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Read The 2020 Hot Indications List

How can companies determine where to focus as they develop their pipelines and determine new growth opportunities? Kx Advisors’ 2020 Hot Indications List can help. In our 6th annual analysis of global R&D investment, our experts identified the top indications for industry focus.

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Category: Insights

Health Equity: The Kx Research Approach and Case Study

Posted on by Evelyn Tee

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

Posted on by Bob Serrano

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

Posted on by Bob Serrano

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.

Women’s Health: The Opportunity in Gynecology and Beyond

Posted on by Jenna Riffell, PhD

Women’s Health: The Opportunity in Gynecology and Beyond

Women’s healthcare and FemTech are garnering increasing attention, yet unmet need remains high, leaving opportunity for investment in an area with significant white space for growth. In this article, we highlight why investment in women’s health is important, where funding gaps lie, and demonstrate the potential for growth if these markets receive sufficient research and development (R&D).

An Underfunded Area in Healthcare

Women comprise half of the population worldwide, yet the women’s health space, which Kx defines as diseases only or disproportionately affecting women, has been consistently underfunded and often disregarded.

In 2021, excluding oncology, only 2% of treatments in the development pipeline were for women’s health conditions. In the US, a recent study analyzing National Institutes of Health (NIH) funding found that 93% of diseases underfunded by the NIH disproportionately affect women, while 58% of overfunded diseases are male-dominant.1 Lack of scientific knowledge of women’s health conditions can then make companies reluctant to develop treatments, a risky venture even when knowledge of the disease is advanced.2,3

Case Study: Endometriosis

Endometriosis occurs in 10% of women between the ages of 15-45,4 typified by tissue similar to the uterine lining growing outside of the uterus. The resulting pain significantly decreases patients’ quality of life, negatively impacting their performance at work, personal relationships, and mental health. Diagnosis is challenging, due to low awareness of the disease and the need for a laparoscopy to make a definitive diagnosis, leaving many patients without appropriate treatment. On average, a patient with endometriosis incurs $10,000 more direct healthcare costs annually than those without, from inpatient, outpatient, and surgical treatment alongside prescription costs. Over-the-counter (OTC) pain relief medications costs are added to these fees. Furthermore, endometriosis costs the US economy over $2,000 more than the average worker in annual absence and short-term disability costs.5 Current treatment options remain limited to painkillers, laparoscopic removal of lesions, and hormonal therapies. For those contraindicated or unresponsive to these treatments, a hysterectomy remains the only option.

Currently, the most effective pharmacotherapies are Gonadotropin Releasing Hormone (GnRH) analogs, such as elagolix (Orilissa) and relugolix (Myfembree, in combination with estradiol and norethindrone acetate), which work by inducing quasi-menopause. However, side effects including bone mineral density loss, depression, and severe nausea can be detrimental to a woman’s long-term health, and have led the FDA to restrict the duration an individual can stay on the treatment to just two years.

The current pipeline looks similarly bleak. Kissie’s Linzagolix, the only treatment in Phase III, has the same GnHR mechanism of action but with greater levels of bone mineral loss compared to approved medications. Although Phase II therapies show more promise, the market remains wide open and given the high prevalence and unmet need in endometriosis, the successful development of a safe drug would likely garner high reward.

It is not just gynecological women’s health conditions that have failed to garner sufficient R&D investment to develop effective treatments. For example, Irritable Bowel Syndrome (IBS) is a chronic disease with significant patient burden with a high prevalence in women (14%), who comprise two-thirds of all IBS patients.6 Symptoms, which include diarrhea, constipation, and bloating, can substantially impact everyday life. Inadequate treatments only targeting symptoms and low market development have left unmet need high.

There are multiple women’s health conditions ripe for development; collectively, the opportunity is vast. In endometriosis alone, a safe treatment displacing GnRHs could see peak sales of up to $3.9bn in the US.7-13

The Case for Investment

Some women’s health diseases that have already seen major market development offer an insight into the high potential patient value that can be unlocked with R&D and commercial investment.

Chronic migraine is one such example. Affecting 1 in 5 women vs 1 in 16 men, it is the leading cause of disability amongst young women.14 In 2009, the market was small, with US sales totaling $1.1bn.15 Treatment options were predominantly limited to triptans, an abortive class of medication that treats individual migraine episodes as and when they occur.16 Though effective, they are not preventative and are not suitable for those who suffer from more frequent episodes due to the risk of medication-overuse headaches (MOH), also known as analgesic rebound headaches.17

However, the market has since experienced explosive growth propelled by two treatment developments: the approval of AbbVie’s Botox in 2010 and, in 2018, the arrival of three calcitonin gene-related peptide (CGRP) antagonist mAbs; Aimovig (erenumab), Ajovy (freanezumab), and Emgality (galcanezumab). Both novel classes of treatment gave prescribers the tools to move away from treating the symptoms of chronic migraine, and towards preventing future episodes.

These landmark changes in the treatment paradigm resulted in a 200% increase in annual US sales in the last four years, from 2018 to 2022.15 Since 2020, newer oral CGRPs have been approved, further reducing patient burden in migraine. With these and further developments, the market is expected to continue to grow exponentially, with total annual US sales predicted to reach >$9bn by 2028.15

The high ROI within chronic migraine shows how a shift from reactively treating symptoms, as in endometriosis and IBS, to developing well-tolerated treatments targeting the underlying cause of women’s health diseases is both desperately needed and a significant upside opportunity. Multiple relatively untapped markets offer just such opportunity on this scale.

