Washington, D.C. (April 20, 2022) – AIDS United, National Alliance of State & Territorial AIDS Directors (NASTAD), National Viral Hepatitis Roundtable (NVHR), Ryan White Clinics for 340B Access (RWC-340B), The AIDS Institute (TAI), and Treatment Action Group (TAG) today released the following joint statement regarding recent manufacturer action against the 340B Drug Pricing Program:
“We are concerned by recent actions taken by pharmaceutical manufacturers of hepatitis C medications that require safety-net hospitals, health centers, community-based clinics, tribal organizations, and state, local, and tribal health departments participating in the 340B Drug Pricing Program (340B Program) to submit claims data from contract pharmacies to receive 340B drug pricing. These actions by manufacturers impose an administrative burden on covered entities while diverting scarce resources away from patient care, disincentivize covered entities from developing comprehensive hepatitis C programs to serve patients with complex medical and social needs, and impede our ability to address health inequities and eliminate hepatitis C.
“The 340B Program was designed by Congress to provide affordable, high-quality health care to underserved populations by requiring manufacturers to provide drug discounts to qualifying hospitals and clinics. The 340B Program enables these covered entities to support and tailor care models that address health disparities among underserved populations identified in the HHS Viral Hepatitis National Strategic Plan. The Strategic Plan documents stark disparities in hepatitis C prevalence among African Americans, people living with both HIV and hepatitis C, and people with histories of substance use disorder, as well as hepatitis C-related mortality among Native Americans, African Americans, and people born before 1965.
“While we appreciate the commitment to using the 340B Program for the benefit of its intended communities, unilateral actions by manufacturers without commensurate measures to support the safety net undermine the shared goals of health equity and viral hepatitis elimination. 340B Program integrity efforts must fall within the mandate of the statutory roles of HRSA and HHS and any actions aimed at preserving the Congressionally-authorized function of the 340B Program require collaboration and consensus across all stakeholders. Amid the COVID-19 pandemic and in the absence of equitable alternatives, progress towards eliminating hepatitis C as a public health threat by 2030 requires maintaining and preserving established and predictable models of health care financing and delivery for underserved populations.
“We strongly encourage manufacturers of hepatitis C medications to reconsider their 340B covered entity reporting requirements and contract pharmacy limitations, and work with stakeholders towards meeting the shared aim of forging an equitable path towards curing and ultimately eliminating hepatitis C.”
In August 2021, Merck (manufacturer of Zepatier) announced that it will require hospital covered entities to submit contract pharmacy claims data to a third-party platform (340B ESP). Federal grantees were encouraged to submit claims data voluntarily.
In January 2022, AbbVie (manufacturer of Mavyret) announced that it will require hospital covered entities to submit contract pharmacy claims data to 340B ESP. AbbVie does not require federal grantees to submit claims data.
In March 2022, Gilead (manufacturer of Epclusa, Harvoni, Vosevi, and Sovaldi) announced that it will require all covered entities – including both hospitals and federal grantees – to submit contract pharmacy claims data for all branded hepatitis C products to 340B ESP.
The Office of Pharmacy Affairs (OPA), a division in the Health Resources and Services Administration (HRSA), is the federal agency responsible for administering and overseeing the 340B Drug Pricing Program (340B Program). Audits are performed on covered entities to ensure compliance with the 340B programs rules and regulations. Since 2012, the audit program has escalated for safeguarding the integrity of the program across all entities.
About AIDS United
AIDS United’s mission is to end the HIV epidemic in the U.S. through strategic grant-making, capacity building and policy. AIDS United works to ensure access to lifesaving HIV care and prevention services and to advance sound HIV-related policy for populations and communities most impacted by the U.S. epidemic.
About National Alliance of State & Territorial AIDS Directors (NASTAD)
NASTAD is a leading non-partisan non-profit association that represents public health officials who administer HIV and hepatitis programs in the U.S. We work to advance the health and dignity of people living with and impacted by HIV/AIDS, viral hepatitis, and intersecting epidemics by strengthening governmental public health through advocacy, capacity building, and social justice.
About National Viral Hepatitis Roundtable (NVHR)
The National Viral Hepatitis Roundtable, an initiative of HEP, is a national coalition fighting for an equitable world free of viral hepatitis. NVHR seeks to eliminate viral hepatitis in the United States and improve the lives of those affected through advocacy, education, and support to national, state and local partners.
About Ryan White Clinics for 340B Access (RWC-340B)
Ryan White Clinics for 340B Access (RWC-340B) is a national association of HIV/AIDS health care clinics and service providers receiving support under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act.
About The AIDS Institute (TAI)
The AIDS Institute is a national, non-partisan, non-profit organization dedicated to supporting and protecting health care access for people living with chronic and serious health conditions including HIV/AIDS and viral hepatitis.
About Treatment Action Group (TAG)
Treatment Action Group (TAG) is an independent, activist, and community-based research and policy think tank committed to racial, gender, and LGBTQ+ equity; social justice; and liberation, fighting to end HIV, tuberculosis (TB), and hepatitis C virus (HCV).
AIDS United – Warren Gill, email@example.com (202) 599-8259
NASTAD – Maya Hamilton, mhamilton@NASTAD.org
NVHR – Josh Berkowitz, firstname.lastname@example.org (703) 939-7056
RWC-340B – Trent Smith, email@example.com
TAI – Frank Hood, firstname.lastname@example.org (202)-774-0034
TAG – Natalie Shure, email@example.com