Health Equity: The Kx Research Approach and Case Study

Health Equity:

The Kx Research Approach and Case Study

Health Equity in Advanced Treatments

How does health equity impact advanced treatments?

Advanced healthcare treatments require patients to pass through multiple specialists or undergo significant surgical procedures. As a result, health inequities are especially salient for patients to receive adequate and timely care. Specifically, in multi-step referral processes, patients move from one specialist to another, and receive a plethora of tests at each step. With the added inequities tied to determinants of health, like access, race, socio-economic status, education, and environment, the patient journey for advanced treatments can go from complicated to unnavigable.

Research on understanding the patient journey is the first step in identifying solutions for such inequities and is a necessary element of any health equity initiative.

How do you begin health equity research and initiatives?

For companies looking to kick off health equity initiatives, start with defining a patient pathway. Doing so will help identify where general points of friction occur and set a “baseline” from which underserved peoples’ experiences may vary.

A typical patient journey goes from initial detection of disease to referrals to specialists to discussions of treatment options to the ultimate treatment a patient receives. At each point of the patient journey, patients may experience multiple inequities, layering on top of each other creating significant friction. For most diseases requiring advanced treatment (e.g., surgery, infusion treatments), patients go through four key stages, from initial identification and education to confirmation and treatment.

Even in the most efficient and straightforward cases, going through the standard care pathway to reach a specialist may take months and involve at least three different diagnostic assessments.

In the following case study, Kx explores how to conduct health equity research in advanced treatments, like surgery or biologic usage, specifically focusing on challenges faced by Black patients.

Kx Case Study: Health Equity Research Identifying Barriers to Care for Black Patients Receiving Advanced Treatments

Define the Patient Journey

In disease management, a condition may first be detected by a general practitioner (GP), who then refers the patient to a specialist. Depending on the diagnostic testing and treatment types, patients may then go through multiple other specialists before receiving an advanced treatment. These patient journeys are often complex, and serve as a baseline for understanding patient challenges in obtaining treatment.

To start, Kx defined the process that all patients typically go through, regardless of race, when receiving advanced treatments, starting with initial ID and education.

Pinpoint Provider-Identified Challenges

After exploring the patient journey in advanced treatments, Kx identified four categories of stakeholders who interact with patients:

For the highest and most immediate impact, Kx focused research on specialists (core specialists, treatment administrators, and physician extenders & staff). To tease out unconscious biases, the Kx team designed interview questions to ask not only about a practitioner’s self-identified habits, but also trends they noticed among their peers. Furthermore, with the inclusion of relevant physician extenders, Kx was able to understand challenges from multiple perspectives.

Kx found physicians are highly aware of logistical challenges related to race. Physicians noted in their practice, Black patients have been disproportionately impacted by these barriers. For example, physicians noted the work-up and test requirements prior to surgery, such as dental examinations, can cause unnecessary delay for patients needing treatment. Also, lifestyle factors like poor diet and lack of exercise may lead to comorbidities, like diabetes, that further complicate results.

Additionally, diagnostic testing is often needed for the diagnosis and long-term follow up of patients on the pathway to advanced treatment. However, comorbidities (e.g., diabetes and hypertension), which are more prevalent among Black patients, can skew diagnostic measuring and symptom identification. In the case of advanced cardiological treatments, such comorbidities have specific and direct impacts on diagnostic echocardiograms, which are used to identify disease and assess severity.

Physicians struggled to self-identify challenges in recognizing patients’ disease understanding and prioritization of their healthcare. Specialists and relevant extenders acknowledge the process-oriented limitations of short patient interactions and long wait times but advocated for their own techniques and bedside manner. Many physicians also acknowledged generalized trends in their patient populations. Specifically, 1 out of 4 physicians interviewed mentioned observations related to Black patients and lower socioeconomic status that drive initial preconceived notions.

Understand the Patient Perspective

The next step of Kx’s research process focuses on gathering perspectives from patients. In the case of non-emergent cardiac surgeries, Black patients highlighted a number of challenges centering around social determinants of health which disproportionately impact Black patients in the US.

Through conversations with patients at different points of the advanced treatment pathway, it is evident these social determinants of health not only serve as predictors for individual challenges frequently faced by Black patients, but also impact the entirety of the experience. During patient interviews, Kx was able to identify, pinpoint, and aggregate the most frequent occurrence of challenges, whether during initial detection, follow-up, referral, or treatment.

Combining it with Epidemiological Evidence

Ultimately, after understanding patient and provider perspectives, Kx was able to combine findings with epidemiological evidence about patient flow-through by race and identify where patients were facing the most significant burdens.

