Monday, April 12, 2021

AMCP Annual Meeting

SPARx’s Susan Trieu, PharmD, VP Trade Relations, moderated a PTCE session about Alzheimer’s Disease with Gary Small, PharmD, Chief Physician at Behavioral Health Services of Hackensack University Medical Center and Winston Wong, PharmD, President of W-Squared Group.

Session Review

In the session, participants learned about the clinical progression of Alzheimer’s Disease (AD) and the value of biomarkers of the disease in early diagnosis as they relate to treatment selection and patient management. The speakers analyzed challenges in current treatment and management strategies in AD, and discussed classifying clinical data for emerging disease-modifying therapies and their importance in early identification of disease. The panel also highlighted future managed care strategies that will allow for the uptake of future disease-modifying therapies in AD.

According to Dr. Wong, treatment options available today are only to help alleviate symptoms. Current research and drug development in AD is focused on disease modification by treating amyloid plaques and “tangles” seen in brains of patients with AD. There are currently 28 active clinical trials and one agent, aducanumab, is under review at and FDA with a decision date in June 2021. The panel discussed several agents and the difficulty with developing new drugs that investigate new targets such as plaques and tangles and where they are clinically relevant.

President Biden has put forth a three-pronged national plan for AD. The first step, Operation “Warp Speed,” will allow regulators to cut through red tape and work closely with the FDA. The second step will make greater investments in research, and the third step will push the AD fight to the global stage.

Dr. Small reviewed historical data and the difference between normal brains and those with MCI, Mild Cognitive Impairment, and those with Alzheimer’s Disease and Related Dementias (ADRD). Patients with MCI are still functional, but patients diagnosed with ADRD require assistance. Biomarkers used to track changes in the brain such as serum, blood, CSF, and imaging tests, as well as other strategies can be used to identify early indicators of AD.

Caregivers are often the ones that identify issues with the patient and unfortunately become burdened with caring for the patient or loved one. Earlier diagnosis shows benefits for both for patients and caregivers including management of symptoms early on, patient safety, and cost savings. Barriers to identification and treatment include suicide, lack of training, diagnostic uncertainty, and reluctances of care.

A panel discussion was also covered on how patients should be treated, how pharmacists would know to use new drugs that are in clinical trials, intervention of adverse effects for symptomatic drugs, and how healthcare systems will keep up with new drugs that will come to market and a new frame of mind on how to treat and diagnose AD patients earlier.

The Potential Cost Burden of ADRD

Dr. Wong highlighted that Alzheimer’s Disease is the most expensive disease in the United States, with an estimated cost of $236 billion per year, excluding unpaid family caregiving. As the disease progresses, patients with dementia can utilize services in the home, adult day centers, assisted living facilities, and nursing homes. More than one of these services can be utilized over the long course of the disease.

Currently, Medicaid is the only public program that covers the long nursing home stays that most patients with dementia will require in the severe stage of the illness. The economic burden from treating AD patients is significant and projected to increase in the coming years as the population ages. The direct costs of care for patients with AD are attributed to skilled nursing care, home healthcare, and Hospice care, which are all expected to increase rapidly with the approval of disease-modifying treatments in the pipeline today.

Managed Care Organizations are in the unique position to create programs supporting the National Plan for Alzheimer’s Disease and Related Dementias effort through early diagnosis, patient care coordination, and patient and caregiver education and support. MCOs should actively pursue early review of emerging therapies, care coordination, and provide covered nonpharmacologic interventions, such as MTM services, PT, OT, and CST.

Are you interested in learning more about these emerging therapies that are in pipeline to be approved by the FDA?

Contact SPARx today to get your health system pharmacy ahead of the curve and be ready for what will be approved soon.