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As PBMs, payers, employers, and health systems increasingly adopt biosimilars to manage costs, it is critical to distinguish between two fundamentally different patient populations: treatment-naïve patients and stable patients on established therapy. While many biologic agents, both originators and biosimilars, are used across autoimmune diseases, ankylosing spondylitis (AS or SpA) presents unique risks when disease control is disrupted. AS is a chronic autoimmune disorder that primarily affects the spine and sacroiliac joints, causing progressive pain, stiffness, and structural damage; loss of control can result in irreversible spinal or hip fusion, severe chronic pain, and permanent, life-altering mobility impairment.<blockquote>This issue is not academic for me.</blockquote>I have ankylosing spondylitis and have been clinically stable on Humira (adalimumab) for three plus years — a stability achieved through evidence-based care and it has changed my life thanks to Brian Horgan, PA-C and AHN Rheumatology. Yet despite sustained disease control, I continue to face pressure to switch therapies from PBMs for non-medical reasons, reinforcing why advocacy grounded in clinical evidence matters for patients beyond my own experience.<h3>What the Evidence and Guidelines Say</h3>The 2019 American College of Rheumatology(ACR), Spondylitis Association of America(SAA), and Spondyloarthritis Research and Treatment Network (SPARTAN) guidelines provide a strong recommendation against mandated non-medical switching from originator TNF inhibitors to biosimilars in patients with stable ankylosing spondylitis.[1] This isn't about biosimilar efficacy — it's about the clinical risks of non-medical switching in patients who have achieved disease control.<h3>What the Data Shows:</h3><ul><li>The ABILITY-3 Trial showed 53% of patients who discontinue Humira (adalimumab) experience disease flare, and critically, 44% NEVER regain disease remission upon retreatment. This is real risk if the biosimiliar is ineffective [2]</li><li>Real-world studies demonstrate that non-medical switching is associated with reduced remission rates from 92.7% to 80.9%, with some biosimilars showing[3] 12-month drug survival rates as low as 73% compared to 90% for others [4]</li><li>Non-Medical switching increases total healthcare costs by ~$4,000 per patient per year, with healthcare resource utilization rising[5] 4-37% post-switch, potentially[6] offsetting any drug cost savings</li><li>Moreover, 80% of AS costs are work-related productivity losses — disease flares drive disability and employee absenteeism, not just medical expenses [7]</li></ul><h3>The Right Approach:</h3>✅ Biosimilars as first-line therapy in treatment-naïve patients supported by comparable efficacy data ✅ Biosimilars after treatment failure or intolerance = appropriate clinical indication with viable opportunity ❌ Mandated switching in stable patients introduces unnecessary clinical risk without clear benefit and risk “breaking” what is “fixed”<h3>A Call for Attention from the Stakeholders</h3>The goal should be sustainable cost management, not short-term drug cost reduction that increases downstream utilization. Shared decision-making between physicians and patients (not administrative mandates) should guide treatment decisions in stable patients.<h3>Key Stakeholders:</h3><ul><li>PBMs: Express Scripts Pharmacy Benefit Services, CVS Caremark, Optum Rx, Prime Therapeutics</li><li>Specialty Pharmacies: CVS Specialty, Walgreens Boots Alliance, Optum Specialty Pharmacy, Accredo Specialty Pharmacy, Amber Specialty Pharmacy, Avella Specialty Pharmacy, Senderra Specialty Pharmacy</li><li>Manufacturers: AbbVie, Amgen, Samsung Bioepis, Sandoz, Boehringer Ingelheim, Pfizer, Coherus BioSciences, Organon, Mark Cuban Cost Plus Drug Company, PBC&nbsp;</li></ul>I would like to give special commendation and recognition to Rightway Healthcare and Jordan Feldman, who are leading new disruptive PBM approaches and recognized a unique recognition path forward with exception in this disease state in their biosimilar strategy.<h3>Evidence-based formulary design should recognize that:</h3><ul><li>Treatment-naïve patients are ideal candidates for biosimilar initiation Stable patients on originator biologics face real clinical risks from non-medical switching</li><li>Total cost of care includes flares, work disability, and healthcare resource utilization</li></ul>The majority of US physicians (84%) oppose non-medical switching in stable patients, with concerns about treatment efficacy (57%), patient safety (53%), and mental health impacts (59%) especially in AS/SpA.[8]Let's align Payer and PBM policy with clinical evidence and guidelines. Biosimilars have an important role in healthcare, but that role should be defined by medical appropriateness, not blanket switching mandates in the absence of the full economic picture.<h2>References</h2>1. Ward MM, Deodhar A, Gensler LS, et al. <a data-mce-href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764882/" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764882/">2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis</a>. Arthritis &amp; Rheumatology. 2019.&nbsp;2. Landewé R, Sieper J, Mease P, et. al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/29961640/" href="https://pubmed.ncbi.nlm.nih.gov/29961640/">Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study.</a> Lancet. 2018 Jul 14;392(10142):134-144. doi: 10.1016/S0140-6736(18)31362-X. Epub 2018 Jun 29.3. Scrivo R, Castellani C, Mancuso S, et al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/35916302" href="https://pubmed.ncbi.nlm.nih.gov/35916302">Effectiveness of Non-Medical Switch From Adalimumab Bio-Originator to SB5 Biosimilar and From ABP501 Adalimumab Biosimilar to SB5 Biosimilar in Patients With Chronic Inflammatory Arthropathies: A Monocentric Observational Study</a>. Clinical and Experimental Rheumatology. 2023.&nbsp;4. Glintborg B, Loft AG, Omerovic E, et al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/30396903" href="https://pubmed.ncbi.nlm.nih.gov/30396903">To Switch or Not to Switch: Results of a Nationwide Guideline of Mandatory Switching From Originator to Biosimilar Etanercept. One-Year Treatment Outcomes in 2061 Patients With Inflammatory Arthritis From the DANBIO Registry</a>. Annals of the Rheumatic Diseases. 2019.&nbsp;5. Wolf D, Skup M, Yang H, et al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/28363696" href="https://pubmed.ncbi.nlm.nih.gov/28363696">Clinical Outcomes Associated With Switching or Discontinuation From Anti-TNF Inhibitors for Nonmedical Reasons</a>. Clinical Therapeutics. 2017.&nbsp;6. Liu Y, Skup M, Yang M, Qi CZ, Wu EQ. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/35737227" href="https://pubmed.ncbi.nlm.nih.gov/35737227">Discontinuation and Switchback After Non-Medical Switching From Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies From 2012 to 2018. </a>Advances in Therapy. 2022.&nbsp;7. Cooksey R, Husain MJ, Brophy S, et. al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/26185984/" href="https://pubmed.ncbi.nlm.nih.gov/26185984/">The Cost of Ankylosing Spondylitis in the UK Using Linked Routine and Patient-Reported Survey Data.</a> PLoS One. 2015 Jul 17;10(7):e0126105. doi: 10.1371/journal.pone.0126105. PMID: 26185984; PMCID: PMC4506082.8. Teeple A, Ellis LA, Huff L, et al. <a data-mce-href="https://pubmed.ncbi.nlm.nih.gov/30712393" href="https://pubmed.ncbi.nlm.nih.gov/30712393" data-mce-selected="inline-boundary">Physician Attitudes About Non-Medical Switching to Biosimilars: Results From an Online Physician Survey in the United States</a>. Current Medical Research and Opinion. 2019.&nbsp;

