Exclusive-CVS holds off adding Gilead's new HIV prevention shot to drug coverage lists
(Reuters) -CVS Health, which runs the largest U.S. pharmacy benefit manager, will not add Gilead Sciences' new HIV prevention drug to its commercial plans for now, a spokesperson told Reuters, despite the medicine's proven effectiveness.
CVS based the decision on clinical, financial, and regulatory factors, spokesperson David Whitrap said in an email. It also will not cover Yeztugo under its Affordable Care Act formularies, since its ACA preventive program follows recommendations and mandates from the U.S. Department of Health and Human Services (HHS), Whitrap said.
Current HIV prevention recommendations from the U.S. Preventive Services Task Force (USPSTF), which is supported by HHS, include only three older drugs.
A source familiar with the situation suggested that Gilead is still negotiating with CVS over Yeztugo, a twice-yearly injection with a U.S. list price of more than $28,000 a year.
The decision by CVS is "a grave disappointment and frankly a missed opportunity," said Mitchell Warren, executive director of the AIDS nonprofit AVAC. "It does reflect a price that is too high and a U.S. pharmaceutical pricing structure that is frankly not sustainable."
He and other AIDS activists have said Yeztugo could be a transformative tool in ending the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million.
Gilead said it is "extremely pleased" with progress in its conversations with payers, most of whom continue to cover HIV prevention products with no cost sharing or coverage barriers. The company said it is on track to secure 75% U.S. insurer coverage of Yeztugo by year-end and 90% coverage by June 2026.
Pharmacy benefit managers, or PBMs, act as middlemen between drug companies and consumers. They negotiate volume discounts with drug manufacturers on behalf of employers and health plans based on coverage terms.
The three largest - CVS Caremark, UnitedHealth Group's OptumRX and Cigna's Express Scripts - control about 70% of specialty drug prescriptions in the U.S.
Optum said Yeztugo will be reviewed for coverage in the coming weeks, while Express Scripts did not respond to requests for comment.
U.S. government healthcare programs, including the Veterans Administration and the Medicare program for people over age 65, have already added Yeztugo to coverage lists. Gilead said earlier this month that several state-run Medicaid plans, including California and New York, were covering the drug.
Gilead, its investors, and AIDS activists have high hopes for Yeztugo. Approved in June for people at high risk of HIV, the drug was shown to be nearly 100% effective at preventing infection in large trials, fueling fresh optimism about limiting the spread of the deadly virus.
Some analysts have warned that a recent Supreme Court ruling affirming broad HHS authority over the USPSTF could affect coverage prospects while Robert F. Kennedy Jr is in charge of the agency. Medical groups have expressed alarm about reports that Kennedy could replace members of the task force.
The 16-member task force reviews evidence and public input, then recommends preventive services that catch disease early or prevent worsening, which insurers must cover without patient cost-sharing. For HIV prevention, it endorses daily PrEP pills Truvada, which is available as a generic, and Gilead's Descovy, as well as ViiV Healthcare's bimonthly shot Apretude.
Gilead CEO Daniel O'Day has stressed that the lifetime cost of treating an HIV patient can exceed $1 million, making a preventive treatment cost effective.
