November 11, 2005

Mr. George B. Abercrombie
President/CEO
North American Pharmaceuticals Operations
Hoffman-La Roche, Inc.
340 Kingsland Street
Nutley, NJ 07110-1199

Dear Mr. Abercrombie:

 

We the undersigned organizations and individuals are writing to urge Roche to
remove the current restrictions on access to its patient assistance program (PAP) for
individuals living in states whose AIDS Drug Assistance Programs (ADAPs) have not
included Fuzeon™ on their formulary or that have, in your company’s estimation,
placed unreasonable caps or restrictions to the drug’s access.
The National Alliance of State and Territorial AIDS Directors’ (NASTAD) ADAP Crisis
Task Force partnered with Roche in March 2003 when Fuzeon™ received FDA
approval. This partnership included Roche’s participation in negotiations with the Task
Force to offer Fuzeon™ to all state ADAPs at a reduced cost. The Task Force followed
up by promoting the inclusion of Fuzeon™ on state ADAP formularies, providing
technical assistance on the drug’s benefits, as well as sharing data from other states’
Fuzeon™ utilization. The Task Force members, all of whom are AIDS Directors or
ADAP Coordinators, comprehend the overwhelming cost of research and development
of new drug formulations as well as the extreme need for “salvage” therapies for those
individuals who have outlived other more traditional regimens.
Some ADAPs have been unable to add Fuzeon™ to their formularies due to fiscal
constraints, yet have a sincere desire to increase access to it for individuals in need of
the drug. As you are aware, ADAPs have been seriously under-funded by the federal
government for the past four years. Despite the financial challenges facing many
ADAPs, the number of states with Fuzeon™ on their formulary has increased
substantially over time. Currently, 79 percent or 41 ADAPs report having Fuzeon™ on
their drug formularies. This is an increase from 65 percent in June 2003. Of eleven
ADAPs not covering Fuzeon™, five report having client waiting lists for ALL DRUGS
due to severe financial constraints. Within the 41 ADAPs covering Fuzeon™ on their
formularies, however, there are states that have placed a “cap” on the number of
individuals eligible to receive Fuzeon™ through the ADAP or have put prior
authorization in place to ensure that Fuzeon™ is prescribed when medically
appropriate. According to NASTAD’s ADAP Watch released on October 12, 2005, three
states reported 69 individuals on waiting lists for Fuzeon™ as of September 19, 2005.

 