When Cost Savings Aren't Really Savings: The Hidden Economics of Non-Medical Switching in Ankylosing Spondylitis

<h2>Business Models That Health Systems Can Actually Adopt</h2>If adoption and utilization are the real measures of success, then business models must be designed to support them economically, not just clinically.The good news is that viable alternatives already exist. The more uncomfortable truth is that they require MedTech to move beyond the capital sales mindset that has defined the industry for decades.Across cardiac, imaging, orthopedics, and digitally enabled workflows, several commercial models are emerging that better align innovation with how providers actually operate and get paid. One of the reasons capital sales persist is that reimbursement logic has historically been anchored to hardware and technical fees. But when you map the full clinical and billing workflow, a different picture emerges. Software, AI acquisition, AI post-processing, and clinical interpretation already align more naturally to per-use and OpEx economics, even when hardware remains capitalized. The opportunity is not theoretical. It is already sitting inside the billing stack. The models that follow simply align MedTech economics to this reality.<ul><li>Flat subscription model:, often described as MedTech as a Service (MTaS) bundle hardware, software, maintenance, upgrades, and support into a predictable monthly fee. This approach works best in environments with stable volumes and a need for budget certainty. For health systems, the benefit is straightforward. Cost shifts from a large capital outlay to an operating expense that fits within annual budgets and cash flow planning. The tradeoff is inefficiency for low utilization sites, but adoption barriers drop immediately. This pattern is increasingly visible in platform-based offerings from <a data-mce-href="https://www.siemens-healthineers.com/" href="https://www.siemens-healthineers.com/">Siemens Healthineers</a>.</li><li>Pay-per-use or tiered utilization pricing ties fees directly to procedures, scans, or AI inferences, often informed by payer mix. This model aligns cost with reimbursement and significantly lowers upfront risk. More importantly, it reframes ROI in terms CFOs recognize. Instead of underwriting a multi-year capital bet, breakeven can be evaluated monthly or quarterly based on utilization. Connected device ecosystems such as those from <a data-mce-href="https://www.medtronic.com/" href="https://www.medtronic.com/">Medtronic</a>, <a data-mce-href="https://us2.ai/" href="https://us2.ai/">US2.ai</a>, and <a data-mce-href="https://www.ultromics.com/" href="https://www.ultromics.com/">Ultromics</a> illustrate how utilization-driven economics naturally incent adoption, workflow integration, and sustained use.</li><li>Hybrid outcome-linked models layer performance-based economics on top of OpEx pricing. A base operating fee covers fixed costs, while portions of payment are tied to adherence, utilization quality, or outcomes. These structures are more complex to contract and govern, but they create the strongest alignment with payers and providers. Platforms such as <a data-mce-href="https://www.dexcom.com/" href="https://www.dexcom.com/">Dexcom</a> demonstrate how outcomes, utilization, and recurring revenue can reinforce each other over time.</li><li>Other: <a data-mce-href="http://www.stryker.com" href="http://www.stryker.com">Stryker</a> is incorporating flexible payment and usage-aligned approaches that resemble MedTech-as-a-Service (MTaaS), though often framed as financial and service offerings rather than a pure subscription model. The company’s offerings include pay-per-use pricing and bundled service contracts that reduce upfront burden and better align cost with provider cash flow, signaling movement toward more utilization-friendly business models.</li></ul><h3>What unites these models is not pricing creativity, but rather alignment</h3>As adoption and utilization grow, contract value grows alongside provider volume. Recurrent revenue expands in a way that fits naturally into provider revenue cycles rather than fighting them. The relationship shifts from transaction to partnership, and lifetime value compounds instead of peaking at install. Instead of asking a system to underwrite a seven-figure purchase with a multi-year payback, the breakeven conversation moves to a monthly or quarterly horizon. For example, if a health system generates eight hundred dollars in reimbursement per scan and pays one hundred dollars per scan for technology and services, breakeven may occur at fifteen to twenty incremental procedures per month. That math fits naturally into operating reviews, not capital committees.As adoption and utilization grow, something important happens - the long-term contract value grows with it over the life of the contract...perhaps to 2-3X the CapEx contract value. Revenue scales alongside provider volume rather than being fixed at install. The partnership deepens because the vendor is now incented to support workflow integration, training, and sustained use. Recurrent revenue expands without breaking the provider’s back because it backs directly into their native cash-flow cycle and accounts receivable timing.