19-30

Polycystic ovary syndrome (PCOS), a largely understudied disease that causes metabolic issues, is one example. There are no approved treatment options despite its high prevalence, significant impact on quality of life due to hirsutism, sub-fertility, and increased risk of comorbidities such as type 2 diabetes. The generics used such as combined oral contraceptives and metformin, although effective at inducing ovulation, have little impact on metabolic issues and have tolerability concerns. The development pipeline is also particularly bleak and offers limited potential to address the high unmet need.

In irritable bowel syndrome (IBS), as discussed earlier, unmet need is high with over half of patients dissatisfied with their treatment due to side effects and inadequate efficacy,18 though there are seven marketed treatments. Pipeline development is sluggish with only two drugs currently in Phase III and nine in Phase II. This slow development can largely be attributed to poor knowledge of disease pathogenesis, linked to chronic underfunding.

Conclusion

It is evident there is extensive opportunity and necessity for development in multiple women’s health conditions. Not only are these diseases often chronic and highly prevalent, but they can significantly impact patients’ long-term health outcomes and quality of life, both key for pricing potential and market access.

Unlocking the opportunity in women’s health will require development beyond R&D. To truly address high unmet need and maximize the market opportunity, pharma companies and investors should adopt a three-pronged approach:

  • Increasing awareness of women’s health diseases is vital. In endometriosis, for example, the average delay from symptom onset to diagnosis is 8 years, while 70% of patients with PCOS remain undiagnosed in primary care. Poor PCP awareness leads to misdiagnosis, slow referrals, and a prolonged impact on quality of life.
  • Improving diagnostic tools is crucial to unlocking the full patient population. Endometriosis can only be confirmed with a laparoscopy, which is both invasive and expensive to healthcare systems, and for PCOS there is no single diagnostic test, making diagnosis challenging given the wide range of presenting symptoms. Developing diagnostic biomarkers in IBS could enable treatments to target the cause rather than symptoms, drastically improving patient outcomes.
  • Targeting investment towards effective, safe therapies that go beyond treating symptoms is key to changing outcomes. Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs) or hormonal contraceptives are heavily relied upon, particularly in gynecological women’s conditions. However, not only are women trying to conceive unable to use hormonal contraceptives, but side effects such as headaches or nausea can be unpleasant or even life-threatening in the rare case of blood clots, leading to poor compliance rates.

How Kx can help harness the opportunity in Women’s Health

The experts at Kx Advisors help evaluate opportunities, develop strategy, prioritize pipelines, and bring new treatments in Women’s Health to market. Our unique approach combines real-world experience with qualitative and quantitative data to provide unique solutions supporting our clients’ strategic growth initiatives. To learn more about how Kx Advisors can support your goals in Women’s Health, contact Jenna Riffell at jenna.riffell@kxadvisors.com.

 

Contact Our Team Today

 