Moving Forward

As more advanced treatments enter the US market, healthcare access and equity for Black patients become increasingly significant. The administrative requirements and time leading up to life-changing treatments can create obstacles and delay treatment for underserved or marginalized populations. However, healthcare providers and medical manufacturers that focus on the patient pathway to lower barriers to treatment can increase penetration of novel treatments and grow their eligible patient populations.

 

How Kx Can Help

With our expertise, Kx Advisors can guide your team in addressing health equities and targeting underpenetrated patient populations. Our experts will analyze the patient pathway to treatment, identify obstacles, and create a strategy to operationalize a health equity initiative. To learn more about how Kx can support your Health Equity initiatives, contact Evelyn Tee at evelyn.tee@kxadvisors.com.

Contact Our Team Today


References
  1. Ostchega Y, Fryar CD, Nwankwo T, Nguyen DT. Hypertension prevalence among adults aged 18 and over: United States, 2017–2018. NCHS Data Brief, no 364. Hyattsville, MD: National Center for Health Statistics. 2020.
  2. Stierman B, Afful J, Carroll MD, Chen TC, Davy O, Fink S, et al. National Health and Nutrition Examination Survey 2017–March 2020 prepandemic data files— Development of files and prevalence estimates for selected health outcomes. National Health Statistics Reports; no 158. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:106273..
  3. Garg S, de Lemos JA, Matulevicius SA, et al. Association of concentric left ventricular hypertrophy with subsequent change in left ventricular end-diastolic volume. Circulation: Heart Failure. 2017;10(8). doi:10.1161/circheartfailure.117.003959
  4. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2021.
  5. Poverty rate by race/ethnicity. KFF. https://www.kff.org/other/state-indicator/poverty-rate-by-raceethnicity/currentTimeframe=0&sortModel=%7B%22colId%22%3A%22Location%22%2C%22sort%22%3A%22asc%22%7D. Published October 28, 2022. Accessed April 10, 2023.
  6. Lopez C, Kim B, Sacks K. Milken Institute; 2022. https://milkeninstitute.org/sites/default/files/2022-05/Health_Literacy_United_States_Final_Report.pdf. Accessed April 10, 2023.

Evolving Considerations for Segmenting Aesthetic Practices

Evolving Considerations for Segmenting Aesthetic Practices

The global aesthetics market for product sales has more than doubled in the past 10 years, from $6B[1] to $12.5B[2]. Simultaneously, the number of US aesthetics practices has exploded to exceed 40,000[3] today.  Kx Advisors has worked across many of the drivers behind this growth, including novel treatment & service offerings (e.g., non-invasive fat reduction, RF microneedling), broader consumer activation & demand (e.g., millennials, beautification in a virtual age), and strong consumer pricing power.

As US aesthetic practices grow, so does their diversity in service offerings and business models. Manufacturers’ ‘old school’ segmentation approaches for their customers included core vs. non-core, practice type & size, and location. But these elements no longer tell the full story, as competition between practices increases and their mix of treatments & consumer engagement tactics continue to evolve.

How Kx Can Help

Kx Advisors has identified four additional ‘new school’ considerations for segmenting & targeting practices based on our extensive research and expertise. Contact our aesthetics team Bob Serrano bob.serrano@kxadvisors.com, Sean Vander Linde sean.vanderlinde@kxadvisors.com & Chris Waybill chris.waybill@kxadvisors.com to explore the changing industry landscape and discover how Kx Advisors can assist in achieving your Aesthetic Medicine expansion goals.

Contact Our Team Today


References

[1] The Aesthetic Academy Sets New Standards for Medical Aesthetic Training. Business Wire. Published February 10, 2014. Accessed April 18, 2023. https://www.businesswire.com/news/home/20140210005308/en/THE-Aesthetic-Academy-Sets-New-Standards-for-Medical-Aesthetic-Training

[2] Medical Insight. miinews.com. Accessed April 18, 2023. https://miinews.com/about

[3] Revance. Investor Presentation. https://investors.revance.com/static-files/3d765f7c-1d06-49ae-bac4-0fa4cf46a092. Published March 2023.

