HPV: Who immunizes? Who pays?

October 15, 2010

The anticipated approval of Gardasil for women 27 to 45 years of age has thrown the issue of vaccine reimbursement for pharmacists into the spotlight.

Key Points

The anticipated approval of Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, Merck] for women 27 to 45 years of age has thrown the issue of vaccine reimbursement for pharmacists into the spotlight.

A Merck spokeswoman told Drug Topics that the company expects to hear from FDA by year's end on whether the vaccine will be approved for women up to age 45. At present, Gardasil is approved for females 9 through 26 years of age to help prevent 2 types of human papillomavirus (HPV) that cause cervical cancer and 2 types that cause genital warts. The HPV vaccine also can help protect against vulvar and vaginal cancers.

Gardasil also has been approved for males 9 to 26 years of age, to protect against genital warts. HPV can be contracted from sexual contact.

Both Gardasil and Cervarix protect against HPV types 16 and 18, which are responsible for 70% of cervical cancer in the United States and many parts of the world, said Gregory D. Zimet, PhD, professor of pediatrics at Indiana University and senior author of a Merck-funded study examining the attitudes of older women who might take Gardasil if it were approved for their age group.

A matter of cost

In the study "Human papillomavirus vaccine acceptability among a national sample of adult women in the USA," researchers from Indiana University and Columbia University surveyed 1,323 women between 27 and 55 years of age to find out how they viewed the vaccine. The results were published in the August edition of Sexual Health.

Researchers concluded that while most women viewed the vaccine favorably, they wouldn't seek the 3-shot regimen, which costs $360, if their insurance plans did not pick up the tab.

Pharmacy or clinic?

By a small margin, women said they preferred to be vaccinated at their doctor's office or clinic, rather than at a pharmacy.

"I think it would be reasonable to say that alternative vaccine delivery strategies should be considered. One such might be having PharmDs administer vaccines in local drug stores," Dr. Zimet said, adding that obtaining vaccination in a pharmacy might be easier than making an appointment with a doctor or waiting at a clinic, and might also be less traumatic for teens.

No magic bullet for coverage

If Gardasil for women up to age 45 wins approval and is covered by health plans, will plans reimburse pharmacists administering the vaccine, as well?

"I think not," said Mitchel C. Rothholz, RPh, MBA, chief of staff at the American Pharmacists Association. "Pharmacists are recognized as providers by Medicare, some Medicaid programs, and some private insurance companies and PBMs. But there is no magic bullet to getting coverage. We continue to reach out to the various players to articulate the value of pharmacists' inclusion [in reimbursement plans]."