<h3>AI software accelerates the need for this shift</h3>When AI is decoupled from hardware, it can be priced per use or bundled flexibly across departments and sites. Early adopter agreements increasingly include data sharing and evidence generation clauses. Low-risk pilots generate real-world data. That data supports coverage, coding, and reimbursement conversations. As reimbursement evolves, utilization increases and the economic flywheel turns faster.Legacy equipment does not disappear in this transition. Much of the installed base remains clinically functional. In many cases, SaMD overlays, retrofits, or grant-supported modernization provide a more realistic path than full replacement. Capital barriers drop. Utilization rises and innovation advances without forcing disruptive capital resets.<h3>Table 1: What Business Model Evolution May Look Like&nbsp;</h3><table border="1" data-mce-style="border-collapse: collapse; width: 100%; margin-left: auto; margin-right: auto;" style="border-collapse: collapse; width: 100%; margin-left: auto; margin-right: auto;"><tbody><tr><td style="width: 19.9981%;">Component</td><td style="width: 19.9981%;">MedTech Current State</td><td style="width: 19.9981%;">MedTech Future State</td><td style="width: 19.9981%;">How Providers Get Paid</td><td style="width: 20.0073%;">Why This Matters</td></tr><tr><td style="width: 19.9981%;">Core Hardware / Devices</td><td style="width: 19.9981%;">Large upfront capital or lease sale</td><td style="width: 19.9981%;">Capital remains, but decoupled from software and AI value</td><td style="width: 19.9981%;">Paid per procedure regardless of device age</td><td style="width: 20.0073%;">Capital risk sits fully with the provider</td></tr><tr><td style="width: 19.9981%;">Core Platforms (PACS, RIS, VNA)</td><td style="width: 19.9981%;">Annual licenses tied to installs or users</td><td style="width: 19.9981%;">Fees tied to active use and uptime</td><td style="width: 19.9981%;">Included in procedure payment</td><td style="width: 20.0073%;">Software cost disconnected from utilization today</td></tr><tr><td style="width: 19.9981%;">Clinician Interpretation</td><td style="width: 19.9981%;">---</td><td style="width: 19.9981%;">---</td><td style="width: 19.9981%;">Paid per case (professional fee)</td><td style="width: 20.0073%;">Revenue already scales with volume</td></tr><tr><td style="width: 19.9981%;">AI for Image Capture</td><td style="width: 19.9981%;">Bundled into capital purchase as a feature</td><td style="width: 19.9981%;">Per-use or tiered utilization pricing</td><td style="width: 19.9981%;">Paid per case or add-on (if CPT/HCPCS code available)</td><td style="width: 20.0073%;">Forces measurement of adoption and workflow value</td></tr><tr><td style="width: 19.9981%;">AI for Post-Processing &amp; Insights</td><td style="width: 19.9981%;">Embedded in capital price with no usage tracking</td><td style="width: 19.9981%;">Utilization- or outcome-based OpEx</td><td style="width: 19.9981%;">Paid per case or add-on (if CPT/HCPCS code available)</td><td style="width: 20.0073%;">Aligns revenue to clinical and economic impact</td></tr></tbody></table><h3>None of these models are margin neutral</h3>They trade short-term certainty for long-term durability. They require diligence and investment in product metadata infrastructure, cloud and data governance strategy, compliance, transparent service-level agreements, HEOR capabilities, and new sales and finance operating models.What they unlock is worth it. Predictable recurring revenue. Contracts whose lifetime value grows as adoption grows. Deeper provider trust. And partnerships built on shared success rather than one-time transactions.The next decade of MedTech will not be won by shipping more features. It will be won by aligning innovation with how care is actually paid for and sustained.<blockquote>"Installed Base" ends at install. "Adoption and utilization" compound over time and land in brand partnership capital.</blockquote><h3>Connect to Compare Notes</h3>If you are a MedTech leader rethinking capital sales, utilization-based models, enterprise transformation and how to better align innovation with incumbent cash flow models in the healthcare value , I am actively comparing notes. Always open to thoughtful collaboration and leadership conversations. Grab some time to connect <a data-mce-href="https://zcal.co/erikabel" href="https://zcal.co/erikabel">here</a>.

