Merck Cervical Cancer Shot May Not Win Routine Use for Boys
Oct. 21 (Bloomberg) -- Giving Merck & Co.’s Gardasilvaccine to boys may not boost protection against cervical cancerenough in girls to gain recommendation from a U.S. governmentprogram that provides free shots to 60 percent of children.
An advisory panel for the U.S. Centers for Disease Controland Prevention, made up of 15 doctors who provide advice forwhich vaccines should be given and at what age and dose, is setto decide today whether to urge that Gardasil be given as aroutine shot for boys, and covered by the vaccination program.
The U.S. Food and Drug Administration on Oct. 16 clearedGardasil as an effective protection for genital warts in boys.The vaccine works against human papillomavirus, or HPV, asexually transmitted infection that can lead to cervical cancerin women and a rare cancer of the penis in men. Such a ruling,which would add as much as $300 million in yearly sales, isn’tlikely, said Seamus Fernandez, a Leerink Swann & Co. analyst.
“We expect a permissive, not routine, vaccinationrecommendation,” Fernandez said in a note to investors. Merckmay struggle selling Gardasil for boys because the public-healthbenefit may not outweigh the expense, Fernandez said.
Merck, based in Whitehouse Station, New Jersey, fell 3cents, or less than a percent, to $33.69 at 9:37 a.m. in NewYork Stock Exchange composite trading. The shares had increased9 percent in the 12 months before today.
‘Value in Vaccinating’
“Approximately 75-80 percent of males and females willacquire one or more types of HPV in their lives and HPV-relateddiseases cause significant personal and public health burden forboth men and women,” said Merck spokeswoman Pam Eisele in an e-mail. “As such, we believe there is value in vaccinating bothyoung men and women with Gardasil to help protect them fromcertain diseases caused by HPV.”
William Schaffner, chairman of the department of preventivemedicine at Vanderbilt University in Nashville, Tennessee, saidthe panel will be asking itself “if we vaccinate all the girls,how much additional benefit will we get by vaccinating the boys?
“The answer will be ‘some,’ but at least according to themathematical models, it’s not huge,” he said in a telephoneinterview. Schaffner is not a panel member.
Decisions by the Advisory Committee on ImmunizationPractices are regularly adopted by the U.S. government.
Preference Vote
The committee also will vote today whether to voice apreference for Gardasil or GlaxoSmithKline Plc’s competingproduct, Cervarix, which was approved Oct. 16 in the U.S. toprevent cervical cancer in females ages 10 to 25. Concerns aboutCervarix’s safety contributed to a regulatory delay in 2007,helping give Merck a head start.
A CDC recommendation of allowing “permissive use” forboys, where vaccination is left to a doctor’s discretion, mayadd $200 million to $300 million in annual Gardasil sales by2015, Leerink Swann’s Fernandez wrote in a note to clients onOct. 19. Gardasil sales fell 5 percent last year to $1.4billion, the company has said.
It would cost more than $290,000 to vaccinate enough boysand girls to save one year of life, compared with about $40,000when vaccinating girls alone, according to a study by HarvardUniversity School of Public Health researchers, released Oct. 9in the British Medical Journal.
Any vaccine that costs less than $100,000 per year saved,also known as Quality-Adjusted Life Year, or QUALY, isconsidered “a good deal,” Schaffner said. The QUALY modelincreases the numbers of years saved to include some benefit forliving without nuisance diseases, such as warts.
Merck Studies
Merck’s studies, which assume higher vaccination rates andlower vaccine prices than the Harvard study, found it would cost$50,000 for both boys and girls. Merck’s studies assumed a 100percent vaccination rate at a price of $400 per person.
In a Merck-funded study released last year, researchersgave 4,065 boys and men ages 16 to 26 the vaccine or a placebo,then tracked them for signs of infection with HPV. After about30 months, three men getting Gardasil developed genital wartsand none had pre-cancerous growths linked to the HPV virus,compared with 28 cases of warts and three pre-cancerous lesionsin the placebo group.
The vaccine committee is “faced with something quiteextraordinary: an anti-cancer vaccine that is very very safe andby every indication is exceedingly effective,” Vanderbilt’sSchaffner said. “Over the last five and six years, cost-benefitanalyses have played a larger and larger role in vaccinedebates. The committee has gone back and forth and reallyagonized about that.”
Patient Rebate
Merck will expand a patient rebate and dose replacementprogram to help cover the cost of the vaccine for 19- to 26-year-old men without health insurance and those with privateinsurance with partial or no coverage for the shots, accordingto a company statement.
Gardasil, which is given in three shots over a six-monthperiod, protects against four of the most common of 40 strainsthat can infect the genital area. More than 1 million cases ofgenital lesions, which can lead to cancer, occur in men andwomen in the U.S. each year, and 30 million cases occurworldwide, according to Merck.
Gardasil and Cervarix are given in three doses during asix-month period to trigger immune responses that help protectagainst the two HPV strains responsible for most U.S. cervicalcancer cases. Gardasil also protects against two additionalstrains of HPV that cause 90 percent of genital warts.
Glaxo Challenge
London-based Glaxo faces a challenge in winning doctors’and parents’ support for Cervarix because of Gardasil’s addedprotection against genital warts. Cervarix is cleared in 100countries and had sales of 125 million pounds ($232 million)last year, about one-sixth as much as Gardasil.
While 20 million Americans are infected with HPV, most willbe able to fight off the infection naturally, according to theNational Cancer Institute. About 1 percent of sexually activemen in the U.S. will develop genital warts from HPV, the CDCsaid. Gardasil is approved for males in 40 countries worldwide.
The most common side effect is fainting after getting theinjection, followed by irritation around the skin site anddizziness, according to a government analysis of side-effectreports. For every 100,000 shots, eight patients will faint,seven will have reactions at the area of the injection and sevenwill become dizzy, according to a study published in the Journalof the American Medical Association and conducted by the CDC.
To contact the reporters on this story:Tom Randall in New York at trandall6@bloomberg.net;Shannon Pettypiece at spettypiece@bloomberg.net.
Last Updated: October 21, 2009 09:53 EDTSource: Bloomberg
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