References

  1. Mirin AA. Gender disparity in the funding of diseases by the U.S. National Institutes of Health. Journal of Women’s Health. 2021;30(7):956-963. doi:10.1089/jwh.2020.8682
  2. Stengel G. Female Founders Are Energizing Investment in Women’s Healthcare: Expect More In 2023. Forbes. January 2023. https://www.forbes.com/sites/geristengel/2023/01/04/female-founders-are-energizing-investment-in-womens-healthcare-expect-more-in-2023. Accessed February 20, 2023.
  3. Norris J, Bousleiman R, Scolamieri A, Atsavapranee B. Healthcare Investments and exits report annual 2022. Healthcare Investments and Exits. https://www.svb.com/trends-insights/reports/healthcare-investments-and-exits?utm_source=svb&utm_medium=pr&utm_campaign=gb-2023-01-aw-tl-ag-na-lh-na&utm_content=1pr_pct_oc_na_di_na_lp_pr. Published January 2023. Accessed February 21, 2023.
  4. Endometriosis. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/endometriosis#:~:text=Endometriosis%20is%20a%20disease%20where,and%20girls%20globally%20(2). Published March 31, 2021. Accessed February 21, 2023.
  5. Soliman AH, Surrey E, Bonafede M, Nelson JK, Castelli-Haley J. Real-World Evaluation of Direct and Indirect Economic Burden Among Endometriosis Patients in the United States. Advances in Therapy. http://doi.org/10.1007/s12325-018-0667-3. Published February 15, 2018. Accessed February 24, 2023
  6. International Foundation for Gastrointestinal Disorders. IBS Facts and Statistics. About IBS. https://aboutibs.org/what-is-ibs/facts-about-ibs/#:~:text=IBS%20affects%20between%2025%20and,3%20IBS%20sufferers%20are%20male. Published April 29, 2022. Accessed March 3, 2023.
  7. Worldometer. United States population (live). Worldometer. https://www.worldometers.info/world-population/us-population/. Published February 21, 2023. Accessed February 21, 2023.
  8. Wold Bank. Population, female (% of total population) – United States. https://data.worldbank.org/indicator/SP.POP.TOTL.FE.ZS?locations=US. Published January 1, 2021. Accessed February 21, 2023.
  9. World Bank. Population ages 15-64 (% of total population). https://data.worldbank.org/indicator/SP.POP.1564.TO.ZS. Published January 1, 2021. Accessed February 21, 2023.
  10. Shafrir AL, Farland LV, Shah DK, et al. Risk for and consequences of endometriosis: A critical epidemiologic review. Best Practice & Research Clinical Obstetrics & Gynaecology. 2018;51:1-15. doi:10.1016/j.bpobgyn.2018.06.001
  11. Bulletti C, Coccia ME, Battistoni S, Borini A. Endometriosis and infertility. Journal of Assisted Reproduction and Genetics. 2010;27(8):441-447. doi:10.1007/s10815-010-9436-1
  12. Bontempo AC, Mikesell L. Patient perceptions of misdiagnosis of endometriosis: Results from an online national survey. Diagnosis. 2020;7(2):97-106. doi:10.1515/dx-2019-0020
  13. Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating response and failure of medical treatment of endometriosis: A systematic review. Fertility and Sterility. 2017;108(1):125-136. doi:10.1016/j.fertnstert.2017.05.004 ages 15-64 (% of total population). https://data.worldbank.org/indicator/SP.POP.1564.TO.ZS. Published January 1, 2021. Accessed February 21, 2023
  14. Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world’s causes of disability, and first among young women: Findings from GBD2019. The Journal of Headache and Pain. 2020;21(1). doi:10.1186/s10194-020-01208-0
  15. Evaluate Pharma. Migraine: Indication Overview. Evaluate Pharma. https://app.evaluate.com/ux/WebReport/tabbedsummarypage.aspx?itemId=631&lType=modData&compId=1019&tabId=. Published February 15, 2023. Accessed February 21, 2023.
  16. Cameron C, Kelly S, Hsieh SC, et al. Triptans in the Acute Treatment of Migraine: A Systematic Review and Network Meta-Analysis. Headache. 2015;55 Suppl 4:221-235. doi:10.1111/head.12601
  17. De Felice M, Ossipov MH, Wang R, et al. Triptan-induced latent sensitization: a possible basis for medication overuse headache. Ann Neurol. 2010;67(3):325-337. doi:10.1002/ana.21897
  18. The Lancet Gastroenterology & Hepatology. Unmet needs of patients with irritable bowel syndrome. The Lancet Gastroenterology & Hepatology. 2018;3(9):587. doi:10.1016/s2468-1253(18)30236-x
  19. Alzheimer’s Therapeutics Market Size Report, 2022-2030. https://www.grandviewresearch.com/industry-analysis/alzheimers-therapeutics-market. Published July 2022. Accessed March 3, 2023.
  20. Acumen Research and Consulting. Irritable bowel syndrome treatment market size. https://www.globenewswire.com/en/news-release/2022/10/03/2526998/0/en/Irritable-Bowel-Syndrome-Treatment-Market-Size-is-expected-to-reach-at-USD-4-7-Billion-by-2030-registering-a-CAGR-of-9-5-Owing-to-Increasing-Incidences-of-Gastrointestinal-Disorder.html. Published October 3, 2022. Accessed March 3, 2023.
  21. DataM Intelligence. Uterine Fibroids Treatment Market. DataMIntelligence. https://www.datamintelligence.com/research-report/uterine-fibroids-treatment-market. Published June 6, 2022. Accessed March 3, 2023.
  22. Facts & Factors. Global demand of rheumatoid arthritis drugs market size & share to grow at a CAGR of 1.75%, expected to hit USD 70.1 billion mark by 2030 | rheumatoid arthritis drugs industry trends, Analysis & Forecast Report by FNF. Yahoo! Finance. https://finance.yahoo.com/news/global-demand-rheumatoid-arthritis-drugs-160000928.html#:~:text=In%20terms%20of%20revenue%2C%20the,growing%20cases%20of%20rheumatoid%20arthritis. Published February 2023. Accessed March 3, 2023.
  23. Global Data. Migraine drug market size, share & trends analysis and forecast by strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications 2020 – 2030. Market Research Reports & Consulting | GlobalData UK Ltd. https://www.globaldata.com/store/report/migraine-market-analysis/. Published February 8, 2022. Accessed March 3, 2023.
  24. Grand View Research. Endometriosis treatment market size & trends report, 2030. Endometriosis Treatment Market Size & Trends Report, 2030. https://www.grandviewresearch.com/industry-analysis/endometriosis-treatment-market-report#:~:text=The%20global%20endometriosis%20treatment%20market%20size%20was%20estimated%20at%20USD,USD%201%2C328.89%20million%20in%202023. Published November 2022. Accessed March 3, 2023.
  25. Mordor Intelligence. Urinary tract infection therapeutics market analysis – industry report – trends, Size & Share. Urinary Tract Infection Therapeutics Market Analysis – Industry Report – Trends, Size & Share. https://www.mordorintelligence.com/industry-reports/urinary-tract-infection-therapeutics-market#:~:text=The%20urinary%20tract%20infection%20therapeutics%20market%20was%20valued%20at%20USD,the%20forecast%20period%202022%2D2027. Accessed March 3, 2023.
  26. Persistence Market Research. Polycystic ovary syndrome (PCOS) treatment market revenue to close value of US$ 6.31 bn with CAGR of 4.7% by 2032- persistence market research. GlobeNewswire News Room. https://www.globenewswire.com/en/news-release/2022/10/27/2542922/0/en/Polycystic-Ovary-Syndrome-PCOS-Treatment-Market-Revenue-to-close-Value-of-US-6-31-Bn-with-CAGR-of-4-7-by-2032-Persistence-Market-Research.html. Published October 27, 2022. Accessed March 3, 2023.
  27. Alzheimer’s Association. Why does alzheimer’s disease affect more women than men? new alzheimer’s association grant will help. Alzheimer’s Disease and Dementia. https://www.alz.org/blog/alz/february_2016/why_does_alzheimer_s_disease_affect_more_women_tha. Accessed March 3, 2023.
  28. American College of Rheumatology. Rheumatoid arthritis . https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis. Published December 2021. Accessed March 3, 2023.
  29. Buck Louis GM, Hediger ML, Peterson CM, et al. Incidence of endometriosis by study population and Diagnostic Method: The endo study. Fertility and Sterility. 2011;96(2):360-365. doi:10.1016/j.fertnstert.2011.05.087
  30. Butler CC, Hawking MKD, Quigley A, McNulty CAM. Incidence, severity, help seeking, and management of uncomplicated urinary tract infection: A population-based survey. British Journal of General Practice. 2015;65(639). doi:10.3399/bjgp15x686965

For Patient Engagement solutions looking for an exit, 2023 could be their year

Posted on by Rachael England

For Patient Engagement solutions looking for an exit, 2023 could be their year

After a fraught 2022 that saw a significant slowdown in acquisitions from 2021’s volume and valuation highs, product companies view M&A as a potential strategy in 2023 to enhance their value proposition and achieve efficiencies of scale. Deal volume may rebound moderately from a slump in the latter half of 2022 while lower valuations are likely to result in reduced average deal size. Kx took the opportunity to validate industry signals at events in Q4 2022, gauging deal sentiment through conversations and a survey.