Part 4 | Capital Sales: MedTech’s Business Model and Growth Problem

<h2>From "Installed Base" to "Adoption &amp; Utilization"</h2>If Parts 1 and 2 of this series explain why health systems cannot buy innovation, the next question is more uncomfortable.&nbsp;<blockquote>What happens when MedTech accepts that "installed base" is no longer the right success metric?</blockquote>Installed base measures what was sold. It says nothing about whether technology is adopted, consistently used, or economically relevant in delivering value. In today’s environment, that distinction matters more than ever.<h3>Adoption and utilization are where value is created or lost.</h3>When technology is installed but rarely used, health systems risk seeing sunk cost, not transformation. When AI is deployed as a pilot but never scaled, evidence generation stalls and confidence erodes. When utilization lags, reimbursement enablement conversations never mature. Innovation quietly dies without ever being rejected outright.This shift forces MedTech to confront something deeper than pricing. It requires a change in mindset across commercial, finance, and leadership teams and a shift in identity from "Vendor" to "Partner".The traditional CapEx model rewards placement. Sales teams were optimized to close transactions. Finance teams were optimized around one time revenue recognition. Once the equipment is installed, success is largely assumed.That model does not survive an environment where capital is constrained and value must be demonstrated continuously.<ul><li>Adoption and utilization based models demand different capabilities. Financial leaders must understand recurring revenue, utilization ramps, and forecasting under variability. They must also understand how cash actually flows through health systems, including payer mix, revenue cycles, and accounts receivable timing.</li><li>Sales incentives must evolve as well. Compensation structures that reward one time placements reinforce the very behavior that is now failing. In contrast, models that reward retention, utilization growth, training adoption, and multi year value creation change how teams engage customers.</li></ul><h3>This is not a minor operational tweak. It is a talent and leadership shift.</h3>Historically, the CapEx model does not require deep understanding of provider economics. That era is ending. MedTech leaders who are unwilling to evolve their financial and commercial thinking will find themselves optimizing a model that no longer scales.<blockquote>"If you do not like change, you will like irrelevance even less." - Eric Shinseki&nbsp;</blockquote>In the final part of this series, I will look at what can actually work in practice and which commercial models are proving capable of aligning innovation with how care is paid for.

