The ALS Association is deeply concerned and disappointed about the delay in FY24 government funding. ALS research needs to be funded and increased—NOW. People living with ALS cannot wait. We call upon policymakers to prioritize ALS research and swiftly appropriate the necessary funds to support innovative research initiatives, clinical trials and the development of potential treatments.

The possibility of a government shutdown could have far-reaching and disastrous consequences for people living with ALS and those who depend on government-funded programs and support systems. A shutdown will disrupt the vital services and resources that many individuals with ALS and their families rely on daily.

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 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.

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 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.

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.

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.  

Maryland lawmakers are considering a bill spearheaded by The ALS Association that would prohibit life insurance, long-term care insurance, and disability insurance policies from discriminating against people based on the results of a genetic test.

The United States Department of Veterans Affairs has made RELYVRIO available for the treatment of ALS for veterans who are living with the disease who receive care at VA clinics or ALS specialists, becoming one of the first health care payers or insurers to provide access to the drug.

The ALS Association recently sent letters to 43 of the largest insurance companies and health care payers to make RELYVRIO, which was formerly developed as AMX0035 and approved by the FDA for use in the treatment of ALS in September, available and accessible for people living with ALS.

The ALS Association is leading a fight to increase support for The Justice for ALS Veterans Act. The bill would make sure spouses of veterans who lose their battle with ALS are not denied access to survival benefits they are owed.

The National Academies of Sciences, Engineering, and Medicine (NAS) is undertaking a study into accelerating the development of treatments and improving quality of life for people with ALS. This is a huge win for the community. The ALS Association led an effort to get Congress to direct NAS to undertake a study on ALS and also fought for $1 million to fund the study.  

We filed comments urging the U.S. Department of Health and Human Services Office of Civil Rights to finalize a proposed rule that would strengthen civil rights protections against discrimination on the basis of disability in federal health care programs.

We strongly disagree with ICER’s final report on new ALS drugs, which may result in people living with ALS being unable to access life-extending treatments. ICER’s flawed conclusions were based on their discriminatory methodology, as the National Council on Disability has documented.  

An FDA advisory committee voted overwhelmingly (7-2) to support approval of AMX0035 for the treatment of ALS. A phase 3 clinical trial will continue to test the effectiveness of AMX0035.

Today, we filed comments with the FDA imploring them to ask the right question when it reconvenes its advisory committee in September to consider a new drug application (NDA) for AMX0035.

A committee convened by the Institute for Clinical and Economic Review voted overwhelmingly on August 19 that oral edaravone and AMX0035 provide meaningful clinical benefit to people with ALS and have a positive impact on quality of life, but that neither drug provides sufficient value to justify the presumed cost to insurers.