Amidst the record-setting number of attendees from across the healthcare ecosystem at HLTH Conference 2022, health tech leaders were abuzz with 2023 growth plans, key concerns, and areas for excitement. Kx’s Digital Health team met with dozens of solution company C-levels, corporate development, and strategy leaders who expressed one common sentiment with surprising frequency: “we are ready to do a deal, or two.”

To further gauge the Mergers & Acquisitions sentiment expressed by leaders on the show floor, in the networking lounges, and even at the puppy park, Kx surveyed over 350 HLTH attendees. The results confirmed Kx’s ingoing hypothesis: technology providers are cautiously optimistic on M&A for 2023 due to both sell- and buy-side dynamics. On the buy side, some vendors prefer inorganic growth while others view acquisition as a quicker route to enhanced offerings and improved efficiencies. On the sell side, cash constraints and the possibility of a down-round may motivate start-ups to consider an M&A exit.

Digital health leaders interpret M&A in 2023 as a potentially attractive option to augment their offerings and address the market forces that are top-of-mind concerns to their customers, including staffing shortages & provider budget shortfalls, inflation & the looming economic downturn, and increased emphasis on patient experience and engagement. Customer requirements continue to grow, demanding tangible proof of efficacy, demonstrable ROI soon after implementation, and options for meeting patient/member expectations for convenient consumer experiences. The market continues to prefer multifunctional platform options – ideally those that perform as well as individual point solutions. Vendors see the need to position themselves as an “enterprise, end-to-end” solution that reduces the burden on their customer to stitch together disparate systems & data sources and engage with their patients/members.

Vendors with aggressive product roadmaps may find that they prefer a buy-and-build approach vs. de novo build to bulk out their offerings. This is especially true for revenue-generating acquisitions with at least some penetration in the market and further expansion potential.

More specific Kx Survey findings include:

  • Over 83% of respondents anticipate their organization will complete at least one acquisition this year.
  • Of survey respondents whose organizations closed at least one deal in 2022, two-thirds anticipate no change in the size of deals while the remainder foresee a slight decrease in size
  • Regardless of their company’s size, respondents indicated three main acquisition drivers:
    1. Nearly two-thirds indicated growth via acquisition is their organization’s preferred growth strategy;
    2. 20% indicated that more favorable valuations enhance the attractiveness of pursuing an acquisition;
    3. The increase in companies open to acquisition was the key motivator for the remaining 15% of respondents

Trends in Health IT, Digital Health mergers and acquisition for 20232

  • Respondents view acquisitions in 2023 as a tactical opportunity to execute within their core markets or expand into a closely adjacent market rather than expanding into new markets
  • While many more organizations expressed intent to complete deals in 2023 vs. 2022, respondents expect the same amount of or a slight decrease in competition
  • One area where significant competition may arise is Patient Engagement/Digital Front Door solutions
    • 80% of respondents that intend to complete an acquisition in 2023 indicate Patient Engagement and/or Digital Front Door companies as their top priority
    • Solutions in Screening, Monitoring, and Diagnostics ranked first for the remaining respondents

The heightened appeal of patient engagement/digital front door capabilities can be attributed to the coalescence of several macro-environmental factors, including:

  • Labor shortages necessitating a shift to self-service workflows such as online scheduling;
  • Consumer demand for personalized digital interactions prompting the implementation of algorithm and “AI”- driven chatbots and automated messaging
  • CMS patient/member experience requirements encouraging streamlined intake, claims, and complaints processing tools like “digital front doors”
  • Reimbursement & cost savings opportunities from Remote Patient Monitoring & Hospital at Home programs impelling user-friendly mobile apps integrated with EHRs

When compared to H2 2022 deal volume, it appears the 2023 digital health market is poised for some M&A uplift. Companies intend to face the current headwinds by focusing on their core markets and driving tangible value via enhanced capabilities for end users. Time will tell whether anticipated M&A activity materializes in 2023 as digital solutions continue to evolve and their impacts drive positive clinical, financial, operational, and experiential outcomes. Either way, Kx is already looking forward to the discussions about it at the 2023 HLTH Conference puppy park.

 

How Kx Can Help

Is your organization considering M&A to enhance your value proposition to customers? Is the decision made and you’re ready to move forward with landscape mapping, target identification, and due diligence?  Kx’s Digital Health team supports clients throughout the process with tailored solutions informed by dialogue and reinforced by data.

Want to learn more? Contact Rachael England via e-mail (rachael.england@kxadvisors.com)  or LinkedIn.

 

Contact Our Team Today

5 Misconceptions for MedTech Market Access Strategy

Posted on by Jenna Riffell, PhD

5 Misconceptions for MedTech Market Access Strategy

Market access in MedTech is a complex and rapidly evolving environment, with increasingly intense scrutiny on the costs and benefits of new technologies as the pressure on budgets increases globally. The ability to prepare for and navigate market access strategy is, now more than ever, crucial to the success of a new product, and is frequently assessed by potential partners and acquirers with the same priority as the scientific rationale or potential for favourable regulatory approval.

During the recent MedFit 2022 event in Grenoble, we discussed the most common pitfalls that may affect market access planning and strategy with leading European experts and start-up companies. Here are the top five misconceptions for market access strategy we identified.