Hoffman-La Roche, Inc.
November 11, 2005
Page Two
We find it unacceptable that Roche is placing inconsistent restrictions on the Fuzeon™
PAP from one state to another. Furthermore, despite financial constraints within many
ADAPs and the continuing progress that ADAPs nationwide have made in including
Fuzeon™ on their formularies, we find it unconscionable that Roche continues to
enforce restrictions on access to its Fuzeon™ PAP for individuals living in states where
ADAPs are unable to afford adding the drug to its formulary or that have included it
with utilization caps or access restrictions. Holding patients in need of this medication
hostage in order to cajole resource poor ADAPs to add Fuzeon™ to their formularies is
clearly unethical and in blatant opposition to your company’s posted mission statement.
Roche’s “Accelerated Simultaneous Access Program (ASAP),” through which
physicians and clients can now easily obtain two months of free Fuzeon™, is another
example of questionable company ethics that is creating untenable clinical situations.
By initially providing two months of free Fuzeon™ through this program and later
denying continuation of treatment through the Fuzeon™ PAP in states with no or
limited ADAP access for Fuzeon™, Roche encourages initiation of treatment and then
forces patients to stop their antiretroviral therapy/participation in clinical trials when
they cannot obtain Fuzeon™ through their state ADAP. This callous use of people
living with HIV as a marketing tactic is unethical and reprehensible.
The ADAP Crisis Task Force has worked diligently with representatives from Roche
over the past year, demanding removal of these Fuzeon™ PAP restrictions.
Unfortunately, there has been no movement by Roche in meeting the requests of the
Task Force to ease these restrictions. We now join with the ADAP Crisis Task Force in
urging Roche to remove the PAP restrictions in all jurisdictions and make the lifesaving
drug available to all individuals living with HIV who otherwise qualify for the
PAP and are desperately in need of Fuzeon™.
We look forward to your response and a continuing partnership that benefits the
individuals we serve. Please contact Lanny Cross at 518-279-1224 or
ltc02@... should you have any questions.
Sincerely,
Organizations
Acadiana CARES
ACT UP NY
ACT UP Philadelphia
ADAP Crisis Task Force
AIDS Action (Washington, DC)
AIDS Action Baltimore
AIDS Action Committee
AIDS Action Project NorthWest
AIDS Drug Assistance Program, Utah Department of Health
AIDS Education Global Information System
AIDS Emergency Fund
AIDS Foundation of Chicago
AIDS Healthcare Foundation, Los Angeles, CA
AIDS Legal Referral Panel
AIDS Project Los Angeles
AIDS Services for the Monadnock Region
AIDS Services of Austin
AIDS Task Force of the Upper Ohio Valley
AIDS Taskforce of Greater Cleveland
AIDS Treatment Activists Coalition (ATAC)
AIDS/HIV Health Alternatives
Alaska HIV/STD Program
Alaskan AIDS Assistance Association
Allies Linked for the Prevention of HIV & AIDS
Americans For Safe Access
Arizona Department of Health Services, Office of HIV/AIDS
ATAC - Drug Development Committee
*Bright Start*, HIV Prevention, ACCESS NH, New Hampshire Minority Health Coalition
Caritas House, Inc.
Children, Youth & Family Health Services, Howard Phillips Center - HUG-Me Program
Christie's Place
Community Fitness Today, Inc.
Community HIV/AIDS Mobilization Project (CHAMP)
Community Service Network Inc.
Comprehensive Care Center
Cook County Westside Healthcare Center
Cooper Early Intervention Program
Department Community Health Promotion, Northern Kentucky District Health
END AIDS NOW
Equality Louisiana
F.O.U.N.D.
Family Service Association of Bucks County
Frannie Peabody Center
Georgia Department of Human Resource, HIV Care Program
Georgia Rural Urban Summit
Healing Waters Mission & Wellness Center
Health Global Access Project
HIV/AIDS Law Project
HIV/AIDS Services for African Americans in Alaska
Hyacinth AIDS Foundation
Idaho Department of Health & Welfare, STD/AIDS Program
Interfaith Medical Center, M. Martin-Naar MD
Interior AIDS Association (Fairbanks, Alaska)
Jersey City Connections, Inc.
Jersey City Episcopal Community Development Corporation
Kentucky Department for Public Health, HIV/AIDS Branch
League of Young Voters
Lee County Health Department
Living Room, Inc.
Maine HIV Advisory Committee
Massachusetts Department of Public Health, HIV/AIDS bureau
Matters of the Heart Ministries, Inc.
McGregor Clinic, Inc
Michigan HIV/AIDS Council
Michigan Positive Action Coalition
Mobile AIDS Support Services
Nashville CARES
National Alliance of State and Territorial AIDS Directors
National Association of People with AIDS
NETWORTH/Positive Action, Inc.
New Mexico AIDS Services
New York AIDS Coalition
New York State Department Of Health Uninsured Care programs
Nightsweats & T-cells, Co
NM POZ Coalition
Northern Colorado AIDS Project
Ohio AIDS Coalition
Open Door Clinic
PACO/GRIP
Pan Pacific Consulting
Pennsylvania/Mid Atlantic AIDS Education and Training Center
Positive Livin’ Inc.
Project Inform
Recovery Options
Ryan White Title 1 EMA Planning Council, Las Vegas, Nevada
Salt Lake Community Action Program, HOPWA program case manager
San Antonio AIDS Foundation
San Francisco AIDS Foundation
San Luis Valley HIV/AIDS Coalition
Save ADAP Committee, AIDS Treatment Activists Coalition, USA
SLO HEP C PROJECT
South Carolina Campaign to End AIDS
South Carolina Women's Advocacy Council
South Mississippi AIDS Task Force
Southern AIDS Coalition
Southern Illinois Effort for AIDS, Inc
Southern NH HIV/AIDS Task Force
STREET WORKS
Tarrant County Samaritan Housing, Inc
Texas AIDS Advocacy Coalition
The AIDS Institute
The Center for AIDS Information & Advocacy
The Miriam Hospital, The Immunology Center
The River Fund
The Well Project
TII Community AIDS National Network
Total Health Awareness Team
Treatment Action Group
Tri-State AIDS Task Force
University Medical Center Consumer Advisory Board, Las Vegas, Nevada
University of Iowa Healthcare, Dept of Internal Medicine
Utah AIDS Foundation
Vanderbilt University, Division of Infectious Diseases
Washington State Department of Health, HIV Client Services Program
West Virginia Coalition for People with HIV/AIDS
West Virginia HIV Care Consortium
West Virginia HIV/AIDS and STD Program
West Virginia University - Charleston Division, Charleston Area Medical Center
West Virginia University, Council on Sexual Orientation
Western Pacific Re-Hab
Westside Health Center of Cook County
Individuals
Bobby Hawker
Amy M. Klingler, MS, PA-C
brett wilcots
Cindy Boerger
Elizabeth Perez, New Jersey
Felix and Paula Sirls
Grant Gailey
James Murphy, New Hampshire
Jay Adams, West Virginia
Jeff Bloom, Washington, DC.
Jeffrey Sibille, California
John Shaw
Joyce Turner Keller
Joyce Turner Keller, Louisiana
Kathy Morris
Michael Wong, MD
Nelson Vergel
Pamela Neely
Patricia L. Schreiber, Rhode Island
R. S. and Betty Kilburn, California
Rev. Franklin B. Evans
Rev. Melinda Foster
Richard Rosenthal
Ricky G. Wadlow, Illinois
Robert J. Saqueton, MD
Roger Goodman, M.Div.
Shawn Aldridge, North Carolina
Stuart Merrill
Wendy Craytor, Alaska
Sharon Zandman-Zeman (Anchorage, Alaska)
Cc: Franz B. Humer, Roche Holding Ltd., Basel Switzerland
William M. Burns, Roche Holding Ltd., Basel Switzerland
Steven D. Skolsky, Trimeris, Inc.
Dani P. Bolognesi, Trimeris, Inc.