Historic CMS Directive Expands Access to Qalsody for ALS Patients on Medicare Advantage Plans

In a significant step forward for the ALS community, the Centers for Medicare & Medicaid Services (CMS) has introduced a pioneering directive that mandates Medicare Advantage plans to cover Qalsody, a cutting-edge treatment for individuals with genetic SOD1-ALS. This groundbreaking decision reflects the mission of the ALS Association and reinforces the need for immediate access to essential treatments for those living with ALS.

Calaneet Balas, the president and CEO of the ALS Association, expressed her gratitude, stating, "This is a victory for the entire ALS community. 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."

This directive not only signifies a monumental win for ALS patients but also serves as a message to the wider rare disease community and the pharmaceutical industry, indicating that new treatments can be developed and made available for those in need. Balas emphasized the importance of developing and approving more ALS treatments to improve the lives of all individuals affected by this disease.

The ALS Association has been instrumental in advocating for the accessibility of Qalsody, funding crucial research and development since its inception. The organization initially invested over $1.3 million in research focused on ALS-specific antisense oligonucleotide (ASO) technology, which laid the groundwork for Qalsody’s subsequent development. Their efforts included pioneering preclinical studies and the first clinical trials that established SOD1 as a viable therapeutic target. The successful FDA approval of Qalsody in 2023 was a direct result of the ALS community's unwavering advocacy for accelerated treatment options.

The CMS directive also sets a precedent for other state regulators and private insurers, potentially paving the way for broader coverage of life-changing treatments. The Valor study published in 2022 highlighted Qalsody's significant potential, showing that it effectively reduced mutated SOD1 protein levels in cerebral spinal fluid, resulting in slower disease progression and improved quality of life for patients after a year of treatment.

However, the path to access has not been smooth. When insurance companies began denying Qalsody coverage, citing its 'experimental' status, the ALS Association took prompt action. They collaborated with CMS to investigate these denials, presenting evidence that outlined the critical need for intervention and support for ALS patients.

In tandem with their advocacy efforts, the ALS Association engaged lawmakers, organized strategic meetings, and championed the rights of patients to secure their access to this essential treatment. Their relentless pursuit of justice has empowered many ALS patients to get the care they need.

For those who have previously faced denial from their Medicare Advantage plans for Qalsody, the ALS Association encourages immediate contact with their ALS specialists to initiate access to the treatment. As new therapies emerge and regulations adapt, the ALS Association is committed to ensuring that ALS becomes a livable disease while continuing the urgent search for more effective treatments and a cure.

To learn more about the CMS directive and its implications for ALS patients, visit ALS Association's official website.

About the ALS Association

The ALS Association stands as the largest organization dedicated to ALS globally, funding extensive research initiatives, providing support networks for those affected by the disease, and advocating for policies that improve the lives of ALS patients. The association's ongoing work is focused not only on making ALS manageable but also on discovering new therapies and ultimately a cure.

For further details regarding the ALS Association's mission and its relentless quest for solutions, please visit als.org.