“We want to get the approval first, then we will plan for market access”

Engagement with payers early in product development is essential. Companies should define a path to reimbursement, and understand how payers will assess their product, as early as the concept stage to use payers’ feedback to shape the technology into a marketable product and create patient and company value. Leaving engagement with payers until late in development, or after approval, can often lead companies to:

  • overlook crucial requirements
  • mistarget patient populations
  • fail to expectations to gain market access
  • fail to gain critical pricing insights to size the commercial potential

Missing the opportunity to treat payers as your sounding board can cause delays and significant restrictions in access, while timely and iterative payer engagement has the potential to speed up the development process.

“The evidence we are generating for regulators will be sufficient for our market access strategy”

Regulatory decisions are at the top of priority lists for MedTech entrepreneurs both in the US and Europe. Selection of the right pathway and preparation of required submission dossiers are time-consuming and costly and constitute a necessary condition for market access. Late-stage start-ups agree, nonetheless, that it is far from sufficient, and payers themselves corroborate this perspective. In a recent Kx Advisors study, 100% of interviewed executives for major US payers agreed going beyond the evidence required for regulatory approval is key for market access strategy. Payers increasingly require demonstration of patient value not only with differentiated clinical efficacy and safety but through increased compliance and improved patient outcomes and satisfaction. They are also seeking additional sources of data, such as real-world evidence, insurance claims, and adverse event reports. MedTech companies should plan and pre-empt these requirements by carefully designing their studies for a payer-targeted set of endpoints as early as possible and generating evidence with not only regulators but also payers in mind.

“There is an established price for devices like ours”

Existing pricing and reimbursement benchmarks provide valuable insights for market access strategy, as showing cost-effectiveness in comparison to the current standard of care is an important part of any MedTech company’s economic narrative. However, payers’ focus is shifting towards a more holistic view, with greater interest in:

  • improved patient outcomes
  • demonstrated longer-term value
  • ease of use
  • adherence to treatment
  • patient satisfaction

Four out of every five payers recently interviewed by Kx Advisors indicated a preference for increased value over purely lower cost of treatment and were ready to assess pricing based on a complete view of benefit for the patient and healthcare system. The approach MedTech companies take to frame, measure, and present this value becomes a tactical choice, and a key element of a broader commercialisation strategy, that should not be dismissed or made based on a simple competitive analysis.

“We will focus on a market we know and aim for broad market access”

Many MedTech companies decide to first target their home geographic market, building on their familiarity with it, knowledge of the local language and system, and network of contacts. This approach, while easier from a product development perspective, may not allow companies to fully capture their commercial potential. In conversations with Kx Advisors, start-ups with prior product launch experience highlighted the need for fast market deployment and the value of testing the product with first adopters (and getting the product paid for early on) typically outweighs the breadth of market access. The choice of the first markets in which to launch is a strategic decision, and market access becomes one of the key drivers that should be considered in careful prioritisation of the highest potential markets. Entrepreneurs should be aware of both regional (e.g., US vs EU) and intrinsic (e.g., openness to innovative technologies) differences among payers, as well as differing patient population structures and accessibility, and explore avenues that expedite first market access, such as targeting research institutions or venturing into new geographies.

“Payers are not willing to consider innovative reimbursement models”

Getting paid for innovative technologies is notoriously difficult, especially when there is no easy way to make them fit within the established market access pathways for medical devices. The emergence of digital therapies and connected health, as well as the ongoing shift towards at-home therapies accelerated by the COVID pandemic, have only made the landscape more complex. At the same time, the awareness and urgency to address these challenges is on the rise among payers. Approximately 60% of payers recently interviewed by Kx Advisors stated they are exploring value-based reimbursement options and new, alternative pricing models for medical technologies (e.g., subscriptions or device-as-a-service arrangements) will be an increasingly welcome element of future coverage decisions. Building a differentiated market access strategy that accounts for multiple possible business models and reimbursement scenarios and exploring those early with key stakeholders can allow MedTech companies to create and leverage these opportunities.

 

Has your commercialisation strategy ever been impacted by any of these common misconceptions? Or are you currently facing other strategic decisions that will be crucial for your MedTech company’s growth? Feel free to contact Kx Advisors for a follow-up discussion.

Contact Our Team Today

 

Jenna Riffell is a Managing Partner at Kx Advisors, based in London.

Przemek Czerklewicz is a Principal at Kx Advisors, based in London. During the recent MedFit Event 2022 he led an expert panel titled “Innovators’ checklist for market access”.

 

 

Using the Patient Journey to Understand Health Equity Challenges

Posted on by Evelyn Tee

Health Equity: Overview of Health Systems and Patient Pathway

Unequal healthcare access among different groups leads to less preventative care, and more urgent and intensive procedures. Such disparities in access currently cost the US healthcare system approximately $320 B annually and is projected to grow to as much as $1 trillion annually in 2040[1]. In economically and socially disadvantaged communities, patients face barriers that impact their ability to receive necessary and equal care.

For life sciences companies, inequities lead to patients receiving inadequate or delayed care, and in its worst form, causes patients to miss treatment opportunities that utilize their products.

Life science companies can begin to tackle some of the drivers and determinants of health equity by using a patient-centric approach, as patients’ primary point of interaction with the healthcare system is through their providers. A closer examination of those interactions can reveal how manufacturers and medical technology companies can create initiatives to support greater equity. Examining the patient pathway can reveal specific moments when inequities “add-up” causing significant treatment drop out.

Solutions to equity barriers are not static – companies need to set themselves on a continuous path to improvement. The place to start is understanding what drives friction between patients and their own healthcare and focusing on the patient-provider interaction to identify solutions and expand their presence in underserved markets.

