In October 2018, the FDA expanded the approved age range for use of the nine-valent HPV vaccine from 9-26 years to 9-45 years in both women and men. Subsequently, the CDC's Advisory Committee on Immunization Practices voted to update its recommendation for use of the nine-valent HPV vaccine, raising the upper age for catch-up vaccination for men from 21 to 26 to match that for women. For patients 27-45 who had not been adequately vaccinated, meanwhile, the committee recommended that HPV vaccination be based on shared clinical decision-making between the physician and patient.
After the FDA's 2018 action, a multinational team of investigators created a mathematical model to examine the long-term health impacts and costs of the updated recommendation with the aim of informing the ACIP's deliberations. Their research,(annals.org) published in the Jan. 7 issue of Annals of Internal Medicine, found that expanding HPV vaccination to age 45 could generate some additional health benefits in this older cohort but would not be as cost-effective as it is in younger patients.
Study Details and Conclusions
The researchers estimated the health benefits and costs of HPV vaccination according to four scenarios -- namely, extending the program to cover vaccination in men and women up to ages 26, 30, 40 and 45. They performed a series of simulations using a model that accounted for factors such as sexual behavior, HPV transmission rates and vaccination history.
- In July 2019, the Advisory Committee on Immunization Practices voted to expand its HPV vaccination recommendation to include women and men as old as 45 based on shared clinical decision-making with their physician.
- Researchers developed a model to measure the health benefits and cost-effectiveness of the updated recommendation compared with the vaccination protocol previously in place.
- They found that expanding HPV vaccination coverage to age 45 would produce small additional health benefits but would not be as cost-effective as the earlier recommendation.
Two main outcomes were measured. For health benefits, the researchers estimated the number of HPV-associated outcomes that would be averted during the next 100 years. For costs, the main outcome was cost per quality-adjusted life-year gained (a measurement of years lived in perfect health).
Regarding health benefits, the authors estimated that compared with no vaccination, the current strategy of HPV vaccination in women through age 26 and in men through age 21 would
- reduce diagnoses of anogenital warts by 82% (32 million),
- reduce diagnoses of grade 2 or 3 cervical intraepithelial neoplasms by 80% (13 million),
- reduce cases of cervical cancer by 59% (653,000) and
- reduce cases of noncervical HPV-associated cancer by 39% (769,000).
Extending HPV vaccination through age 45 in both men and women would further reduce these same outcomes by 0.4%, 0.4%, 0.2% and 0.2%, respectively.
From an economic standpoint, the authors wrote that the current vaccination strategy reduces costs and can be expected to produce substantial gains in quality-adjusted life-years during the next century. Expanding coverage to include men and women through ages 30, 40 and 45, however, would be much less cost-effective, with 90% of model simulations producing incremental cost-effectiveness ratios of more than $124,000; $382,000; and $463,000 for every quality-adjusted life-year gained, respectively. Median incremental costs would be $830,000; $1,843,000; and $1,471,000, respectively, per quality-adjusted life-year gained.
Overall, compared with the current recommendation, the researchers estimated extending HPV vaccination to age 45 would cost as much as $15 billion over the next 100 years. The actual costs would depend on a number of factors, including the natural history of HPV, historical vaccine coverage and vaccine efficacy.
"Our results suggest that the current vaccination program in the United States will substantially reduce HPV-associated diseases and is cost-saving, whereas vaccinating mid-adult women and men through age 30, 40 or 45 years is predicted to produce small additional reductions in HPV-associated diseases and to result in substantially higher ICERs than the current program," the authors wrote.
Additional research is needed, they noted, to identify which individuals older than 26 would benefit most from HPV vaccination, and to analyze the current recommendation's effects on reducing the incidence of HPV-associated diseases in unvaccinated women and men through age 45.
FP's Perspective and Guidance
It's also important to note that the analysis looked at the costs associated with vaccinating entire age groups regardless of risk. However, some patient populations are at increased risk of HPV-related cancers and complications and, as such, are more likely to benefit from vaccination than others.
Marie-Elizabeth Ramas, M.D., who practices in Nashua, N.H., and was the 2015-2016 new physician member of the AAFP Board of Directors, told AAFP News she weighed the risks and benefits of vaccination for herself. In December,(twitter.com) she tweeted about getting the third and final dose of the vaccine, which she proudly referred to as the "best Christmas gift to myself."
"As a black woman, statistics do not fall within my favor as far as risk for morbidity from cervical cancer," Ramas explained. "Although the rates of cervical cancer have dropped dramatically since the development of the HPV vaccine, black women still have a higher mortality rate and lower five-year survival rate(blackdoctor.org) than their white or Latino counterparts."
"Every medical decision is a personal one," Ramas added. "While many vaccines have proven to save lives, there is still a degree of time needed to see if the benefits of expanded administration of the HPV vaccine will pose a population benefit for all. In the meantime, I have opted to err on the side of safety, given the benefits to me outweigh the risks."
For Ramas, the study revealed several important findings for FPs to contemplate.
"As family physicians, we should be mindful of our specific populations that we service, and consider vaccination especially for those who may not have reliable screening history, have higher risk behavior patterns or for groups or populations that may have historically delayed cervical cancer detection rates," she said.
"Depending on the practice type, one's patient mix may benefit from the extended age range for administration of the HPV vaccine," Ramas added. "One should discuss the risks and benefits of HPV vaccine administration with their patients and evaluate their risk potential for acquiring cervical cancer. Some considerations would include (the) likelihood of getting routine Pap smears or high-risk sexual behavior in patients with multiple encounters of unprotected sex."
Some patients, Ramas said, may hesitate to get the vaccine for reasons not directly related to personal health.
"As many of my patients are of different cultures, it is important for me to consider their level of comfort or trust in the medical system to provide care that is not detrimental to them. Specifically, when it comes to vaccinations, many patients still have relatives who come from an era of the Tuskegee trials. Other patients discuss how the Pap smear was discovered by the use of cells from an African American woman without consent,(www.britannica.com) and we need to discuss the hard decision to trust from this historical standpoint," said Ramas.
"I see my role in patient care as that of a consultant to wellness and healthy living. While I do not try to persuade my adult patients into getting their HPV vaccine, I do take the time to discuss the pathophysiology of developing cervical cancer and the importance in monitoring and prevention. Thus, it is vital to our practice to approach conversations with an open mind and understanding where the patient comes from," she concluded.
Related AAFP News Coverage
CDC Underscores Need to Boost HPV Vaccination Coverage
Dual Reports Highlight Vaccine's Value in Cancer Prevention