Latest news with #Yeztugo
NBC News
18 hours ago
- Health
- NBC News
By maintaining Obamacare pillar, Supreme Court hands win to HIV advocates
The Supreme Court on Friday granted the HIV-prevention field a historic win — yet with a major caveat — as it upheld a federally appointed health task force's authority to mandate no-cost insurance coverage of certain preventive interventions, but clarifying that the Health and Human Services secretary holds dominion over the panel. The 6-3 decision in Kennedy v. Braidwood Management, Inc. essentially leaves in place a popular pillar of the Affordable Care Act, which mandates that most insurers cover various task force-recommended preventive screenings, therapies and interventions, with no out-of-pocket costs imposed on patients. The case reached the high court after a group of Christian businesses in Texas objected to being compelled to cover a certain drug used for HIV prevention, known as PrEP, given their claims that it 'promotes homosexuality.' 'Since our efforts to address HIV in the U.S. are under attack on so many levels, preserving insurers' requirement to cover preventive services, including PrEP, will help ensure access to people who need it,' said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, a patient advocacy group in Washington, D.C. But the court clarified the scope of the task force's independence, thus potentially compromising its impact. Addressing concerns that the 16-member volunteer task force's power over insurers was unconstitutional, the justices asserted that the health secretary holds the authority to appoint and dismiss the panelists and to block their new recommendations from mandating insurance coverage. The secretary could also possibly direct the panel, including one stocked with his or her own hand-picked members, to revisit previous recommendations that have already gone into effect. Given the unpredictable nature and unconventional approach to health policy of the current health secretary, Robert F. Kennedy Jr., HIV advocates are concerned that he might undermine the task force's current or future endorsements of HIV-prevention medications, known as PrEP. The ruling 'is a victory in the sense that it leaves intact the requirement to cover task-force recommendations,' said attorney Richard Hughes, a partner with Epstein Becker Green in Washington, D.C., who represented a group of HIV advocacy organizations in submitting a friend-of-the-court brief in the casel. 'It was always going to be a double-edged sword, as the political accountability that salvaged its authority comes with the ability to alter its recommendations.' The U.S. has secured only a modest decline recently in HIV cases, and HIV advocates stand at a crossroads amid the Trump administration's dramatic withdrawal of support for their cause. Promisingly, the Food and Drug Administration last week approved a long-acting injectable form of PrEP, Yeztugo, made by Gilead Sciences. Injected every six months, Yeztugo overwhelmingly bested Truvada, a daily-pill form of PrEP also made by Gilead, at lowering HIV transmissions in clinical trials. But Yeztugo has debuted as the Trump administration is gutting the Centers for Disease Control and Prevention's HIV-prevention division and after it canceled scores of HIV-related research grants. HIV experts have warned that this upheaval could lead HIV to rise again. Kennedy v. Braidwood Management, Inc. The plaintiffs' initial religious-liberty complaint was ultimately dropped from the case. The court more narrowly considered the constitutionality of an ACA provision that lent effective authority to a longstanding volunteer medical task force to mandate no-cost insurance coverage to preventive interventions that the expert group rated highly, including PrEP. The plaintiffs argued that because the task force was not appointed by the president and confirmed by the Senate, granting it such power over insurance markets violated the Constitution's appointments clause. The justices grappled with the task force's balance of independence versus accountability. In particular, they sought to determine whether the task force members were appointed by the Senate-confirmed Health and Human Services secretary. In addition to PrEP, the task force has issued high scores, for example, to screening for lung cancer, diabetes, and HIV; treatment to help quit smoking; and behavioral counseling to prevent heart disease. Had the Supreme Court fully sided with the plaintiffs, insurers would have been free to drop such popular benefits or, at the very least, to impose related co-pays and other cost sharing. Writing for the majority, Justice Brett Kavanaugh found that the health secretary has the power 'to appoint Task Force members, and no statute restricts their removal.' He was joined by an ideological mix of colleagues, including Chief Justice John Roberts and Justice Amy Coney Barrett on the right, and Justices Sonia Sotomayor, Elena Kagan and Ketanji Brown Jackson on the left. Concerns and uncertainty about Kennedy HIV advocates expressed concern that Kennedy might undo the task force's recommendation for PrEP, or at the least deprioritize ensuring that Yeztugo receives a clear coverage mandate. Earlier this month, Kennedy dismissed the entire CDC Advisory Committee on Immunization Practices, or ACIP, and replaced them with his own hand-picked selections, including one notable anti-vaccine activist. At the first meeting of the newly formed committee this week, ACIP dropped recommendations for some flu vaccines over claims, widely debunked by researchers, that one ingredient in them is tied to autism. Mitchell Warren, executive director of the HIV advocacy nonprofit AVAC, expressed concern about 'what happened with the CDC ACIP this week, as it could be a harbinger of what a secretary of HHS can do to twist committees and task forces that should be composed of experts guided by science to ones that are guided by ideology and politics.' In an email to NBC News, Carmel Shachar, faculty director of the Health Law and Policy Clinic at Harvard Law School, characterized Kennedy's potential approach to overseeing the health task force as unpredictable. 