approved only for younger age groups based on the clinical trials that were conducted at its introduction, Zorn said.

Its original formula, called Gardasil, was approved by the FDA in 2006, and Gardasil 9, which treats more strains of HPV, was approved in 2014.

Zorn said promoting the vaccine in Arkansas has been challenging.

Reimbursement issues have made some smaller medical providers hesitant to stock it, and physicians have heard from patients about "stigma," religious objections and misconceptions about safety.

But the vaccine is "incredibly safe," Zorn said, with limited side effects including pain at the injection site and a sudden drop in heart rate and blood pressure that can cause fainting after getting the shot. Other adverse events have been "scrutinized really closely."

Zorn said it's important to note that HPV-caused cancers often strike people in the prime of life, who may be caring for children or their parents, and preventing cancer has benefits that spread beyond the individual.

"We are slowly but surely chipping away at those concerns, and helping people understand the real value of the vaccine," she said. "[And] vaccination is always going to be much more economically advantageous than treating cancer."

Metro on 10/15/2018

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