(Reporting By Deena Beasley; Editing by Patrick Wingrove and Diane Craft)
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
AAHI Partners with Quratis to Strengthen Global Vaccine Manufacturing and Accelerate Access to Lifesaving Vaccines
SEATTLE--(BUSINESS WIRE)--Access to Advanced Health Institute (AAHI), a global leader in translating high-impact science into scalable, field-ready vaccine solutions, today announced an exciting new partnership with Quratis, a premier biotechnology company and advanced Contract Development and Manufacturing Organization (CDMO). This collaboration marks a pivotal step forward in breaking through barriers in global health equity around the world. Under this strategic alliance, Quratis has been selected as AAHI's preferred manufacturer for high-quality pre-clinical and clinical vaccine supplies, with the capacity to expand into commercial-scale production for global markets. This collaboration will accelerate the development of AAHI's innovative vaccine candidates targeting deadly diseases such as tuberculosis, and of vaccines that rely on AAHI's vaccine adjuvants to provide protection against malaria, HIV, and other global health threats. Quratis brings a world-class GMP-certified bioplant and cutting-edge CDMO expertise in biopharmaceutical raw material development, process optimization, and finished pharmaceutical manufacturing. By designating Quratis as preferred partner, AAHI strengthens both its scientific capabilities and access to scalable, cost-effective production of its groundbreaking vaccine formulations—including dry vaccines that eliminate cold chain dependencies and needle-free delivery systems for superior respiratory protection. The partnership ensures a seamless supply chain platform, enabling swift clinical development and broader deployment to the world's most vulnerable populations. "Partnering with Quratis is a very important step in AAHI's strategy to advance practical, life-saving vaccines, that can be deployed at scale where they're needed most,' said Keeley Foley, CEO of AAHI. 'Quartis' innovative cutting edge, safe, world-class CDMO capabilities makes it possible for AAHI to deliver on our mission – and helps ensure our efforts to combat infectious diseases and foster health autonomy worldwide. Together, we're not just manufacturing vaccines—we're delivering an important mission to revolutionize global health." Quratis, renowned for its global innovation in healthcare, brings unparalleled expertise in vaccine development and manufacturing to the table. With a track record of success in TB and COVID-19 vaccines like QTP101 and QTP104, Quratis' advanced processes will enhance AAHI's pipeline, ensuring high-quality, efficient production from pre-clinical stages through clinical trials. "We are honored and thrilled to join forces with AAHI, a pioneer in immune-enhancing technologies and sustainable vaccine solutions," said Soung Joon Kim, CEO of Quratis. "This partnership aligns perfectly with our vision of making people happy and healthy through borderless healthcare innovations. By supporting AAHI's pipeline, we expect to create value not only for global health, but also for our shareholders through long-term growth opportunities.' The partnership builds on existing collaborations, including the co-development of the ID93+GLA-SE tuberculosis vaccine candidate (QTP101), and underscores a shared commitment to strengthening international vaccine supply chains, advancing equitable access, and fostering worldwide manufacturing capacity for sustainable program deployment. For more information about this partnership or to explore collaboration opportunities, and order pre clinical materials please contact info@ About Access to Advanced Health Institute (AAHI) Access to Advanced Health Institute (AAHI) is a global leader in developing practical, cost-effective vaccines to combat deadly diseases such as tuberculosis, malaria, and HIV. With a mission to translate high-impact science into scalable, field-ready solutions, AAHI breaks through barriers in global health by creating innovative vaccine formulations, building worldwide manufacturing capacity, and fostering partnerships to ensure sustainable, equitable health outcomes. For more information, visit or contact us at info@ About Quratis Quratis Inc. is a leading biopharmaceutical company specializing in innovative vaccine development and advanced biologics manufacturing. With a state-of-the-art GMP facility and strong global partnerships, Quratis is at the forefront of developing next-generation vaccines against infectious diseases, including tuberculosis, COVID-19, schistosomiasis, and neglected tropical diseases. In addition to its core vaccine pipeline, Quratis offers superior CDMO capabilities, including expertise in mRNA–LNP drug delivery platforms that provide seamless bench-to-field support from research through commercial production. By combining cutting-edge R&D with scalable manufacturing, Quratis is committed to delivering high-quality, accessible, and life-saving solutions to patients worldwide. For more information, visit
Politico
an hour ago
- Politico
Supreme Court lets Trump admin cut off health grants it says advance DEI or ‘gender ideology extremism'
Chief Justice John Roberts joined the court's liberals in dissent from the court's decision to permit the funding halt. The Supreme Court is allowing the Trump administration to cut off health research grants it contends advance diversity, equity and inclusion efforts or promote 'gender ideology extremism.' By a 5-4 vote, the justices lifted an order a federal court judge in Boston issued forcing the National Institutes of Health to restore funding for more than 1,700 grants focused on heart disease, HIV/AIDS, Alzheimer's disease, alcohol and substance abuse and mental health issues. Chief Justice John Roberts joined the court's liberals in dissent from the court's decision to permit the funding halt.
