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Gilead, ViiV Healthcare Announce Agreements with ADAP Crisis Task Force for Further Drug Discounts

At a time when AIDS Drug Assistance Programs (ADAPs) across the country are facing budget shortfalls that have forced some to cap enrollment and limit formularies, advocates with the ADAP Crisis Task Force reached agreements with 2 pharmaceutical companies -- Gilead and ViiV Healthcare (the specialist HIV company established by GlaxoSmithKline and Pfizer) -- to provide deeper discounts and expanded patient assistance to help low- and middle-income individuals obtain needed drugs. The changes will also help people who are on ADAP waiting lists. As previously reported, in May the task force announced agreements with 3 other companies, Abbott, Merck, and Tibotec.Below are excerpts from 2 press releases from the Gilead and the ADAP Crisis Task Force describing these agreements.

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. and Washington, DC -- June 4, 2010 -- 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 (emtricitabine and tenofovir disoproxil fumarate), Viread (tenofovir disoproxil fumarate) and Emtriva (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, Viread and 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 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.

ADAP Crisis Task Force Reaches Agreement with
ViiV Healthcare to
Assist Struggling ADAPs

• Calls for Emergency Federal Funding

Washington, DC -- June 2, 2010 -- As part of ongoing efforts by the ADAP Crisis Task Force (ACTF) and the pharmaceutical industry to address the unprecedented need for access to antiretroviral medicines through AIDS Drug Assistance Programs (ADAP), the ACTF announced that it has reached an agreement with ViiV Healthcare. The agreement will extend additional cost savings to ADAPs that provide access to medications for HIV positive individuals enrolled in their programs. Further discounts on the most widely used HIV medicines produced by ViiV Healthcare will be provided to the country's ADAPs, beyond existing ones mandated by health reform and included in previous agreements with the ACTF.

"ViiV Healthcare recognizes that now, more than ever, swift action must be taken to stem the dramatic and increasing gap that exists with patients' access to HIV medicines through ADAPs. We are committed to doing all that we can to ensure that the needs of HIV patients are met," said Bill Collier, Head of North America, ViiV Healthcare.

The agreement with ViiV Healthcare comes at a time when the combination of the nation's current economic situation, increased HIV testing efforts and state budget cuts has resulted in an unprecedented acceleration in the number of ADAP enrollees, resulting in severe cost containment measures in many ADAPs. As of May 20, there were 1,143 individuals in ten states on waiting lists for ADAP. In fact, 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.

"We appreciate ViiV's efforts and understand that industry alone cannot close the entire gap. Additional state and federal funding is required to avoid a growing public health crisis," stated Jennifer Brown, Director of the Bureau of Epidemiology at the Utah Department of Health and spokesperson for the ACTF.

The National Alliance of State and Territorial AIDS Directors (NASTAD) routinely monitors the status of ADAP programs. While the program will yield savings from agreements with pharmaceutical partners, the ongoing state budget crises coupled with the increased numbers of clients seeking ADAP services will continue to require a significant increase in funding. NASTAD estimates the program is in need of an additional $126 million in FY2010 emergency federal funding as well as critical state funding. Increased funds from the federal and state governments in addition to price freezes and increased discounts and rebates from companies are all necessary to sustain ADAPs until health reform is fully implemented in 2014.

"As ACTF, community groups, and industry have come together to address the current crisis in ADAPs, we ask that individuals concerned about issues of access to life saving medicines for persons with HIV contact their legislators to voice support for an emergency appropriation to close the funding gap for ADAPs across the country," declared Julie Scofield, NASTAD's Executive Director.

The ACTF previously reached agreements with Abbott Laboratories, Merck, Inc. and Tibotec Therapeutics. Negotiations continue with Boehringer Ingelheim, Bristol-Myers Squibb, Genentech and Gilead Sciences. "We are confident that agreements with the remaining manufacturers, similar to this one with ViiV Healthcare and those already in place with Abbott, Merck and Tibotec, can be accomplished soon," noted Dwayne Haught, Manager of the HIV Medication Program for the Texas Department of State Health Services and a member of the ACTF. "These agreements are a critical component of our nation's collective response to help meet the medication needs of nearly 200,000 HIV-positive Americans," added Haught.

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.

6/8/10

Sources

Gilead Sciences. Gilead Sciences and ADAP Crisis Task Force Announce New Initiatives to Support AIDS Drug Assistance Programs (ADAPs). Press release. June 4, 2010.

National Alliance of State and Territorial AIDS Directors. ADAP Crisis Task Force Reaches Agreement with ViiV Healthcare to Assist Struggling ADAPs. Press release. June 2, 2010.