The speech language pathologist, commonly called speech therapist, has an important role in managing the symptoms of ALS. Creating thoughts, words and phrases, no matter if in verbal or written forms, is a complex process involving regions of the brain and a complex network of nerves and muscles throughout the body.
The ALS Association and The Association for Frontotemporal Degeneration (AFTD) are launching a research funding opportunity to support collaborative development of digital assessment tools for both ALS and frontotemporal degeneration (FTD).
We continue to press Cigna to reverse course and make Relyvrio treatment available for people living with ALS on Cigna plans. While Cigna initially revised its policy, those changes were insufficient to ensure timely access to Relyvrio for people living with ALS.
The ALS Association commends the FDA for approving tofersen under the agency’s accelerated approval pathway for the treatment of people living with ALS connected to mutations in the SOD1 gene. This marks the first time the FDA has approved a treatment for ALS under accelerated approval and serves as a promising endorsement of the antisense technology that underlies tofersen.
The ALS Association recently submitted a series of regulatory filings to reduce administrative burdens placed on people living with ALS. The filings are in support of administrative rule changes at the Centers for Medicare and Medicaid Services that would reduce some administrative delays by improving prior authorization claims processes, instituting how and when Medicare Advantage plans develop and use coverage criteria and utilization management policies, and ensure that Medicare Advantage coverage policies are equivalent to traditional Medicare coverage.
The ALS Association and the Focused Ultrasound Foundation are partnering to advance transformational treatments for people with ALS. Leveraging a $500,000 ALS Association Partnership Grant and $500,000 in matching funds from the foundation, this new collaboration will support research into diagnosing and treating ALS using focused ultrasound technology.
The ALS Association celebrates the accomplishment of San Diego State University assistant men’s basketball coach Mark Fisher, who will become the first known person living with ALS to coach in a Final Four. Mark was diagnosed with ALS in 2011 and has been serving as an assistant coach for the Aztecs since 2001.
We thank the FDA Advisory Committee for their clear and compelling recommendation that tofersen be approved under the accelerated approval pathway. We urge the FDA to swiftly approve this urgently needed new treatment. Americans living with this rare and aggressive genetic form of ALS cannot wait.
The U.S. House and Senate are preparing legislation that determines how much will be spent on research. We need as many members as possible of the House and Senate to sign “Dear Colleague” letters committing to support increased funding for ALS.
The ALS Association submitted comments to the FDA’s Central and Peripheral Nervous System Advisory Committee, urging it to recommend approval of tofersen for people with ALS linked to a SOD1 gene mutation. The committee will meet virtually on March 22 to review data associated with Biogen’s new drug application.
The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and the Northeast ALS (NEALS) Consortium announced topline results from Regimen D of the HEALEY ALS Platform Trial, which is evaluating pridopidine versus placebo in adults with ALS.
Medicare is in the final stage of adding power seat elevation systems in power wheelchairs as a new benefit for disabled individuals including people living with ALS. The Centers for Medicare and Medicaid Services recently released a proposal to deem the equipment medically necessary to preform weight-bearing transfers – a huge win for ALS advocates who have been fighting for years for coverage.
The fight for the Genetic Testing Protection Act in Maryland continued Thursday with ALS Association leaders pressing the state’s House of Delegates to advance the policy. The bill would prohibit companies that offer life insurance and disability insurance in that state from using the results of genetic testing to deny coverage or engage in price discrimination. Similar bills have been proposed in New York, Illinois and Tennessee.
The ALS Association filed a formal objection to health insurer CIGNA for the company’s decision to exclude Relyvrio from its formulary. In a letter also shared with the Centers for Medicare and Medicaid Services and the Veterans Administration, the Association called on CIGNA to reverse its decision.
ALS Association leaders and people living with ALS urged Maryland senators to advance legislation that would prohibit companies that offer life and disability insurance from using the results of genetic testing to deny coverage or influence pricing decisions. John Knowles, a caregiver for his wife, Teri, testified about the impact familial ALS has had on his family. Teri’s twin sister died in 2013, and another sister died in 2020 after living with ALS. John talked about the need for genetic testing for family members and the fear that the results could be used against them.
The ALS Association has awarded $4.9 million to help speed the testing of ALS therapies through clinical trials. The Association’s inaugural Trial Capacity Awards will support efforts at 13 established and emerging ALS clinical trial sites to increase the number and diversity of people living with the disease who have the opportunity to participate and improve the efficiency and pace at which these studies are conducted.
ALS Association leaders and advocates from the ALS community will press lawmakers in Maryland to pass legislation that would prevent insurance companies from using genetic testing information to deny coverage or influence price considerations.
The ALS Association is launching an ambitious slate of federal and state policy priorities for 2023. The priorities build upon the successes achieved and focus on augmenting our work to accelerate the search for new treatments and cures, optimize care for people living with ALS today, prevent ALS, and empower everyone with ALS and their families to live life on their own terms.