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NBC News
20 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.'
The Hill
18-06-2025
- Health
- The Hill
FDA approves 6-month HIV prevention shot
Pharmaceutical company Gilead Sciences announced Wednesday the Food and Drug Administration (FDA) has approved its six-month, twice-yearly HIV PrEP injection, which was found in trials to be more than 99.9 percent effective among participants. Gilead's product Yeztugo, a form of lenacapavir, was approved for reducing the risk of sexually acquired HIV in adults and adolescents when injected twice a year. Lenacapavir is also marketed as Sunlenca, administered orally or through injection, as a treatment for HIV/AIDS in combination with other drugs. The drug is solely manufactured by Gilead. There are currently three available HIV PrEP options: two oral pills taken daily — Truvada and Descovy — and a long-acting injection called Apretude administered every two months. 'Yeztugo could be the transformative PrEP option we've been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Carlos del Rio, co-Director of the Emory Center for AIDS Research, said in a statement shared by Gilead. In a Phase 3, double-blind, randomized study, there were only two HIV infections among 2,179 participants who received Yeztugo subcutaneous injections twice a year. Lenacapavir is currently not approved for HIV prevention outside of the U.S., though it is approved for treating HIV in several countries. 'In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo,' the company said in a statement. 'Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.' Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, called the approval a 'monumental advance in HIV prevention.' 'Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections—if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service,' said Shmid. 'Recent actions by the Trump administration to decimate HIV prevention jeopardize access to preventive measures such as PrEP,' he added. 'In fact, the president's budget zeroes out all CDC HIV prevention and surveillance funding, hampering our nation's ability to make people aware of and access new HIV prevention measures. Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP.' The Hill has reached out to the White House for comment.
Yahoo
18-06-2025
- Health
- Yahoo
FDA approves new twice-yearly HIV shot. What to know
The Food and Drug Administration on Wednesday approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections. Gilead did not immediately say how much it will charge for the biannual shot, but company officials said it would be comparable to existing HIV prevention drugs. The drug will be marketed under the name Yeztugo. Advocates say the long-acting medication is promising because it's more convenient than existing HIV prevention drugs that must be taken daily. Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Gilead officials lauded the FDA's approval of lenacapavir, which has been studied and developed over nearly two decades. "We now have a very real opportunity to end the HIV epidemic," said Daniel O'Day, chairman and CEO of Gilead Sciences. "Lenacapavir has shown to be remarkably effective and only needs to be given twice a year, which represents a whole new way of preventing HIV.' Pre-exposure prophylaxis, or PrEP, medications are sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Another injectable medication, Apretude, is taken every two months after two initial shots taken one month a part. The overwhelming majority of PrEP users take daily versions, but "it's hard to take a pill every day ... when it's for prevention," said Johanna Mercier, Gilead's chief commercial officer. "So we see adherence levels as low as 50% to 55%," which does not provide adequate protection for at-risk populations. People are more likely to stay on the medication if they only need to take the medication twice a year, rather than daily oral doses, Mercier said. In one study of women and adolescent girls in sub-Saharan Africa and Uganda, lenacapavir was 100% effective at preventing HIV infections. A second study reported the twice-a-year injections lowered the HIV infection rate by 96% in groups of cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa and Thailand. Schmid said the studies show people are much more likely to take the medication as recommended when it's dosed twice a year compared to daily pills. "This makes it so much easier and better for adherence and also for people who have other challenges in their life like mental health issues, work or stigma, " Schmid said. Important read: Here's why most at-risk populations don't use HIV prevention drugs Mercier said the company intends to price the drug "in line with other branded medicines in this area." Out-of-pocket costs for uninsured patients who take Truvada and Descovy, which Gilead also markets, can range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides pharmacy drug pricing information. Gilead expects health insurance companies will cover the full cost of lenacapavir as they do for other prevention medications. The U.S. Preventive Services Task Force, an independent advisory panel of national experts that evaluates medical treatments and services, assigned an "A" rating for PrEP medications when prescribed to adolescents and adults at increased risk of HIV. Under the Affordable Care Act, that means insurers must cover the full costs of the medication as preventive care. Still, activists say insurers have charged copays or other cost sharing from required lab tests and medical visits. People must test negative for HIV before starting the medication. While on the treatments, they must take routine tests for HIV, other sexually transmitted infections and kidney health. In case you missed: The Supreme Court may hinder access to this HIV prevention, gay sex drug. Why? Every year, more than 1 million people globally become newly infected with HIV, according to the World Health Organization. About 10 million worldwide need to take PrEP to meet global HIV prevention goals, WHO said. About 2.5 million take PrEP, WHO said. More than 39,000 U.S. residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, the virus that weakens the immune system and causes AIDS, the CDC said. A June study estimated as many as 2.2 million Americans could benefit from HIV prevention medications. Men account for nearly 80% of new cases, mostly involving gay or bisexual men, the CDC said. Research shows White patients are far more likely to take PrEP than their Black or Latino counterparts, even though White patients are less likely to get infected with HIV. Geographically, the South accounts for more than half of new HIV cases. "We hope to reduce those numbers and potentially get to a day when zero infections are reported," Mercier said. This article originally appeared on USA TODAY: FDA approves new twice-yearly HIV shot in bid to end epidemic