Part 3 | Capital Sales: MedTech’s Business Model and Growth Problem

<h2>A "Click" Deeper into the CapEx Model Mismatch in MedTech&nbsp;</h2>Health systems are often framed as slow adopters of innovation. That narrative misses the more important question: where capital dollars are actually going.Post-2020, capital inside health systems has become defensive. Leaders are prioritizing what keeps the enterprise operational before they fund what makes individual pieces of equipment marginally better. IT modernization, cybersecurity, EHR optimization, infrastructure, and workforce stabilization now compete directly with traditional MedTech purchases for scarce capital.In that environment, “better technology” is not enough.At the same time, most imaging, cardiac, and procedural upgrades arrive with no meaningful change in CPT, HCPCS, or FFS reimbursement. The clinical capability may improve, but the economic signal does not. If reimbursement does not move, margin does not move. If margin does not move, capital does not follow.This creates a structural disadvantage for innovation sold as CapEx. Even when a new system offers incremental efficiency or intelligence, the financial case often depends on future promises rather than present economics. Finance leaders are asked to underwrite risk without a clear path to return.The mismatch deepens when vendors expect large upfront payments while providers collect revenue on 30- to 90-day accounts receivable cycles. Cash timing is misaligned before value is proven. Evidence that upgrades materially improve throughput, staffing ratios, or downstream outcomes is frequently thin, delayed, or highly site-specific.From a health system perspective, the choice becomes clear. Preserve capital for enterprise risk and stability, or deploy it on equipment upgrades that do not change reimbursement and may not materially change operating performance.The outcomes are predictable.<ul><li>Purchases are deferred.</li><li>Technology that is acquired is underutilized. </li><li>Pilots dry up and HEOR remains unproven.</li><li>MedTech revenue becomes cyclical and boom-bust.</li></ul>This is not a failure of innovation.It is a failure of economic alignment and business model innovation. It is not just a matter of where does my solution fit in the value chain, but also how does it fit and align to my client business model, site of care and cash flow process.Health systems are not rejecting technology. They are rejecting risk without return. Without a clear, credible path to adoption and sustained utilization that aligns with how care is paid for, even objectively good technology will struggle to scale.In the next part of this series, I’ll explore what happens when MedTech shifts its success metric from installed base to adoption and utilization and why that shift forces a fundamental change in commercial models, financial leadership, and incentives.

Part 2 | Capital Sales: MedTech’s Business Model and Growth Problem

<h2>Why Health Systems Aren’t ‘Sold’ on MedTech Innovation</h2>MedTech continues to ship smarter, more capable technology, yet adoption keeps stalling inside health systems that actually want innovation. The problem isn’t clinical value. It’s that most innovation is still packaged in business models that collide with constrained capital, flat reimbursement, and rational CFO decision-making. This series examines why that mismatch persists and what has to change if innovation is going to move beyond the demo.MedTech doesn’t have an innovation problem. It has a business model innovation problem. It is stuck in the inertia of CapEx mentalities and transactional sales.We keep seeing feature-laden devices, AI-enabled upgrades, and increasingly sophisticated capabilities, then act surprised when health systems hesitate. Clinicians may see promise, but buying decisions are not made in the reading room or the cath lab. They are made in finance offices, capital committees, and budget reviews.Most MedTech innovation is still sold through large upfront capital purchases into organizations operating on three- to five-year contract cycles, with limited capital flexibility and reimbursement structures that rarely reward incremental improvement. If the legacy equipment works and reimbursement does not change, the “upgrade” is simply additional cost.Even AI SaMD often falls into the same trap. Instead of changing the economic equation, it is frequently buried into the bundled CapEx price. Sales teams and leadership talk about creativity and differentiation, but ultimately fall back on the same crutch: capital sales.In that context, the client's decision not to buy is not conservative. It is rational.Capital dollars inside health systems are being pulled toward what keeps the enterprise functioning: IT modernization, cybersecurity, EHR optimization, facilities, and workforce stabilization. Against those demands, feature-rich equipment with no clear economic upside struggles to compete, regardless of how impressive the technology may be.The result is predictable. Shiny new systems become financial liabilities instead of levers. Sales cycles extend. Market adoption slows. Utilization lags. Evidence generation stalls. Innovation stops at the hospital door.The market signals are already clear. When more than half of an installed base is 10–15 years old and customers are not investing in new, feature-laden replacements, the right question is not “why aren’t they innovating?” It is “why doesn’t this innovation clear the CFO’s bar?”Sit across from the client's CFO and the simple, but powerful questions come fast:<ul><li>What is the reimbursement and margin if we continue using our existing, functional assets?</li><li>What incremental reimbursement or margin does this new system, AI, or upgrade actually unlock?</li><li>Is there credible evidence it improves staffing efficiency or resource utilization versus today?</li><li>Does it move durable metrics like quality, safety, length of stay, or outcomes?</li></ul>The answers are often uncomfortable.Reimbursement is largely unchanged, with little CPT, HCPCS, or FFS upside. Existing equipment remains functional. Excitement about features and future use cases is replaced with hard evidence. And then, silence.This cycle repeats while budgets tighten and confidence in long-term device and AI roadmaps remains too shaky to justify major capital risk. The result is familiar: feature-laden solutions sitting idle, pilots that never scale, and inventions that fall short of their promised impact.To healthsystems, these new feature-rich devices and AI SaMD become cost centers rather than revenue drivers. AI and devices get installed “to test,” but adoption stalls and utilization never materializes. Sales cycles stretch. Innovation once again stalls at the health system front door.This is not resistance to change. It is disciplined financial decision-making.It is also a failure to fully understand the customer’s business model, revenue cycle, and cash-flow reality.For too long, MedTech has treated "Installed Base" as a commercial proxy for success. In today’s environment, that metric is at best an incomplete&nbsp;"Leading Metric" and at worst misleading regarding commercial success. What matters is whether technology is adopted, used, and sustained in a way that delivers value and aligns with how care is actually paid for.Installed base tells you what was sold. Adoption and utilization tell you whether innovation survived reality.In the next part of this series, I’ll examine where health system capital is actually going and why “better technology” alone is no longer enough to win it back.

