Formation of Patient, Physician, Industry Alliance to Solve Problems of Access to Hum

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

WASHINGTON, May 10 /PRNewswire/ — 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 being 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 can be easily
managed with regular IVIG 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-Barre 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 reimbursements 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)

Contact: K-B Gressitt, FFF Enterprises
Ph: 800-843-7477 C: 760-522-1064

SOURCE Alliance for Plasma Therapies