A downside to heralded HPV drug: Cost, access

PHILADELPHIA (MCT) — Pediatrician Steven Shapiro thinks the new vaccine against cervical cancer is a major medical advance that will benefit all of society.

Even so, he isn’t offering Gardasil to his patients. He says insurance reimbursements don’t cover his costs to buy, store and administer it.

“I’m in practice with four physicians and we simply can’t afford it,” said Shapiro, who also chairs the pediatrics department at Abington Memorial Hospital.

Seven months after the federal government approved Merck & Co. Inc.’s much-heralded immunization for females ages 9 to 26, Gardasil can be difficult for patients to obtain.

By all accounts, the vaccine could eventually save thousands of lives and billions of dollars annually in this country. But right now, it is a case study in the ragged economics of U.S. health care.

The base price — $360 for three shots given over six months — makes it the most expensive of an ever-growing list of childhood vaccines. Private insurance coverage of Gardasil is in flux. Many physicians are complaining about under-reimbursement. And for the uninsured, free or discounted vaccines are very limited for women over 18.

So far, only New Hampshire and South Dakota have set up programs to provide Gardasil for free. But these, too, set age 18 as the cutoff. In general, family-planning clinics that receive public funding are not offering vaccine assistance — at least, not yet.

Many colleges have started to offer Gardasil — to students who pay up front. The fee varies, with the University of Pennsylvania charging $130 per dose, for example; Rutgers University, $140 a dose; and Cornell University, $165 a dose.

“We’ve had people who decided not to get it because they couldn’t afford it,” said Melodee Lasky, Rutgers’ director of student health services.

Even women who are willing and able to pay out of pocket may find getting Gardasil is even more difficult than getting an appointment with their gynecologist. Sheila Lynn, for example, discovered that her gynecologist, like most, is not yet offering Gardasil. So she is taking her 18-year-old daughter back to the pediatrician.

“I would never think to call my kid’s baby doctor,” Lynn said, if not for Gardasil.

Gardasil prevents infection with two strains of sexually transmitted human papillomavirus (HPV) that cause benign genital warts, and two strains that cause about 70 percent of cervical-cancer cases. Because the cancer protection is not complete, women still need regular screening with Pap smears.

Federal experts have recommended that all girls be vaccinated at age 11 or 12 because Gardasil provides maximum protection before exposure to genital HPV.

In the United States, cervical cancer is rare thanks to screening. Still, each year nearly 10,000 women are diagnosed, 3,700 die and $3 billion is spent on HPV-related treatment, most involving the removal of precancerous cervical changes.

Merck is spending heavily on marketing, partly to boost public awareness of HPV and cervical cancer. A national survey in 2005 — before Gardasil was available — found only 40 percent of women had heard of HPV, and less than half of that group knew of the cervical-cancer connection.

Merck had sold about $80 million worth of Gardasil through October — an “extraordinary uptake,” said Richard Haupt, the company’s media-affairs executive director.

He said the vaccine’s price tag reflected Merck’s investment in development, as well as its value to society in preventing disease.

Merck recognized the need for vaccine assistance for women ages 19 to 26, almost a third of whom are uninsured. So the company set up a program that offers the vaccine for free to women who are low-income and uninsured.

Pediatricians — already responsible for administering many vaccines against a host of illnesses — have emerged as the primary providers of Gardasil. The problem, they say, is that insurers are not paying enough to cover their administrative expenses, which add 18 percent to 25 percent to the vaccine’s $360 base price.

And reimbursement rates vary. Pediatricians say Independence Blue Cross, the major private carrier in Southeastern Pennsylvania, for example, pays significantly less than Highmark Blue Shield or Capital Blue Cross, which cover other parts of the state.

“It’s the difference between losing your shirt and breaking even,” said pediatrician Mark Reuben, author of an American Academy of Pediatrics report on vaccine costs. “Medicare’s administrative fee for Gardasil is $18. (Independence) isn’t even paying what Medicare pays.”

Independence reimburses $127 per Gardasil dose but won’t divulge administrative payments, said company spokeswoman Judimarie Thomas. The other Blues plans would not reveal any reimbursement rates.