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

I have to admit that the idea for this week’s column comes from watching “Buy It Now,” a new show about competitors pitching their products in hopes for a spot in Amazon’s “Buy It Now” shop, with my teenage girls. One of the products pitched was a line of skin care products that included marine algae as one of the many ingredients. This sparked a discussion about skin care in general and the many varieties out there — all designed to entice those seeking that perfect glow to try out something new. While I’m obviously a skeptic, I’m also quite curious as to why certain ingredients are chosen and if and how they actually “work.” While Maine isn’t usually on the cutting edge of the latest trend, when it comes to skin care, there are some neat products out there that are pretty innovative, and they take advantage of the variety of sea life available in Maine. The biggest category of these products are those that include seaweed. Seaweed has a number of health benefits both when eaten and when used topically. The biggest one that is the most obvious to me is its ability to absorb water. Think of a dried piece of seaweed, like the kind you would buy to use in a soup stock, and imagine it 1,000 times heavier. That’s how much weightier a single piece of seaweed can be once it has soaked up the seawater around it. Looking at my dry, wintery hands, I am compelled by the power of the moisture-attracting power of seaweed to try a cream made from it. In addition, seaweed has lots of antioxidants that are apparently good at slowing down the aging process and Vitamin C that is said to make skin look brighter. I can attest to the anti-inflammatory properties, another benefit of seaweed, from my seaside experiments with my girls squirting out the “goo” inside the tips of seaweed fronds to make a “healing potion” which, to my surprise, actually worked on barnacle-scraped feet and sunburned arms. There are a number of local companies making everything from creams and oils to soaps and scrubs with a variety of locally grown and harvested seaweed types. Cold Current Kelp is one of these small Maine businesses. The company, based in Kittery, which already produces Kelp Glow Facial Oil, recently received Small Business Innovation Research (SBIR) funds through the USDA to continue its research into refining their extraction technique using non-toxic chemicals to derive bioactive compounds from sugar kelp. The company is owned by two women, one a marine biologist by background, and the other an entrepreneur. It’s exciting to see the effort they are putting into the research behind their products. There are many other Maine-based companies making great products including Westbrook-based Planet Botanicals and Maine Coast Sea Vegetables, which makes edible seaweed products as well as products like their Seaweed Dream Cream. Perhaps more unusual than the suite of products utilizing seaweeds are those that utilize lobster as an ingredient- lobster blood, to be exact. Marin Skincare is an innovative company that works with Luke’s Lobster to utilize a byproduct from their processing facility in Saco. They are able to extract glycoprotein, which occurs in the lobster’s circulatory fluid, to use in their creams and lip balms. The glycoprotein is said to have anti-inflammatory properties that are very effective for conditions like eczema, a condition suffered by one of the company’s founders, which led to the development of this unique product line. If you’re looking for a unique gift for someone in your family this holiday season, now you know a few options for something soothing and moisturizing as we head into the dry depths of Maine winter. It’s a good way to support Maine businesses that utilize sustainable ingredients from the sea. Susan Olcott is the director of strategic partnerships at Maine Coast Fishermen’s Association. Comments are not available on this story. Send questions/comments to the editors. « Previous Next »In the midst of the rumors and gossip, let us all come together to send our thoughts and prayers to Liu Yuning during this uncertain time. May she find strength and healing, and may her resilience inspire us all to face life's obstacles with grace and determination.In addition to the stellar cast, "Moonlight Knock!" boasts an impressive lineup of supporting actors, including veteran performers such as Liu Wei and Zhao Yihan. The film's production team has spared no expense in creating a visually stunning and immersive world for the characters to inhabit, with lavish sets and elaborate costumes that capture the essence of the story.

The meeting with the Ministry of Labour and Social Security and the Jamaica Medical Doctors Association (JMDA) yield some success as junior doctors are to return to work later this evening. The leadership of the JMDA said in the best interest of patient care junior doctors will resume duties at 6:00 p.m. JMDA president Dr Renae Badroe told The STAR a short while ago that a meeting is planned for Tuesday at which time her association will meet with officials from the Ministry of Finance and the Public Service and the Ministry of Health to address the concerns raised by the doctors. Public healthcare was severely disrupted this morning after junior doctors started calling in sick. The Ministry of Health and Wellness reported earlier that public health facilities across Jamaica have begun to operate under emergency protocols, as junior doctors have called in sick. While emergency rooms remain open, the health ministry says outpatient services and elective surgeries have been significantly scaled down or otherwise suspended. At the same time, primary care facilities have also been affected. Junior doctors have complained that despite an ultimatum given to the Ministry of Finance and the Public Service and the Ministry of Health and Wellness up to late Sunday neither of the two ministries has reached out to the JMDA. Highlighting what it describes as the major areas of concern, the JMDA says the finance ministry does not want to pay retroactive sums owed to doctors. It says the ministry wants to impose its rates for overtime and does not want to reinstitute incentive allowance that it unilaterally discontinued. We want to hear from you! Email us at star@gleanerjm.com and follow @thejamaicastar on Instagram and on X @JamaicaStar and on Facebook: @TheJamaicaStar