Barriers Arise During Patient-Provider Interactions

In order to maximize patient access and health outcomes for life science companies and manufacturers, the patient-provider interaction is key to understanding barriers to treatment. Acute analysis of these barriers is the first step to understanding where life science teams have the most influence on health equity and patient treatment access.

  1. Barriers limiting patient-provider interaction Before a patient walks into a doctor’s office, they may already face structural and socio-economic challenges impacting their interaction with the physician and their ability to follow a treatment plan. Such barriers include a lack of insurance, lack of transportation resources, and lack of availability. For example, Black Americans were 3x more likely to report loss of health insurance during the pandemic compared to white respondents. Structural and socioeconomic challenges also drive additional comorbidities, such as obesity and hypertension[2], which may limit treatment options.
  2. Patient perspectives and hesitancies during provider interaction When treating patients, providers interact with patient groups with differing attitudes towards the healthcare system, their diagnoses, and treatment options. For example, Black patients are more likely to mistrust the healthcare system due to long-standing racial inequalities. A nationwide poll by The Undefeated and the Kaiser Family Foundation found 7 out of 10 Black Americans say they’re treated unfairly by the healthcare system and 55% percent say they distrust it[3]. Lower trust among patients can lead to slower and less vigilant follow-up, and potentially patient drop-off from treatment. Patient groups also have varying awareness and understanding of their diagnosis due to education levels, and a patient’s perspective on the severity of a disease can be a major driver for urgency and vigilance with treatment follow-up
  3. Provider biases and pre-conceived notions Finally, physicians can also be impacted by racial bias, impacting the delivery of healthcare to racial minorities. Studies testing implicit association among physicians have found low to moderate levels of bias against racial minorities[4], and a public health study found 32% of Black Americans have reported being discriminated against when receiving healthcare treatment[5]. Although this bias may be unintentional, implicit bias from physicians negatively impacts patient behavior. A Journal of Family Practice study found patients who felt racial discrimination in a healthcare setting were less likely to follow physician recommendations and more likely to delay care[6]. Although many healthcare curriculums have developed to increase understanding of race-based impacts, negative impacts of bias on patient outcomes remain.

Health Equity Barriers to Patient Care

How can Kx Support Your Health Equity initiatives?

Research in Health Equity can be challenging. Understanding how to create a more equitable environment, and how to support underserved populations requires a nuanced and detailed approach to research supporting such initiatives. Kx Advisors helps clients frame research challenges using the patient pathway to understand where and how health equity initiatives should be targeted. To learn more about how Kx can support your Health Equity initiatives, contact Evelyn Tee at evelyn.tee@kxadvisors.com to learn more.

 

Contact Our Team Today

 

[1] McKinsey COVID-19 Consumer Survey as of June 8, 2020
[2] Akil L, Ahmad HA. Effects of socioeconomic factors on obesity rates in four southern states and Colorado. Ethn Dis. 2011;21(1):58-62.
[3] Common Wealth Fund: Medical mistrusts among Black Americans
[4] Sabin J, Nosek BA, Greenwald A, Rivara FP. Physicians’ implicit and explicit attitudes about race by MD race, ethnicity, and gender. J Health Care Poor Underserved. 2009;20(3):896-913. doi:10.1353/hpu.0.0185
[5] NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health, “Discrimination in America: Experiences and views of African Americans,” 2017, Figure 1.
[6] Blanchard J, Lurie N. R-E-S-P-E-C-T: patient reports of disrespect in the healthcare setting and its impact on care. J Fam Pract. 2004;53(9):721–30.

Key Insights & Takeaways: American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo

Posted on by Brian McNally, PhD

The Clinical Chemistry Annual Meeting did not disappoint with great attendance, engaging talks, and some innovative exhibits. After digesting all our notes (and a bit of Chicago’s finest culinary fare) from the busy week, we walked away with five key takeaways:

Innovative culture on display

If new products and technologies capture your attention, the Clinical Expo did not disappoint. Headlined by the Disruptive Technology Award winner, Nanopath, who led with a solid-state biosensing platform that removes the need for nucleic acid amplification. However, the Clinical Expo was full of new product launches, with some breaking new ground, such as Angle, plc with a system for harvesting cancer cells from patients’ blood for analysis. As expected, a stream of Monkeypox virus controls and assays were starting to be announced to address the now declared public health emergency. With promising innovations come questions about their ability to displace existing technologies, improve testing workflows, the size of addressable markets, and go-to-market plans. Members of the Kx team support clients by answering these types of questions every day and can assist you in thinking through how best to tackle these issues.

Still have VALID fears

On the heels of Europe having a regulatory shakeup in diagnostics (In-Vitro Diagnostic Medical Devices Regulation (IVDR) implementation), it seems likely the United States is about to follow suit with the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) coming to a vote in Congress as early as next month. With so many clinical laboratorians converging on the conference, we expected to hear various positions and forecasts. AACC organizers did an excellent job putting forward an update through a session titled “Valid Vital LDTs: Current State of Regulation Legislation of Laboratory-Developed Tests.” However, we are left with the impression several laboratorians are upset with the impact this legislation could have on their business. Kx Advisors is keeping a close eye on this legislation and will be providing an update as the situation evolves. Get in touch if you would like to be kept informed and up to date on the latest developments.

