Gilead Sciences and ADAP Crisis Task Force Announce New Initiatives to Support AIDS Drug Assistance Programs (ADAPs)
Lower Prices for Gilead HIV Medicines under ADAPs, Effective July 1, 2010
New Pricing Frozen to ADAPs through 2013
Key Enhancements Made to Gilead HIV Patient Assistance and Co-Pay Programs
FOSTER CITY, Calif. & WASHINGTON, Jun 04, 2010 (BUSINESS WIRE) --Gilead Sciences and the ADAP Crisis Task Force (ACTF) today announced a series of initiatives to help state AIDS Drug Assistance Programs (ADAPs) continue to provide antiretroviral medicines to people living with HIV in the United States. The new measures are a response to budget shortfalls being experienced by a number of ADAPs across the country, and the growing number of individuals on ADAP waiting lists who are not receiving the HIV treatment they need.
The initiatives announced today by Gilead and the ACTF include:
Additional discounts and extension of pricing freeze to ADAPs for Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R) (emtricitabine) through December 31, 2013
Expanded eligibility for Gilead's patient assistance program
Elimination of minimum payment for patients through Gilead's co-pay assistance program
Support for creation of "universal" patient assistance application
As of May 20, 2010, there were 1,143 individuals on ADAP waiting lists in 10 states. ADAP waiting lists have increased more than ten-fold in the last year (99 individuals were on ADAP waiting lists in May 2009). In addition to waiting lists, 16 states have implemented other access restrictions such as lowering financial eligibility criteria, removing drugs from their formularies and limiting expenditures.
"Gilead's willingness to help with the current ADAP crisis by agreeing to these initiatives demonstrates that they are committed to serving the needs of people living with HIV in the U.S. who have no access to life-saving medicines except through ADAP," stated Jennifer Brown, Director of the Bureau of Epidemiology at the Utah Department of Health and spokesperson for the ACTF. "The ADAP Crisis Task Force and Gilead Sciences have come together to find ways to bridge the gap that ADAPs are experiencing, strengthening the case for further assistance from the federal and state governments at this critical time of unprecedented need for ADAPs and their clients," added Brown.
"Gilead is committed to ensuring that a drug's price is never a barrier to access for those in need," said Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences. "As one of the first companies to freeze pricing for ADAPs in 2008, we remain focused on developing solutions that ensure that individuals living with HIV, regardless of where they live or their income level, have access to our therapies."
New Lower Prices and Extension of ADAP Price Freeze
Effective July 1, 2010, Gilead will set lower ceiling prices for its HIV medicines Truvada, Vireadand Emtriva. The revised prices will include supplemental discounts that are in addition to any federally-mandated discounts.
Additionally, Gilead's new ceiling prices will be frozen through December 31, 2013. This extends Gilead's original ADAP price freeze that was established in 2008 and continued through 2010. Taken together, these changes will result in lower net prices for ADAPs.
Expanded Eligibility for Gilead Patient Assistance Program
Gilead's U.S. Advancing Access(R) patient assistance program was developed in conjunction with feedback from advocates in the HIV community. The program utilizes a rapid and simple process that ensures clients who apply and qualify for assistance can receive immediate, same-day access to Gilead's antiretrovirals.
Effective on or before July 1, 2010, Gilead will increase the income eligibility guidelines of this program from 300 percent of the Federal Poverty Guidelines to 500 percent of the Federal Poverty Guidelines as published by the U.S. Department of Health and Human Services.
This change results in income criteria that currently matches or exceeds all state ADAPs. This is an important change for clients eligible for ADAPs but on waiting lists as all now will have access to this program until they are accepted into ADAP. Clients seeking further information on the program should contact U.S. Advancing Access at 1-800-226-2056, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern).
Enhanced Co-Pay Assistance Program
Effective on or before July 1, 2010, Gilead will eliminate the requirement for clients with private insurance to pay the first $50 of out-of-pocket expenses before co-pay assistance begins. Going forward, Gilead will pay up to $200 per month ($2,400/year) toward out-of-pocket expenses for Truvada, Viread or Emtriva. All clients in the U.S. with private insurance are eligible, except where prohibited by law. Clients seeking further information on Gilead's co-pay program should call 1-888-358-0398 to request a pharmacy Co-Pay Card for use when filling prescriptions.
New Effort to Create Universal Patient Assistance Program Application
Gilead recognizes the challenges that case managers and client advocates face in coordinating access to care across multiple pharmaceutical company patient assistance programs. Gilead therefore supports and will participate in a new collaboration between industry and community partners to develop a universal application system for patient assistance programs that would simplify access to HIV combination therapy for clients requiring medications from different manufacturers.
About the ADAP Crisis Task Force (ACTF) and the National Alliance of State and Territorial AIDS Directors (NASTAD)
The ADAP Crisis Task Force (ACTF) was formed in December 2002 by a group of state AIDS/ADAP directors concerned about the nationwide fiscal crisis facing ADAPs. The ACTF works with pharmaceutical manufacturers of antiretroviral medications to reduce drug costs and improve access to medications for clients in the nation's ADAPs. NASTAD provides logistical support for the ACTF. Founded in 1992, NASTAD is a nonprofit national association of state and territorial health department HIV/AIDS program directors who have programmatic responsibility for administering HIV/AIDS and viral hepatitis health care, prevention, education, and supportive services programs funded by state and federal governments. For more information, visit www.NASTAD.org.
About Gilead Sciences
Gilead Sciences (Nasdaq: GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that Gilead may modify aspects of its ADAP-related drug pricing prior to December 31, 2013 or change the arrangements under its patient assistance or co-pay assistance programs in the future. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the first quarter of 2010, as filed with the U.S. Securities and Exchange Commission. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Full U.S. prescribing information for Truvada is available at www.truvada.com.
Full U.S. prescribing information for Viread is available at www.viread.com.
Full U.S. prescribing information for Emtriva is available at www.gileadhiv.com.
Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc.
SOURCE: Gilead Sciences