LEVY: I have been discussing the vaccine with eligible women and mothers of young girls for several months. Even before payers stepped up with coverage, no patient was seriously concerned about the cost. Clearly, this will not be true for everyone, but when offered an opportunity to avoid cancer, my patients have been happy to pay for it. In addition, many offices now accept credit cards, which may make it possible for patients to make payments over time.
I think success will depend in large part on how we educate our patients. I frequently discuss preventive care in the context of other things we do in our lives for “maintenance.” For example, none of us would expect our automobile insurance to cover the cost of changing the oil or buying new tires. The HPV vaccine is comparable: The costs incurred now may prevent significant health risks in the near future.
Further, the price of the vaccine series is quite low relative to the potential costs of office visits for follow-up of abnormal Pap smears or treatment of genital warts.
We must stress to our patients that Pap smears aid in the detection of cervical cancer precursors, but the vaccine is an opportunity to prevent cervical cancer.
The poor and uninsured have several alternatives
WRIGHT: In the predominantly Latin American neighborhood where I am located, there are many uninsured who simply cannot afford $500 for the full course of 3 vaccinations. For uninsured children and adolescents, or those on Medicaid up to age 19, the federally funded Vaccines for Children program will cover the cost. However, for women aged 19 and older, vaccinations are considered an “optional” benefit under Medicaid, which means that individual states must decide whether the HPV vaccine will be a covered service.
One bit of good news: Merck plans to provide free vaccines, including the HPV vaccine, to low-income and uninsured adults 19 years and older who visit private clinicians who already provide Merck vaccines. Although the details of this initiative have not been finalized, the program may help individuals in states that decide not to cover the HPV vaccine with Medicaid.
Vaccine appears safe near time of conception
WRIGHT: I have heard varying opinions about the level of risk vaccination poses if a woman becomes pregnant shortly afterward. What do the data show?
GALL: It is inevitable that this vaccine will be administered to some women who are not yet aware they are pregnant. In the Merck trials, more than 1,000 pregnancies occurred in both the vaccine and placebo groups. There were 15 abnormal infants in the vaccine group and 16 in the placebo group. The abnormalities were nonrepetitive and did not raise concern at the FDA.
Among the women who received an injection within 30 days of conception, there were 5 abnormalities, compared with none in the placebo group—but none of the abnormalities were repetitive and some involved such things as an extra digit.
The vaccine was accorded a pregnancy category B. This is a landmark for the FDA because no other vaccine has this designation, even those used extensively during pregnancy, such as the trivalent inactivated influenza vaccine (TIV) and hepatitis B.
At present, clinicians are asked to report any women who receive the quadrivalent vaccine and become pregnant, but I can foresee a time when we will administer this vaccine during pregnancy.
How ObGyns are reacting
WRIGHT: Dr. DeFrancesco, you are involved in managing almost 200 ObGyns. How do you expect the specialty to respond to the new vaccine?
DeFRANCESCO: Vaccination is not a traditional ObGyn responsibility, but I think most of us are comfortable administering other injections, such as Rho(D) immune globulin, leuprolide acetate, and depot medroxyprogesterone acetate, or even hepatitis B vaccines for our staff. The HPV vaccine is a different injection with a different purpose, but well within our expertise to administer. I am pleased to report that—in record time!—all our practices are offering the vaccine and implementing this new service. It clearly is the right thing to do.
ObGyns need to build a vaccination infrastructure
WRIGHT: There are related issues: maintaining stocks of vaccine in ObGyn offices, developing and using consent forms, and implementing a tracking system to make sure patients get all 3 injections of the vaccine. How are you addressing these issues?
DeFRANCESCO: We have implemented a clinical guideline consistent with the ACIP and ACOG policy statements, along with a model informed consent and insurance waiver within our large group practice. This helps us ensure that providers are up-to-date on the latest recommendations and are ready to provide this service.