IVIG shortage driving patients to hospitals

Patients requiring immune globulin (IG) are finding the therapy difficult to acquire because of tightening supplies of the plasma-derived biologic and new, lower Medicare reimbursements, according to patient groups and industry analysts.

An oversupply of IG in the early part of the decade helped drive several companies out of the business, and the ensuing consolidation resulted in tightening supplies last year. Beginning in January, Medicare lowered the rates it pays for physician-administered intravenous IG (IVIG), which is causing doctors to send patients to hospitals, which, in turn, have been unable to buy enough of the product.

Michelle Vogel, VP of government affairs and reimbursement services at the Immune Deficiency Foundation, predicted that, absent Congressional action, the problem would only become more dire next year, when hospital reimbursement is cut. "This could get a lot worse before it gets better." She noted that patients with immune deficiencies who are prone to contract life-threatening infections are not well served by policies that drive them into hospitals.

At the Geisinger Health System in Pennsylvania, Dean Parry, a pharmacist who directs pharmacy utilization management for the organization, said that his group has already made decisions about who will and will not get the biologic in the future. He plans to hold the line against new uses of the treatment while supply remains tight.

"It's a day-by-day, week-by-week process," explained Parry, who said the Geisinger hospitals have seen an increased patient load from doctors who cannot treat these patients without losing money. "Don't get me wrong. In a hospital, that's very difficult. In a private practice situation, it's intolerable."

The supply outlook remains uncertain, said Fox. The Red Cross, a major supplier of a cheaper, lyophilized IG product, has exited the market, and though Baxter is expected to maintain that production, the specifics of that transition are cloudy.

In the meantime, Vogel said she is working with other advocates to win changes in the law governing reimbursement. The group has already asked the Department of Health & Human Services to declare a public health emergency-a move that would allow the Centers for Medicare & Medicaid Services to boost payments to doctors-but Vogel said she does not expect action soon and has turned her attention to Congress.

Immune-deficient patients, however, could get a reprieve from some of the supply problems if new supplies of the biologic become available. One firm, ZLB Behring, has determined that it can increase production by offering a single lyophilized IVIG product, Carimune NF. Carimune NF is produced by a method that yields more IVIG per liter of plasma than Behring's other IVIG, Gammar-P IV. Vogel added that the company has shifted production of its Carimune agent to a European facility that may be able to churn out larger supplies of the therapy.

ZLB Behring is also working to win Food & Drug Administration approval for a subcutaneous (SC) form of the agent-IV preparations are the standard in the United States-which would give patients not only another source of IG, but a new way of administering the product as well. According to experts speaking at the Immune Deficiency National Conference in June, the SC therapy could be a viable option for patients who have problems with IVIG due to poor access to veins or side effects from the therapy.

Though SC IG therapy must be given more often than the IV form-as often as two or three times a week-it can be administered at home without medical assistance. Melvin Berger, a professor of medicine at Case Western Reserve University, said he expects a balance in the choice patients make when they choose immune globulin: About half will opt for the less-frequent but more-involved IV treatment, about half will accept the responsibility and gain the flexibility of SC IG.

Brian Reid is a writer based in the Washington, D.C., area.