Part 1 | Capital Sales: MedTech’s Business Model and Growth Problem

<h2>Introduction</h2>Eosinophilic esophagitis (EoE) is a chronic immune-mediated inflammatory disorder of the esophagus with a growing population impact. Prevalence estimates range from 13 to 49 cases per 100,000 people globally, with substantially higher rates reported in the United States at approximately 26 to 163 cases per 100,000 individuals.(1-3) This epidemiology makes clear that EoE is no longer a niche diagnosis. It is a common chronic disease with meaningful implications for patients, families, and the healthcare system.The scientific foundation for EoE diagnosis and treatment is strong. The challenge is not evidence quality. The challenge is that the way EoE care is delivered often imposes a level of burden that many patients cannot realistically sustain.As a clinician, a patient with EoE for more than 20 years, and a parent of a child with EoE, I see a growing divide between what guidelines recommend and what patients can realistically sustain. The issue is not the quality of the evidence. The issue is whether the current care model is operationally feasible for families navigating months of dietary restriction, serial sedated endoscopies, and constant lifestyle adjustment. Bridging that gap requires preserving rigor while rethinking how care is sequenced, monitored, and personalized.<h3>Clinical Burden Across the Lifespan</h3>EoE presents differently across age groups, but disease burden is substantial throughout life. Adults most commonly experience dysphagia, food impaction, and chest discomfort, while children often present with feeding difficulties, vomiting, abdominal pain, and impaired growth.(4,5) Across all ages, EoE is strongly associated with atopic comorbidities including asthma, allergic rhinitis, atopic dermatitis, and food allergy.(4,5)Treatment typically includes dietary elimination or elemental diets, proton pump inhibitors (PPIs), swallowed topical corticosteroids (STCs), and procedural interventions such as endoscopic esophageal dilation for fibrostenotic disease.(6,7) Swallowed topical corticosteroids have demonstrated greater effectiveness at inducing clinical and histologic remission compared with PPIs and are recommended over systemic corticosteroids because of superior safety profiles.(6,7)Despite these options, disease control frequently requires prolonged therapy, iterative adjustments, and objective monitoring over months to years.<h3>The Cost of the Current Care Model</h3>Real-world insurance claims data quantify what patients and clinicians experience anecdotally. In a large U.S. retrospective analysis, individuals with newly diagnosed EoE incurred significantly higher all-cause healthcare costs than matched controls both before and after diagnosis. Mean per-patient costs exceeded ten thousand dollars annually at baseline and rose to more than fifteen thousand dollars during follow-up, representing several-fold higher costs than individuals without EoE.(8)Cost burden varies meaningfully by age. Annualized EoE-related healthcare costs during follow-up were highest among pediatric patients and adolescents, with mean expenditures exceeding five thousand dollars per year.8 In these populations, outpatient encounters, physician office visits, and pharmacy utilization were the primary cost drivers. In adults, EoE-related costs were driven predominantly by inpatient admissions and ambulatory surgical center visits, reflecting greater reliance on procedural care.(8)These findings reflect routine clinical practice rather than controlled trial environments and reinforce that current EoE care pathways are resource-intensive across the lifespan.<h3>The Problem Is Not Efficacy…. It Is Feasibility</h3>Empiric elimination diets are highly effective. The six-food elimination diet achieves histologic remission in 61 to 73 percent of patients, while less restrictive two-food or four-food approaches achieve remission in 43 to 54 percent.(9,10) These outcomes justify their central role in clinical guidelines.Yet long-term adherence remains poor. Discontinuation rates approach 40 to 50 percent in both adult and pediatric populations.(9,10)&nbsp; The drivers are consistent. Broad dietary restriction, increased food costs, family burden, social disruption, nutritional complexity (food labeling), health literacy and the requirement for repeated endoscopic confirmation of response.For many patients, particularly families managing pediatric disease, a broad empiric elimination is not simply challenging. It is not realistic.<h3>The Monitoring Burden Drives Attrition</h3>Because symptoms correlate poorly with histologic activity, EoE management relies on objective monitoring.(4,5) Serial endoscopy has been the standard. While scientifically justified, this approach contributes substantially to procedural fatigue, cost, and care discontinuation.Esophageal string testing (EST) offers a validated, minimally invasive alternative for monitoring and surveillance (see Enterotrack). EST correlates strongly with histologic disease activity, with an area under the curve of 0.83 and sensitivity and specificity near 80 percent.11 Pediatric data demonstrate high completion rates and fewer required endoscopies when EST is incorporated into care.