Witnesses tell of deaths due to IVIG shortage

November 6, 2006

A late September hearing saw patients and advocates telling the government that people are dying due to lack of access to intravenous immune globulin therapy (IVIG). It also recorded allegations about suspected artificial shortages, federal foot-dragging, and supplies directed to less-deserving patients. The "town hall" meeting, held recently in Arlington, Va., took five-minute statements from about three dozen witnesses as part of an independent study the Department of Health & Human Services (HHS) contracted for. Patients have been unable to get IVIG, get it in the best setting, or get the brand that works for them.

A late September hearing saw patients and advocates telling the government that people are dying due to lack of access to intravenous immune globulin therapy (IVIG). It also recorded allegations about suspected artificial shortages, federal foot-dragging, and supplies directed to less-deserving patients. The "town hall" meeting, held recently in Arlington, Va., took five-minute statements from about three dozen witnesses as part of an independent study the Department of Health & Human Services (HHS) contracted for. Patients have been unable to get IVIG, get it in the best setting, or get the brand that works for them.

"While Congress and Health & Human Services continue to study this, people are dying. And my days are numbered," said Rose Mary Istre, a patient and support group leader of the Myositis Association. Atop the list of reasons cited for IVIG problems was the 2005 shift in Medicare Part B reimbursement from Average Wholesale Price to Average Sales Price. According to HHS, that cut reimbursement by 35% for the powder form of IVIG and 15% for the liquid form.

Susan Pappas, director of operations for Critical Care Systems, an alternate-site infusion provider with 46 branch pharmacies and a specialty in IVIG treatment, said that because of the reductions, "physicians and outpatient clinics are generally unwilling to serve these patients, in effect leaving no outpatient treatment settings available for these patients."

Testimony also noted that IVIG is being used for numerous diseases beyond primary immune deficiency, including some kinds of cancer, as well as autoimmune, neurological, and systemic inflammatory conditions. In addition, because contracts are based on a facility's past usage, dislocations occur when patients change settings.

Ronald Hartmann, Pharm.D., VP of MedAssets, a large group purchasing organization that secures contracts on behalf of hospitals and others, said his company has a significant role in determining where products go. But, he said, while many contracts are based on historic purchases, patients change settings and providers change GPOs. He challenged the industry "to support a system whereby the product moves with the customer." HHS officials have also told Congress that, among other factors, because IVIG is derived from human plasma, it takes significant start-up time to increase supply, and supply has historically been cyclical.

Edith Marshall, director of legal affairs for the Public Hospital Pharmacy Coalition (PHPC), said the "340B" provision of the Public Health Service Act requires manufacturer discounts to "safety-net" providers on outpatient drugs. Still, she said, field reports and the coalition's survey indicate that half of public hospitals have problems getting enough IVIG, and even more-almost 80%-are unable to get the 340B discounted price. A copy of PHPC's survey results can be found at http://www.phpcrx.org/.

Mary Kruczynski, a member of Community Oncology Alliance, said that in light of experiences with IVIG, she can see "a similar problem on the horizon with chemotherapy drugs and associated drug therapies stemming from the reimbursement issues."

The IVIG study, being done by the Eastern Research Group Inc., is due for completion in the first quarter of 2007. It will put together all information that has been compiled by various sources, according to HHS staff.

THE AUTHOR is a writer based in the Washington, D.C., area.