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HPV Vaccine Stirs Economic Debate
  Federal Panel to Consider
Questions About Expense,
Benefits and Distribution

Wall St Jnl
June 29, 2006
While a debate rages over the morality of giving girls as young as nine Merck & Co.'s new Gardasil vaccine against the sexually transmitted human papillomavirus, a separate economic concern is emerging over the vaccine's hefty price and its impact on the nation's health-care costs.
After gaining regulatory approval on June 8, Merck's Gardasil was priced at $360 for a three-shot regimen, making it one of the priciest vaccines now on the market. The vaccine would be given to adolescent girls to reduce their risk of HPV-linked cervical cancer later in life. Immunizing 12-year-old girls alone could cost insurers and the government up to $700 million a year just for the vaccine.
Merck and others argue that when Gardasil's costs are compared with its potential impact on women's health, the vaccine could be considered a bargain. Some studies have found that the vaccine would be cost effective by providing additional protection against cervical cancer, reducing the frequency of abnormal pap smears and allowing screening to be conducted less frequently. Other experts argue that much is still unknown about the vaccine, such as whether booster shots will be needed and how widely it will be adopted.
The question of cost effectiveness will be among the issues discussed at the Centers for Disease Control and Prevention today and tomorrow, when the Advisory Committee on Immunization Practices meets to formulate its recommendations regarding HPV vaccines. The ACIP will consider whether girls and women should be vaccinated, the recommended ages for the shot, whether a booster is needed, and -- most crucially for the drug's maker -- whether the vaccination should be part of a routine immunization regimen.
Some opponents have argued that inoculating girls against a sexually transmitted disease might send the message that sexual activity is acceptable. Public comments along these lines may occur at the meeting.
The CDC's recommendations serve as best-practice guidelines for doctors. Insurers often follow the CDC recommendations in covering the cost of vaccinations. Merck has a strong track record winning recommendations for its childhood vaccines, but Gardasil is unusual because it targets a young population in order to prevent a fairly rare cancer in the U.S. that usually doesn't strike until middle age or later.
HPV infection is a significant cause of cervical cancer, which each year is diagnosed in an estimated 9,700 women (by comparison, there are 215,000 breast-cancer diagnoses a year). Gardasil aims to prevent infection from four strains of the HPV virus, including two strains that are considered high-risk for cancer. Many other HPV strains also exist.
The cost of cervical-cancer detection and treatment is high. Pap smears, which look for early signs of cancer, cost about $30 a test, and follow-up testing required for abnormal Paps is even more expensive. Treating cervical cancer costs the Medicare system alone about $1.7 billion a year.
Many of the cost-benefit studies done to date involved Merck or GlaxoSmithKline PLC, which is also developing an HPV vaccine. In many studies, including some done independent of drug companies, HPV vaccines like Gardasil appear cost effective if used to inoculate 12-year-old girls, giving them a booster shot five to 10 years later, and providing Pap smears every two or three years. The studies generally calculate cost effectiveness as a measure of the quality years of life that the intervention saves across the population.
Although there's no formal rule, interventions under $50,000 to $100,000 per quality-adjusted life year are generally considered cost effective. Vaccines for measles and mumps are so cost effective they actually save money. On the other hand, Pap smears, which test for early signs of cervical cancer, run anywhere from $150,000 to $1 million per quality-adjusted year of life saved if given annually rather than every three years, health-services researchers say.
These analyses also raise questions of exactly how many girls need to be vaccinated in order for rates of infection -- and later cervical cancer -- to decrease in the population as a whole.
Gillian Sanders, a cost-effectiveness analyst at Duke Clinical Research Institute, has conducted two HPV vaccine cost-effectiveness studies. Dr. Sanders's analysis shows that because of "herd immunity" -- when a vaccine's impact goes beyond just the people who are inoculated -- only about 70% of girls need to be vaccinated to bring the rate of cervical cancer down significantly in the population as a whole.
Many nations, including England, Australia, and Canada, use cost-effectiveness information to help make coverage and pricing decisions about treatments. The U.S. tends to shy away from formally using the information. Medicare, for instance, doesn't take costs into account in coverage decisions. The government-run vaccine fund for uninsured children doesn't either.
Cost-effectiveness calculations, however, can vary tremendously depending on what is included in the models, according to Marthe Gold, a professor at City College of New York who organized the U.S. Panel on Cost-Effectiveness in Health and Medicine in the 1990s that examined inconsistencies in how such analyses were conducted.
And some factors can't be predicted, such as whether another strain of HPV will develop if the currently most prevalent strains are eliminated. Data from Merck's Phase II and III trials suggest that no type replacement occurred in those studies, according to Merck spokeswoman Mary Elizabeth Blake, but Merck will be watching closely to see what happens to the HPV viruses when the vaccine is introduced.
Another issue is just how long the vaccine will be effective. So far the data show that the vaccine is good for at least five years, according to Ms. Blake.