(12) Despite this, adoption remains limited, driven largely by reimbursement, payer adoption and workflow barriers rather than evidence gaps.(11,12)Integrating EST into routine monitoring represents a clear opportunity to reduce procedural burden while maintaining objective disease assessment.<h3>Where Sensitivity-Based Elimination Fits</h3>Allergy and gastroenterology societies appropriately caution against using IgG or IgG4 testing as diagnostic tools for food allergy.(6,7) Aside from managing provider ordered tests, groups like <a data-mce-href="https://www.everlywell.com/" href="https://www.everlywell.com/">EverlyWell</a> offer food sensitivity testing as an at-home IgG/IgG4<a data-mce-href="https://www.everlywell.com/products/food-sensitivity-comprehensive-test/" href="https://www.everlywell.com/products/food-sensitivity-comprehensive-test/"> Food Sensitivity Test</a>, which checks your blood for IgG antibodies to potentially triggering foods. Mediator release testing such as <a data-mce-href="https://www.nowleap.com/mrt-iii-the-future-of-food-sensitivity-testing/" href="https://www.nowleap.com/mrt-iii-the-future-of-food-sensitivity-testing/">MRT-LAA</a> by <a data-mce-href="https://www.nowleap.com/" href="https://www.nowleap.com/">Oxford Laboratories</a> is not addressed in current EoE guidelines and lacks direct EoE-specific validation.(6,13) These limitations are real and should be acknowledged.However, absence of diagnostic precision does not equate to absence of potential clinical utility in all contexts. This presents the scenario where sometimes, staunch clinicians take firm stances against such testing and reinforce the only option as empiric elimination diets. &nbsp;Unfortunately, these stances lead to disengaged patients that look elsewhere for answers and a missed opportunity for listening to the patient and family to develop a pragmatic and guided plan.Emerging evidence demonstrates that food-specific IgG4-guided elimination yields histologic remission in approximately 45 percent of adults with EoE.(14) Combined tissue IgG4 and peripheral T-cell assays show moderate accuracy, ranging from 53 to 75 percent, in identifying likely food triggers.(6) Standard allergy test-based diets continue to show modest predictive value and variable response rates.(13,15)In patients for whom broad empiric elimination is not feasible, sensitivity-based approaches can function as hypothesis-generating tools. When framed appropriately, IgG4 or MRT-LAA patterns may help prioritize a smaller set of foods for initial elimination – as steps towards feasible change management. Results should be communicated as signals rather than proof and applied within a step-up framework that escalates only if inflammation persists.This shifts the clinical question from “What can we definitively prove?” to “Where should we reasonably start for this patient?”<h3>A Hybrid Model That Balances Rigor and Real-World Reality</h3>A sustainable and patient-centered EoE care model can preserve guideline-based rigor while reducing unnecessary burden:<ol><li>Confirm diagnosis with endoscopy and histology(4,5)</li><li>Complete a twelve-week high-dose PPI trial(6)</li><li>Use empiric elimination when it is truly feasible and acceptable to the patient(9,10)</li><li>When empiric elimination is not feasible, apply sensitivity-based targeted elimination using IgG4 or MRT-LAA as adjunctive tools(6,14)</li><li>Incorporate EST for interim monitoring to reduce reliance on serial sedated endoscopy(11,12)</li><li>Apply a step-up philosophy to dietary escalation(9,10)</li><li>Reserve endoscopy for diagnosis, confirmation of remission, and discordant clinical scenarios&nbsp;</li></ol>This framework respects the hierarchy of evidence while acknowledging patient capacity, cost, and adherence as determinants of success.<h3>Why This Matters</h3>EoE is a lifelong condition. The science has matured, but delivery has not. Real-world data show that current care pathways carry substantial economic and procedural burden, particularly for children and families.(8) When patients disengage because care is unsustainable, outcomes suffer regardless of therapeutic efficacy. They disengage on treatments, the repeated endoscopies and also pursue alternatives for including food sensitivity testing all while attempting to develop a reasonable dietary plan. Why not embrace the journey and align on tests that may reasonably guide the patient, develop a monitoring that is less costly and burdensome. The elephant not yet on the table and underappreciated, is that elimination diets and their maintenance likely far exceed the medical costs that have been contemplated in the literature.Thus, advancing EoE care will require broader adoption of noninvasive monitoring, rigorous evaluation of sensitivity-based elimination as an alternative entry point, greater investment in nutrition support, and reimbursement models that reward high-value care rather than procedural volume.We can preserve the science while modernizing the experience and that evolution is overdue.