USA Today
18-06-2025
- Health
- USA Today
FDA approves new twice-yearly HIV shot. What to know
FDA approves new twice-yearly HIV shot. What to know Show Caption Hide Caption New COVID booster guidelines set by FDA for healthy adults under 65 The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65. The Food and Drug Administration on Wednesday approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections. Gilead did not immediately say how much it will charge for the biannual shot, but company officials said it would be comparable to existing HIV prevention drugs. The drug will be marketed under the name Yeztugo. Advocates say the long-acting medication is promising because it's more convenient than existing HIV prevention drugs that must be taken daily. Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Gilead officials lauded the FDA's approval of lenacapavir, which has been studied and developed over nearly two decades. "We now have a very real opportunity to end the HIV epidemic," said Daniel O'Day, chairman and CEO of Gilead Sciences. "Lenacapavir has shown to be remarkably effective and only needs to be given twice a year, which represents a whole new way of preventing HIV.' How does lenacapavir compare to other HIV prevention drugs? Pre-exposure prophylaxis, or PrEP, medications are sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Another injectable medication, Apretude, is taken every two months after two initial shots taken one month a part. The overwhelming majority of PrEP users take daily versions, but "it's hard to take a pill every day ... when it's for prevention," said Johanna Mercier, Gilead's chief commercial officer. "So we see adherence levels as low as 50% to 55%," which does not provide adequate protection for at-risk populations. People are more likely to stay on the medication if they only need to take the medication twice a year, rather than daily oral doses, Mercier said. What did the lenacapavir studies show? In one study of women and adolescent girls in sub-Saharan Africa and Uganda, lenacapavir was 100% effective at preventing HIV infections. A second study reported the twice-a-year injections lowered the HIV infection rate by 96% in groups of cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa and Thailand. Schmid said the studies show people are much more likely to take the medication as recommended when it's dosed twice a year compared to daily pills. "This makes it so much easier and better for adherence and also for people who have other challenges in their life like mental health issues, work or stigma, " Schmid said. Important read: Here's why most at-risk populations don't use HIV prevention drugs How much will lenacapavir cost? Mercier said the company intends to price the drug "in line with other branded medicines in this area." Out-of-pocket costs for uninsured patients who take Truvada and Descovy, which Gilead also markets, can range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides pharmacy drug pricing information. Gilead expects health insurance companies will cover the full cost of lenacapavir as they do for other prevention medications. The U.S. Preventive Services Task Force, an independent advisory panel of national experts that evaluates medical treatments and services, assigned an "A" rating for PrEP medications when prescribed to adolescents and adults at increased risk of HIV. Under the Affordable Care Act, that means insurers must cover the full costs of the medication as preventive care. Still, activists say insurers have charged copays or other cost sharing from required lab tests and medical visits. People must test negative for HIV before starting the medication. While on the treatments, they must take routine tests for HIV, other sexually transmitted infections and kidney health. In case you missed: The Supreme Court may hinder access to this HIV prevention, gay sex drug. Why? More than 1 million new HIV cases each year Every year, more than 1 million people globally become newly infected with HIV, according to the World Health Organization. About 10 million worldwide need to take PrEP to meet global HIV prevention goals, WHO said. About 2.5 million take PrEP, WHO said. More than 39,000 U.S. residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, the virus that weakens the immune system and causes AIDS, the CDC said. A June study estimated as many as 2.2 million Americans could benefit from HIV prevention medications. Men account for nearly 80% of new cases, mostly involving gay or bisexual men, the CDC said. Research shows White patients are far more likely to take PrEP than their Black or Latino counterparts, even though White patients are less likely to get infected with HIV. Geographically, the South accounts for more than half of new HIV cases. "We hope to reduce those numbers and potentially get to a day when zero infections are reported," Mercier said.
Reuters
18-03-2025
- Health
- Reuters
Trump administration weighing future of CDC's HIV prevention division
WASHINGTON, March 18 (Reuters) - The U.S. health department said on Tuesday it is reviewing the Centers for Disease Control and Prevention's HIV prevention division for overlap with other agencies but no final decision had been made about its future. The Department of Health and Human Services made the statement after the WSJ and NBC, citing unnamed sources, reported the division could be dismantled. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The CDC's $1.3 billion Division of HIV Prevention is tasked with tracking infections across the United States and promoting testing and prevention, including the use of the HIV prevention medications, also known as PrEP. Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute in Washington, told Reuters he had been told by a government agency source that the division might be shut down and that a decision would be made this week on the funding of HIV prevention at the CDC. Schmid, who co-chaired the Presidential Advisory Council of HIV/AIDS during President Donald Trump's first term, said he understood all of the division's funding is "up in the air". HHS, which oversees the CDC, said in a statement it was looking at all divisions for potential overlap as part of Trump's broader efforts to restructure the federal government and that no final decision had been made on the CDC's HIV Prevention Division. "If this decision is even made, this work would be continued elsewhere at HHS," a department official said. Another HHS agency, the Health Resources and Services Administration, contains the Ryan White HIV/AIDS Program which provides HIV health services to low-income people. The Trump administration's approach to HIV/AIDS policy is undergoing a broad shift. In January, the White House ordered an immediate halt to the distribution of HIV medications by U.S.-funded foreign clinics, disrupting treatment for millions worldwide.
