Treatment advances for Alzheimer’s disease took a quantum leap last year. As of early 2021, there were 126 unique agents in the pipeline for Alzheimer’s,1 and in June 2021, the U.S. Food and Drug Administration (FDA) approved the first drug for Alzheimer’s since 2003.2 Despite these advances, there have been many challenges and the field of medicine is not prepared.

Prevalence is increasing: In 2020 there were 5.8 million Americans with Alzheimer’s, and this is projected to nearly triple to 14 million by 2060.3 Since providers have historically had limited treatment options for Alzheimer’s, they reserved screenings for those who had signs of mild cognitive impairment.4 Pharmaceutical companies must consider primary care providers (PCPs) an integral stakeholder in choosing suitable patients for treatment. Neurologists, PCPs, and pharmaceutical companies can align on screening and referral protocols to ensure appropriate and equitable access to Alzheimer’s treatments.

Neurologists Aren’t in the Business of Screening—PCPs Are

When a new drug comes to market, pharmaceutical companies often focus on the patient and the prescriber, typically a specialist; however, the situation is different with Alzheimer’s disease. Initially patients present with signs of mild cognitive impairment (MCI) to the PCP, and the origins of this impairment can stem from a variety of sources, for example, nutritional, atherosclerotic, or psychiatric.5 Even when a patient is finally diagnosed with Alzheimer’s, the PCP primarily handles management with lifestyle modifications and acetylcholinesterase inhibitors that treat symptoms but do not slow progression.5 Frankly, a PCP cannot refer every person with MCI to neurology; there are just not enough neurologists.6

Screening for MCI

In 2020, the United States Preventive Services Task Force (USPSTF) released an updated guideline on screening asymptomatic patients over 65 for cognitive impairment.4 It found insufficient evidence to recommend screening. While 94% of PCPs believe it is essential to assess and screen all older patients for cognitive impairment, only 47% say they do so as standard practice.7

PCPs typically reserve screening for symptomatic patients and administer simple, quick, in-office tests such as the Mini-Mental State Examination and Mini-Cog®.8 However, in clinical trials using monoclonal antibodies against amyloid in Alzheimer’s, participants required testing with multiple instruments, including the Alzheimer’s disease composite score (ADCOMS), ApoE4 testing, and positron emission tomography (PET) scanning for amyloid plaques9—none of which are used by PCPs currently as a standard part of practice.

Three Arguments for Coordinated Screening

Why should we broaden our screening effort? One, the pathological changes in the brain associated with Alzheimer’s occur years before the onset of symptoms.10 Earlier diagnosis of Alzheimer’s may aid in preventing rapid progression of disease. Screening for symptoms—rather than waiting for patients to report them—may improve therapeutic outcomes.11

Second, a screening protocol ensures that all populations have an opportunity for treatment. For example, African Americans have been underrepresented in clinical trials, but they may have two to three times greater risk than the non-Hispanic white population.10

Finally, PCPs can assess patients for treatment by implementing standardized protocols and only refer the most appropriate patients. These protocols may include genetic testing, PET scans, and advanced cognitive testing. Coordinated referrals may mitigate the capacity issues associated with the limited number of neurologists and allow neurology/PCP/payer alignment on criteria for referral and treatment.

Tools to Align Stakeholders

Pharmaceutical companies can facilitate cognitive impairment assessment training in several ways, including:

  1. Develop a playbook that details unmet needs, screening and risk assessment tools, and strategies for shared decision-making to health systems and IDNs.
  2. Partner with medical associations to create continuing medical education for PCPs and neurologists, because PCPs will quickly need to pivot in approaching memory loss and cognitive impairment.
  3. Develop EHR order sets to assess patients who screen positive and streamline the referral and payer approval process.
  4. Engage with key opinion leaders to drive coordination between PCPs and neurologists to streamline screening and referral.
  5. Create value-based alliances with health systems and payers to address the growing burden of Alzheimer’s and associated costs.

References:

1. Cummings J, Lee G, Zhong K, et.al. “Alzheimer’s disease drug development pipeline: 2021.” Alzheimers Dement (N Y). Published online May 13, 2021. Doi: 10.1002/trc2.12179.

2. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug.

3. https://www.cdc.gov/aging/aginginfo/alzheimers.htm#Who.

4. Patnode CD, Perdue LA, Rossum RC, et al. “Screening for Cognitive Impairment in Older Adults: Updated Evidence Report and Systematic Review for the US Preventative Services Task Force.” JAMA. 2020;323(8):764-785. doi:10.1001/jama.2019.22258.

5. Arvanitakis Z, Shah RC, Bennett DA. “Diagnosis and Management of Dementia: Review.” JAMA. 2019;322(16):1589-1599. doi:10.1001/jama.2019.4782.

6. Majersik JJ, Ahmed A, W-Hwei AC, et al. “A Shortage of Neurologists—We Must Act Now: A Report From the AAN 2019 Transforming Leaders Program.” [published online ahead of print, 2021 Apr 30]. Neurology. 2021;10.1212/WNL.0000000000012111. doi:10.1212/WNL.0000000000012111.

7. “2019 Alzheimer’s disease facts and figures.” Alzheimers Dement. 2019;(15):321-387.

8. Tsoi KK, Chan JY, Hirai HW, Wong SY, Kwok TC. “Cognitive tests to detect dementia: A systematic review and meta-analysis.” JAMA Intern Med. 2015;175(9):1450-1458. doi:10.1001/jamainternmed.2015.2152.

9. Huang LK, Chao SP, Hu CJ. “Clinical trials of new drugs for Alzheimer disease.” J Biomed Sci. 2020;27(1):18. doi:10.1186/s12929-019-0609-7.

10. Barnes LL, Bennett DA. “Alzheimer’s disease in African Americans: risk factors and challenges for the future.” Health Aff (Millwood). 2014;33(4):580-586. doi:10.1377/hlthaff.2013.1353.

11. Sperling RA, Aisen PS, Beckett LA, et al. “Toward defining the preclinical stages of Alzheimer’s disease: recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease.” Alzheimers Dement. 2011;7(3):280-292. doi:10.1016/j.jalz.2011.03.003.

  • Cynthia Miller, MD, MPH, FACP

    Cynthia Miller, MD, MPH, FACP is Vice President, Medical Director, Access Experience Team at PRECISIONvalue. Cynthia is a trained internist with over 10 years of patient care experience. In addition, she has over four years of experience in the payer space at both WellCare Health Plans and Centene. At PRECISIONvalue, Cynthia’s focuses on market access for national health plans and health systems.

  • Reta Mourad, PharmD

    Reta Mourad, PharmD is Vice President, Access Experience Team at PRECISIONvalue. Reta is a leader in managed care strategic relationships uniquely versed in all aspects of pharmacy and medical benefit management across the health plan, PBM, and specialty payer segments. Since joining Precision, Reta has provided managed care strategic guidance to clients across a variety of specialty and rare disease therapeutic areas, including oncology, hematology, immunology, central nervous system disorders, enzyme deficiencies, and biosimilars.

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