In a move that will please those hoping to lower America’s high rates of HPV infection and cervical cancer and will no doubt upset anti-vaxxers, the FDA announced Friday that the HPV vaccine Gardasil 9 is now approved for men and women ages 27 to 45.
The vaccine, which protects against nine different strains of the cancer-causing human papillomavirus, was previously approved for people ages 9 to 26, with many assuming it provided no benefit for those over 26.
But the FDA has now expanded that range, in line with new findings that the vaccination is still effective in people up to 45 years old—88 percent effective, in fact. According to the agency’s press release:
In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.
Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) …
Preteens are encouraged to get immunized before becoming sexually active to prevent the spread of the infection, which can cause cervical cancer, the fourth most common type of cancer in women, as well as cancers of the anus, penis, vulva, vagina, and throat (not to mention genital warts). HPV is so pervasive—nearly half the 18- to 59-year-old population is currently infected—that the CDC says that nearly all people will encounter at least one strain in their lifetimes. But even if you’ve been exposed to one strain, the vaccine is still effective in immunizing against others. Gardasil isn’t the only HPV vaccine on the market, but it protects against the most strains, including HPV 16 and 18, those responsible for the majority of cervical cancers in women (not to mention 90 percent of HPV-related cancers in men), making it worthwhile even for this older age range.
The vaccine works—not just on a case-by-case level but on a broader scale, when implemented properly. The FDA’s decision came just days after the publication of a major study in the Lancet Public Health: It said that Australia, which introduced a national publicly funded HPV vaccination program in schools in 2007, is on course to all but eliminate cervical cancer. In 2016, 79 percent of girls and 73 percent of boys who turned 15 were fully vaccinated against HPV, and research indicates that such high levels of vaccination dramatically reduces the risk of infection (by 87 percent) even for unvaccinated individuals. By contrast, less than half of all U.S. teens are fully vaccinated, even though the CDC recommends that all preteens get vaccinated.
But approval is one thing, affordability another. Gardasil 9 is priced at $205 per dose, according to ABC News, but the “fair price” one can expect in Brooklyn, according to healthcarebluebook.com, is around $285. Those who get it before the age of 15 need only two shots, but three are recommended for older people. You also have to take into account vaccine administration fees, “facility fees,” and whatever else doctors feel like adding on, and it could end up a lot higher. One doctor I called Monday told me it would cost $250 for the injection plus a $250 visit fee, just for one dose.
The expansion has some ages 27 and up who are not yet infected with the most dangerous strains asking: Does my insurance cover the HPV vaccine? As NBC was quick to point out, the FDA approval “does not necessarily mean that health insurance will pay for it.”
Gardasil 9 is covered by most insurance plans for those in the approved age range—9 to 26—because it counts as preventive care, which is supposed to involve no charge or copay. Healthcare.gov lists “immunization vaccines,” and specifically the HPV immunization, under its list of services that “all Marketplace health plans and many other plans must cover,” but follows it up with a specific disclaimer: “Doses, recommended ages, and recommended populations vary.” According to Verywell Health, it’s gendered too, despite the fact that immunizing both genders is important: “The age group for which the vaccine is covered as well as whether it is covered for females and males or females alone also varies.” Even the Gardasil website is wary, stating that “while many private health plans provide coverage for GARDASIL 9, the availability of coverage and the level of coverage can vary.”
It’s also not clear whether approval by the FDA for 27- to 45-year-olds signals that insurance companies will accept the vaccine as “preventive” for that group. The approval is very new, but sites including that of the American Cancer Society still suggest that those over 26 needn’t bother with the vaccine. (On Monday afternoon, the ACS’ HPV page was updated to reflect the approval change, but remained consistent in its assessment of its utility: “The Gardasil 9 vaccine is approved for women and men up to age 45, though not recommended after age 26. While the vaccine is safe, it is unlikely to provide much, if any, benefit as people get older.”)
Some insurers I called said that the HPV immunization is covered as preventive care and had no specific age range listed in their systems. But another company told my colleague that it would not be covering it unless the CDC changes its recommendation. At the moment, the agency only recommends the vaccine through age 26. The American Cancer Society says that insurance plans generally cover immunization if it is administered “according to national guidelines.” But there is some good news: The New York Times reports that the CDC’s Advisory Committee on Immunization Practices has been discussing the data and will likely be making a recommendation soon, hopefully making for a stronger guarantee of coverage.
There are ways young people without insurance are able to access the vaccine, though it’s not clear if these will extend to those over 26 either. The Vaccines for Children program, often pointed to as an affordability option, won’t apply, nor will the Merck Vaccine Patient Assistance Program; as it stands, those eligible for assistance from the drug’s manufacturer must be 19 to 26 years old—though, as a friendly customer service rep told me, as long as you’re under 27 for the first dose, they’ll keep ’em coming. (Merck has updated its product info sheet to reflect the new age range, but not its patient assistance program eligibility. They were not able to provide a response to questions regarding expanding the assistance program in time for this article.) Medicaid covers the vaccine for those under 20 and for 21- to 27-year-olds in some states, while certain Planned Parenthood health centers, college medical clinics, and local health departments are also able to offer the vaccine for free. But with finite resources, will Planned Parenthood and local health departments be able to assist those for whom the vaccine is, as the American Cancer Society puts it, “unlikely to provide much, if any, benefit”?
It looks like those who missed out on HPV protection because they were too old to be considered worth immunizing when the drug was young are about to be doubly screwed over—and potentially several hundred dollars out of pocket, if they want the vaccine. America is riddled with HPV, and unless the CDC or insurers decide adults need this vaccine too, it’s probably going to remain that way for the time being.