CNBC
an hour ago
- CNBC
Supreme Court allows Trump's cuts to health research grants over DEI policies
The Supreme Court on Thursday allowed Trump administration broad cuts to National Institutes of Health grants as part of the federal government's campaign against diversity, equity and inclusion policies. But in a mixed decision the court left in place a different part of the lower court judge's ruling that threw out the administration's guidance document that introduced the policy, raising questions about whether it can be applied moving forward. The justices, on a 5-4 vote, granted in part an emergency request filed by the administration seeking to put a Massachusetts-based federal judge's ruling on hold. The court did not fully explain its reasoning, but the majority indicated that groups seeking to challenge the funding cuts have to file separate lawsuits in a different federal venue — the Court of Federal Claims. Conservative Justice Amy Coney Barrett was the deciding vote in crafting the decision. Four justices, all conservatives, said they would have granted the Trump administration's application in full, while four others — conservative Chief Justice John Roberts and the court's three liberals — would have denied it in full. "As today's order states, the District Court likely lacked jurisdiction to hear challenges to the grant terminations, which belong in the Court of Federal Claims," Barrett wrote in a concurring opinion. But, she added, "the Government is not entitled to a stay of the judgments insofar as they vacate the guidance documents." The National Institutes of Health (NIH) is a collection of agencies within the Department of Health and Human Services that receives billions of dollars from Congress to fund medical research at universities, hospitals and other institutions. When President Donald Trump took office in January, he vowed to end so-called diversity, equity and inclusion, or DEI, policies, saying that rather than fostering equality as intended, they are a form of discrimination, primarily against white people. He has also taken aim at policies recognizing transgender rights, including access to gender transition care. The NIH then conducted a review of grants and determined that more than 1,700 of them were not consistent with Trump's directives and terminated them, including studies into HIV prevention and gender identity among teens. The moves were challenged by 16 states led by Massachusetts and the American Public Health Association, among others. After a trial, U.S. District Judge William Young in Massachusetts ruled that the government had failed to follow correct legal processes in implementing the policy, in violation of a law called the Administrative Procedure Act. In rushing to implement Trump's agenda, NIH "simply moved too fast and broke things, including the law," Young wrote. He also said that DEI was "an undefined enemy," noting that government lawyers had not been able to explain exactly what it meant. Young found that there was "pervasive racial discrimination" and "extensive discrimination" against gay, lesbian and transgender people in how grants were selected for termination. He also found "an unmistakable pattern of discrimination against women's health issues." Young declined to put his ruling on hold, as did the Boston-based 1st U.S Circuit Court of Appeals, which also kept the grants intact. In asking the Supreme Court to intervene on behalf of the Trump administration, Solicitor General D. John Sauer argued that the case is similar to another that arose in Massachusetts in which a judge blocked Trump administration plans to terminate teacher training grants on anti-DEI grounds. The Supreme Court in April blocked that ruling on a 5-4 vote. "This application presents a particularly clear case for this court to intervene and stop errant district courts from continuing to disregard this court's rulings," Sauer wrote. Lawyers for the states pushed back on Sauer's narrative, saying it "bears little resemblance to reality, with Young's ruling a "run-of-the mill" example of a court intervening when the government violates the law. The justices Thursday disagreed over whether the April decision governed the outcome in the latest case. In a brief opinion, Roberts, who dissented in the earlier case, said it was different, with Young's findings "well within the scope of the district court's jurisdiction." But conservative Justice Neil Gorsuch, in his own separate opinion, criticized Young for failing to abide by the April decision. "Lower court judges may sometimes disagree with this court's decisions, but they are never free to defy them," he wrote. The Trump administration has regularly turned to the Supreme Court when its broad use of executive power is challenged in court and has prevailed in the majority of cases. Trump and his allies have also harshly criticized judges who have ruled against him.