 

Alzheimer’s Disease Therapeutics and Diagnostics – Parallel Advancements for Patient Care

Alzheimer’s Disease Therapeutics and Diagnostics – Parallel Advancements for Patient Care

2023 has already been a landmark year in Alzheimer’s disease (AD) therapeutics: lecanemab (Leqembi), co-developed by Biogen and Eisai, received FDA accelerated approval in January, and Phase 3 results for donanemab (Eli Lilly) are expected in 2Q23, with submission for FDA full approval shortly thereafter (accelerated approval was rejected in January). With the potential for widespread availability of novel treatments in the coming years, enabling timely, accurate diagnosis of Alzheimer’s disease should be front of mind for commercial strategy teams. Alzheimer’s complexity can make early diagnosis difficult, and misdiagnosis is common1. Fortunately, there is a burgeoning neurodiagnostics field aiming to offer clinicians and patients more certainty in their condition through a variety of CLIA-certified or FDA-approved diagnostic tests. The thoughtful selection and use of neurodiagnostics in clinical trials and the larger marketplace will be critical in the coming years to enable expanded access for Alzheimer’s Disease therapeutics.

Novel AD Treatments Necessitate Improved Diagnostics

Looking at the Alzheimer’s Disease (AD) therapeutic pipeline, there are over 30 disease-modifying therapies in late-stage clinical development2 with Eisai’s lecanemab (Leqembi) and Eli Lilly’s donanemab garnering the most attention. In their confirmatory phase 3 trials, both treatments included patients suffering from early symptomatic disease or mild cognitive impairment (MCI) due to AD and aim to measure an improvement from baseline in cognitive function tests using different metrics and brain amyloid plaque deposition using PET scans. Summarized in the table below, lecanemab relies on Clinical Dementia Rating scale Sum of Boxes (CDR-SB) as the primary outcome measure while donanemab utilizes the Integrated Alzheimer’s Disease Rating Scale (iADRS):

 Testing Approaches for Diagnosing Alzheimer’s Disease

Test CategoryStrengthsDrawbacks
Cognitive, Functional, and Behavioral Tests: Evaluate an individual’s mental abilities to identify changes in cognitive function
 
Notable examples: Clinical Dementia Rating scale Sum of Boxes (CDR-SB); Integrated Alzheimer’s Disease Rating Scale (iADRS)
Familiar and good track record
 
Low cost and quick administration
 
Able to detect disease progression
Relies on HCP consistency in application and interpretation; errors are common among PCPs
 
Relies on heterogenous clinical symptoms; CFB tests alone lead to misdiagnosis and cannot detect pre-clinical AD
Structural Brain Imaging: Segments and measures volumes of key brain structures; used for the detection of AD biomarkers

Notable examples: Volumetric Magnetic Resonance Imaging (vMRI); PET scan; CT scan
Well-established for AD diagnosis, particularly PET scans
 
Provides an objective measure
 
Differentiates AD from other forms of dementia (such as vascular dementia and frontotemporal)
High cost and large footprint scanning machines required
 
Not suited/accessible to primary care settings
 
False positives; brain changes may not be indicative of AD
 
Patient experience; potential sedation risk to achieve needed stillness
Cerebrospinal Fluid (CSF) Tests: Detection of AD biomarkers in CSF samples, such as β-amyloid, t-tau, and p-tau

Notable examples: Lumipulse® Aβ42/40 assay (Fujirebio); Elecsys CSF phospho-tau181/Aβ42 assay (Roche)
Accuracy improvements (when used alongside other tests)
 
Routine use in specialist healthcare settings
 
Differentiates from other forms of dementia (such as Lewy body and frontotemporal)
Invasive procedure required (lumbar puncture); risk of side effects and some patients are contraindicated (e.g., anticoagulants use)
 
Limited accessibility in primary care settings
 
Not validated in diverse populations
Blood Tests: Detection of AD biomarkers in blood samples, such as levels of β-amyloid, tau protein and neurofilament light (NfL) protein

Notable examples: PrecivityAD® (C2N Diagnostics); Quest AD-Detect (Quest Diagnostics)
Low cost
 
Easy to administer/minimally invasive
 
Routine across relevant healthcare settings
Currently less accurate /definitive than brain imaging or CSF analysis
 
Requires more sensitive measurement due to low biomarker concentrations
 
Lower specificity in later stages of AD when biomarkers are more indicative of general neurodegeneration
Genetic Testing: Detection of genetic variants associated with an increased risk of developing AD

Notable examples: APOE ε4 variant (for early- and late-onset AD); PSEN1, PSEN2 and amyloid precursor protein (APP)
Identifies risk of developing AD, supporting earlier diagnosisLimited predictive power
 