Panel Endorses HPV Vaccine
By Merck for Pre-Teen Girls

Wall St Jnl
June 29, 2006 2:46 p.m.
ATLANTA -- A federal vaccine advisory panel unanimously recommended Thursday that 11- and 12-year-old girls receive a new vaccine designed to protect against cervical cancer.
The Advisory Committee on Immunization Practices, or ACIP, which advises the Centers for Disease Control on vaccination matters said the vaccine, Gardasil by Merck & Co., should be added to the routine vaccination schedule for children and adolescents. The vote makes it highly likely that the vaccine will be covered by private insurers. The panel is expected to vote soon to add the vaccine to a federal program that offers reduced or free vaccines to children.
Melody Drnach of The National Organization for Women Action and Independent Women's Forum CEO Michelle Bernard debate whether the new HPV vaccine should be mandatory for school-age girls.
The panel also said that doctors could vaccinate girls as young as nine and that girls and women ages 13 to 26 should also receive the vaccine even if they have already become sexually active. Ideally, girls and women would receive the vaccine before becoming sexually active.
The recommendation regarding vaccination of 11- to 12-year old girls is designed to coincide with other routine vaccinations given in that age group.
The panel recommendations will next go to the CDC director and the Secretary of Health and Human Services for final approval. Those officials typically follow ACIP's recommendations.
Gardasil is designed to protect against HPV strains 16 and 18, which account for about 70% of cervical-cancer cases, and strains 6 and 11, which account for 90% of genital warts cases. Studies of the vaccine also showed it offered protection against cases of vaginal and vulvar cancer linked to HPV infection. The Food and Drug Administration approved the vaccine for use in girls and women ages 9 to 26 earlier this month.
GlaxoSmithKline PLC is working on a similar cervical-cancer vaccine, Cervarix, which it plans to submit for FDA approval by year's end.
There are more than 100 strains of HPV, however, so the vaccine would not offer full protection against cervical cancer and genital warts. The virus is spread mainly through sexual contact and is the most common sexually-transmitted disease in the U.S. But in most cases, HPV infection clears up on its own without causing cancer and other health problems.
The panel said women still need to undergo routine screening for cervical cancer with Pap tests because the vaccine doesn't protect against all HPV strains linked to cervical cancer.
About 10 people during the meeting spoke in favor of the vaccine. Several of the speakers, including Deborah Arrindell, vice president of health policy for the American Social Health Association, said steps needed to be taken to ensure low-income girls and women without health insurance had access to the vaccine. Gardasil is priced at $120 per dose, and would be given in three doses over six months, making it one of the most expensive vaccines on the market.
Some conservative groups have said the decision to vaccinate young women should be left to parents and shouldn't be state-mandated, however, they didn't speak at the meeting. It will be up to each individual state to decide whether an HPV vaccination will be required to attend public schools.
Otis Brawley, an oncology professor at Emory University in Atlanta, told the panel that boys and young men should also be vaccinated in order for the vaccine to have the best chance of cutting cancer rates as men can spread HPV to women. HPV infection has also been linked to some cases of head and neck cancer in men.
Merck studied the vaccine in more than 20,000 girls and women up to age 26, and the data showed the vaccine prevented precancerous lesions and cervical cancer in patients. Merck also studied the vaccine in boys ages 9 to 15. That data, however, included only tests of Gardasil's ability to induce immune responses in boys, but not data on its effect in preventing disease. For now, the FDA has limited approval for use in girls and women and the CDC panel followed suit.
About 9,710 new cases of invasive cervical cancer are expected to be diagnosed in the U.S. this year, and about 3,700 women are expected to die from the disease, according to the American Cancer Society. Worldwide there are more than a half-million cases of cervical cancer annually, and deaths from cervical cancer are the second-leading cause of cancer deaths worldwide.
Panel to Mull Additional Chickenpox Vaccine Dose
The CDC vaccine panel is expected to consider a proposal later Thursday that children ages 4 to 6 receive a second dose of another Merck vaccine, Varivax, designed to protect against varicella, the virus that causes chickenpox. Children currently receive one dose of the vaccine at about age 12-to 15-months. However, there is evidence of chickenpox outbreaks among some vaccinated school-age children, suggesting the need for a second shot.
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