Merck Adds Gardasil, Other Vaccines to PAP for Public Hospitals, Clinics

Print Article

By Karin Rives

Los Angeles County, population 10 million, has four 340B-covered hospitals and more than 20 health clinics that serve 2 million patients annually. In addition to the discounts they receive through the 340B program, county pharmacies rely to a large extent on patient assistance programs, or PAPs, to provide free drugs to area residents.

So when Gardasil, a drug that can prevent cervical cancer, entered the market, L.A. County Pharmacy Director Amy Gutierrez thought it would be a good fit. Only problem was, the manufacturer of the drug, New Jersey-based Merck & Co., didn’t offer Gardasil or any other vaccines through its PAP to public hospitals or clinics.

The State of California offers free vaccines to children under the age of 18, but Gardasil has been approved and recommended for patients aged 9 to 26, leaving a coverage gap for young women above 18. The vaccine is used to prevent cervical cancers caused by four strains of the human papilloma virus and is taken in three doses over a six-month period. It was also recently approved by regulators for the prevention of vaginal and vulvar cancers caused by the same virus.

“The cost of the three doses is $400, which is a lot of money for people who are not covered by Medicaid. But when I contacted Merck’s vaccine program, I was told that government-owned or publicly funded entities were not covered through patient assistance,” said Gutierrez. “They basically told me they didn’t feel that public entities knew how to handle a PAP for vaccines.”

Astonished, Gutierrez decided not to take no for an answer. In May 2008, she and L.A. County’s senior medical director fired off a letter to Richard Clark, Merck’s chief executive officer, to request that Merck reconsider its policy.

It didn’t take long before Gutierrez got a call back from Merck, which wanted to discuss the matter. Soon after, Merck officials flew to California to meet with her and other county health officials. Long story short: In December, Merck contacted Gutierrez to let her know that going forward, Gardasil and all other vaccines covered under the company’s patient assistance program would be available to publicly funded health providers nationwide.

Fighting Cancer with Free Vaccines

“She called me and told me ‘We won!’” recalled Dr. Robert Israel, a professor and the director of the University of Southern California’s Women’s Health Clinics, who had participated in the meetings with Merck. “In 10-15 years we’ll have a decrease in cervical cancers thanks to this, particularly in the Latino population. I’m just very pleased that our population now has access to this vaccine.”

Merck spokeswoman Amy Rose said in an e-mail that it was always Merck’s intention to “evaluate the feasibility of participation by public entities” in the vaccine PAP program, which began in 2006.

“In fact, Merck began discussions in 2007 around the potential of creating a separate program for the public health sector that would address some of the complexities involved with providing a vaccine patient assistance program within the state public health infrastructure,” Rose wrote.

During those discussions, Merck received questions from numerous public health entities, including public hospitals, about opening up [Merck’s regular vaccine patient assistance program] to public entities.” Los Angeles County Department of Health Services was one of them, she said.

Gardasil got off to a healthy start during its first full year on the market, with 25 percent of girls in the United States receiving the vaccine in 2007, the Centers for Disease Control and Prevention reported last October. Today, it makes up 85 percent of vaccine doses supplied by Merck’s PAP. The company is now informing public hospitals and other safety-net entities that they recently became eligible for Gardasil and other vaccines provided by the PAP, Rose said

Cultural Barriers

So far, however, Dr. Israel’s health clinics have only qualified a handful of young women for the program, a mission he predicts will take time. Gardasil has been controversial since its launch, with some scientists having questioned its safety and some conservative groups complaining that the vaccine gives tacit approval of premarital sex. In 2008, worldwide sales of the vaccine dropped by 5 percent to $1.4 billion, Merck reported in February.

“There’s a lot of education that has to take place,” Gutierrez acknowledged. “We’re dealing with social and cultural issues. But if we can impact cervical cancer in L.A. County we’ve succeeded.”