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Plans Required to Cover Treatment for SOD1-ALS ARLINGTON, Va. , Dec. 11, 2024 /PRNewswire/ -- The Centers for Medicare & Medicaid Services (CMS) has announced a first-of-its-kind directive requiring Medicare Advantage plans to approve coverage for Qalsody, a treatment for people living with genetic SOD1-ALS. This decision reflects the ALS Association's commitment to ensuring that people living with ALS have access to promising ALS treatments without delay. "This is a victory for the entire ALS community," said Calaneet Balas, president and CEO of the ALS Association. "It's critical that FDA-approved treatments are made accessible rather than being labeled as 'experimental.' We are grateful to everyone in our community who helped make this day happen." Balas added: "We hope this sends a message to the entire rare disease community and pharmaceutical industry that new treatments can be developed and made accessible to those who will benefit from them. We need to ensure more ALS treatments are developed and approved that will help everyone living with ALS." The ALS Association played a key role in the historic CMS directive by participating and advocating for the research, approval, and accessibility of Qalsody for people living with ALS. In 2004, the ALS Association was the first to fund research into ALS-specific antisense oligonucleotide (ASO) technology, investing over $1.3 million in groundbreaking studies that laid the foundation for the development of Qalsody. This early commitment supported preclinical studies, safety trials, and the first-in-human phase 1 trial, which established SOD1 as a viable therapeutic target. In 2023, Qalsody became the first gene-based therapy approved for ALS , thanks in part to the ALS Association's efforts, including a united push from the ALS community for FDA accelerated approval. This new CMS directive provides precedent for state regulators to issue similar actions for other private insurers. According to the Valor study published in 2022 , Qalsody, which was developed specifically to target the RNA produced by mutated SOD1 genes, has demonstrated significant promise in clinical trials and real-world studies. In the phase 3 VALOR trial, Qalsody reduced levels of mutated SOD1 proteins in cerebral spinal fluid by 35% within eight weeks and decreased bloodstream levels of neurofilament light chain (NfL)—a key biomarker of neurodegeneration—by 50% within 12-16 weeks. These biological changes translated into measurable clinical benefits, including slower disease progression, improved respiratory function, and enhanced quality of life after 52 weeks of treatment. Real-world data has since validated these findings, with some patients stabilizing or even experiencing improvements in motor function and quality of life. When insurance companies began denying access to Qalsody, labeling it as "experimental," the ALS Association took decisive action, working directly with CMS to launch an investigation into these unjust denials. By presenting evidence of widespread insurance rejections and demonstrating the critical need for immediate intervention. In addition to working with CMS, the ALS Association actively engaged policymakers, held strategic meetings with state and federal legislators, and served as a staunch advocate for patients, ensuring their voices were heard and their rights to life-changing treatment were upheld. The ALS Association urges anyone previously denied Qalsody by their Medicare Advantage plan to contact their ALS specialist immediately to begin the process of securing access to this critical treatment. For more information on the CMS directive visit als.org About the ALS Association The ALS Association is the largest ALS organization in the world. The ALS Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.als.org . About ALS Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Over the course of the disease, people lose the ability to move, to speak, and eventually, to breathe. The disease is always fatal, usually within five years of diagnosis. Few treatment options exist, resulting in a high unmet need for new therapies to address functional deficits and disease progression. View original content to download multimedia: https://www.prnewswire.com/news-releases/groundbreaking-directive-ensures-als-patients-on-medicare-advantage-gain-access-to-qalsody-302329525.html SOURCE The ALS Association Stay Informed: Subscribe to Our Newsletter Today
Jane D Hartley will praise the work of the Multibank, which helps to distribute clothes, bedding, baby, hygiene, toy and furniture through a network of local charities and care professionals. Ms Hartley says the Multibank is “one of the best tools we have to provide essential goods to the people who need them the most”. At the reception in London on Tuesday, she will urge more companies to get involved in the charity. The Multibank was launched three years ago by Mr Brown, with help from Amazon, redistributing surplus stock from the online giant’s returns centre in Fife, to families supported by The Cottage Family Centre, in nearby Kirkcaldy, where Mr Brown is a long-time patron. There are now five Multibank charity centres across Britain, which have distributed five million products to half a million families. Support professionals report getting Multibank goods to the families who need them is preventing them from falling into crisis, and stopping children from being taken into care. Ms Hartley and Mr Brown will be joined at the reception by Amazon UK country manager John Boumphrey and Comic Relief chief executive Samir Patel. Amazon UK and Comic Relief announced a £6 million commitment over the next four years to the Multibank Comic Relief Fund to help expand Multibanks across the UK. Ms Hartley said: “We must lift up the most vulnerable when they are down and equip young people with resources as they grow. “In both the UK and the United States, there are still too many families living in poverty, but we can make a difference when we combine the reach of government with the innovation of the private sector. “This game-changing new commitment will boost the reach and the sustainability of the Multibank programme, one of the best tools we have to provide essential goods to the people who need them the most. I have always believed that companies have a responsibility to give back to the world; to do good, not just to do well.” Mr Brown said: “I’m delighted US Ambassador Jane Hartley is joining our Multibank Coalition of Compassion. She joins football, rugby and sports clubs, celebrities from film, theatre and music – including David Tennant, Peter Capaldi, Michael Sheen and Simon Cowell – in calling on suppliers and funders to donate goods to Britain’s Multibank so we can put a smile on thousands of children’s faces this Christmas and show them we care. “The Multibank model is simple: businesses have household good surpluses, and via our community-based charity partners we can get them straight to the people who need them. No product ever needs be wasted whilst we have families in need of them.” Mr Boumphrey said: “Our goal is to help as many families as possible by connecting surplus goods from Amazon and other businesses, with those who need it most.” Mr Patel said: “The Multibank is an invaluable lifeline to people and their families in being able to access essential goods and keep themselves and their children warm and healthy. “Whether it’s clothes, bedding, essential hygiene products or school uniforms, the power of this innovative cross-organisation partnership provides critical help within communities across the UK.”Groundbreaking Directive Ensures ALS Patients on Medicare Advantage Gain Access to QalsodyFalcons feeling the pressure at .500 as Cousins' interceptions put spotlight on downturn for offense
