For the first time in almost 30 years, a government panel is adding a vaccine, for shingles, to the list of preventive shots recommended for older adults against debilitating or life-threatening illnesses.
The Advisory Committee on Immunization Practices voted yesterday to recommend Merck & Co.'s new Zostavax vaccine for shingles in people over age 60. The committee of doctors and immunization experts convenes three times a year to shape vaccination policy for the Centers for Disease Control and Prevention, and its recommendations help determine both medical practice and insurance coverage policies.
Until now, the major vaccines recommended for older Americans have been to protect against flu and pneumonia.
The Food and Drug Administration approved Zostavax in May to prevent shingles, or herpes zoster, in patients over 60. Shingles emerges in people who have had chickenpox after the dormant virus reactivates in older adults. The virus causes pain and ultimately erupts on the skin as blisters and rash. About one million cases of shingles are reported annually in the U.S., of which 250,000 turn into more severe postherpetic neuralgia, or chronic nerve pain, according to Mark Feinberg, vice president for medical affairs and health policy in Merck's vaccine division.
The market -- and the CDC nod -- represents a boon for Merck, the only company selling a shingles vaccine, but the product won't necessarily be a blockbuster, analysts said. Zostavax had $11 million in third-quarter sales. With an estimated 50 million Americans over age 60 -- a population that stands to increase as baby boomers reach that age -- analysts estimate annual sales may approach $1 billion but more likely will top off around $600 million.
Unlike vaccines for school children, the shingles vaccine isn't required. "With seniors, there are questions about whether to go to the doctor, whether they want the vaccine," said Barbara Ryan, a pharmaceutical analyst at Deutsche Bank, who said she thinks the vaccine could potentially reach $400 million in U.S. sales. "There are a lot of reasons not everyone chooses to get vaccinated."
The one-dose, roughly $150 vaccine is a more potent version of Merck's chickenpox vaccine approved in 1995. In a large clinical trial, Zostavax reduced the incidence of shingles by 51% and the risk of long-term pain by two-thirds. The condition occurs most frequently in older people, yet Merck is testing Zostavax in younger age groups in hopes of expanding the market, Dr. Feinberg says.
"Shingles can be a pretty debilitating illness, and postherpetic neuralgia causes excruciating pain that has been very challenging to treat," said Sharon Brangman, a specialist in geriatric medicine at SUNY Upstate Medical University, in Syracuse, N.Y.
Dr. Brangman, a board member of the American Geriatrics Society, looks to the government recommendations to determine how to treat her roughly 3,000 elderly patients. Until now, though, she hasn't administered Zostavax, to be cautious with new medicines and mindful of how they may interact with the many treatments older patients tend to require.
"You don't want to give them something that makes it worse," she said.
Some health-care plans, such as Aetna Inc., began covering the vaccine when it came out. Others, such as Cigna Corp. and WellPoint Inc., are updating their plans based on the panel's recommendation. Merck estimated that plans covering 43% of insured patients reimbursed for the vaccine before the panel's recommendation. The vaccine costs $3 for so-called dual-eligible Medicare and Medicaid patients, while people in health plans may pay up to a 25% co-pay on the list price of about $150, Merck said.
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