'RFK has been skeptical of the medical approach to HIV/AIDS in the past, and that may color his attitude to revising PrEP guidance,' Shachar said. HHS did not immediately respond to a request for comment about the HIV advocates' concerns. In 2019, the health task force granted Truvada as PrEP a top rating. The drug was already widely covered by insurers. But under ACA rules, the task force's recommendation meant that by January 2021, insurance plans needed to cease imposing cost-sharing for the drug. The Centers for Medicare and Medicaid Services, or CMS, then clarified that insurers were also forbidden to impose cost sharing for the quarterly clinic visits and lab tests required for a PrEP prescription. A CDC study published in October found that about 200,000 people were using PrEP at any point in 2023. In 2019, the FDA approved another Gilead daily pill, Descovy, for use as PrEP. In late 2021, ViiV Healthcare's Apretude — an injection given every two months — was also green lit. The health task force gave top ratings to both of the newer forms of PrEP in 2023, which triggered a mandate for no-cost coverage to begin in January. A generic version of Truvada emerged in 2020 and now costs as little as $30 per month. The list prices of the three brand-name PrEP drugs range from about $2,200 to $2,350 a month. How the court's ruling could play out for HIV prevention Were Kennedy to appoint task force members who ultimately voided the PrEP coverage mandate, generic Truvada, at the very least, would still likely remain widely covered by insurance. But insurers would be free to demand cost-sharing for all forms of PrEP, including for required clinic visits and lab tests. And they could restrict access to the more expensive versions, including by imposing prior authorization requirements and higher cost sharing. Research suggests that even a small increase in monthly out-of-pocket costs for PrEP can depress its use and that those who accordingly forgo a prescription are especially likely to contract HIV. Johanna Mercier, Gilead's chief commercial officer, said even before the health task force's 2023 insurance mandate for Descovy went into effect in January, the drug's coverage was still pretty solid. Private insurers provided unrestricted coverage of Descovy for PrEP to 74% of commercially insured people, and 40% of prescriptions for the drug had no co-pay. After the mandate went into effect — including after CMS released a clarification on the PrEP-coverage mandate in October — those rates increased to 93% and 85%, respectively. This experience, Mercier said, has left the company optimistic that an increasing proportion of health plans will cover Yeztugo during the coming months. Health-policy experts are not certain whether the existing PrEP rating from the task force automatically applies to Yeztugo, or whether the drug will require its own rating to ensure coverage comes with no cost sharing. If Apretude's history is any guide, a requirement for Yeztugo to receive a specific rating could delay a no-cost insurance-coverage mandate for the drug from going into effect until January 2027 or 2028. It's also possible that CMS could release guidance clarifying that the existing mandate for PrEP coverage applies to Yeztugo, which would likely have a more immediate impact on coverage. However, Elizabeth Kaplan, director of health care access at Harvard's Health Law and Policy Clinic, said in an email that 'given this administration's and RFK's stated priorities,' the publication of a guidance on Yeztugo coverage by an HHS division 'appears unlikely.'
Yahoo
2 days ago
- Health
- Yahoo
FDA approves Gilead's twice-yearly injectable Yeztugo for PrEP
The US Food and Drug Administration (FDA) has approved Gilead Science's Yeztugo for the prevention of human immunodeficiency virus (HIV) infection. This is the first and only FDA-approved HIV pre-exposure prophylaxis (PrEP) option offering six months of protection. The approval was based on the Phase III PURPOSE 1 and PURPOSE 2 trials, which showed that more than 99% of participants remained HIV-negative on the twice-yearly injectable therapy. Yetzugo is a long-acting HIV-1 capsid inhibitor that reduces the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Yeztugo will compete with Gilead's own oral PrEP therapies Truvada and Descovy, as well as ViiV Healthcare's Apretude, the only other injectable PrEP therapy available in the US. However, Apretude requires more frequent dosing than Yetzugo, as it is typically administered once every two months. The approval of Yeztugo is a momentous step in improving PrEP options available for people vulnerable to contracting HIV. Currently, the majority of PrEP therapies require daily oral administration. Key opinion leaders (KOLs) previously interviewed by leading data and analytics company GlobalData noted that there is often a psychosocial burden when taking daily PrEP due to stigma, and patients have concerns about others discovering their medication or adherence challenges. Yeztugo could address these key issues. However, KOLs noted that the cost of the drug could be a major barrier to uptake. Gilead has announced the US price of Yeztugo for PrEP at $28,218 per year for each patient. KOLs expressed doubts about whether insurance companies will cover the cost of this drug since generic versions of oral PrEP medications are widely available and much less expensive. Additionally, this situation may be exacerbated by the HIV funding cuts that have been proposed by US President Donald Trump's administration. Furthermore, PrEP usage has not been maximised across the US thus far. According to GlobalData epidemiologists, 437,425 people were on PrEP in the US in 2022, but this figure had the potential to be much higher. In the same year, only 36% of people in the US who met the Centers for Disease Control and Prevention's (CDC) eligibility criteria for PrEP were prescribed a form of PrEP. CDC data shows that vulnerable populations in the US are not yet using PrEP at rates that could end the transmission of the virus at the population level, with particular gaps for women, Black/African American, and Hispanic/Latino people. Increasing awareness and access will be an important element of reducing HIV through PrEP use and maximising Yetzugo's sales. Yeztugo is likely to be approved in other countries shortly, as Gilead has filed for regulatory approval in several markets, including the European Medicines Agency, where it is under accelerated review. "FDA approves Gilead's twice-yearly injectable Yeztugo for PrEP" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
