State Senator Announces Formation of Patient, Physician, Industry Alliance to Solve Problems of Access to Human Plasma-Based Therapies

May 10, 2007 Media Release

WASHINGTON, D.C., May 10, 2007 - At today’s meeting of the U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability, Nebraska State Senator Abbie Cornett will announce the formation of the Alliance for Plasma Therapies. The Alliance, chaired by Cornett, was formed to help resolve the complex challenges patients and healthcare providers face in obtaining fair access to and reimbursement for human plasma products and their administration.

The first challenge the Alliance will tackle is the current intravenous immune globulin (IVIG) access crisis affecting patients and healthcare providers across the United States. IVIG, a plasma product used to treat many critical and chronic illnesses, became difficult to access after the January 2005 implementation of a new IVIG reimbursement method defined in the Medicare Modernization Act.

The IVIG access crisis has had a seriously negative impact on healthcare. “Patient care has been compromised by lack of access to IVIG,” Cornett explained. “Many providers are no longer treating with IVIG due to reimbursement restrictions, and no other organization exists to provide a unified voice for all patients and providers of plasma therapies.”

Creating a unified voice for patient organizations, physicians and industry is the primary goal of the Alliance. Cornett, in addition to being in her third year of service representing Nebraska’s 45th Legislative District, is also a patient. She has common variable immune deficiency, one of the many chronic diseases treated with IVIG. Other Alliance board members include physicians who treat patients with IVIG, a plasma products manufacturer and one of the leading U.S. plasma product distributors.

Board member Jonathan Katz, MD, treats patients with neurological diseases requiring IVIG therapy, and he is keenly aware of the impact of the IVIG crisis. “This is a difficult medical area because cases are hard to diagnose, treatments are expensive and many patients lack access to care. The Alliance for Plasma Therapies creates an opportunity to develop the best and most rational way to treat patients by combining so many different perspectives.”

Patrick M. Schmidt, whose company FFF Enterprises is a leading distributor of IVIG, believes the Alliance is an essential part of the IVIG access crisis solution. “HHS has recently released two reports that confirm a serious decline in patient care since January 2005. We hear from patients, almost daily, whose IVIG treatments have been reduced or discontinued. The crisis has remained unresolved because of the complex and divergent solutions suggested by various stakeholders. The Alliance will bring a unified voice to the debate, something all patients who rely on IVIG desperately need.”

Flemming Nielsen, general manager of Octapharma USA, a global manufacturer of human plasma products, believes the key to the Alliance’s success is to secure access to all available IVIG products for patients in all sites of care. Nielsen explained: “This will restore the integrity of the physician-patient relationship, allowing them to make product and treatment decisions based on patient care criteria, not on product access issues.”

The Alliance board member’s concerns are reflected in the organization’s initial objectives, which include:

  • To ensure fair and adequate reimbursement for all brands of IVIG in all sites of care: physician office, independent clinic, hospital and homecare
  • To update IVIG coverage and dosing guidelines for all relevant diseases
  • To be an IVIG access information resource for patient organizations, provider communities, Congress, federal and state agencies and others
  • To advocate to Congress and the U.S. Department of Health and Human Services for fair access to IVIG.

As a patient and an elected representative, Cornett brings a uniquely personal and public policy perspective to the Alliance. “Our vision is to make sure patients can access the treatment they need to stay healthy, to stay alive, to live the lives they deserve to live. The Alliance looks forward to working with the Advisory Committee on Blood Safety and Availability, with Congress, with the Department of Health and Human Services, with industry and, most important, with the patients and providers who are waiting for our collective leadership—to resolve our IVIG access crisis.”

Background

Alliance for Plasma Therapies Board Members

Chair, State Senator Abbie Cornett has served the public as a Senator for Nebraska’s 45th Legislative District since 2005. She previously served as a police officer with the City of Omaha for 10 years. The Senator was diagnosed during her campaign with common variable immune deficiency, a primary immune deficiency disease that for many patients is easily managed with regularIVIG therapy.

Jonathan Katz, MD, a neurologist, practices at Forbes Norris MDA/ALS Research Center at California Pacific Medical Center and serves on the boards of the Guillain-Barré Syndrome and CIDP International Foundation, the Neuropathy Action Foundation and the California Myasthenia Gravis Foundation. Katz has published extensively on neurological diseases requiring IVIG therapy.

Roger Kobayashi, MD is a clinical professor at UCLA who practices immunology in Nebraska and is a national consultant to the Immune Deficiency Foundation.

Flemming Nielsen is general manager of Octapharma USA, a global manufacturer of products derived from human plasma. A Danish native, Nielsen graduated from the Copenhagen Business School and joined Octapharma in 2003 at its headquarters in Switzerland. He relocated to the United State in 2004 and helped establish the U.S. organization as vice president of finance and operations. He assumed the role of general manager in April 2005.

Patrick M. Schmidt is founder, president and CEO of FFF Enterprises, an IVIG distributor, and NuFACTOR, which provides IVIG services to homecare patients, and publisher of IG Living magazine. FFF’s responsible management of plasma products, particularly in times of shortage, has won Schmidt recognition as an innovative expert in the management of critical-care biopharmaceuticals.

IVIG Access Reports
Reports recently released by the U.S. Department of Health and Human Services Office of the Inspector General (OIG) and the Assistant Secretary for Planning and Evaluation (ASPE), along with information from independent surveys, confirm a serious decline in patient care. Below is a sampling of the findings.

  • Since implementation of the new Medicare reimbursement rules for physicians instituted in January 2005, 42 percent of Medicare patients receiving IVIG therapy in physician’s offices in 2004 had been shifted to other locations by the end of 2005. (Source: ASPE)
  • In 2006 only about half of hospitals and physicians could purchase IVIG below the Medicare reimbursement rate. (Source: OIG)
  • An independent survey of hospital pharmacy directors showed that 32 percent of hospitals reported turning away patients for IVIG treatment at some point during 2006. (Source: Immune Deficiency Foundation)
  • Another independent survey of hospital outpatient clinics and physician providers found that 14.4 percent had already discontinued their IVIG infusion services and 45.4 percent planned to discontinue those services if reimbursement were not adequate. (Source: FFF Enterprises)
  • Home infusion services generally are not accepting new primary immune deficiency patients with only Medicare coverage because healthcare providers are not able to acquire IVIG at prices at or below the Medicare Part B reimbursement level and because they are not reimbursed for the infusion service. (Source: ASPE)