Approximately 96% physicians feel it is important to assess patients aged 60 years and older for cognitive impairment, but 48% of these patients have no had assessments from their physician.
Dementia is an umbrella term to describe a range of symptoms associated with cognitive impairment, said Nicole Purcell, DO, MS, a neurologist and senior director of Clinical Practice at the Alzheimer’s Association, during a session at the Academy of Managed Care Pharmacy Nexus 2023 conference. Dementia is caused by biological changes in the brain, with the most common cause being Alzheimer disease (AD); however, patients can have mixed dementia, Purcell said.
“More than 6.7 million Americans have dementia in the United States alone,” Purcell said in the session. “The percent of individuals with [AD] increases with age. We do know that age is the strongest risk factor for developing dementia.”
Approximately 98% of primary care physicians said that it is important to diagnose mild cognitive impairment, Purcell noted. Further, she said that 96% of physicians feel it is important to assess patients aged 60 years and older for cognitive impairment, but 48% of these patients have not had assessments from their physician.
“We do know that [AD] tends to work on a continuum. More patients start out in an asymptomatic phase, and it's thought that they'll start to develop pathology in the brain accumulation of proteins normally 20 to 30 years before they start showing symptoms, which is why risk factor modification needs to start in midlife, so around our 50s, and then some patients will progress on to mild cognitive impairment,” Purcell said in the session.
Purcell added that 85% of Americans want to know whether they have AD early, with 47% worrying about developing mild cognitive impairment in the future, which is the first stage of AD and dementia, according to Purcell. Mild cognitive impairment is characterized by subtle changes in memory and thinking but is not part of the typical aging process.
“Some [patients] think that it's part of aging, and it's not. It's never part of the typical aging process. It's never normal, but it can be a broad set of symptoms, so again, it's not just about memory, but it can be about function, [and] it can be about psychiatric symptoms,”Purcell said.
Those with non-memory concerns, such as functional decline, personality change, depression, deterioration of other chronic illnesses without explanation, and falls or balance, should be evaluated for cognitive changes.
There are 3 key medications that were highlighted in the session: aducanumab (Aduhelm; Biogen) lencanemab (Lequembi; Biogen, Eisai), and donanemab (Eli Lily). The medications are all monoclonal antibodies that were studied in mild cognitive impairment and mild AD. Adverse events can include amyloid-related image abnormality, edema or hemorrhage, headaches, and falls.
Aducanumab received accelerated approval and required additional testing to confirm the clinical benefit, according to Purcell. The trial for lecanemab met its primary endpoint of a statistically significant reduction of clinical decline.
Although these drugs have been found to yield positive results, fewer than 5% of individuals in the trial were Black, Hispanic, American Indian, Alaskan Native, and Asian American, despite Black individuals being twice as likely to develop AD and Hispanic individuals 1.5 times as likely, Purcell said.
“We have more work to do with making sure that the medications that are being approved are being evaluated in diverse populations that they're intended to serve,” Purcell said in the session.
Sarah S. Yoon, PharmD, director of Drug Information at Centene Pharmacy Services, discussed the regulatory, clinical, and nonclinical considerations in managed care. For formulary decision-making, the FDA approval pathway is a key factor. Further, the CMS National Coverage Determination has key requirements to consider as well. Early diagnosis of patients is also considered. For formularies, clinical efficacy outcomes and safety are considered by drug.
Purcell N, Yoon SS. Alzheimer’s Disease Treatment Advances: Integrating Patient Value into Managed Care Decision-Making. AMCP Nexus 2023. October 18, 2023. Accessed October 18, 2023.