HPV Vaccine Gardasil Might Not Be Cost-Effective For Adult Women, NEJM Study Says

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 22 Aug 2008 - 7:00 PDT

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Vaccinating young teens to prevent cervical cancer might be cost-effective, but a new study questions the cost-effectiveness of vaccinating older teenagers and women in their 20s, the Wall Street Journal reports. The study, conducted by researchers at the Harvard School of Public Health, was published Thursday in the New England Journal of Medicine.

Gardasil is approved by FDA for girls and women ages 9 to 26. The vaccine targets two strains of HPV that cause about 70% of cervical cancer strains, as well as two HPV strains that cause most cases of genital warts. CDC recommends routine vaccination with Gardasil for girls ages 11 and 12, as well as temporary "catch up" vaccination for girls 13 to 26 who have not received the vaccine. Merck would also like to market it to women ages 27-45. The vaccine, introduced in 2006, costs about $360 (Loftus, Wall Street Journal, 8/21).

For the study, the researchers used computer models to predict the health outcomes of girls and women who receive Gardasil, as well as Pap tests and other screenings for cervical cancer. The researchers included the cost of the vaccine, screenings, and treatment for cervical cancer and other illnesses targeted by the vaccine in the analysis (Stobbe, AP/Baltimore Sun, 8/20). According to the Journal, some researchers use a model that says a treatment or vaccination is cost-effective if it costs less than $50,000 for each year of a life gained -- known as "quality-adjusted life years," or QALYs -- while other researchers use a higher maximum of $100,000 per year.

The researchers found that it would cost about $43,600 for each QALY gained for girls who receive Gardasil at age 12. According to the study, the cost effectiveness of Gardasil would cost $97,300 per QALY for women who are vaccinated at age 18, $120,400 per QALY for women vaccinated at age 21 and $152,700 per QALY for women and girls vaccinated up to age 26. The cost per QALY was reduced when the researchers factored in protection against genital warts, according to the Journal. The calculations also assumed that Gardasil would produce lifelong immunity against HPV. The study concluded that Gardasil's cost per QALY would increase if it is determined the vaccine is not as effective after 10 years (Wall Street Journal, 8/21).

The researchers concluded that it is not cost-effective to vaccinate women in their 20s. Although the researchers did not calculate the cost effectiveness of vaccinating women ages 27 to 45, lead author Jane Kim said that Gardasil "becomes less cost-effective" as girls and women get older. Some policy experts noted that an individual woman in her 20s might decide that HPV vaccination is worth the cost even if it is not considered cost-effective for all women in their 20s (AP/Baltimore Sun, 8/20).

The study was funded by CDC, the National Cancer Institute and the Bill & Melinda Gates Foundation (Szabo, USA Today, 8/21).

Reaction

Merck rejected the study's findings and claimed that its own calculations found the vaccine is cost-effective, the Journal reports. Rick Haupt, Merck's head of clinical research for Gardasil, said that the company's research indicated that Gardasil's cost per QALY is "well under $50,000" for women up through age 26. According to the Journal, Merck calculations included the potential for genital warts in men, while the NEJM study did not. In addition, the NEJM study accounted for patient time and travel costs, while the Merck's calculations did not.

"We believe there's important value in vaccinating all women who are in the indicated age groups," Haupt said (Wall Street Journal, 8/21). Dale Morse, chair of CDC's Advisory Committee on Immunization Practices, noted that the agency does not have plans to revise its guidelines for the vaccine, adding that CDC considers a vaccine's safety and potential to prevent disease in addition to its cost (USA Today, 8/21).

Related Commentary

An accompanying editorial in the NEJM by Norwegian physician Charlotte Haug says that there is still good reason to be cautious about introducing large-scale vaccination programs. She labels the "base-case assumptions" of the study as "quite optimistic" (AP/Baltimore Sun, 8/20). Haug writes it is unclear whether the researchers' assumptions that the vaccine will provide lifelong immunity against HPV will have the same effect in young adolescent girls and older women and that women will continue to be screened for cervical cancer are "reasonable." She writes that such issues need to be examined in further research, adding that if the authors' "baseline assumptions are not correct, vaccination becomes less favorable and even less effective than screening alone" (Haug, NEJM, 8/21).

~ ABC's "World News" on Wednesday reported on the study. The segment includes comments from ABC correspondent Sharyn Alfonsi, Diane Harper of the Women's and Gender Studies Program at Dartmouth College, Haupt and ABC medical director Timothy Johnson (Gibson, "World News," ABC, 8/20).

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