Will the HPV vaccine compel-at last-an overhaul of US immunization policy?

December 1, 2006

If the promise of new vaccines, such as Gardasil, is to be achieved, pediatricians and family physicians must be relieved of the burdens associated with purchasing and administering them.

In June, the Food and Drug Administration approved the use of human papillomavirus vaccine (Gardasil) for the prevention of genital HPV infection and cervical cancer in women. Licensing of this vaccine on the heels of a new, and apparently safe, rotavirus vaccine (Rotateq) should have been an occasion for rejoicing by pediatricians, family physicians, and others who provide preventive care for children. Instead, the FDA's approval of Gardasil, and a forthcoming recommendation by the American Academy of Pediatrics and the Advisory Committee for Immunization Practices that it be administered routinely to girls as early as 9 years of age, has generated frustration and anger among many health-care providers whose patients would benefit from immunization.

The anticipated cost of the three-injection series of the HPV vaccine needed for complete immunization is $360. Unlike other pharmaceutical products prescribed by physicians, vaccines must be purchased by providers in anticipation of their use and under the expectation that the up-front cost will be reimbursed by insurers (or by patients' parents). But there is uncertainty about that expectation.

Consider the position of a pediatrician who has 100 female patients who will turn 11 years old in a given calendar year. Enough vaccine to accommodate those patients costs the pediatrician approximately $36,000, and the purchase would be made under several assumptions:

None of these problems are new. Pediatricians have, for years, expressed concern about the expectation that the benefits of the nation's immunization policy-benefits that accrue not only to the individual child and her family but to society-come at considerable expense to medical practices and individual physicians. Gardasil has brought these matters to the fore-because the cost of the vaccine is so high and because the health benefits of vaccination are not likely to be appreciated for at least 10 years after the first doses of the vaccine are given. This is a vaccine that is likely to save health insurance companies, and society, a great deal of money in the long run but that presents a significant financial burden to providers who choose to include it in their program of preventive care.

So, which providers will choose to provide Gardasil? Interestingly, the medical specialty whose members have generally not (at least so far) chosen to provide the HPV vaccine to their patients is the one whose patients would benefit most directly and most quickly: gynecologists. It should be instructive to observe that the costs associated with purchasing, storing, and administering Gardasil have dissuaded physicians whose mission is to provide health care to women from implementing a program to prevent one of the most significant threats to their patients' health. Surely, reluctance on the part of gynecologists is a signal that the immunization program in the United States requires overhaul.

It's generally agreed that immunizations were one of the most important health-care interventions of the 20th century-and continue to be. Regrettably, the cost of this phenomenal achievement has been borne disproportionately by pediatricians and family physicians. New but expensive vaccines, such as Gardasil, have the potential to reduce medical costs and lost time at work and to enhance health throughout adult life. But if the promise of these new, 21st-century vaccines is to be achieved, pediatricians and family physicians must be relieved of the burdens associated with purchasing and administering them. For more on this subject, see Updates in this issue.