Medicare Expands Access to Alzheimer’s Diagnostic Scans, Boosting New Treatment Prospects

The U.S. Centers for Medicare and Medicaid Services (CMS) recently announced a significant development in Alzheimer’s disease diagnosis and treatment. On October 13, the CMS removed its previous limit of one beta-amyloid PET scan per patient’s lifetime, marking a pivotal shift in Alzheimer’s care.

The decision to broaden coverage for beta-amyloid PET scans comes on the heels of the recent U.S. Food and Drug Administration (FDA) approvals for groundbreaking drugs designed to combat the disease. These monoclonal antibodies, which target amyloid plaque deposits in the brain, have raised new hope for Alzheimer’s patients.

Key Takeaways

Removal of Coverage Limit: The CMS decision signifies the end of the previous national coverage determination and coverage with evidence development for beta-amyloid PET scans. This change is a positive step toward improving Alzheimer’s diagnosis and treatment.

Local Coverage Decisions: Medicare coverage for amyloid PET scans will now be determined by local Medicare Administrative Contractors (MACs). These contractors will assess individual patient characteristics and evidence of brain amyloid pathology to determine the appropriateness of anti-amyloid treatments.

Diagnostic Significance: Amyloid PET scans are crucial diagnostic tools that enable healthcare providers to identify amyloid plaques in the brains of Alzheimer’s patients. This confirmation is vital for selecting the most suitable treatments.

Positive Reception: The CMS decision has received support from national associations and medical professionals. Organizations like the Society of Nuclear Medicine and Molecular Imaging (SNMMI) have commended the move, emphasizing its importance in expanding access to essential nuclear medicine tests.

Call for Consistency: Despite the positive step forward, patient advocacy groups and national associations had hoped for a national coverage ruling instead of leaving determinations to local Medicare Administrative Contractors (MACs). The CMS, however, believes that MACs will provide consistent coverage across regions based on evidence.

The decision by the CMS to broaden coverage for beta-amyloid PET scans is a significant development in the field of Alzheimer’s diagnosis and treatment. As the CMS and MACs work together, this change aims to provide seamless and consistent coverage for amyloid PET scans, ultimately benefiting Alzheimer’s patients and paving the way for innovative treatments.

Emerging Companies in Alzheimer’s Treatment:

Seelos Therapeutics (SEEL) Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company’s robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington’s disease, Alzheimer’s disease, and Parkinson’s disease.

Synaptogenix (SNPX) Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases. Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer’s disease. Preclinical studies have also demonstrated bryostatin’s regenerative mechanisms of action for the rare disease Fragile X syndrome, and for other neurodegenerative disorders such as multiple sclerosis, stroke, and traumatic brain injury. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs.

Neurosense Therapeutics (NRSN) NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

Alzamend Neuro (ALZN) Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.