In many respects HPV is like hepatitis B. I have heard some experts say that we may eventually vaccinate all at-risk women—essentially, all sexually active women.
WRIGHT: Women older than 26 are already asking whether they should be vaccinated. What do we know about the safety and efficacy of the vaccine in these women?
GALL: Even though the number of women infected with at least 1 HPV type, or who have evidence of such infection, exceeds 60% by age 50, only a small number of women will have been exposed to all 4 HPV types covered by the vaccine. Thus, it seems likely that sexually active women over age 26 will benefit from vaccination.
The safety data on the vaccine are excellent. In our experience, the quadrivalent vaccine has been less reactogenic than the influenza vaccine. There is no reason to suspect that the HPV vaccine will be less safe in women over age 26.
Recently, immunogenicity data for the bivalent vaccine—not yet approved by the FDA—were presented to the American Society of Clinical Oncology for women aged 26 to 55 years, and excellent immune responses were observed. All we need to recommend vaccination of sexually active women over age 26 is the efficacy data, and I see no reason to think that the HPV vaccine will not be effective.
Counsel older women about off-label use
WRIGHT: What would you tell a recently divorced 32-year-old who got married in college, has had only a couple of partners, and is beginning to date again?
DeFRANCESCO: The vaccine is approved and recommended only for females aged 9 to 26, so vaccinating an older woman would be off-label—or “off-recommendation,” as those who specialize in vaccination say.
We also know that the immune system is generally more responsive in younger people, although the immunogenicity data that Dr. Gall just mentioned indicate that the bivalent HPV vaccine is highly immunogenic in older women. I would be hard-pressed to deny the apparent protection of the vaccine to a 32-year-old woman simply because she is over age 26.
However, given the medicolegal climate, I would ensure that informed consent includes a caveat about use of the vaccine in someone outside the approved age range and makes it clear that the patient has acknowledged being informed about the “off-recommendation” use.
Readers will want to know that Phase III trials are now assessing the safety and efficacy of the quadrivalent and bivalent vaccines in women over 26; data should be available in the next couple of years.
WRIGHT: I agree completely. In today’s litigious world, it is vital to counsel women appropriately and obtain informed consent prior to any vaccination. One way to educate the patient about potential benefits and risks is by providing her with a Vaccine Information Sheet, available for download from the CDC’s Web site (www.cdc.gov/nip/publications/VIS/default.htm#hpv).
Can an adolescent give her own consent?
WRIGHT: It has not yet been fully clarified whether a sexually active adolescent can provide consent on her own, or whether a parent must sign the consent form. Most states have laws that allow at least some adolescents to seek reproductive services, as well as screening and treatment for sexually transmitted diseases, without parental notification. However, at several meetings I attended recently, lawyers specializing in the legal rights of adolescents said it remains unclear which of these state laws extend to the HPV vaccine.
DeFRANCESCO: I’ve been told the same thing by our legal advisors. Pending clarification, it is important to emphasize to our patients that the vaccine is a cancer vaccine, not a drug to prevent sexually transmitted infection. The vaccine does not give young people “permission” to have sex, but helps prevent them from ever developing cervical cancer. Young people should not have to sneak around to get this protection.
WRIGHT: One of the really big issues is how we are going to pay for the HPV vaccine, which has a list price of $120 per dose and requires 3 injections. If you add the cost of 3 office visits, that’s almost $500.
LEVY: Most insurance companies in our area have already determined that they will cover the HPV vaccine. Even carriers that are usually slow to make coverage decisions added the HPV vaccine to their list of covered services fairly promptly.
WRIGHT: That’s good news for people who have health insurance. What about women who don’t, or who have high deductibles or carve-outs for “preventive services”?
Patients may be willing to foot the bill