India Today
2 days ago
- Health
- India Today
FDA approves first HIV prevention drug: All about it
FDA approves first HIV prevention drug: All about it Credit: Getty Images The US Food and Drug Administration (FDA) has approved lenacapavir as a long-acting injectable drug to prevent HIV. HIV is one of the most dangerous diseases that attacks the immune system. If left untreated, it can lead to AIDS, the most advanced stage of HIV. What is HIV? Lenacapavir is being sold under the brand name Yeztugo. There is currently no cure for HIV or AIDS. Credit: AFP This makes Yeztugo the first and only HIV pre-exposure prophylaxis (PrEP) option in the United States that is required just twice a year. First HIV preventive drug Data from clinical trials suggest 99.9% of people who received Yeztugo remained HIV-negative during the study period. It is being manufactured by Gilead Sciences and was first approved in 2012. It is a unique antiretroviral that works by blocking HIV (Human Immunodeficiency Virus) at multiple stages of its life cycle, unlike most drugs that target just one. How it works It is not a complete treatment for people who already have HIV, and people must be tested for HIV before starting the injection. Several Indian pharmaceutical companies have signed a deal with Gilead to produce generic versions of lenacapavir. Credit: India Today
Black America Web
3 days ago
- Health
- Black America Web
FDA Approves First And Only Twice-Yearly PrEP Option
Source: YakubovAlim / Getty It has been a very long journey in the ongoing fight to end the HIV/AIDS epidemic, and now it appears we might be one step closer towards our goal with the FDA approval of Yeztugo. According to a new report by Gilead Sciences, Yeztugo (lenacapavir) will be the first and so far only option that gives people who need or want PrEP the option of injecting only twice a year. READ MORE STORIES Take a look below for details on the trials that helped make this advancement possible, via Gilead : 'The FDA approval of Yeztugo, granted under priority review, is supported by data from the Phase 3 PURPOSE 1 trial ( NCT04994509 ) and PURPOSE 2 ( NCT04925752 ) trials conducted by Gilead, part of the most intentionally inclusive HIV prevention clinical trial program ever designed. ≥99.9% of participants who received Yetzugo in PURPOSE 1 and PURPOSE 2 remained HIV negative.' The unfortunate reality when it comes to PrEP is that it's being drastically underused. Even with the first PrEP medication being approved over a decade ago in 2012, more than 100 people contracted HIV per day as recently as 2023. And yes, that mainly included the Black population, Hispanic population, women in general and those living in southern America. It's believed that a twice-yearly PrEP option like Yeztugo can help decrease those stats thanks to its discreet approach and an availability to those with and without insurance coverage. Head over to Gilead for the full report, and trust that we'll be keeping our eyes on this advancement that's being called the 'Breakthrough Of 2024.' Here's to our health! LIKE US ON FACEBOOK . FOLLOW US ON INSTAGRAM & TWITTER . SUBSCRIBE TO OUR YOUTUBE . STAY INFORMED! CLICK HERE TO SIGN UP FOR OUR NEWSLETTER! HEAD TO THE HOMEPAGE SEE ALSO
Yahoo
4 days ago
- Health
- Yahoo
NIH office to phase out HIV guidelines by next year
June 21 (UPI) -- The National Institutes of Health office responsible for issuing federal guidelines related to treatment of HIV and AIDS patients in the United States plans to phase them out next year. The NIH Office of AIDS Research or OAR told its employees this week it intends to phase out the guidelines by next June, the Washington Post reported, citing an internal staff email. According to the office, OAR "coordinates HIV/AIDS research across the National Institutes of Health and provides the largest public investment in HIV/AIDS research globally." "In the climate of budget decreases and revised priorities, OAR is beginning to explore options to transfer management of the guidelines to another agency within NIH," the letter obtained by The Post reads. The OAR guidelines contain guidelines related to diagnosis and treatments of HIV and AIDS. There are currently more than 1 million people living with HIV in the United States. It was not immediately clear what the other agency referred to in the letter was or how such a move may affect the guideline, the Post reported. The news comes as President Donald Trump and Secretary of State Marco Rubio move to cut over $8 billion from the U.S. Agency for International Development, USAID and merge it into the State Department. State Department officials say the move comes with the expectation that other countries will increase their roles in delivering aid around the world. An April report published in the Lancet medical journal found around half a million children globally could die from AIDS by 2030 if the United States cuts its global relief funding. Earlier this week, the U.S. Food and Drug Administration approved use of the HIV drug lenacapavir, which is produced by California-based biopharma firm Gilead Sciences under the name Yeztugo. "Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," Gilead Science Chairman and Chief Executive Officer Daniel O'Day said in a statement on the company's website