Tech influences testing

Algorithms, connectivity, and smartphones were highlighted not only on the main stage, but across the Expo floor. Artificial intelligence and machine learning were featured in Dr. George Church’s plenary session discussing how machine learning will support a laboratory’s desire for multiplex testing, simultaneously gathering anywhere from tens up to billions of data points. On the show floor, we saw several connectivity products and features on display falling into two basic categories. First, solutions, such as Planet Innovation’s NeoSync(TM) and BrightInsight’s Connected Diagnostics Platform, focus on flexible configurations that may integrate into existing or future medical devices. The second category leverages smartphones as a connectivity conduit, with applications spanning from mobile phlebotomy to test analysis for blood clotting, infectious disease and more. Implementation of connectivity and algorithm-driven testing schemes as either products or product attributes require a strong understanding of testing behaviors and user segmentation. Kx Advisors utilizes novel behavioral modeling, and environment/user segmentation frameworks to support prioritizing the ideal tech-enabled features and products.

Character matters

As an industry, we all watched the collapse of Theranos, and the subsequent convictions of Elizabeth Holmes and Ramesh Balwani on fraud charges. These events surfaced discussions on the intersection of startup culture and clinical diagnostics, public trust in laboratory medicine, and the role of government oversight. AACC organizers wisely “read the room” and highlighted a discussion on ethics and accountability with Theranos whistleblowers, Erika Cheung, and Tyler Shultz. As a part of the diagnostics community, I applaud the efforts of AACC to facilitate these discussions.

Thank you, Chicago!

Chicago offers more than hot dogs and pizza – If you read our previous post about the hot topics of AACC, Bob Serrano and I voted for our favorite Chicago signature foods. Well, thank you Chicago for some amazing food and great hospitality— even if we missed grabbing a dog.

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences or our key takeaways from the 2022 American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo. Contact Brian McNally, PhD brian.mcnally@kxadvisors.com.

Contact Our Team Today

Rare Disease Drug Development & Commercialization Learnings, Opportunities & Debates at World Orphan Drug Congress USA 2022

Posted on by Jenna Riffell, PhD

The Kx team attended the World Orphan Drug Congress (WODC) in Boston, MA last week and came away energized from three days of sharing ideas, inspirational stories, and panel discussions. This event brings together the full range of stakeholders who drive and support orphan drug development, regulatory approval, treatment delivery, and patient/caregiver support services. Here we discuss a few themes we heard across meetings and presentations:

Capturing the full market potential for a new orphan drug is a challenge; diagnosis and treatment gaps add to the unmet needs a new treatment needs to address

Repeatedly, newly approved treatments for rare diseases with a strong clinical profile (i.e., safe and effective) have not achieved the degree of adoption forecasted pre-launch. Why? With humility, drug developers acknowledged their own shortcomings in not building a comprehensive ecosystem of care for target patients, their caregivers, HCPs, and payers.

Unfortunately, there is no universal go-to-market (GTM) playbook for launching a treatment in an orphan indication; however, key questions to ask when GTM planning in rare diseases in have become clear:

  • What is the daily reality and emotional state of patients and caregivers?
  • What breakpoints exist in the patient journey, and how can we address those?
  • How can barriers to delivery be mitigated through just-in-time delivery infrastructure and treatment sites creation for gene therapies?
  • How should value be measured (to ensure access and coverage continuation)?

The term “beyond the pill” is still a popular idea, but there is a need to define what that means for meeting the needs of different patient, HCP, and payer populations. By establishing trusting, longitudinal relationships with the patients, caregivers, and HCPs they strive to serve, drug developers are successfully building tailored, comprehensive GTM strategies today for the next wave of orphan drug launches, building the foundation for “beyond the pill” to be more than a catchphrase. 

Value differentiation is best achieved through focus on simple, straightforward clinical endpoints

For over a decade, rare disease treatments have seen greater flexibility from regulators on primary endpoint designations than treatments for more prevalent indications; however, we consistently heard that leniency in clinical trial design may fade. Until now, drug developers could drive endpoints selection based on early trial results and carry these through to regulatory approval reviews. As noted by Simone Boselli, Public Affairs Director, EURODIS, during one of the panel discussions, too often today these endpoints are abandoned post-approval given challenges with continued tracking in real-world settings.

Going forward, drug developers should pursue greater prospective consideration and engagement to ascertain how regulatory bodies (FDA, EMA, health technology assessment (HTA) bodies) expect data packages to be constructed. Emphasis will be placed on using clinical endpoints that are simple to compare across studies by competing developers and straightforward to extrapolate to functional benefits for patients, as well as feasible to continue to measure in the real world as drug developers aim to build a real-world evidence base. In the future, drug developers presenting unique (rather than universally accepted) clinical endpoints may run into delays or rejections, costing time, revenue, and patient access to novel treatments.

Rare disease patients desire true partnership, including greater influence over the risk tolerance decisions and transparency on drug development setbacks

Appropriately, keynote presentation sessions often included patient advocates such as Allyson Berent, COO, GeneTx*, who shared her experience from her daughter’s Angelman Syndrome (AS) diagnosis at 6 months old. When she realized there were no approved treatments for the condition, she dedicated her time and energy to pursuing an effective treatment, ultimately becoming the Chief Science Officer of Foundation for Angelman Syndrome and co-founder of GeneTx.

(*note: GeneTx was acquired by Ultragenyx on 7/19/22)

We at Kx Advisors applaud the dedication of individuals, such as Allyson Berent, who work relentlessly to bring innovative therapies to patients. Also, we are telling her story here because her asks to industry were echoed by others at WODC:

  • Further elevate patients’ voices and requests – creating an ecosystem of care requires early and frequent patient input 
  • Consider that the risk-reward tolerance when patients are desperate for a lifeline may be different than industry’s view; many felt patients should have more influence on the calculus 
  • Increase transparency of critical feedback from the FDA to drug developers when reviewing clinical results, as patients are central to progress and deserve transparency on both advancements and setbacks; this sharing rarely occurs today, and collectively holds back innovation for the sake of competitive advantage

 

How Kx Can Help

Do you want to discuss further our takeaways from the World Orphan Drug Conference? Does your organization need to address specific challenges in rare disease asset planning and launch strategy? If so, please contact Brett Larson brett.larson@kxadvisors.com or Jenna Riffell at jenna.riffell@kxadvisors.com.

