
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. SOURCE The ALS AssociationNone
As one of the world's premier superstar athletes, often finds himself on the receiving end of criticism over his views on basketball, life, and the world of politics. MMA star Colby Covington became the most recent public figure to call him out and even went viral for calling James a "f***ing scumbag." Javascript is required for you to be able to read premium content. Thanks for the feedback.
Sanwo-Olu presents N3.005 trillion budget for 2025FRISCO, Texas (AP) — Dallas Cowboys linebacker DeMarvion Overshown could miss the 2025 season recovering from the right knee injury sustained in a loss to Cincinnati, coach Mike McCarthy said Tuesday. McCarthy said Overshown has a “long road of rehab in front of him.” The second-year player tore multiple ligaments when a Bengals lineman crashed into his leg in the Cowboys' 27-20 loss Monday night. Overshown missed all of his rookie year in 2023 after tearing the ACL in his left knee in a preseason game. The latest injury came in his first game since a spectacular 23-yard interception return for a touchdown in a 27-20 victory over the New York Giants on Thanksgiving. “DeMarvion is getting ready to have a big surgery in front of him,” McCarthy said of the procedure planned this week. “His physical and football talent speaks for itself. He’s such a bright light. He’s got a great, infectious personality — a tough young man. He is definitely going to be missed.” The former Texas standout, drafted in the third round last year, was second on the team to star pass rusher Micah Parsons with five sacks when he went down. The December timing of Overshown's injury means rehab is likely to extend past training camp and into the regular season next year, after he turns 25. Parsons was emotional when asked about Overshown after the Cincinnati game. “I cried,” he said. “It’s like my little bro, bro. He doesn’t deserve that either. Just to understand what he’s going to go through and to be there for him physically, mentally. It’s just so challenging because of the year he was having. I really just don’t think that’s fair either.” The loss of Overshown comes with defensive end DeMarcus Lawrence close to return from a foot injury that has sidelined him since Week 4. But the Cowboys (5-8) are all but out of the playoffs as they prepare to visit Carolina (3-10) on Sunday. AP NFL: https://apnews.com/hub/nfl
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