With many ALS drugs now in phase II and III clinical trials, The ALS Association is considering strategies that will ensure any new treatments are accessible and affordable. We used our second ALS Roundtable to explore several important questions for our community including: How will these new therapies get paid for? How can people access to them? How long will it take to get access?
With heavy hearts, The ALS Association joins the ALS community in celebrating the legacy and mourning the loss of Pete Frates, who died Monday at age 34 after a seven-year battle with ALS. Pete lived a Hall of Fame life.
The ALS Association is partnering with, and will be directly investing in, the ALS Investment Fund II to raise $100 million to accelerate investment in ALS research and development. This second venture fund with offices in Boston and Amsterdam, succeeds a fund that started in The Netherlands and raised $25 million in two-and-a-half years to invest in companies with ALS initiatives.
November is National Family Caregivers Month, a time to recognize and honor the tremendous contributions of family caregivers. Throughout the month we have been sharing stories of caregivers in the ALS community. Caregiving is a full-time job, and many caregivers also maintain full time jobs while dealing with the financial and emotional stress that comes with being a caregiver.
Jen LeVasseur’s caregiver journey began while she was still a newlywed. Her husband, Noel, was diagnosed with ALS just 17 months after their wedding. Noel has two daughters from a previous marriage, Jen two sons. (They embrace the Brady Bunch, blended family analogy.) We sat down with Jen earlier this year to talk about caregiving and how ALS impacts the holidays.
Lynn Hogan became a caregiver early in her relationship her fiancé, Steve Ziegler. “On our first date we went out and he was sitting next to me and he said, ‘You might notice -- don't get weirded out or anything -- but you might notice some twitching, weird stuff going on with my arms. We don't know what it is yet. But one of the things it could be is ALS,’” she recalled.
The ALS Association submitted a report to the FDA documenting the real impact ALS has on people living with the disease and their caregivers in order to inform the development of treatments. The information in the report draws from a survey of people living with ALS.
Anthony Vick spent 16 years serving his country in the Army and Air Force Reserves, including 10 years in the civil service. Vick says he was lucky to be able to serve his country, service that came to an end in 2017 when he was diagnosed with ALS.
Maya Bulmer was thrust into the role of caregiver at a young age. Like many seniors in high school, Maya spent the 2018-2019 school year filling out college applications, readying for the next chapter in her life.
The ALS Association and its partners submitted comments to the Food and Drug Administration to further inform the agency’s implementation of the final guidance on the development of drugs and treatments for ALS. The comments underscore the need for urgency and commend the FDA for including voices from our community in its rulemaking process. Click here to view the comments.
A bill championed by The ALS Association was introduced in Congress today that would remove noninvasive ventilators from Medicare’s competitive bidding program. Reps. Morgan Griffith (R-Va.), Peter Welch (D-Vt.), Gus Bilirakis (R-Fl.), John Larson (D-Ct.), and Darren Soto (D-Fl.) have introduced H.R.4945, the Safeguarding Medicare Access to Respiratory Therapy (SMART) Act of 2019.
A coalition of patient, clinician, and provider groups – including the ALS Association, the American Association for Respiratory Care (AARC), the National Association for Medical Direction of Respiratory Care (NAMDRC), American Association for Homecare (AAHC), and the Council for Respiratory Care (CQRC) – today commend Representatives Morgan Griffith (R-VA) and Peter Welch (D-VT) for introducing legislation to protect Medicare beneficiaries’ access to critical home ventilation therapy. The Safeguarding Medicare Access to Respiratory Therapy (SMART) Act of 2019 would delay the inclusion of ventilators from the Medicare durable medical equipment competitive bidding program for five years, and establish a technical expert panel (TEP) to update that national coverage policies for home mechanical ventilator devices so that they reflect technological advancements and peer-reviewed science.
November is National Family Caregivers Month. Join The ALS Association in honoring caregivers throughout the month. “Being a caregiver of someone with ALS is incredibly challenging, and my role hasn't even begun to be that physical yet,” said Jen LeVasseur. Her husband, Noel, was diagnosed with ALS in 2017, just over a year after they were married.
A global, centralized, cloud-based repository of ALS genetic data is being assembled with funding from The ALS Association. This is the first such repository of its kind. Much of the research aimed at finding a cure for ALS is in the area of genetics. Such work requires genomic sequencing, a process whereby individuals' genes are mapped in a way that can be compared to the genes of others who do not have ALS in an effort to identify variations that may be factors in the development or progression of the disease.
When the Biology Honors class kicked off a special course to learn more about neurological diseases, they turned it into a unified effort to educate their community and raise over $3,000 for ALS research. The ALS Association spoke to some of the folks behind the project.
Last week Congress passed, and the president signed, a continuing resolution that will fund all federal programs at current levels through November 21. Before the continuing resolution expires, Congress must either pass full appropriations bills for the 2020 fiscal year or pass another continuing resolution.
On Monday, the Food & Drug Administration (FDA) issued a finalized ALS Drug Development Guidance for Industry. This is one important step in comprehensive efforts to bring therapies to people with ALS more quickly. Five years ago, there was no clarity around what the FDA expected from companies pursuing ALS treatments. The ALS Association recognized this problem, galvanized the broader community, and engaged the FDA to provide a clear roadmap that also can respond to new science as it emerges. The FDA Guidance is one part of a commitment that will not be complete until we have a cure for all people with ALS.