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Back to Home > News > Friday, Apr 06, 2007 Nation Posted on Fri, Apr. 06, 2007 email this print ... High hopes, high price for
The biological product, at about $100 per gram and up to $10,000 per treatment course, is among the most expensive therapeutic substances in the medical marketplace. And sufferers of any number of immunological diseases say that without regular intravenous immunoglobulin treatment, they would be severely disabled or worse.
But the product's high cost - and its growing popularity for use against conditions as varied as baldness and infertility, autism and Alzheimer's disease - has insurers balking. Strict controls on reimbursement have left some patients without means to pay for the treatment.
IVIG, as it is commonly known, is made up of antibodies derived from thousands of pooled blood donations. Given intravenously over several hours, IVIG is most typically used in people with impaired immune systems.
Although doctors cannot explain exactly how IVIG works, the general understanding is that the antibodies infused into the patient's body replace or take on the existing antibodies that are causing damage or disease.
When Romero's symptoms first surfaced, in 2003, she was leading "an active, exciting life," raising two daughters, working full time for the Girl Scouts and helping with her husband's music ministry.
Numbness in her toes, shortness of breath, and tingling hands were the first clues to a diagnosis that would take months to figure out. Stumbles, falls and broken bones made the mysterious deterioration that much more aggravating.
Finally, Romero was given a name for her condition: "chronic inflammatory demyelinating polyneuropathy." Known as CIDP. The disease is caused by damage to the myelin sheath, the fatty covering that surrounds and protects the peripheral nerves.
Eventually, neurologist Stephen Knox prescribed IVIG. At the time, Romero was getting around with the help of a walker, moving, she said, "like a 90-year-old woman."
After three treatments with IVIG and physical rehabilitation, she said she felt like a new person and planned a return to work. But as would be the case over two subsequent years, the improvements were fleeting. Once the IVIG treatment wore off, her condition returned so overwhelmingly that some days she could only crawl from her bedroom to the bathroom.
Romero's doctors, wary of the high costs of IVIG, tried other treatments, including steroid drugs and drugs that suppress the immune system. None worked; the relapses continued. The last resort - IVIG - was the only thing that helped. To Romero's relief, her insurance company continued to cover the infusions.
By March of last year, Knox, the neurologist, decided to try weaning Romero off the blood product, gradually extending the time between infusions. The approach is working. Her condition appears to be in remission.
At the same time, however, Romero's health insurance company began refusing to pay for many of the treatments, apparently because they were deemed unnecessary. By the end of March, she said, she had about $40,000 in unpaid bills.
Coverage problems for IVIG first surfaced during the phased implementation of the 2003 Medicare Prescription Drug, Improvement, and Modernization Act. The legislation changed reimbursement rates to doctors and hospitals for drugs, said Michelle Vogel, a health care consultant in Washington, D.C.
Even as the treatment price increased, she said, doctors' reimbursement rates were cut 30 percent, making it impossible to purchase for patients. One year later, she said, hospitals saw another 40 percent cut in reimbursement rates.
"What happens is the hospitals start shutting down outpatient (IVIG infusion) facilities because it is not economical," Vogel said. "They are losing money."
In a written response to questions, Medicare spokeswoman Ellen B. Griffith said the former reimbursement rate for IVIG was based on an average wholesale price self-reported by its "manufacturers (at grossly inflated prices." The new rates for most prescription drugs, she said, are based on 106 percent of the manufacturers' average sales price.
The Centers for Medicare & Medicaid Services are working with the FDA to monitor access to the treatment, she said, and "so far the FDA has not found a shortage, and the Secretary of Health & Human Services has declined to declare a public health emergency."
Many large health insurers followed Medicare's lead on drug pricing, so the effects have been widespread, said Patrick M. Schmidt, CEO of FFF Enterprises in Temecula, which distributes more than one-third of the U.S. supply of IVIG, worth an estimated $750 million per year.
Unlike the antibiotic Cipro, for example, which was in high demand during the anthrax scare, IVIG takes human blood donations and a complicated, international manufacturing process to bring IVIG to market, he said.
"When (the federal government) called the makers of Cipro and ordered 900 million tablets, Bayer was able to turn that out in 90 days," Schmidt said. "If you donated blood today, (IVIG) would come to us as a finished product eight to nine months from now."
Pricing and reimbursement are complicated by the fact that doctors and patients are anxious to try IVIG for ailments for which the product was not approved by the Food and Drug Administration.
When reviewers at Blue Shield of California studied IVIG use by its member doctors, they found it prescribed for one type of baldness, chronic fatigue syndrome, epilepsy, malaria, gastroenteritis and even in conjunction with in vitro fertilization.
The health plan now requires prior authorization before approving its use, and typically limits coverage of IVIG to the handful of FDA-approved uses, including treatment for certain immune and autoimmune disorders.
"As a physician, it is very concerning that medicine is being used for things for which there is no proof that it works," said Dr. Fiona Wilmot, medical director of medical policy, pharmacy and therapeutics at Blue Shield.
Dr. Jonathan Katz, a neurologist at California Pacific Medical Center in San Francisco, said he understands both sides of the issue. He said he wrote the criteria for the appropriate use of IVIG in patients with neuropathy.
"We see some patients who get back the use of their hands because of the medicine who had been totally paralyzed for years," he said. "And sometimes, it's a last chance for the patient, something that might work, and you don't want to say no, even though the chances are low."
"Last time I got (an infusion) was six weeks ago," she said. "We are just going to pray that my body has gotten to a point where I am in a true remission. I am scared to death."
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