Limited use for diagnosis of late-onset AD; no strongly associated mutations
 
Ethical considerations; potential for psychosocial impact of test results

Both primary endpoints, CDR-SB and iADRS, diagnose behavioral symptoms rather than biomarker measurement in their scoring. CDR-SB is frequently chosen as an endpoint as it detects disease progression by assessing cognition and function in personal care, problem-solving, memory, and other functions; however, it has been criticized for its inconsistent reproducibility in detecting treatment differences. 5 On the other hand, iADRS is argued to reliably detect disease progression and treatment effects in participants across the spectrum of disease by measuring similar cognition and function categories through a composite score of ADAS-Cog-13 and ADCS-iADL.5 A point of concern is that payers may require biomarker data to supplement these cognitive tests to approve access to costly AD therapy and restrict access when inconsistencies arise. Forward-thinking therapeutic developers should consider now which sources of biomarker data will remove barriers to access to therapeutics and how best to validate this ability.

Breadth of Innovation in Diagnostics Development

Recently, diagnostics companies have collaborated with key players in AD therapeutics trials by measuring inclusion criteria and endpoint biomarkers. In November, C2N Diagnostics announced the PrecivityAD test’s use in the AHEAD trial, a lecanemab extension study, as part of the inclusion criteria of quantifying elevated brain amyloid.6 Specifically, PrecivityAD, a blood test, satisfies the requirement to show a plasma, cerebrospinal fluid (CSF), or positive PET result predictive of intermediate or elevated amyloid before screening. Neurodiagnostics contribute to endpoint measurements as well. When Eisai presented their ClarityAD results, all the target engagement and drug activity data from a panel of fluid biomarkers- including plasma pTau-181, GFAP and NfL – were from Quanterix Corporation’s ultrasensitive Simoa assay kits. 7 Overall, diagnostics are already useful at the clinical trial stage and may supplant less accessible and expensive gold-standard testing like amyloid PET in the future.

Outside clinical trials, the emerging neurodiagnostics landscape is rife with innovation, using various modalities testing for different biomarkers. Fujirebio’s Lumipulse Aβ42/40 and Roche’s Elecsys CSF phospho-tau181/Aβ42 assay both offer FDA approved Aβ42/40 measuring tests using cerebrospinal fluid (CSF) to assist clinicians in making diagnoses beyond clinical examination.8,9 This advance comes at the cost of the patient’s comfort due to the invasiveness of CSF collection. Quest Diagnostics and C2N Diagnostics address this through their CLIA-certified plasma blood tests, Quest-AD and PrecivityAD respectively, whose results approximate that of amyloid PET scan findings. Will we soon see a “Test and Treat” future in AD? Not so fast. Considerable work remains before widespread clinical adoption of plasma tests can occur.10 One major barrier is the lack of plasma test performance data in diverse patient populations with comorbidities like chronic kidney disease or a history of stroke that may boost AD biomarkers in the blood. Researchers also stress that CSF and plasma tests shouldn’t be used in cognitively healthy individuals since the disease has a long preclinical phase and may not manifest in the patient’s lifetime, causing undue distress and financial ramifications. All these companies face the current headwinds of defining and achieving their reimbursement strategy in an environment where therapeutic clinical utility is still evolving. The definition of coverage policies and diagnostic criteria by CMS and major commercial payers will drive the adoption and utilization of tests moving forward.

Future Challenges Facing AD Patients

It is unclear how many patients will receive the benefit of Leqembi and other anti-amyloid therapies. In April 2022, CMS effectively denied Medicare coverage of any anti-amyloid therapies, a decision they recently re-iterated after denying petitioning from the Alzheimer’s Association.11 Despite this, the Veteran’s Health Administration has determined it will cover access to Leqembi to veterans who fit the VHA’s criteria and the FDA label indication. In response to Aduhelm’s accelerated approval, CMS’s Chief Medical Officer left the door open to broad access if a therapeutic shows evidence of clinical benefit through the traditional full FDA approval process. 12 A decision on full approval for Leqembi is expected in July, preceded by an FDA Advisory Committee meeting scheduled for June 9th. Once a therapeutic overcomes this hurdle, questions about clinical utility for both a therapeutic and a diagnostic will be more settled and replaced with a simple one: what diagnostic tests can help accelerate access for an AD disease-modifying therapy?

In the near future, partnerships between diagnostics companies and drug developers can make a big difference for the millions of people grappling with the impact of dementia on their health and families. Early collaborations like the one between Eisai and C2N Diagnostics in the AHEAD study may mark the beginning of new and deeper partnerships between these two fields. New therapeutics will benefit from a robust diagnostics industry helping patients get an earlier diagnosis and diagnostics manufacturers will receive wider adoption and uptake. Future joint commercial partnerships can allow caregivers and physicians to test an individual and match them to the most appropriate treatment available.