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Q&A with Kx: Spotlight on AACC 2022

Posted on by Bob Serrano

Q&A with Kx: Spotlight on AACC 2022

American Association for Clinical Chemistry (AACC)
2022 Annual Scientific Meeting & Clinical Lab Expo
July 24 -28, 2022
McCormick Place Convention Center
Chicago, Illinois USA

Before they head off to the Windy City for this year’s AACC Annual Scientific Meeting & Clinical Lab Expo, we asked Bob Serrano and Brian McNally for their insights on what they hope to learn, see, and are excited to discover at this year’s conference!

Q: What takes life science growth strategy consultants to the American Association for Clinical Chemistry Annual Meeting?

Bob: At Kx Advisors, we focus on partnering with life sciences clients to deliver actionable insights that fuel growth. Clinical diagnostics has always been a market with technical innovations, but now more than two years since the start of the COVID-19 pandemic, we see significant investments being made. Those investments are in a market where patients demand greater value from testing. Models that decentralize molecular diagnostics right into our homes or adding genome sequencing to doctor’s visits, are both examples of those new models. Conferences like AACC are a great venue for us to listen to various perspectives and share our own insights.

Brian: As a former bench scientist, I find myself drawn to new products and technologies. After all, new gadgets in clinical diagnostics hold the promise of a healthier future for all of us. With almost 300 new exhibitors since 2019, I’m excited to see the future of diagnostics in the lab and at home. So, you can expect to find me talking to exhibitors about their new study results and how they expect it will bring greater value to labs.

 

Q: What do you expect to be the hot topics in laboratory medicine?

Brian: While COVID testing is here to stay given the endemic-like nature of SARS-CoV-2, we see three outcomes of the pandemic impacting the labs. First, pandemic preparedness. We see this being tested with the spread of new SARS-CoV-2 variants as well as monkeypox. Second, advances in characterizing host-pathogen interactions, brings a new dimension to supporting clinical practice from diagnosis through treatment. Lastly, we expect labs will be sharing their perspectives on how to support patients with post-COVID syndromes.

Bob: I expect a hot topic for attendees will be what the inclusion of Verifying Accurate Leading-edge Development (VALID) into the Medical Device User Fee Amendments (MDUFA) will mean for innovation. VALID establishes a risk-based framework for in vitro clinical test (IVCT) regulation, which would give the FDA authority over LDTs (laboratory-developed tests). AACC has asked its membership to oppose VALID’s inclusion, while the industry group AdvaMed has endorsed VALID. So, while VALID’s language is not yet finalized, and there is a proposed five-year phase-in, we still expect to hear a lot from the Expo attendees on how VALID is going to impact them. Specifically, how will a risk-based regulatory structure be applied to new testing models that are less hypothesis-driven, and more proactive?

 

Q: What technologies do you see making headlines on the Expo floor?

Bob: While the headlines might be from earlier this year, the news surrounding decreasing costs of next generation sequencing will resonate with clinical laboratories. Costs are a key barrier to the recent push we see for comprehensive genomic profiling (CGP). At this past month’s American Society of Clinical Oncology meeting, Illumina hosted a networking event where a panel of clinicians shared case studies where CGP was transformational for the patient. The panelists went on to describe reimbursement as a barrier to adoption; so obviously, if costs keep decreasing, we could see CGP’s growth accelerate.

Brian: AACC does a fantastic job of providing some built-in technology headlines with the Disruptive Technology award. This year, there are three finalists who we expect will be getting a lot of attention moving forward. First, the Verita™ lab-on-a-chip platform by Biological Dynamics offers a nanoparticle-based isolation solution for streamlined multi-omic testing. This type of platform technology should garner broad appeal with biomarker discovery groups as well as assay developers. Next, Nanopath has focused their attention on women’s infectious diseases and looks to use their expertise in nanotechnology to offer a compelling physician office testing platform. Lastly, Visby Medical has launched a palm-size PCR testing platform for COVID and sexually transmitted infections. All these finalists are great representatives for the trends we have seen coming in the molecular diagnostic space, so now we need to find what’s next.

 

Q: What do you expect to share with your clients when you get back from the Meeting & Expo?

Brian: With COVID bringing diagnostic testing into our homes, we have all participated in the adoption of decentralized diagnostic testing. Now we are looking at the next wave of patient-focused testing, both in the home as well as distributed throughout the healthcare setting. The innovations we see coming are not only from the test technology, i.e., how fast can PCR be done, but how the tests fit into these new environments, and how they communicate with the broader healthcare system.

Bob: An event like AACC is a great way to share perspectives and gather experiences firsthand from the clinical laboratory. The insights I expect to share with our clients will then be focused on how laboratories are going to deliver value to patients. As an example, how can labs deliver greater clinical insights in a post-VALID environment? And what impact will greater competition in the genomics space have? So, we look forward to hearing perspective of the labs, the diagnostic developers and partnering with them to help identify the best way to help patients and clinicians.

 

Q: Last question for you both, Deep Dish Pizza or Chicago Dog?

Brian: Chicago Dogs for me. No way to pass up all those toppings.

Bob: Deep Dish all the way! More specifically, Deep Dish from Pizzeria Due, the original chain restaurant of Pizzeria Uno. This is the true pride and soul of Chicago. 🍕

 

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences (or the great pizza vs. hot dog debate of 2022), join us in Chicago for AACC Annual Scientific Meeting & Clinical Lab Expo.  Contact Bob Serrano bob.serrano@kxadvisors.com or Brian McNally, PhD brian.mcnally@kxadvisors.com

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