<h3>A Practical Call to the Field</h3>For healthcare researchers, clinicians, professional societies, payers, and innovators working in EoE, there is significant value in observing how patients and families navigate this disease outside the clinic. Online peer-support communities provide unfiltered insight into where current care pathways break down, where guidance is insufficient, and where patients struggle to translate recommendations into daily life.Two such communities offer a particularly clear window into the lived experience of EoE:<ul><li><a data-mce-href="https://www.facebook.com/share/g/17pBz8eUab/?mibextid=wwXIfr" href="https://www.facebook.com/share/g/17pBz8eUab/?mibextid=wwXIfr">Facebook EoE Support Group</a></li><li><a data-mce-href="https://www.reddit.com/r/EoEsupport/s/41cjA0B5QO" href="https://www.reddit.com/r/EoEsupport/s/41cjA0B5QO">Reddit EoE Support Community</a> &nbsp;</li></ul>Reviewing these discussions offers insights into recurring gaps in patient education, diet implementation, monitoring strategies, and longitudinal support. For those committed to improving outcomes in EoE, these communities represent an important source of insight into real-world needs and opportunities to evolve how care is delivered.Advancing EoE care will require collaboration across gastroenterology, allergy, pediatrics, nutrition, and patient advocacy. Organizations such as American College of Gastroenterology, American Gastroenterological Association, NASPGHAN, American College of Allergy, Asthma and Immunology (ACAAI), and APFED are uniquely positioned to help close the gap between guideline intent and real-world experience. As EoE therapies advance, manufacturers such as Sanofi, Regeneron, Takeda, and others have an opportunity to lead not only on efficacy, but on feasibility, adherence, and real-world care delivery.<h3>References</h3><ol><li>Hirano I, Chan ES, Rank MA, et al. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters Clinical Guidelines for the Management of Eosinophilic Esophagitis. Gastroenterology. 2020;158(6):1776-1786.</li><li>Muir A, Falk GW. Eosinophilic esophagitis: a review. JAMA. 2021;326(13):1310-1318.</li><li>Dellon ES, Muir AB, Katzka DA, et al. ACG clinical guideline: diagnosis and management of eosinophilic esophagitis. Am J Gastroenterol. 2025;120(1):31-59.</li><li>Muir A, Falk GW. Eosinophilic esophagitis: a review. JAMA. 2021;326(13):1310-1318.</li><li>Dellon ES, Muir AB, Katzka DA, et al. ACG clinical guideline: diagnosis and management of eosinophilic esophagitis. Am J Gastroenterol. 2025;120(1):31-59.</li><li>Molina-Infante J, Lucendo AJ. Dietary therapy for eosinophilic esophagitis. J Allergy Clin Immunol. 2018;142(1):41-47.</li><li>Hirano I, Chan ES, Rank MA, et al. Gastroenterology. 2020;158(6):1776-1786.</li><li>Xu X, Maslova E, Kielar D, et al. Characteristics, treatment patterns, healthcare resource utilization, and costs in patients with eosinophilic esophagitis in the United States: a retrospective analysis of insurance claims data. Ther Adv Gastroenterol. 2025;18:1-20. doi:10.1177/17562848251391090.</li><li>Mayerhofer C, Kavallar AM, Aldrian D, et al. Efficacy of elimination diets in eosinophilic esophagitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2023;21(9):2197-2210.e3.</li><li>Molina-Infante J, Lucendo AJ. J Allergy Clin Immunol. 2018;142(1):41-47.</li><li>Al Abdulqader AK. Advances in diagnostic techniques for eosinophilic esophagitis: a systematic review of emerging noninvasive methods. Eur J Med Res. 2025;30(1):924.</li><li>Quinn LA, Andrews R, Bauer M, Nguyen N. Utilization and impact of esophageal string testing in children with eosinophilic esophagitis: a 1-year experience. J Pediatr Gastroenterol Nutr. 2024;79(3):631-635.</li><li>Pitsios C, Vassilopoulou E, Pantavou K, et al. Allergy-test-based elimination diets for the treatment of eosinophilic esophagitis: a systematic review of their efficacy. J Clin Med. 2022;11(19):5631.</li><li>Lim AHW, Ngoi B, Perkins GB, et al. Outcomes of serum food-specific immunoglobulin G4 to guide elimination diet in patients with eosinophilic esophagitis. Am J Gastroenterol. 2024;119(6):1066-1073.</li><li>Visaggi P, Mariani L, Pardi V, et al. Dietary management of eosinophilic esophagitis: tailoring the approach. Nutrients. 2021;13(5):1630.</li></ol>

Modernizing Eosinophilic Esophagitis Care: When Evidence Meets Real-World Feasibility

Erik Abel

Thought Leader Portfolio (clean hero, blog, and about).

Erik Abel is a healthcare strategist and operator bridging clinical, payer, and MedTech ecosystems to scale AI and digital health solutions that improve access, outcomes, and profitability across fee-for-service, hybrid, and value-based models. With over two decades of leadership translating innovation into reimbursable, market-ready solutions—including a nine-figure acquisition, nationwide diagnostic deployment, and measurable payer adoption—he is recognized for advancing healthcare innovation and commercial growth through research, thought leadership, and advisory work that converts complex care, technology, and policy environments into sustainable value across the healthcare continuum.


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