How Kx can help

We at Kx are monitoring the Alzheimer’s Disease space evolution closely and see opportunities for commercial planning teams to meet the technology of the future through concrete, forward-looking steps today. To join us and discuss further, contact Brett at brett.larson@kxadvisors.com.

Contact Our Team Today

 

 

Thank you to Jean Santos for his contributions in the development of this piece.


References

  1. Gaugler JE, Ascher-Svanum H, Roth DL, Fafowora T, Siderowf A, Beach TG. Characteristics of patients misdiagnosed with alzheimer’s disease and their medication use: An analysis of the NACC-UDS database – BMC geriatrics. Characteristics of patients misdiagnosed with Alzheimer’s disease and their medication use: an analysis of the NACC-UDS database. https://bmcgeriatr.biomedcentral.com/articles/10.1186/1471-2318-13-137. Published December 19, 2013. Accessed February 2, 2023.
  2. Alzheimer’s Disease Therapeutics. https://www.alzforum.org/therapeutics/search?fda_statuses%5B%5D=851&target_types=&therapy_types=&conditions%5B%5D=145&keywords-entry=&keywords=. Accessed January 29, 2023.
  3. Commissioner Oof the. FDA grants accelerated approval for Alzheimer’s disease treatment. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment. Accessed January 29, 2023.
  4. Rogers MB. No accelerated approval for Donanemab. No Accelerated Approval for Donanemab. https://www.alzforum.org/news/research-news/no-accelerated-approval-donanemab. Accessed January 29, 2023.
  5. Wessels AM, Rentz DM, Case M, Lauzon S, Sims JR. Integrated alzheimer’s disease rating scale: Clinically meaningful change estimates. Alzheimer’s & Dementia: Translational Research & Clinical Interventions. 2022;8(1):197-210. doi:https://doi.org/10.1002/trc2.12312.
  6. Consortium ACT. New blood test to identify people at risk of developing Alzheimer’s symptoms will be used in clinical trial aiming to prevent memory loss. New Blood Test To Identify People At Risk Of Developing Alzheimer’s Symptoms Will Be Used In Clinical Trial Aiming To Prevent Memory Loss. https://www.prnewswire.com/news-releases/new-blood-test-to-identify-people-at-risk-of-developing-alzheimers-symptoms-will-be-used-in-clinical-trial-aiming-to-prevent-memory-loss-301422214.html. Published November 11, 2021. Accessed January 29, 2023.
  7. Quanterix’s Simoa® technology drives advances in Alzheimer’s disease research presented at 2022 clinical trials on Alzheimer’s disease (CTAD) conference. Quanterix’s Simoa Technology Drives Advances In Alzheimer’s Disease Research Presented At 2022 Clinical Trials On Alzheimer’s Disease (CTAD) Conference. https://www.quanterix.com/press-releases/quanterixs-simoa-technology-drives-advances-in-alzheimers-disease-research-presented-at-2022-clinical-trials-on-alzheimers-disease-ctad-conference/. Published December 6, 2022. Accessed January 29, 2023.
  8. FDA permits marketing for new test to improve diagnosis of alzheimer’s disease. FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease. https://content.govdelivery.com/accounts/USFDA/bulletins/3165b47. Published May 4, 2022. Accessed January 29, 2023.
  9. Zinkovich C. Roche alzheimer’s Disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis. Roche Alzheimer’s disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis. https://diagnostics.roche.com/us/en/news-listing/2022/roche-alzheimers-disease-cerebrospinal-fluid-assays-receive-fda-clearance.html. Published December 8, 2022. Accessed January 29, 2023.
  10. Rogers MB. FDA approves Fujirebio’s CSF test for ad-quest diagnostic offers plasma test. FDA Approves Fujirebio’s CSF Test for AD—Quest Diagnostic Offers Plasma Test. https://www.alzforum.org/news/community-news/fda-approves-fujirebios-csf-test-ad-quest-diagnostic-offers-plasma-test. Published May 21, 2022. Accessed January 29, 2023.
  11. Fact sheet Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease. Published April 7, 2022. Accessed January 29, 2023.
  12. Press release CMS finalizes Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of alzheimer’s disease. CMS Finalizes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. https://www.cms.gov/newsroom/press-releases/cms-finalizes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment. Published April 7, 2022. Accessed February 7, 2023.